JUNE SMARTER BUSINESS. BETTER PATIENT CARE ... · Kenneth Bowden, CHBC Berkshire Professional...
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Medical Economics LEVERAGE YOUR VALUE: HOW TO NEGOTIATE NARROW NETWORKS ■ FATE OF THE ACA ■ CME: GET THE MOST FOR YOUR MONEY JUNE 10, 2016 Fate of the ACA What a new president could mean SMARTER BUSINESS. BETTER PATIENT CARE. MedicalEconomics.com JUNE 10, 2016 VOL. 93 NO. 11 L EVERAGE YOUR VALUE CME Get the most for your money High deductibles Balancing cost and care
Transcript of JUNE SMARTER BUSINESS. BETTER PATIENT CARE ... · Kenneth Bowden, CHBC Berkshire Professional...
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Fate of the ACA What a new president could mean
SMARTER BUSINESS. BETTER PATIENT CARE. MedicalEconomics.com JUNE 10, 2016 VOL. 93 NO. 11
LEVERAGEYOUR VALUE
CMEGet the most
for your money
High
deductiblesBalancing
cost and care
MedicalEconomics.com MEDICAL ECONOMICS��]��JUNE 10, 2016 5
FIRST TAKE
troubling new study about the “unhealthy behaviors” of millions of Americans documented a reality that has increas-
ingly become all too familiar to me and the 209,000 other primary care physi-cians in the United States.
More than 25 million adults have at least three behaviors that inevita-bly lead to poor health. Because we stand at the vanguard of medical care, primary care doctors can’t help but see patients every day who smoke, drink too much, don’t get enough sleep, don’t exercise or are obese.
Th e health consequences are sig-nifi cant. Th e study, conducted by the United Health Foundation and released in partnership with Family Medicine for America’s Health, found that adults who report having three or more of fi ve unhealthy behaviors are at more than six times as great a risk of fair or poor health than those reporting none.
It gets worse for those reporting all fi ve: an 8.5 times greater risk for heart disease and other chronic conditions linked to morbidity and mortality. Even adults who say they have only one unhealthy behavior are twice as likely to be at risk than those with none.
While it may be common sense that more unhealthy behaviors add up to greater odds of poor health, this study is the fi rst to quantify the impact. For me, it drives home just how impor-
tant behavior is to health and should help those of us in medical practice communicate more eff ectively with our patients about the risks to their health.
We’re in the best position in the healthcare universe to help the 72% of American adults with these behaviors. We know it because our calling, indeed our professional responsibility, is to manage all aspects of our patients’ health—mental and physical—and not just each in isolation.
Th at includes taking action to reduce the prevalence of unhealthy behaviors and motivate our patients to take better care of themselves.
Th is is nothing new. From the earli-est days of our nation’s history, doctors serving rural and small-town America knew their patients well and cared for entire families, doing it all from treating illness to delivering babies and comforting the dying.
In urban America, primary care is no less important today than it was then. Margaret Chan, MD, director-general of the World Health Organiza-tion (WHO), underscored the point when, in a speech in 2013, she said, “a health system where primary care is the backbone and family doctors are the bedrock delivers the best health outcomes, at the lowest cost and with the greatest user satisfaction.”
Yes, Chan says, we need specialists and hospitals, but we “must also have
primary care doctors who care about prevention…doctors who know their patients long enough and well enough to truly manage the totality of health in all its multiple dimensions, includ-ing mental and spiritual needs.”
For far too long, America’s health-care system has been woefully out of balance—a system too often driven by volume over value. To reverse the trend, we need to build a system with the single-minded focus on improving patient health and increasing access to primary care. Improved access will help solve many of our nation’s healthcare problems by helping people live longer and healthier lives and by delivering better quality at a lower cost.
Just by increasing the number of primary care physicians, studies sug-gest we can save more than 127,000 lives a year in the U.S., because in places around the country where there are more primary care provid-ers per capita, death rates for cancer, heart disease and stroke are lower and people are less likely to end up in the hospital.
Today, the role of primary care physicians in building a strong rela-tionship with their patients has never been more essential.
Glen Stream, MD is a family physician in La Quinta, California, and president of Family Medicine for America’s Health.
A
It’s up to physicians to combat bad patient behavior
BY GLEN STREAM, MD
Dealing with high deductibles PAGE 34READ MORE INSIDE
MEDICAL ECONOMICS��]��JUNE 10, 2016 MedicalEconomics.com6
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THE LAST WORD
PAGE 73
The GOP doctors caucus’ 2016 plans From opioid abuse to electronic health records, Republican doctors in Congress have big plans for 2016, writes Joseph Burns
IN EVERY ISSUE
9 Our advisers
10 Interactive
14 Your voice
17 Vitals
72 Advertiser index
32 MIPS and small practices Independent practices likely to face
penalties early on
33 Transition of care management How timing determines whether you
are paid or not
34 The deductible dilemma Rising deductibles change the way
patients approach healthcare
41 Make population health work Managing patient panels requires the
right practice tools
51 The new Meaningful Use Meet the new EHR program, (sort of)
same as the old EHR program
52 HIPAA compliance A step-by-step approach to managing
patient data risk
54 The fate of the ACA What president Trump or Clinton (or
Sanders) would do to health reform
58 Medical malpractice Should you hire private counsel?
Weighing the pros and cons
60 Medicare overpayments What new rules about paying back
Medicare mean for physicians
65 CME on a budget Squeeze your medical education
budget to take you further
Leverage your valueHow to negotiate narrow networks
PAGE 22
VOLUME 93 ISSUE 11JUNE 10, 2016
MEDICAL ECONOMICS��]��JUNE 10, 2016 MedicalEconomics.com8
SOURCES GUIDE TO THE ACTIVITY OF YOUR COLLEAGUES IN THIS ISSUE
“If you can’t explain it, the government fills in their own explanation.”MARK SILBERMAN, JD, HEALTHCARE ATTORNEY
PAGE 60
of physicians in a survey said patients had delayed
treatment due to high costs
PAGE 34
70%Plans still
have to go out and get the physicians they need, so they can’t create a network that’s unsustainable.”ANDERS GILBERG, SENIOR VICE PRESIDENT, MGMA
PAGE 22
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REPATHA® (evolocumab)
BRIEF SUMMARY OF PRESCRIBING INFORMATION
Please see package insert for full Prescribing Information
1. INDICATIONS AND USAGE
1.1 Primary Hyperlipidemia
REPATHA is indicated as an adjunct to diet and maximally tolerated statin therapy for
the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or
clinical atherosclerotic cardiovascular disease (CVD), who require additional lowering
of low density lipoprotein cholesterol (LDL-C).
1.2 Homozygous Familial Hypercholesterolemia
REPATHA is indicated as an adjunct to diet and other LDL-lowering therapies (e.g.,
statins, ezetimibe, LDL apheresis) for the treatment of patients with homozygous
familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C.
1.3 Limitations of Use
The effect of REPATHA on cardiovascular morbidity and mortality has not been
determined.
4. CONTRAINDICATIONS
REPATHA is contraindicated in patients with a history of a serious hypersensitivity
reaction to REPATHA [see Warnings and Precautions (5.1)].
5. WARNINGS AND PRECAUTIONS
5.1 Allergic Reactions
Hypersensitivity reactions (e.g., rash, urticaria) have been reported in patients
treated with REPATHA, including some that led to discontinuation of therapy. If
signs or symptoms of serious allergic reactions occur, discontinue treatment with
REPATHA, treat according to the standard of care, and monitor until signs and
symptoms resolve.
6. ADVERSE REACTIONS
The following adverse reactions are also discussed in other sections of the label:
• Allergic Reactions [see Warnings and Precautions (5.1)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse
reaction rates observed in the clinical trials of a drug cannot be directly compared
to rates in the clinical trials of another drug and may not reflect the rates observed
in clinical practice.
Adverse Reactions in Patients with Primary Hyperlipidemia and in Patients with
Heterozygous Familial Hypercholesterolemia
REPATHA is not indicated for use in patients without familial hypercholesterolemia
or atherosclerotic CVD [see Indications and Usage (1.1)].
The data described below reflect exposure to REPATHA in 8 placebo-controlled
trials that included 2651 patients treated with REPATHA, including 557 exposed
for 6 months and 515 exposed for 1 year (median treatment duration of 12
weeks). The mean age of the population was 57 years, 49% of the population
were women, 85% White, 6% Black, 8% Asians, and 2% other races.
Adverse Reactions in a 52-Week Controlled Trial
In a 52-week, double-blind, randomized, placebo-controlled trial (Study 2),
599 patients received 420 mg of REPATHA subcutaneously once monthly [see
Clinical Studies (14.1)]. The mean age was 56 years (range: 22 to 75 years),
23% were older than 65 years, 52% women, 80% White, 8% Black, 6% Asian,
and 6% Hispanic. Adverse reactions reported in at least 3% of REPATHA-
treated patients, and more frequently than in placebo-treated patients in Study
2, are shown in Table 1. Adverse reactions led to discontinuation of treatment
in 2.2% of REPATHA-treated patients and 1% of placebo-treated patients. The
most common adverse reaction that led to REPATHA treatment discontinuation
and occurred at a rate greater than placebo was myalgia (0.3% versus 0% for
REPATHA and placebo, respectively).
Table 1. Adverse Reactions Occurring in Greater than or Equal to 3% of REPATHA-treated Patients and More Frequently than with Placebo in Study 2
†includes erythema, pain, bruising
Adverse Reactions in Seven Pooled 12-Week Controlled Trials
In seven pooled 12-week, double-blind, randomized, placebo-controlled trials, 993 patients received 140 mg of REPATHA subcutaneously every 2 weeks and 1059 patients received 420 mg of REPATHA subcutaneously monthly. The mean age was 57 years (range: 18 to 80 years), 29% were older than 65 years, 49% women, 85% White, 5% Black, 9% Asian, and 5% Hispanic. Adverse reactions reported in at least 1% of REPATHA-treated patients, and more frequently than in placebo-treated patients, are shown in Table 2.
Table 2. Adverse Reactions Occurring in Greater than 1% of REPATHA-treated Patients and More Frequently than with Placebo in Pooled 12-Week Studies
†140 mg every 2 weeks and 420 mg once monthly combined
Adverse Reactions in Eight Pooled Controlled Trials (Seven 12-Week Trials and One 52-Week Trial)
The adverse reactions described below are from a pool of the 52-week trial (Study 2) and seven 12-week trials. The mean and median exposure durations of REPATHA in this pool of eight trials were 20 weeks and 12 weeks, respectively.
Local Injection Site Reactions
Injection site reactions occurred in 3.2% and 3.0% of REPATHA-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising. The proportions of patients who discontinued treatment due to local injection site reactions in REPATHA-treated patients and placebo-treated patients were 0.1% and 0%, respectively.
Allergic Reactions
Allergic reactions occurred in 5.1% and 4.7% of REPATHA-treated and placebo-treated patients, respectively. The most common allergic reactions were rash (1.0% versus 0.5% for REPATHA and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%).
Neurocognitive Events
In placebo-controlled trials, neurocognitive events were reported in less than or equal to 0.2% in REPATHA-treated and placebo-treated patients.
Placebo (N=302)
%
REPATHA (N=599)
%
Nasopharyngitis 9.6 10.5
Upper respiratory tract infection 6.3 9.3
Influenza 6.3 7.5
Back pain 5.6 6.2
Injection site reactions† 5.0 5.7
Cough 3.6 4.5
Urinary tract infection 3.6 4.5
Sinusitis 3.0 4.2
Headache 3.6 4.0
Myalgia 3.0 4.0
Dizziness 2.6 3.7
Musculoskeletal pain 3.0 3.3
Hypertension 2.3 3.2
Diarrhea 2.6 3.0
Gastroenteritis 2.0 3.0
Placebo (N=1224)
%
REPATHA† (N=2052)
%
Nasopharyngitis 3.9 4.0
Back pain 2.2 2.3
Upper respiratory tract infection 2.0 2.1
Arthralgia 1.6 1.8
Nausea 1.2 1.8
Fatigue 1.0 1.6
Muscle spasms 1.2 1.3
Urinary tract infection 1.2 1.3
Cough 0.7 1.2
Influenza 1.1 1.2
Contusion 0.5 1.0
Low LDL-C Levels
In a pool of placebo- and active-controlled trials, as well as open-label extension studies that followed them, a total of 1988 patients treated with REPATHA had at least one LDL-C value < 25 mg/dL. Changes to background lipid-altering therapy were not made in response to low LDL-C values, and REPATHA dosing was not modified or interrupted on this basis. Although adverse consequences of very low LDL-C were not identified in these trials, the long-term effects of very low levels of LDL-C induced by REPATHA are unknown.
Musculoskeletal Events
Musculoskeletal adverse reactions were reported in 14.3% of REPATHA-treated patients and 12.8% of placebo-treated patients. The most common adverse reactions that occurred at a rate greater than placebo were back pain (3.2% versus 2.9% for REPATHA and placebo, respectively), arthralgia (2.3% versus 2.2%), and myalgia (2.0% versus 1.8%).
Adverse Reactions in Patients with Homozygous Familial Hypercholesterolemia
In a 12-week, double-blind, randomized, placebo-controlled trial of 49 patients with HoFH (Study 4), 33 patients received 420 mg of REPATHA subcutaneously once monthly [see Clinical Studies (14.3)]. The mean age was 31 years (range: 13 to 57 years), 49% were women, 90% White, 4% Asian, and 6% other. The adverse reactions that occurred in at least two (6.1%) REPATHA-treated patients, and more frequently than in placebo-treated patients, included:
• Upper respiratory tract infection (9.1% versus 6.3%)
• Influenza (9.1% versus 0%)
• Gastroenteritis (6.1% versus 0%)
• Nasopharyngitis (6.1% versus 0%)
6.2 Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. The immunogenicity of REPATHA has been evaluated using an electrochemiluminescent bridging screening immunoassay for the detection of binding anti-drug antibodies. For patients whose sera tested positive in the screening immunoassay, an in vitro biological assay was performed to detect neutralizing antibodies.
In a pool of placebo- and active-controlled clinical trials, 0.1% of patients treated with at least one dose of REPATHA tested positive for binding antibody development. Patients whose sera tested positive for binding antibodies were further evaluated for neutralizing antibodies; none of the patients tested positive for neutralizing antibodies.
There was no evidence that the presence of anti-drug binding antibodies impacted the pharmacokinetic profile, clinical response, or safety of REPATHA, but the long-term consequences of continuing REPATHA treatment in the presence of anti-drug binding antibodies are unknown.
The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to REPATHA with the incidence of antibodies to other products may be misleading.
8. USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
There are no data available on use of REPATHA in pregnant women to inform a drug-associated risk. In animal reproduction studies, there were no effects on pregnancy or neonatal/infant development when monkeys were subcutaneously administered evolocumab from organogenesis through parturition at dose exposures up to 12 times the exposure at the maximum recommended human dose of 420 mg every month. In a similar study with another drug in the PCSK9 inhibitor antibody class, humoral immune suppression was observed in infant monkeys exposed to that drug in utero at all doses. The exposures where immune suppression occurred in infant monkeys were greater than those expected clinically. No assessment for immune suppression was conducted with evolocumab in infant monkeys. Measurable evolocumab serum concentrations were observed in the infant monkeys at birth at comparable levels to maternal serum, indicating that evolocumab, like other IgG antibodies, crosses the placental barrier. FDA’s experience with monoclonal antibodies in humans indicates that they are unlikely to cross the placenta in the first trimester; however, they are likely to cross the placenta in increasing amounts in the second and third trimester. Consider the benefits and risks of REPATHA and possible risks to the fetus before prescribing REPATHA to pregnant women.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Data
Animal Data
In cynomolgus monkeys, no effects on embryo-fetal or postnatal development (up to 6 months of age) were observed when evolocumab was dosed during organogenesis to parturition at 50 mg/kg once every 2 weeks by the subcutaneous route at exposures 30- and 12-fold the recommended human doses of 140 mg every 2 weeks and 420 mg once monthly, respectively, based on plasma AUC. No test of humoral immunity in infant monkeys was conducted with evolocumab.
8.2 Lactation
Risk Summary
There is no information regarding the presence of evolocumab in human milk, the effects on the breastfed infant, or the effects on milk production. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for REPATHA and any potential adverse effects on the breastfed infant from REPATHA or from the underlying maternal condition. Human IgG is present in human milk, but published data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts.
8.4 Pediatric Use
The safety and effectiveness of REPATHA in combination with diet and other LDL-C-lowering therapies in adolescents with HoFH who require additional lowering of LDL-C were established based on data from a 12-week, placebo-controlled trial that included 10 adolescents (ages 13 to 17 years old) with HoFH [see Clinical Studies (14.3)]. In this trial, 7 adolescents received REPATHA 420 mg subcutaneously once monthly and 3 adolescents received placebo. The effect of REPATHA on LDL-C was generally similar to that observed among adult patients with HoFH. Including experience from open-label, uncontrolled studies, a total of 14 adolescents with HoFH have been treated with REPATHA, with a median exposure duration of 9 months. The safety profile of REPATHA in these adolescents was similar to that described for adult patients with HoFH.
The safety and effectiveness of REPATHA have not been established in pediatric patients with HoFH who are younger than 13 years old.
The safety and effectiveness of REPATHA have not been established in pediatric patients with primary hyperlipidemia or HeFH.
8.5 Geriatric Use
In controlled studies, 1420 patients treated with REPATHA were ≥ 65 years old and 171 were ≥ 75 years old. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
8.6 Renal Impairment
No dose adjustment is needed in patients with mild to moderate renal impairment. No data are available in patients with severe renal impairment [see Clinical Pharmacology (12.3)].
8.7 Hepatic Impairment
No dose adjustment is needed in patients with mild to moderate hepatic impairment (Child-Pugh A or B). No data are available in patients with severe hepatic impairment [see Clinical Pharmacology (12.3)].
13. NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
The carcinogenic potential of evolocumab was evaluated in a lifetime study conducted in the hamster at dose levels of 10, 30, and 100 mg/kg administered every 2 weeks. There were no evolocumab-related tumors at the highest dose at systemic exposures up to 38- and 15-fold the recommended human doses of 140 mg every 2 weeks and 420 mg once monthly, respectively, based on plasma AUC. The mutagenic potential of evolocumab has not been evaluated; however, monoclonal antibodies are not expected to alter DNA or chromosomes.
There were no adverse effects on fertility (including estrous cycling, sperm analysis, mating performance, and embryonic development) at the highest dose in a fertility and early embryonic developmental toxicology study in hamsters when evolocumab was subcutaneously administered at 10, 30, and 100 mg/kg every 2 weeks. The highest dose tested corresponds to systemic exposures up to 30- and 12-fold the recommended human doses of 140 mg every 2 weeks and 420 mg once monthly, respectively, based on plasma AUC. In addition, there were no adverse evolocumab-related effects on surrogate markers of fertility (reproductive organ histopathology, menstrual cycling, or sperm parameters) in a 6-month chronic toxicology study in sexually mature monkeys subcutaneously administered evolocumab at 3, 30, and 300 mg/kg once weekly. The highest dose tested corresponds to 744- and 300-fold the recommended human doses of 140 mg every 2 weeks and 420 mg once monthly, respectively, based on plasma AUC.
13.2 Animal Toxicology and/or Pharmacology
During a 3-month toxicology study of 10 and 100 mg/kg once every 2 weeks evolocumab in combination with 5 mg/kg once daily rosuvastatin in adult monkeys, there were no effects of evolocumab on the humoral immune response to keyhole limpet hemocyanin (KLH) after 1 to 2 months exposure. The highest dose tested corresponds to exposures 54- and 21-fold higher than the recommended human doses of 140 mg every 2 weeks and 420 mg once monthly, respectively, based on plasma AUC. Similarly, there were no effects of evolocumab on the humoral immune response to KLH (after 3 to 4 months exposure) in a 6-month study in cynomolgus monkeys at dose levels up to 300 mg/kg once weekly evolocumab corresponding to exposures 744- and 300-fold greater than the recommended human doses of 140 mg every 2 weeks and 420 mg once monthly, respectively, based on plasma AUC.
This Brief Summary is based on the REPATHA® Prescribing Information v2, 09/15
REPATHA® (evolocumab)Manufactured by: Amgen Inc.One Amgen Center DriveThousand Oaks, California 91320-1799U.S. License Number 1080Patent: http://pat.amgen.com/repatha/
© 2015 Amgen Inc. All rights reserved. Not for reproduction. v2 09/15
MEDICAL ECONOMICS��]��JUNE 10, 2016 MedicalEconomics.com14
uality Metrics: Helping or hurting medicine (March 10, 2016)” sung the praises of major government programs,
HHS, CMS, ACA, MACRA, and MIPS. We all know the story on health-
care being crushed by acronyms over the last century, and your Medical Economics board member Dr. Joseph Scherger, leads us all down the govern-ment rabbit hole, “you’ve got to basically tell yourself that this (reliance on metrics) is prob-ably a good thing overall, but when it’s applied on the ground it can be frustrating.”
Reading Dr. Scherger’s article rais-es some serious doubts in my mind that if he has ever run a solo private practice where individual care rules the day and always has. He sounds more like an administrator/bureau-crat working for a big organization in the government or an insurance company, detached from the ground reality, while inventing the population medicine farce.
Quality metrics have never been proven to represent any measure-ments of value. So called, ‘value based care’ and ‘population medicine’ are dangerous schemes that will ration care based on some party’s criteria that they will profi t from.
Physician medical care of an individual patient cannot be judged by and equation, third-party, or Government department, but only by the individual patient involved. He or she must also pay directly for the care so that it fi ts their moral, ethical, and budget criteria for their own private value system not any other entities.
Perhaps Medical Economics can return to days of previous years where real debates are held and all sides presented? Th is gives the physician reader respect and the opportunity to formulate, or even change, a posi-tion based on detailed information, dogma, research and opinions from all sides.
Craig M. Wax, DOMULLICA HILL, NEW JERSEY
“Q
YOUR VOICE Have a comment? SEND YOUR THOUGHTS TO [email protected]
FACEBOOK.COM/MEDICALECONOMICS @MEDECONOMICS
Physician medical care of an individual patient cannot be judged by and equation, third-party, or Government.”
Frustrations from quality metrics remain intact
Have a comment? Send your thoughts to [email protected]
NEETWTWORK-ENABLED EHR, PRACTICE MANAGEMENT, CARE COORDINATION, AND PATIENT ENGAGEMENT SERVVICICES
GERMS.BODILY FLUIDS.
STUBBORN PATIENTS.
REMEMBER WHEN THAT WAS
ALL YOU HAD TO DEAL WITH?LET DOCTORS BE DOCTORSTM
MEDICAL ECONOMICS��]��JUNE 10, 2016 MedicalEconomics.com16
YOUR VOICE
ne of the biggest lessons that I got after read-ing “Maintenance of certification: inside the physician revolt” (March 25, 2016), is how
even within the ‘house of medicine’ physicians have to remain vigilant.
Besides insurance companies and malpractice lawyers, there are many forces—such as the ABSM—each with their own special ambitions and desires to extend their influence over doctors.
Medicine enters into just about every segment of our lives. And in our capitalistic culture there are always those industries with the capability and strength to look for new area of profit-pharmaceutical companies and makers of medical instruments imme-diately come to mind.
The ABMS would do well to do away with their punitive approach and pro-vide self-assessment tests with answer booklets for doctors in their various specialties.
Initial certification should be as untouchable as a Bachelor of Arts or PhD degree.
Edward Volpintesta MDBETHEL, CONNECTICUT
O
MOC debate needs to remain balancedI don’t usually write to the editor, but
after glancing at your most recent
Medical Economics online edition,
and seeing the headline “MOC
pushed me out of medicine (April 26,
2016),” I thought, something is not
right here. Doth the lady protest too
much?
MOC has positive and negative
objectives—some well executed
and some poorly executed. I grow
suspicious of a magazine overly
dedicated to one aspect of a debate.
Particularly when it is the easy,
popular, emotion tugging complaint
anyone can bash MOC. Did I miss an
issue defending whatever aspects of
MOC are defensible?
I prepared and passed MOC—
some aspect I did not like other
aspects I enjoyed. I would like to hear
from the ABIM and other governing
bodies their defense of MOC. Again,
if this was covered, please point me.
Gino Freeman, MDBALTIMORE, MARYLAND
My advice to ABMS on certification
Forced to retire amidst all the troubles in medicine
Physician Report still doesn’t make me feel better about income outlook
I just retired my solo practice of IM
after 40+ years in the Washington
D.C.area.
I (recently) turned 70, but felt I
had more years to give my practice.
I just could not stand it anymore,
(even though) I can afford to retire.
It is absolutely stunning that we are
being replaced by non- physicians and
big drug store chains. Oh well, there
are too many issues to discuss. I am
looking forward to improving my golf
handicap.
Nancy Falk, MDCHEVY CHASE, MARYLAND
While I realize that you’re trying to provide an optimistic spin on the An-nual Physician Report, several weak spots jump out at me.
In an attempt to proffer an apparent improvement in practice finances, the Better-Same-Worse categories beg for clarification. As a hospice doc, if I have a guy writhing in pain (10 out of 10) and reduce it to 8 out of 10, that would be ‘better’, but seriously deficient in reaching our goals.
By the same token, if things really sucked financially last year and they haven¹t improved, that would be a ho-hum, ‘about the same’, but I’d still be stressed and struggling. Get my drift? I see 1/3 of docs in the ‘worse’ category year after year as the most telling indi-
cator of our nightmare. This is particularly worrisome
given that most of your respondents were in small, private primary care environments.
Furthermore, I see family docs get a 1.5% income boost. But, wait. With a 0.9% inflation rate last year, that is only a 0.6% increase! My local taxes are providing a 3-10% boost in pay for our local government employees!
My main point is that if we’re treading water, that data doesn’t reas-sure me that we’re getting rescued and still not going to drown!
James B. Vogus, M.D., FAAFP, HMDCREDDING, CALIFORNIA
The ABMS would do well
to do away with their punitive approach.”
MedicalEconomics.com MEDICAL ECONOMICS��]��JUNE 10, 2016 17
Photo courtesy of Kevin Berne
VitalsTHE
Primary care practices will need to adopt some elements of the patient-centered medical home (PCMH) in order to thrive un-
der the new Merit-based Incentive Pay-ment System (MIPS).
That’s the view of Nitin Damle, MD, FACP, a Rhode Island internist and the newly-installed president of the Ameri-can College of Physicians (ACP.) Damle spoke as part of a panel discussion on MIPS and MACRA (the Medicare Ac-countability and CHIP Reauthorization Act) during the ACP’s 2016 Internal Medicine Meeting in Washington, D.C.
“It’s very hard to do this work [with-out the structure of a PCMH],” Damle said. “You have to have a practice with experience in collecting and record-ing data. And you need to understand where your cost centers are.”
Under MIPS, physicians will receive annual performance scores based on four categories: quality, which will ac-count for 50% of the score, advancing care information ( formerly Meaning-ful Use), 25%; clinical practice im-provement activities (15%); and cost/resource use (10%). Scores will start being assigned in 2019 based on data reported in 2017.
A practice that has successfully implemented PCMH concepts, he said, includes four elements: First is increased patient access, such as eve-nings and weekends and same-day ap-pointments. “You need to keep people out of the emergency room,” he said.
Second, “make sure patients under-stand that they are part of the team, that they are important to you.” His practice has formed a patient coun-cil and regularly surveys patients. “It’s remarkable how much we learn from
that, and we’ve made changes based on patient perceptions and requests.”
Third is staff development. “Make sure staff feels empowered to make changes and recommendations that you are going to take seriously,” he said.
Fourth is to maximize practice re-sources by building revenues through ancillary services, such as in-house labs, stress testing and bone density scans. “We’ve found it to be an im-portant practice resource,” he said. The final requirement is close follow-up of patients who have gotten care from specialists or been discharged from the hospital or emergency department.
PCMH care requires more person-nel than primary care practices have traditionally used, and generally in-cludes a clinical nurse manager, an IT specialist and a pharmacist.
A clinical nurse manager is crucial, he said, for tasks such as maintain-ing patient registries, keeping track of
deadlines, and identifying and staying in contact with sick patients to keep them out of the hospital or emergency department.
Damle’s practice also uses scribes. “Scribes will make your life a lot eas-ier,” he said, by reducing the amount of time doctors must spend entering information into EHRs. His practice’s scribes are not with the doctor in the exam room. Instead, doctors record their notes on paper encounter forms, which scribes later enter into the EHR.
Implementing all the requirements of the PCMH model nearly always requires funding beyond what most practices can earn through fee-for-ser-vice. His practice has taken advantage of Rhode Island’s multi-stakeholder PCMH initiative that pays participants a per-patient per-month fee, in ad-dition to the salary of a clinical nurse manager. “We would not have been able to do it otherwise,” he said.
How physicians can succeed under MIPS
COVERAGE
2016
ACP
ACP 2016 was held in Washington, D.C., May 5 to May 7, 2016
MEDICAL ECONOMICS��]��JUNE 10, 2016 MedicalEconomics.com18
While medical schools require future physicians to start learning the ins and outs of electronic health records (EHRs) during their training, federal guidelines are standing in the way of true progress in their learning.
Currently, the Centers for Medicare & Medicaid Services (CMS) guidelines prohibit medical students from being considered legal billing providers for patient care. One of the results of the rule at the medical practice and hospi-tal level is a disincentive for teaching physicians to encourage student EHR documentation for fear of a compli-ance violation.
Add in fears of a possible confiden-tiality issues under the Health Insur-ance Portability and Accountability Act (HIPAA) and technical complexi-ties with multiple systems and logins, and students are essentially being blocked from getting hands-on EHR knowledge.
“It stymies not only the student’s education, but it also stymies good patient care,” said David R. Donners-berger, MD, JD, an internist and clinical assistant professor of medicine at the University of Chicago’s Pritzker School of Medicine.
Donnersberger was part of a panel outlining the conflict at this year’s American College of Physicians (ACP) 2016 Internal Medicine Meeting in Washington D.C. In his work with stu-dents, Donnersberger noted that no one spends more time bedside with the patient than med students and their information is valuable, but their inability to make that knowledge part of the chart–unless re-entered by the physician–is a true disservice, he said.
So while the American Associa-tion of Medical Colleges, for example, stipulates that medical students need to have hands-on experience, includ-ing entering and retrieving informa-
tion in a medical record, CMS states clearly that several billable elements of a patient encounter can only be documented by the doctor and not a student.
Kathryn K. Hufmeyer, MD, an in-structor in general internal medicine and geriatrics at Northwestern Uni-versity’s Feinberg School of Medicine in Chicago, further noted that the Li-aison Committee on Medical Educa-tion (LCME), an accrediting body for medical education programs, states curriculum must prepare medical stu-dents for entry into graduate medical education, including communication skills as they relate to physician re-sponsibilities. That would include EHR documentation and access.
“[The LCME] has this directive … yet we are challenged toward its imple-mentation,” Hufmeyer said.
She also pointed to the core entrust-able professional activities (EPAs) for entering residency by the AAMC that includes multiple competencies for medical students relating to an EHR, such has entering and discussing or-ders and giving or receiving a patient handover to transition care responsibly.
“It seems hard, as medical educa-tors, how to get students the skills for residency day one with billing barriers by CMS on access and limits on use and even what use means,” she said
To help remedy this conflict, the ACP has passed a resolution calling on CMS to change its guidelines to allow teaching physicians to refer to a stu-dent’s documentation of the history and physical examination findings or medical decision making in his or her personal note for documentation of an evaluation and management service.
Phil Masters, ACP’s director of clini-cal content development, said the res-olution has passed and is being imple-mented.
Medical student education, CMS rules clash on EHR use
3 challenges for doctors brought about by rapid changes to healthcareThe business of medicine has drasti-
cally changed over the past 20 years.
Innovation brings unintended con-
sequences to doctors, says Banu E.
Symington, MD, FACP, of St. Luke’s
Health System, Twin Falls, Idaho.
Despite the challenges physicians
are facing, Symington says it is cru-
cial doctors tackle these difficulties
and focus on the promotion of heath
and safety to their patients. Here
are three areas Symington suggests
focusing on:
Employment contracts
Contracts with a physician’s
employer could limit the physi-
cian’s ability to protect patients “by
preventing physicians from speaking
out about hospital quality problems,
(EHR) problems, and by forcing in-
hospital referrals to potentially less
well-trained specialists” as these
would quality as a violation of anti-
trust laws.
Quality measure precautions
Mandates for quality measures
may result in worse care. “Quality
measures have only been demon-
strated to improve care in a handful
of medical diagnoses,” Symington
says. “Meanwhile, the preoccupation
with quality check boxes takes time
and attention away from the living,
breathing patients in front of you.”
Patients are not cars
Symington says efforts to employ
patient care in that company’s man-
agement style can result in subopti-
mal care. Fixed-time encounters—
particularly because of EHRs—limit
open-ended history taking, as
well as time for the physician to
adequately review and integrate the
data to come to a diagnosis. “There
are many genetic, environmental and
physiologic factors that lead to the
need for individualized care.”
VitalsCOVERAGE
2016ACP
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IN DEPTH
MEDICAL ECONOMICS ❚ JUNE 10, 2016
Gett
y Im
ages
/iSto
ck/G
etty
Imag
es P
lus/
goir
HYSICIANS ARE fi nding ways to squeeze them-selves into ever-slimmer health networks, but they should prepare for more change ahead due to payer consolidation and techno-
logical innovation.So-called narrow networks, health
plans that limit consumer choice of pro-vider, have taken diff erent forms. Some plans catering to large employers, for example, negotiate with leading, high-
quality specialists for certain procedures. With the advent of healthcare exchanges
under the Aff ordable Care Act, however, these networks proliferated to encompass broad swaths of both primary and specialty care, and consumer advocates have charged the focus is solely on cost cutting, resulting in inferior care.
In some markets, providers are feeling the pressure to accept signifi cant reimburse-
ment cuts in order to remain in network among a dwindling number of payers. Work-ing within the boundaries of a given mar-ket, providers can maximize their leverage to stay listed in narrow plans—or make the break and try to forego them, experts say.
“Th e concept is here to stay because it’s the bluntest instrument health plans have” to rein in costs, says Anders Gilberg, MGA, se-nior vice president for government aff airs at the Medical Group Management Association.
Indeed, and providers may bear the brunt. In addition to increased patient bad debt from the higher deductibles in the Af-fordable Care Act, lower reimbursement from payers in narrow networks was cited as a risk for not-for-profi t hospitals in a 2014 research note from Moody’s Investors Ser-vice. Th e higher volumes traded for lower reimbursements may not materialize or make up for the shortfall, Moody’s warned.
Still, providers haven’t lost all negotiating power. Despite a scaling back in February
HIGHLIGHTS
Assessing the
market, and knowing
which ones are under
the greatest pressure
to narrow provider
ranks as value-based
pay becomes more
mainstream, is the fi rst
step physicians should
take.
Trends
by JANET KIDD STEWART Contributing author
How to negotiate narrow neworksLEVERAGE YOUR VALUE
MedicalEconomics.com 23 MEDICAL ECONOMICS ❚ JUNE 10, 2016
of network adequacy requirements for 2017 under the Affordable Care Act, plans still need physicians to staff narrow networks, Gilberg says.
“Plans still have to go out and get the phy-sicians they need, so they can’t create a net-work that’s unsustainable,” he says. “There is pressure on every side of these relationships.”
EVALUATE THE MARKETKnowing which course for physicians to take, then, begins with assessing the market, and knowing which ones are under the greatest pressure to narrow provider ranks as value-based pay becomes more mainstream.
In a 2016 study of payer mixes in Minne-apolis, New Orleans and Dallas, consulting firms KPMG and Leavitt Partners found sig-nificant disparity among the three markets’ projected total percentage of care delivered under value-based payment models. New Orleans and Dallas are forecast to lag Min-neapolis and the national average by several percentage points over the next seven years, for example.
“It’s one of those situations where if you’ve seen one network, you’ve seen one network,” says Ashraf Shehata, MBA, a Cincinnati-based partner in KPMG’s Global Healthcare Center of Excellence. Markets are moving at different paces when it comes to account-able care and hospital consolidation, he says, so while Minneapolis is moving quickly, Dal-las and New Orleans are more fragmented.
And that means providers in more frag-mented areas will have more leverage as they join networks, Shehata says. Even in markets with heavier network penetration, he expects some availability of alternatives to narrow provider networks. While con-sumer demand right now is all about cost cutting, quality measures—including incen-tive and alternative pay models called for under the Medicare Access and CHIP Reau-thorization Act (MACRA)—eventually will create more opportunities, he says.
The key to leveraging those opportunities isn’t always to get bigger through mergers, but rather putting a practice in a better posi-tion to demonstrate quality care. Time- and resource-strapped physicians can actually use payer consolidation as an advantage, says Patricia Barrett, vice president of prod-uct design and support for the National Committee for Quality Assurance, a non-profit organization.
“The more physicians can consolidate the patient base with a smaller number of plans, the stronger their position will be with those plans,” she says.
She recommends scrutinizing payer-generated quality reports. Correcting errors on these reports helps both parties’ quality scores, she notes. Also, proactively seeking out third-party certifications—through her own organization, medical associations or state initiatives—is a major plus for smaller practices looking to demonstrate quality, she says.
Practices can also join together for the sole purpose of consolidating quality data, which keeps them highly independent. Keep in mind that while networks are constrict-ing, they aren’t the only game in town, She-hata says.
“I think we’re going to see a model where narrow networks is part of the solution, but not the entire solution,” he says.
Much like the HMO model of the 1990s didn’t completely overtake the fee-for-ser-vice model, narrow networks will co-exist with other payer 28
Narrow networks Trends
NEW NETWORKSMore disruption to the ever-narrowing network model could come in the form of
completely new payers who are outside the traditional insurance market, he says.
Retailers like CVS or Walmart could become more full-service primary care
centers through telemedicine, and specialists would attach to them in lieu of a
traditional third-party payer. Or creative health plans owned by providers in one
market might go looking for orphaned specialists in other markets that have been
shut out of a narrow network, creating an opportunity to get a toe-hold in a new
market. “Those alliances could be very interesting,” says Ashraf Shehata, MBA, of
KPMG’s Global Healthcare Center of Excellence.
And as companies such as Fidelity and Google spread into healthcare—the in-
vestment firm and the Internet company’s Google Capital have reportedly invested
in online insurer Oscar, among other ventures—disruption of insurers’ tight hold
on these networks seems inevitable, sources say.
Already, payers and providers are experimenting with new relationships among
themselves, says Erica Hutchins Coe, MPH, MBA, a principal in McKinsey & Co.
and co-leader of its Center for U.S. Health Systems Reform. A 2016 McKinsey
study of hospital networks participating in federal healthcare exchanges found
that co-branding—where providers typically name and market the plan with an
insurance company backing it—is increasingly common.
Precise relationships vary, Coe says, but essentially an exchange plan would
be branded with a provider name, but the provider wouldn’t bear the full risk.
An insurance entity stands behind the plan, she says. “They are looking for new
avenues to experiment and partner that are positive for both,” she says.
MedicalEconomics.com28 MEDICAL ECONOMICS ❚ JUNE 10, 2016
Trends Narrow networks
models, he says. And even among narrow networks he
sees diversity evolving, particularly among large employers, incorporating premium networks for high-quality care centers with the most prominent providers.
To be sure, there are situations where physicians in a given market will have to opt out of a network because the reimbursement rate is unacceptably low. And on the flipside, networks can drop physicians with little or no explanation.
And then there are situations where phy-sicians will decide to accept ultra-low rates because the payer is so large that to ignore it means effectively closing a practice. As pay-ers continue to consolidate, too, the reduced number of options continues to be a chal-lenge to provider profitability, experts say. How to best navigate the storm?
01/ New costsOne step is to begin evaluating practice costs not from an internal perspective, but from that of patients, Gilberg says.
“Physicians have to be aware of costs that they haven’t been measuring before,” he says. In addition to typical practice costs such as equipment and real estate, physi-cians also must, for example, get a handle on the drug and testing costs their patients are incurring, he says.
02/ Data is kingTracking all kinds of cost and quality data, and being able to quantify it during nego-tiations with payers, is critical, Shehata says. “You have to show you’ve made investments in electronic records and quality reporting and that you’ve benchmarked it regionally and nationally,” he says.
Beyond that baseline, practices need to demonstrate their capabilities for consum-ers, whether it’s offering access to a social worker or home-care coordinator or provid-ing ancillary services related to a specialty, such as rehab services or alternative thera-pies, he says.
03/ OrganizeAnother step practices can take to boost negotiating power to get into narrow net-works—or survive outside them—is to ex-plore organizing amongst other smaller providers without formally taking the step to merge, experts say.
Groups of specialists can work with pri-mary care groups as an informal partner-ship and perhaps go as far as sharing clinical records and some ancillary staff. They can also form networks for coordinating more seamless patient care. The trick, Shehata says, is staying clear of laws governing co-ownership and moving too close to Stark law prohibitions. Eventually these informal part-ners may need to decide if an outright merg-er into a single entity is worth it, and there are a lot of complexities at stake, he says.
04/ Know the risksWhile the Affordable Care Act created mil-lions of newly insured potential patients, it also raised the stakes on taking advantage of the new patient flow, says Joseph Kra, a New York partner with benefits consulting firm Mercer.
“There has clearly been a spike in narrow networks, primarily around cost,” he says referring to health exchange plans. “I can understand a physician being worried about maintaining a viable business.”
Non-exchange plans tend to better re-ward higher-quality providers, and that can drive positive financial outcomes for physi-cians, he says.
05/ Focus on key metricsWhen trying to appear more attractive to a narrow network, it may be tempting to demonstrate a vast array of cost-cutting or quality initiatives. That’s a mistake, because front-line staff and providers lose focus on what’s really important, according to Jona-than Gottlieb, MD, chief medical executive for Indiana University Health.
Gottlieb recently slashed the number of IU Health’s quality metrics its front-line pro-viders actively track from nearly 200 down to 10, based on conversations with physi-cians and staff about what is most impor-tant to patients.
Providers now focus heavily on these 10 metrics:
❚ CAUTI(catheter associated urinary tract infection)
❚ CLABSI (central line associated bloodstream
infection)
❚ Surgical site infections
❚ Clostridium difficult cases
❚ Falls with injury
❚ Medication errors with injury
❚ Hospital acquired pressure ulcers 30
23
David Hormuth, MD, MBA’15
For cardiothoracic surgeon David Hormuth, putting patients fi rst means demanding more
from himself, understanding fi nancial decisions, managing costs, and making the business
case for quality care.
That’s why he chose the Kelley Business of Medicine MBA at Indiana University – a 21-month
program from a top-ranked business school. It’s designed exclusively for physicians with a
curriculum at the intersection of medicine and business.
Watch David Hormuth’s story and learn more at
kelley.iupui.edu/med-econ
Patient advocate.Business strategist.Kelley Physician MBA.
G O F R O M M O M E N T T O M O M E N T U M
MedicalEconomics.com30 MEDICAL ECONOMICS ❚ JUNE 10, 2016
Trends Narrow networks
❚ Procedure related injury and other reportable
events
❚ Venous thromboembolism prevention
❚ Hand hygiene compliance
“Ultimately, we’re trying to build a foundation that will help us navigate this transition from high volume to high value,” Gottlieb says.
Managing a large and changing mix of priorities proved to be ineffective, but focus-ing on a “hot list” of issues creates focus and motivation, he says.
06/ Start at homeWhen Cornerstone Health Care, a North Carolina multispecialty group with more than 330 providers, created a network with Wake Forest Baptist Medical Center about two years ago, the focus was on demonstrat-ing lower cost and better health outcomes among employees of the two systems, says Grace Terrell, MD, Cornerstone’s chief ex-ecutive officer.
The organizations offered a tiered net-work, with a traditional PPO option and cost incentives for patients choosing a nar-rower band of providers. In a trial program among its own workforce, diabetes patients received free medications if they chose an alternative care model.
“From the early data we’ve seen, we be-lieve we’re going to be able to demonstrate improvements in both cost and quality for our own employees, and then we can offer it to other employers in our area,” she says. “If it’s truly a high-performing network, then it’s a value to patients and if you invest in care models and analytics that demonstrate value, that’s a good thing.”
07/ Be wary Some providers still worry about financial motives overtaking the narrow network structure, resulting in sub-par healthcare quality while denying consumers realistic opportunities to opt out.
The recent scaling back of some proposed Centers for Medicare & Medicaid Services’ requirements under the ACA for narrow network adequacy is a case in point, notes R. Myles Riner, MD, an emergency physician in Mill Valley, California. “I understand one of the responsibilities of a health plan is to make sure doctors and hospitals are respon-
sible actors and not doing unnecessary sur-geries or overcharging. I get that,” he says. “But in some cases what’s really happening is economic credentialing.”
Health plans use huge data sets on claims to remove doctors who appear to generate higher costs per patient, which could be doctors who take on sicker patients, he says.
“You weed out the most skilled, effective doctors willing to take on more difficult-to- manage patients” and include doctors who avoid those patients, he says, with the result being a network driven mostly by cost con-cerns. Some doctors who need to fill office hours will be the ones accepting the lower reimbursement rates of a narrow network, creating a bottom-fishing situation, he says.
Riner also worries about a short-term mentality in narrow networks, many of which are heavily laden with health ex-change patients who may be less likely to stay in a plan for many years. So those plans might not include physicians who screen for hepatitis C, for example, because it is a costly test. If a patient stayed with a plan for decades, that screen might pay off in fewer liver transplants, for example, but from a shorter term perspective a plan might not want someone who does a lot of those screenings, he says.
Riner urges physicians to get more in-volved in advocacy regarding narrow net-works and other major healthcare reform issues, which he did several years ago in Cal-ifornia by starting an advocacy fund among providers to pay for a state lobbyist on the issue of balance billing.
Jonathan Gruber, Ph.D., an economics professor at MIT, believes the early evidence shows narrow networks are lowering pa-tient costs without lowering quality.
“I think it’s an important area to study and I’m happy to have my mind changed, but for now doctors shouldn’t be fighting a losing battle” against the existence of net-works, he says. “They should be fighting for smarter networks based on true value—that’s the better direction to head.”
That direction could also lead to more direct—and lucrative—payer relationships, says Kra. “The market may be heading to-ward having a large employer contract di-rectly with a physician group or ACO, with traditional carriers cut out. Providers will ultimately need better metrics to get there, though, and I’m not saying this is easy.”
28
Transition of care codes:How to bill correctlyPage 33
Medicare overpayment rule leaves doctors scramblingPage 60
MORE AHEAD
MedicalEconomics.com 31 MEDICAL ECONOMICS ❚ JUNE 10, 2016
TrendsNarrow networks
08/ Question authorityPayers already are building algorithms to better answer the outcomes issue, and pro-viders must decide if they will sit back and wait for the results or build their own data sets, he says. “There will definitely be winners and losers.”
Providers need to continue to fight against plans that try to cherry pick certain providers for narrow networks and they need to question carriers’ quality and cost
data, says Donald Fisher, Ph.D., president and chief executive officer of the American Medical Group Association.
Insist on transparency, he advises. Physi-cians excluded from a network should ask to see the data that led to the decision. Even those inside a network should understand the metrics the carrier has on their practice so that when it’s time to renegotiate, provid-ers know the benchmarks.
How regulators are approaching the narrow network trend
Commercial marketIn November, the National Association of
Insurance Commissioners finalized its new
Network Adequacy Model Act. It includes
sections on provider network adequacy,
provider directories, disclosures and
consumer notices, out-of-network “surprise
bills” and enforcement. Several states,
including red states Georgia and Texas,
have passed or proposed legislation to
implement parts of the Model Act.
In other states, such as Colorado and
Ohio, Insurance Commissioners have
implemented much of the Model Act via
bulletin. Additional states have passed sur-
prise bill and “any willing provider” laws.
Health insurance exchangesCMS, as the administrator of the exchang-
es in two-thirds of states, has published its
network adequacy review requirements for
the first time and established new require-
ments for consumer notices and surprise
bills. Plans must now create “machine
readable” provider directories which
can be checked regularly by regulators
and researchers, and facilitate inter-plan
comparison.
This fall, the agency will rank Qualified
Health Plan provider networks for the first
time. One state-run exchange, California,
has moved even further—establishing
provisions by which the exchange can
remove providers from a network for low
quality scores.
Medicare advantageOn April 4, CMS published its annual Call
Letter for the Medicare Advantage and Part
D programs. In it, the agency put the man-
aged care industry on notice, stating: “Data
gathered by CMS, as well as continued
stakeholder concerns, has intensified our
concerns with provider directory accuracy.
We will continue to aggressively identify
and pursue instances of non-compliance by
using a host of oversight methods.”
CMS goes on to discuss its intention to
fine and impose enrollment sanctions on
Medicare Advantage plans with substantial
errors in their reported provider networks.
The language is, of itself, newsworthy: In
its final year, the Obama administration will
use waning resources to go after managed
care plans for a decades-old problem—
provider network inaccuracies.
In addition to the Call Letter guidance
noted above, CMS has recently published
other new requirements regarding provider
network directories, consumer notices and
special enrollment periods for midyear
network changes.
The agency has expanded the scope
of its provider network reviews beyond
new applicants. Spurred by a critical GAO
report, the agency has put the industry on
notice that it will levy sanctions against
MA carriers that do not meet its standards
and has foreshadowed requiring machine
readable directories in the future.
MedicaidMedicaid managed care regulation varies
greatly from state to state. A year ago, the
Department of Health and Human Services
Inspector General issued a report docu-
menting significant problems in Medicaid
health plan provider networks and state
oversight.
In April, CMS issued a sweeping
regulation that will remake how Med-
icaid health plans are regulated. The
regulation requires states to: have quan-
titative standards for measuring provider
network adequacy; assure that provider
directories arekept current; and assure
that managed care plans providers that
serve non-English speakers. CMS will
defer to states to set the specific compli-
ance standards, but the regulation forces
states have clear standards in place for
2018.
Meanwhile, some states have already
stepped up their oversight, including
fines exceeding $500,000 in California for
provider network directory errors.
Source: Michael S. Adelberg, senior director, FaegreBD Consulting, first published by Managed Healthcare Executive
Government regulators overseeing health plan provider networks are beginning efforts to check the drive to
narrow networks just as the payer business case for narrow networks grows more compelling. Below is a
brief summary of the regulatory landscape.
MEDICAL ECONOMICS ❚ JUNE 10, 2016 MedicalEconomics.com32
Practical Matters
MACRA likely will mean penalties for small practicesby KEITH L. MARTIN Content Channel Director
The federal government acknowledges that 87% of the
nation’s solo practices will face a penalty in 2019, the first
year of the Merit-based Incentive Payment System (MIPS).
waste,” Lund says.
Under MIPS, physicians
are reimbursed based on
their performance in three
additional categories: cost,
which replaces the current
Value Based Modifier
Program, at 10%; clinical
practice improvement,
at 15%; and advancing
care information, replac-
ing Meaningful Use and
evaluating use of health IT
initiatives, at 25% in year
one of the initiative.
The sooner small prac-
tices deliberate and decide
on quality measures they
will report on, the better.
“The biggest challenge
for the vast majority of phy-
sicians is simply defining
what measures that they
will be required to report
out on best match their
practice,” says John Moore,
founder and managing part-
ner of healthcare analyst
firm Chillmark Research in
Boston, Massachusetts.
He adds that these groups
should examine what qual-
ity measures are the easiest
to collect with existing or
slight modifications to cur-
rent workflow and whether
measure collection will vary
from physician to physician
in a single practice.
If the rule stands as
currently drafted, Lund says
MACRA could profoundly
change the care delivery
landscape. “Independent
groups are going to feel
more vulnerable,” she says.
“We’ll likely see even more
of these physicians look to
be employed. We’ve already
seen a lot of interest in
the merger and acquisi-
tion space [by independent
practices] and this is likely
to boost that interest.”
Taking the first steps In addition to letting
their voices be heard on
the proposed rule, Lund
encourages independent
practices to assume that
their participation will be
through the MIPS path and
not its alternative, advanced
payment models (APMs).
Even CMS estimates that
only 4% of these practices
would qualify for APM
status and even then, they
would need to demonstrate
MIPS data. “Operate as if
THE NEWS IS equally as
pessimistic for practices
of two to nine physicians
(an estimated 124,000
physicians) who could see
penalties to the tune of
$279 million
“There are winners and
losers and smaller prac-
tices are more likely to be
the losers,” Ingrid Lund,
PhD, practice manager for
research and insights at The
Advisory Board Company
told Medical Economics.
“It appears the proposed
rule would create a penalty
system where the big guys
[larger practices] will be
funded by the little guys.”
Lund, who consults
primarily with independent
medical groups, says that
it is up to these smaller
groups to utilize the com-
ment period (through June
26) to push to change the
winners-losers dynamic
under the Medicare Access
and CHIP Reauthorization
Act of 2015 (MACRA) and
preserve the operations of
independent practices.
you are in the MIPS track,”
she advises.
Furthermore, she
strongly advises practices
to not try in the short term
to become an APM model
such as an accountable care
organization or participa-
tion in the Comprehensive
Primary Care Plus program
for the sole reason of APM
track qualification.
“It does not make sense
to dramatically overhaul
your payment model strat-
egy,” she says. “It is too late
and this is too dramatic a
change.“
What practices can do
is start focusing on quality
reporting, especially the six
measures identified under
the quality category that will
comprise 50% of a physi-
cian’s MIPS score.
“Now is the time.
There’s not a minute to
Send your practice management questions to: [email protected].
103,000Approximate number of solo physicians
who are expected to face payment
penalities in the first year of MIPS
Please see Important Safety Information throughout. Please see accompanying Brief Summary of full Prescribing Information, including Boxed WARNINGS, or visit www.XareltoHCP.com/PI.
BEYOONDND EXTENSIVE RANDOMIZED CLINICAL TRIALS, PUBLISHED SAFEFETYTY OUTCOMES FROM OBSERVATIONAL STUDIES
OF REAAL-L-WOWORLRLDD PAPATIT ENENTST †2-13
NOAC = non-vitamin K antagonist oral anticooaguagulanlant.
*Among Factor Xa inhibitors and dd direirectct ththrombin inhibitors. † Based on the foollollowinwingg registries, claims databases, and studies: Optum Labs=16,253; IMS HS HHeaealth LifeLink=1,649; Truven Health=5,55 563;63; DaDanisnish rregieg strs y=1y ,303; XAMXAMOS=OS=8 78,778; Symphony=3,654; ORTHO-TEP=1,043; Japanese registry=1,035; Dresden NOAC=AC=1,776; XALIA=2,505; DOD database=27,467; XANTANTUSUS=6 76,78484.
IMPORTANT SAFETY INFORMATION
#1 PRESCRIBED
NOAC IN THE US*1
†2-13
WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO® INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA
A. PREMATURE DISCONTINUATION OF XARELTO® INCREASES THE RISK OF THROMBOTIC EVENTS Premature discontinuation of any oral anticoagulant, including XARELTO®, increases the risk of thrombotic events. If anticoagulation with XARELTO® is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.
B. SPINAL/EPIDURAL HEMATOMAEpidural or spinal hematomas have occurred in patients treated with XARELTO® who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk
of developing epidural or spinal hematomas in these patients include: Use of indwelling epidural catheters Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-infl ammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants, see Drug Interactions A history of traumatic or repeated epidural or spinal punctures A history of spinal deformity or spinal surgery Optimal timing between the administration of XARELTO® and neuraxial procedures is not known
Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefi ts and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.
RESULTS ARE NOT INTENDED FOR DIRECT COMPARISON WITH CLINICAL TRIALS
SIX INDICATIONS STRONG To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fi brillation (AF). There are limited data on the relative effectiveness of XARELTO® and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well controlled
For the treatment of deep vein thrombosis (DVT)
For the treatment of pulmonary embolism (PE)
For the reduction in the risk of recurrence of DVT and of PE following initial 6 months treatment for DVT and/or PE
For the prophylaxis of DVT, which may lead to PE in patients undergoing knee replacement surgery
For the prophylaxis of DVT, which may lead to PE in patients undergoing hip replacement surgery
* XARELTO® was evaluated versus dose-adjusted warfarin in more than 14,000 patients with nonvalvular AF at moderate to high risk for stroke in a rigorously designed, multicenter, randomized, double-blind, double-dummy, event-driven phase III trial. XARELTO® demonstrated effective reduction in the risk of stroke and non-CNS systemic embolism in patients with prior stroke or multiple comorbidities.14
† Major bleeding from ROCKET AF study was defi ned as clinically overt bleeding associated with a decrease in hemoglobin of Ű2 g/dL, transfusion of Ű2 units of packed red blood cells or whole blood, bleeding at a critical site, or with a fatal outcome.14
AF = atrial fi brillation; GI = gastrointestinal; ICH = intracranial hemorrhage.
A validated computer database algorithm developed by Cunningham et al, which identifi es bleeding-related hospitalizations from a primary discharge diagnosis, was used to identify major bleeding events in this study. The defi nition of major bleeding is not an exact match with the ROCKET AF trial.
LIMITATIONS: This is a retrospective study and there is no comparator arm in the trial. Differences in study design, patient populations, defi nition of safety outcomes, and data collection methods make it diffi cult to make comparisons with clinical trials.13
RATES OF BLEEDING IN ROCKET AF (N=7,111)*14: The event rate per 100 patient-years was 3.6 (n=395) for major bleed and 0.20 (n=27) for fatal bleed†
• 0.8% of patients experienced an ICH (n=55) and 3.1% of patients experienced a GI bleed (n=221)
Results based on 15 months of data from an ongoing, 5-year postmarketing safety surveillance study to evaluate major bleeding in patients receiving XARELTO® in a real-world clinical setting. Cases of major bleeding were identifi ed through electronic health records from the US Department of Defense database, from January 1, 2013, to March 31, 2014.
Real-world safety outcomes from one ongoing US study of 27,467 nonvalvular AF patients13
87%
Mean age: 76
with comorbidities including:
diabetes heart failure renal disease
COMORBID PATIENTS STUDIED20
15
10
5
0
EVEN
T RA
TE/1
00PA
TIEN
T-YE
ARS
0.082.86fatal bleed (n=14) major bleed (n=478)
RATES OF BLEEDING
0.1% ICH (n=36) 1.5% GI bleed (n=423)
IMPORTANT SAFETY INFORMATION (cont’d) CONTRAINDICATIONS Active pathological bleeding Severe hypersensitivity reaction to XARELTO® (eg, anaphylactic reactions)
WARNINGS AND PRECAUTIONS Increased Risk of Thrombotic Events After Premature Discontinuation: Premature discontinuation of any oral anticoagulant, including XARELTO®, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from XARELTO® to warfarin in clinical trials in atrial fi brillation patients. If XARELTO® is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.
Risk of Bleeding: XARELTO® increases the risk of bleeding and can cause serious or fatal bleeding. Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement. Discontinue XARELTO® in patients with active pathological hemorrhage.
• A specifi c antidote for rivaroxaban is not available. Because of high plasma protein binding, rivaroxaban is not expected to be dialyzable.
• Concomitant use of other drugs that impair hemostasis increases the risk of bleeding. These include aspirin, P2Y12 platelet inhibitors, other antithrombotic agents, fi brinolytic therapy, and NSAIDs.
Spinal/Epidural Anesthesia or Puncture: When neuraxial anesthesia (spinal/epidural anesthesia) or spinal puncture is employed, patients treated with anticoagulant agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma, which can result in long-term or permanent paralysis. To reduce the potential risk of bleeding associated with the concurrent use of rivaroxaban and epidural or spinal anesthesia/analgesia or spinal puncture, consider the pharmacokinetic profi le of rivaroxaban. Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of rivaroxaban is low; however, the exact timing to reach a suffi ciently low anticoagulant effect in each patient is not known. An epidural catheter should not be removed earlier than 18 hours after the last administration of XARELTO®. The next XARELTO® dose is not to be administered earlier than 6 hours after the removal of the catheter. If traumatic puncture occurs, the administration of XARELTO® is to be delayed for 24 hours. Should the physician decide to administer anticoagulation in the context of epidural or spinal anesthesia/analgesia or lumbar puncture, monitor frequently to detect any signs or symptoms of neurological impairment, such as midline back pain, sensory and motor defi cits (numbness, tingling, or weakness in lower limbs), or bowel and/or bladder dysfunction. Instruct patients to immediately report if they experience any of the above signs or symptoms. If signs or symptoms of spinal hematoma are suspected, initiate urgent diagnosis and treatment including consideration for spinal cord decompression even though such treatment may not prevent or reverse neurological sequelae.
Use in Patients With Renal Impairment:
• Nonvalvular Atrial Fibrillation: Avoid the use of XARELTO® in patients with creatinine clearance (CrCl) <15 mL/min since drug exposure is increased. Discontinue XARELTO® in patients who develop acute renal failure while on XARELTO®.
• Treatment of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), and Reduction in the Risk of Recurrence of DVT and of PE: Avoid the use of XARELTO® in patients with CrCl <30 mL/min due to an expected increase in rivaroxaban exposure and pharmacodynamic effects in this patient population.
• Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery: Avoid the use of XARELTO® in patients with CrCl <30 mL/min due to an expected increase in rivaroxaban exposure and pharmacodynamic effects in this patient population. Observe closely and promptly evaluate any signs or symptoms of blood loss in patients with CrCl 30 to 50 mL/min. Patients who develop acute renal failure while on XARELTO® should discontinue the treatment.
Use in Patients With Hepatic Impairment: No clinical data are available for patients with severe hepatic impairment. Avoid use of XARELTO® in patients with moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment or with any hepatic disease associated with coagulopathy, since drug exposure and bleeding risk may be increased.
Use With P-gp and Strong CYP3A4 Inhibitors or Inducers: Avoid concomitant use of XARELTO® with combined P-gp and strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, lopinavir/ritonavir, ritonavir, indinavir, and conivaptan). Avoid concomitant use of XARELTO® with drugs that are P-gp and strong CYP3A4 inducers (eg, carbamazepine, phenytoin, rifampin, St. John’s wort).
Risk of Pregnancy-Related Hemorrhage: In pregnant women, XARELTO® should be used only if the potential benefi t justifi es the potential risk to the mother and fetus. XARELTO® dosing in pregnancy has not been studied. The anticoagulant effect of XARELTO® cannot be monitored with standard laboratory testing and is not readily reversed. Promptly evaluate any signs or symptoms suggesting blood loss (eg, a drop in hemoglobin and/or hematocrit, hypotension, or fetal distress).
Patients With Prosthetic Heart Valves: The safety and effi cacy of XARELTO® have not been studied in patients with prosthetic heart valves. Therefore, use of XARELTO® is not recommended in these patients.
Acute PE in Hemodynamically Unstable Patients/Patients Who Require Thrombolysis or Pulmonary Embolectomy: Initiation of XARELTO® is not recommended acutely as an alternative to unfractionated heparin in patients with pulmonary embolism who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy.
DRUG INTERACTIONS
Avoid concomitant use of XARELTO® with other anticoagulants due to increased bleeding risk, unless benefi t outweighs risk. Promptly evaluate any signs or symptoms of blood loss if patients are treated concomitantly with aspirin, other platelet aggregation inhibitors, or NSAIDs.
XARELTO® should not be used in patients with CrCl 15 to <80 mL/min who are receiving concomitant combined P-gp and moderate CYP3A4 inhibitors (eg, diltiazem, verapamil, dronedarone, and erythromycin) unless the potential benefi t justifi es the potential risk.
IMPORTANT SAFETY INFORMATION (cont’d) WARNINGS AND PRECAUTIONS (cont’d)
Please see Important Safety Information throughout.
Please see accompanying Brief Summary of full Prescribing Information, including Boxed WARNINGS, or visit www.XareltoHCP.com/PI.
Janssen Pharmaceuticals, Inc.
XARELTO® is licensed from Bayer HealthCare AG, 51368 Leverkusen, Germany. © Janssen Pharmaceuticals, Inc. 2016 February 2016 045467-160108
USE IN SPECIFIC POPULATIONS
Pregnancy Category C: XARELTO® should be used during pregnancy only if the potential benefi t justifi es the potential risk to mother and fetus. There are no adequate or well-controlled studies of XARELTO® in pregnant women, and dosing for pregnant women has not been established. Use XARELTO® with caution in pregnant patients because of the potential for pregnancy-related hemorrhage and/or emergent delivery with an anticoagulant that is not readily reversible. The anticoagulant effect of XARELTO® cannot be reliably monitored with standard laboratory testing.
Labor and Delivery: Safety and effectiveness of XARELTO® during labor and delivery have not been studied in clinical trials.
Nursing Mothers: It is not known if rivaroxaban is excreted in human milk.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Females of Reproductive Potential: Females of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician.
OVERDOSAGE Discontinue XARELTO® and initiate appropriate therapy if bleeding complications associated with overdosage occur. A specifi c antidote for rivaroxaban is not available. The use of activated charcoal to reduce absorption in case of XARELTO® overdose may be considered. Due to the high plasma protein binding, rivaroxaban is not expected to be dialyzable.
ADVERSE REACTIONS IN CLINICAL STUDIES The most common adverse reactions with XARELTO® were bleeding complications.
Please see accompanying Brief Summary of full Prescribing Information, including Boxed WARNINGS, or visit www.XareltoHCP.com/PI.
0385
73-1
5081
2
IMPORTANT SAFETY INFORMATION (cont’d)
References: 1. Data on fi le. Janssen Pharmaceuticals, Inc. Based on IMS Health, NPA Weekly, December 2015. 2. Beyer-Westendorf J, Förster K, Pannach S, et al. Rates, management, and outcome of rivaroxaban bleeding in daily care: results from the Dresden NOAC registry. Blood. 2014;124(6):955-962. 3. Beyer-Westendorf J, Lützner J, Donath L, et al. Effi cacy and safety of thromboprophylaxis with low-molecular-weight heparin or rivaroxaban in hip and knee replacement surgery. Findings from the ORTHO-TEP registry. Thromb Haemost. 2013;109(1):154-163. 4. Ogawa S, Ikeda T, Kitazono T, et al; on behalf of the Rivaroxaban Postmarketing Surveillance Registry Investigators. Present profi les of novel anticoagulant use in Japanese patients with atrial fi brillation: insights from the rivaroxaban postmarketing surveillance registry. J Stroke Cerebrovasc Dis. 2014;23(10):2520-2526. 5. Laliberté F, Cloutier M, Nelson WW, et al. Real-world comparative effectiveness and safety of rivaroxaban and warfarin in nonvalvular atrial fi brillation patients. Curr Med Res Opin. 2014;30(7):1317-1325. 6. Turpie AGG, Haas S, Kreutz R, et al. A non-interventional comparison of rivaroxaban with standard of care for thromboprophylaxis after major orthopaedic surgery in 17,701 patients with propensity score adjustment. Thromb Haemost. 2014; 111(1):94-102. 7. Abraham NS, Singh S, Alexander CG, et al. Comparative risk of gastrointestinal bleeding with dabigatran, rivaroxaban, and warfarin: population based cohort study. BMJ. 2015;350:h1857. 8. Chang H-Y, Zhou M, Tang W, Alexander GC, Singh S. Risk of gastrointestinal bleeding associated with oral anticoagulants: population based retrospective cohort study. BMJ. 2015;350:h1585. 9. Lauffenburger JC, Farley JF, Gehi AK, Rhoney DH, Brookhart MA, Fang G. Factors driving anticoagulant selection in patients with atrial fi brillation in the United States. Am J Cardiol. 2015;115(8):1095-1101. 10. Olesen JB, Sørensen R, Hansen ML, et al. Non-vitamin K antagonist oral anticoagulation agents in anticoagulant naïve atrial fi brillation patients: Danish nationwide descriptive data 2011-2013. Europace. 2015;17(2):187-193. 11. Ageno W, Mantovani LG, Haas S, et al. Safety and effectiveness of oral rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep-vein thrombosis (XALIA): an international, prospective, non-interventional study. Lancet Haematol. 2016 Jan;3(1):e12-21. 12. Camm AJ, Amarenco P, Haas S, et al; on behalf of the XANTUS investigators. XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fi brillation. Euro Heart J. 2015;1-9. 13. Tamayo S, Peacock WF, Patel M, et al. Characterizing major bleeding in patients with nonvalvular atrial fi brillation: a pharmacovigilance study of 27,467 patients taking rivaroxaban. Clin Cardiol. 2015;38(2):63-68. 14. Patel MR, Mahaffey KW, Garg J, et al; and the ROCKET AF Steering Committee, for the ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fi brillation. N Engl J Med. 2011;365(10):883-891.
Brief Summary of Prescribing Information for XARELTO® (rivaroxaban)
XARELTO® (rivaroxaban) tablets, for oral use See package insert for full Prescribing Information
WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS,
(B) SPINAL/EPIDURAL HEMATOMA
A. PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS
Premature discontinuation of any oral anticoagulant, including XARELTO, increases the risk of thrombotic events. If anticoagulation with XARELTO is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration (2.2, 2.6) in full Prescribing Information, Warnings and Precautions, and Clinical Studies (14.1) in full Prescribing Information].
B. SPINAL/EPIDURAL HEMATOMAEpidural or spinal hematomas have occurred in patients treated with XARELTO who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:• use of indwelling epidural catheters• concomitant use of other drugs that affect hemostasis, such as non-
steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants
• a history of traumatic or repeated epidural or spinal punctures• a history of spinal deformity or spinal surgery• optimal timing between the administration of XARELTO and neuraxial
procedures is not known[see Warnings and Precautions and Adverse Reactions].
Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary [see Warnings and Precautions].
Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis [see Warnings and Precautions].
INDICATIONS AND USAGEReduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation: XARELTO is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.There are limited data on the relative effectiveness of XARELTO and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled [see Clinical Studies (14.1) in full Prescribing Information].
Treatment of Deep Vein Thrombosis: XARELTO is indicated for the treatment of deep vein thrombosis (DVT).Treatment of Pulmonary Embolism: XARELTO is indicated for the treatment of pulmonary embolism (PE).Reduction in the Risk of Recurrence of Deep Vein Thrombosis and of Pulmonary Embolism: XARELTO is indicated for the reduction in the risk of recurrence of deep vein thrombosis and of pulmonary embolism following initial 6 months treatment for DVT and/or PE.Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery: XARELTO is indicated for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.
CONTRAINDICATIONSXARELTO is contraindicated in patients with:• active pathological bleeding [see Warnings and Precautions]• severe hypersensitivity reaction to XARELTO (e.g., anaphylactic reactions) [see
Adverse Reactions]
WARNINGS AND PRECAUTIONSIncreased Risk of Thrombotic Events after Premature Discontinuation: Premature discontinuation of any oral anticoagulant, including XARELTO, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from XARELTO to warfarin in clinical trials in atrial fibrillation patients. If XARELTO is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration (2.2, 2.6) and Clinical Studies (14.1) in full Prescribing Information].Risk of Bleeding: XARELTO increases the risk of bleeding and can cause serious or fatal bleeding. In deciding whether to prescribe XARELTO to patients at increased risk of bleeding, the risk of thrombotic events should be weighed against the risk of bleeding.Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement. Discontinue XARELTO in patients with active pathological hemorrhage. The terminal elimination half-life of rivaroxaban is 5 to 9 hours in healthy subjects aged 20 to 45 years.Concomitant use of other drugs that impair hemostasis increases the risk of bleeding. These include aspirin, P2Y12 platelet inhibitors, other antithrombotic agents, fibrinolytic therapy, and non-steroidal anti-inflammatory drugs (NSAIDs) [see Drug Interactions].Concomitant use of drugs that are combined P-gp and CYP3A4 inhibitors (e.g., ketoconazole and ritonavir) increases rivaroxaban exposure and may increase bleeding risk [see Drug Interactions].
Reversal of Anticoagulant Effect: A specific antidote for rivaroxaban is not available. Because of high plasma protein binding, rivaroxaban is not expected to be dialyzable [see Clinical Pharmacology (12.3) in full Prescribing Information]. Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of rivaroxaban. Partial reversal of prothrombin time prolongation has been
seen after administration of prothrombin complex concentrates (PCCs) in healthy volunteers. The use of other procoagulant reversal agents like activated prothrombin complex concentrate (APCC) or recombinant factor VIIa (rFVIIa) has not been evaluated.
Spinal/Epidural Anesthesia or Puncture: When neuraxial anesthesia (spinal/epidural anesthesia) or spinal puncture is employed, patients treated with anticoagulant agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis [see Boxed Warning].To reduce the potential risk of bleeding associated with the concurrent use of rivaroxaban and epidural or spinal anesthesia/analgesia or spinal puncture, consider the pharmacokinetic profile of rivaroxaban [see Clinical Pharmacology (12.3) in full Prescribing Information]. Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of rivaroxaban is low; however, the exact timing to reach a sufficiently low anticoagulant effect in each patient is not known.An epidural catheter should not be removed earlier than 18 hours after the last administration of XARELTO. The next XARELTO dose is not to be administered earlier than 6 hours after the removal of the catheter. If traumatic puncture occurs, the administration of XARELTO is to be delayed for 24 hours.Should the physician decide to administer anticoagulation in the context of epidural or spinal anesthesia/analgesia or lumbar puncture, monitor frequently to detect any signs or symptoms of neurological impairment, such as midline back pain, sensory and motor deficits (numbness, tingling, or weakness in lower limbs), bowel and/or bladder dysfunction. Instruct patients to immediately report if they experience any of the above signs or symptoms. If signs or symptoms of spinal hematoma are suspected, initiate urgent diagnosis and treatment including consideration for spinal cord decompression even though such treatment may not prevent or reverse neurological sequelae.Use in Patients with Renal Impairment: Nonvalvular Atrial Fibrillation: Avoid the use of XARELTO in patients with CrCl <15 mL/min since drug exposure is increased. Periodically assess renal function as clinically indicated (i.e., more frequently in situations in which renal function may decline) and adjust therapy accordingly. Discontinue XARELTO in patients who develop acute renal failure while on XARELTO [see Use in Specific Populations]Treatment of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), and Reduction in the Risk of Recurrence of DVT and of PE: Avoid the use of XARELTO in patients with CrCl <30 mL/min due to an expected increase in rivaroxaban exposure and pharmacodynamic effects in this patient population [see Use in Specific Populations].Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery: Avoid the use of XARELTO in patients with CrCl <30 mL/min due to an expected increase in rivaroxaban exposure and pharmacodynamic effects in this patient population. Observe closely and promptly evaluate any signs or symptoms of blood loss in patients with CrCl 30 to 50 mL/min. Patients who develop acute renal failure while on XARELTO should discontinue the treatment [see Use in Specific Populations].Use in Patients with Hepatic Impairment: No clinical data are available for patients with severe hepatic impairment.Avoid use of XARELTO in patients with moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment or with any hepatic disease associated with coagulopathy since drug exposure and bleeding risk may be increased [see Use in Specific Populations].Use with P-gp and Strong CYP3A4 Inhibitors or Inducers: Avoid concomitant use of XARELTO with combined P-gp and strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, lopinavir/ritonavir, ritonavir, indinavir, and conivaptan) [see Drug Interactions].Avoid concomitant use of XARELTO with drugs that are combined P-gp and strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, St. John’s wort) [see Drug Interactions].Risk of Pregnancy-Related Hemorrhage: In pregnant women, XARELTO should be used only if the potential benefit justifies the potential risk to the mother and fetus. XARELTO dosing in pregnancy has not been studied. The anticoagulant effect of XARELTO cannot be monitored with standard laboratory testing nor readily reversed. Promptly evaluate any signs or symptoms suggesting blood loss (e.g., a drop in hemoglobin and/or hematocrit, hypotension, or fetal distress).Patients with Prosthetic Heart Valves: The safety and efficacy of XARELTO have not been studied in patients with prosthetic heart valves. Therefore, use of XARELTO is not recommended in these patients. Acute PE in Hemodynamically Unstable Patients or Patients Who Require Thrombolysis or Pulmonary Embolectomy: Initiation of XARELTO is not recommended acutely as an alternative to unfractionated heparin in patients with pulmonary embolism who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy.
ADVERSE REACTIONSThe following adverse reactions are also discussed in other sections of the labeling:• Increased risk of stroke after discontinuation in nonvalvular atrial fibrillation
[see Boxed Warning and Warnings and Precautions]• Bleeding risk [see Warnings and Precautions]• Spinal/epidural hematoma [see Boxed Warning and Warnings and Precautions]
Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.During clinical development for the approved indications, 16326 patients were exposed to XARELTO. These included 7111 patients who received XARELTO 15 mg or 20 mg orally once daily for a mean of 19 months (5558 for 12 months and 2512
XARELTO® (rivaroxaban) tablets
for 24 months) to reduce the risk of stroke and systemic embolism in nonvalvular atrial fibrillation (ROCKET AF); 4728 patients who received either XARELTO 15 mg orally twice daily for three weeks followed by 20 mg orally once daily (EINSTEIN DVT, EINSTEIN PE) or 20 mg orally once daily (EINSTEIN Extension) to treat DVT, PE, and to reduce the risk of recurrence of DVT and of PE; and 4487 patients who received XARELTO 10 mg orally once daily for prophylaxis of DVT following hip or knee replacement surgery (RECORD 1-3).Hemorrhage: The most common adverse reactions with XARELTO were bleeding complications [see Warnings and Precautions].Nonvalvular Atrial Fibrillation: In the ROCKET AF trial, the most frequent adverse reactions associated with permanent drug discontinuation were bleeding events, with incidence rates of 4.3% for XARELTO vs. 3.1% for warfarin. The incidence of discontinuations for non-bleeding adverse events was similar in both treatment groups.Table 1 shows the number of patients experiencing various types of bleeding events in the ROCKET AF trial.
Table 1: Bleeding Events in ROCKET AF*- On Treatment Plus 2 Days
Parameter XARELTON = 7111
n (%/year)
WarfarinN = 7125
n (%/year)
XARELTO vs. WarfarinHR
(95% CI)
Major Bleeding† 395 (3.6) 386 (3.5) 1.04 (0.90, 1.20)
Intracranial Hemorrhage (ICH)‡
55 (0.5) 84 (0.7) 0.67 (0.47, 0.93)
Hemorrhagic Stroke§ 36 (0.3) 58 (0.5) 0.63 (0.42, 0.96)
Other ICH 19 (0.2) 26 (0.2) 0.74 (0.41, 1.34)
Gastrointestinal (GI)¶ 221 (2.0) 140 (1.2) 1.61 (1.30, 1.99)
Fatal Bleeding# 27 (0.2) 55 (0.5) 0.50 (0.31, 0.79)
ICH 24 (0.2) 42 (0.4) 0.58 (0.35, 0.96)
Non-intracranial 3 (0.0) 13 (0.1) 0.23 (0.07, 0.82)
Abbreviations: HR = Hazard Ratio, CI = Confidence interval, CRNM = Clinically Relevant Non-Major.* Major bleeding events within each subcategory were counted once per patient,
but patients may have contributed events to multiple subcategories. These events occurred during treatment or within 2 days of stopping treatment.
† Defined as clinically overt bleeding associated with a decrease in hemoglobin of ≥2 g/dL, a transfusion of ≥2 units of packed red blood cells or whole blood, bleeding at a critical site, or with a fatal outcome.
‡ Intracranial bleeding events included intraparenchymal, intraventricular, subdural, subarachnoid and/or epidural hematoma.
§ Hemorrhagic stroke in this table specifically refers to non-traumatic intraparenchymal and/or intraventricular hematoma in patients on treatment plus 2 days.
¶ Gastrointestinal bleeding events included upper GI, lower GI, and rectal bleeding.
# Fatal bleeding is adjudicated death with the primary cause of death from bleeding.
Figure 1 shows the risk of major bleeding events across major subgroups.
Figure 1: Risk of Major Bleeding Events by Baseline Characteristics in ROCKET AF – On Treatment Plus 2 Days
Note: The figure above presents effects in various subgroups all of which are baseline characteristics and all of which were pre-specified (diabetic status was not pre-specified in the subgroup, but was a criterion for the CHADS2 score). The 95% confidence limits that are shown do not take into account how many comparisons were made, nor do they reflect the effect of a particular factor after adjustment for all other factors. Apparent homogeneity or heterogeneity among groups should not be over-interpreted.
Treatment of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), and to Reduce the Risk of Recurrence of DVT and of PE: EINSTEIN DVT and EINSTEIN PE Studies: In the pooled analysis of the EINSTEIN DVT and EINSTEIN PE clinical studies, the most frequent adverse reactions leading to permanent drug discontinuation were bleeding events, with XARELTO vs. enoxaparin/Vitamin K antagonist (VKA) incidence rates of 1.7% vs. 1.5%, respectively. The mean duration of treatment was 208 days for XARELTO-treated patients and 204 days for enoxaparin/VKA-treated patients.
Table 2 shows the number of patients experiencing major bleeding events in the pooled analysis of the EINSTEIN DVT and EINSTEIN PE studies.
Table 2: Bleeding Events* in the Pooled Analysis of EINSTEIN DVT and EINSTEIN PE Studies
Parameter XARELTO†
N = 4130n (%)
Enoxaparin/VKA†
N = 4116n (%)
Major bleeding event 40 (1.0) 72 (1.7)
Fatal bleeding 3 (<0.1) 8 (0.2)
Intracranial 2 (<0.1) 4 (<0.1)
Non-fatal critical organ bleeding 10 (0.2) 29 (0.7)
Intracranial‡ 3 (<0.1) 10 (0.2)
Retroperitoneal‡ 1 (<0.1) 8 (0.2)
Intraocular‡ 3 (<0.1) 2 (<0.1)
Intra-articular‡ 0 4 (<0.1)
Non-fatal non-critical organ bleeding§ 27 (0.7) 37 (0.9)
Decrease in Hb ≥ 2g/dL 28 (0.7) 42 (1.0)
Transfusion of ≥2 units of whole blood or packed red blood cells
18 (0.4) 25 (0.6)
Clinically relevant non-major bleeding 357 (8.6) 357 (8.7)
Any bleeding 1169 (28.3) 1153 (28.0)
* Bleeding event occurred after randomization and up to 2 days after the last dose of study drug. Although a patient may have had 2 or more events, the patient is counted only once in a category.
† Treatment schedule in EINSTEIN DVT and EINSTEIN PE studies: XARELTO 15 mg twice daily for 3 weeks followed by 20 mg once daily; enoxaparin/VKA [enoxaparin: 1 mg/kg twice daily, VKA: individually titrated doses to achieve a target INR of 2.5 (range: 2.0-3.0)]
‡ Treatment-emergent major bleeding events with at least >2 subjects in any pooled treatment group
§ Major bleeding which is not fatal or in a critical organ, but resulting in a decrease in Hb ≥2 g/dL and/or transfusion of ≥2 units of whole blood or packed red blood cells
EINSTEIN Extension Study: In the EINSTEIN Extension clinical study, the most frequent adverse reactions associated with permanent drug discontinuation were bleeding events, with incidence rates of 1.8% for XARELTO vs. 0.2% for placebo treatment groups. The mean duration of treatment was 190 days for both XARELTO and placebo treatment groups.
Table 3 shows the number of patients experiencing bleeding events in the EINSTEIN Extension study.
Table 3: Bleeding Events* in EINSTEIN Extension Study
Parameter XARELTO†
20 mgN = 598
n (%)
Placebo†
N = 590n (%)
Major bleeding event‡ 4 (0.7) 0
Decrease in Hb ≥2 g/dL 4 (0.7) 0
Transfusion of ≥2 units of whole blood or packed red blood cells
2 (0.3) 0
Gastrointestinal 3 (0.5) 0
Menorrhagia 1 (0.2) 0
Clinically relevant non-major bleeding 32 (5.4) 7 (1.2)
Any bleeding 104 (17.4) 63 (10.7)
* Bleeding event occurred after the first dose and up to 2 days after the last dose of study drug. Although a patient may have had 2 or more events, the patient is counted only once in a category.
† Treatment schedule: XARELTO 20 mg once daily; matched placebo once daily‡ There were no fatal or critical organ bleeding events.
XARELTO® (rivaroxaban) tablets XARELTO® (rivaroxaban) tablets
Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery: In the RECORD clinical trials, the overall incidence rate of adverse reactions leading to permanent treatment discontinuation was 3.7% with XARELTO.
The rates of major bleeding events and any bleeding events observed in patients in the RECORD clinical trials are shown in Table 4.
Table 4: Bleeding Events* in Patients Undergoing Hip or Knee Replacement Surgeries (RECORD 1-3)
XARELTO 10 mg Enoxaparin†
Total treated patients N = 4487n (%)
N = 4524n (%)
Major bleeding event 14 (0.3) 9 (0.2)
Fatal bleeding 1 (<0.1) 0
Bleeding into a critical organ 2 (<0.1) 3 (0.1)
Bleeding that required re-operation 7 (0.2) 5 (0.1)
Extra-surgical site bleeding requiring transfusion of >2 units of whole blood or packed cells
4 (0.1) 1 (<0.1)
Any bleeding event‡ 261 (5.8) 251 (5.6)
Hip Surgery Studies N = 3281n (%)
N = 3298n (%)
Major bleeding event 7 (0.2) 3 (0.1)
Fatal bleeding 1 (<0.1) 0
Bleeding into a critical organ 1 (<0.1) 1 (<0.1)
Bleeding that required re-operation 2 (0.1) 1 (<0.1)
Extra-surgical site bleeding requiring transfusion of >2 units of whole blood or packed cells
3 (0.1) 1 (<0.1)
Any bleeding event‡ 201 (6.1) 191 (5.8)
Knee Surgery Study N = 1206n (%)
N = 1226n (%)
Major bleeding event 7 (0.6) 6 (0.5)
Fatal bleeding 0 0
Bleeding into a critical organ 1 (0.1) 2 (0.2)
Bleeding that required re-operation 5 (0.4) 4 (0.3)
Extra-surgical site bleeding requiring transfusion of >2 units of whole blood or packed cells
1 (0.1) 0
Any bleeding event‡ 60 (5.0) 60 (4.9)
* Bleeding events occurring any time following the first dose of double-blind study medication (which may have been prior to administration of active drug) until two days after the last dose of double-blind study medication. Patients may have more than one event.
† Includes the placebo-controlled period for RECORD 2, enoxaparin dosing was 40 mg once daily (RECORD 1-3)
‡ Includes major bleeding events
Following XARELTO treatment, the majority of major bleeding complications (≥60%) occurred during the first week after surgery.
Other Adverse Reactions: Non-hemorrhagic adverse reactions reported in ≥1% of XARELTO-treated patients in the EINSTEIN Extension study are shown in Table 5.
Table 5: Other Adverse Reactions* Reported by ≥1% of XARELTO-Treated Patients in EINSTEIN Extension Study
System Organ ClassPreferred Term
XARELTON = 598
n (%)
PlaceboN = 590
n (%)
Gastrointestinal disorders
Abdominal pain upper 10 (1.7) 1 (0.2)
Dyspepsia 8 (1.3) 4 (0.7)
Toothache 6 (1.0) 0
General disorders and administration site conditions
Fatigue 6 (1.0) 3 (0.5)
Infections and infestations
Sinusitis 7 (1.2) 3 (0.5)
Urinary tract infection 7 (1.2) 3 (0.5)
Musculoskeletal and connective tissue disorders
Back pain 22 (3.7) 7 (1.2)
Osteoarthritis 10 (1.7) 5 (0.8)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain 6 (1.0) 2 (0.3)
* Adverse reaction (with Relative Risk >1.5 for XARELTO versus placebo) occurred after the first dose and up to 2 days after the last dose of study drug. Incidences are based on the number of patients, not the number of events. Although a patient may have had 2 or more clinical adverse reactions, the patient is counted only once in a category. The same patient may appear in different categories.
Non-hemorrhagic adverse reactions reported in ≥1% of XARELTO-treated patients in RECORD 1-3 studies are shown in Table 6.
Table 6: Other Adverse Drug Reactions* Reported by ≥1% of XARELTO-Treated Patients in RECORD 1-3 Studies
System/Organ ClassAdverse Reaction
XARELTO10 mg
N = 4487n (%)
Enoxaparin†
N = 4524n (%)
Injury, poisoning and procedural complications
Wound secretion 125 (2.8) 89 (2.0)
Musculoskeletal and connective tissue disorders
Pain in extremity 74 (1.7) 55 (1.2)
Muscle spasm 52 (1.2) 32 (0.7)
Nervous system disorders
Syncope 55 (1.2) 32 (0.7)
Skin and subcutaneous tissue disorders
Pruritus 96 (2.1) 79 (1.8)
Blister 63 (1.4) 40 (0.9)
* Adverse reaction occurring any time following the first dose of double-blind medication, which may have been prior to administration of active drug, until two days after the last dose of double-blind study medication
† Includes the placebo-controlled period of RECORD 2, enoxaparin dosing was 40 mg once daily (RECORD 1-3)
Other clinical trial experience: In an investigational study of acute medically ill patients being treated with XARELTO 10 mg tablets, cases of pulmonary hemorrhage and pulmonary hemorrhage with bronchiectasis were observed.
Postmarketing Experience: The following adverse reactions have been identified during post-approval use of rivaroxaban. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and lymphatic system disorders: agranulocytosis, thrombocytopenia
Gastrointestinal disorders: retroperitoneal hemorrhage
Hepatobiliary disorders: jaundice, cholestasis, hepatitis (including hepatocellular injury)
Immune system disorders: hypersensitivity, anaphylactic reaction, anaphylactic shock, angioedema
Nervous system disorders: cerebral hemorrhage, subdural hematoma, epidural hematoma, hemiparesis
Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome
DRUG INTERACTIONSRivaroxaban is a substrate of CYP3A4/5, CYP2J2, and the P-gp and ATP-binding cassette G2 (ABCG2) transporters. Inhibitors and inducers of these CYP450 enzymes or transporters (e.g., P-gp) may result in changes in rivaroxaban exposure.
Drugs that Inhibit Cytochrome P450 3A4 Enzymes and Drug Transport Systems: In drug interaction studies, conducted in subjects with normal renal function, evaluating the concomitant use with drugs that are combined P-gp and CYP3A4 inhibitors (ketoconazole, ritonavir, clarithromycin, and erythromycin) or a moderate CYP3A4 inhibitor (fluconazole), increases in rivaroxaban exposure and pharmacodynamic effects (i.e., factor Xa inhibition and PT prolongation) were observed. The increases in exposure ranged from 30% to 160%. Significant increases in rivaroxaban exposure may increase bleeding risk [see Clinical Pharmacology (12.3) in full Prescribing Information].
When data suggest a change in exposure is unlikely to affect bleeding risk (e.g., clarithromycin, erythromycin), no precautions are necessary during coadministration with drugs that are combined P-gp and CYP3A4 inhibitors.
Avoid concomitant administration of XARELTO with combined P-gp and strong CYP3A4 inhibitors [see Warnings and Precautions].
Drugs that Induce Cytochrome P450 3A4 Enzymes and Drug Transport Systems: Results from drug interaction studies and population PK analyses from clinical studies indicate coadministration of XARELTO with a combined P-gp and strong CYP3A4 inducer (e.g., rifampicin, phenytoin) decreased rivaroxaban exposure by up to 50%. Similar decreases in pharmacodynamic effects were also observed. These decreases in exposure to rivaroxaban may decrease efficacy [see Clinical Pharmacology (12.3) in full Prescribing Information].
Avoid concomitant use of XARELTO with drugs that are combined P-gp and strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, St. John’s wort) [see Warnings and Precautions].
Anticoagulants and NSAIDs/Aspirin: Single doses of enoxaparin and XARELTO given concomitantly resulted in an additive effect on anti-factor Xa activity. Single doses of warfarin and XARELTO resulted in an additive effect on factor Xa
XARELTO® (rivaroxaban) tablets XARELTO® (rivaroxaban) tablets
(FXa) inhibition and PT. Concomitant aspirin use has been identified as an independent risk factor for major bleeding in efficacy trials. NSAIDs are known to increase bleeding, and bleeding risk may be increased when NSAIDs are used concomitantly with XARELTO. Coadministration of the platelet aggregation inhibitor clopidogrel and XARELTO resulted in an increase in bleeding time for some subjects [see Clinical Pharmacology (12.3) in full Prescribing Information].
Avoid concurrent use of XARELTO with other anticoagulants due to increased bleeding risk unless benefit outweighs risk. Promptly evaluate any signs or symptoms of blood loss if patients are treated concomitantly with aspirin, other platelet aggregation inhibitors, or NSAIDs [see Warnings and Precautions].
Drug-Disease Interactions with Drugs that Inhibit Cytochrome P450 3A4 Enzymes and Drug Transport Systems: Results from a pharmacokinetic trial with erythromycin indicated that patients with renal impairment coadministered XARELTO with drugs classified as combined P-gp and moderate CYP3A4 inhibitors (e.g., diltiazem, verapamil, dronedarone, and erythromycin) have increased exposure compared with patients with normal renal function and no inhibitor use. Significant increases in rivaroxaban exposure may increase bleeding risk.
While increases in rivaroxaban exposure can be expected under such conditions, results from an analysis in the ROCKET AF trial, which allowed concomitant use with either combined P-gp and/or weak or moderate CYP3A4 inhibitors (e.g., amiodarone, diltiazem, verapamil, chloramphenicol, cimetidine, and erythromycin), did not show an increase in bleeding in patients with CrCl 30 to <50 mL/min [Hazard Ratio (95% CI): 1.05 (0.77, 1.42)] [see Use in Specific Populations].
XARELTO should not be used in patients with CrCl 15 to <80 mL/min who are receiving concomitant combined P-gp and moderate CYP3A4 inhibitors (e.g., diltiazem, verapamil, dronedarone, and erythromycin) unless the potential benefit justifies the potential risk [see Clinical Pharmacology (12.3) in full Prescribing Information].
USE IN SPECIFIC POPULATIONSPregnancy: Pregnancy Category C: There are no adequate or well-controlled studies of XARELTO in pregnant women, and dosing for pregnant women has not been established. Use XARELTO with caution in pregnant patients because of the potential for pregnancy related hemorrhage and/or emergent delivery with an anticoagulant that is not readily reversible. The anticoagulant effect of XARELTO cannot be reliably monitored with standard laboratory testing. Animal reproduction studies showed no increased risk of structural malformations, but increased post-implantation pregnancy loss occurred in rabbits. XARELTO should be used during pregnancy only if the potential benefit justifies the potential risk to mother and fetus [see Warnings and Precautions].
Rivaroxaban crosses the placenta in animals. Animal reproduction studies have shown pronounced maternal hemorrhagic complications in rats and an increased incidence of post-implantation pregnancy loss in rabbits. Rivaroxaban increased fetal toxicity (increased resorptions, decreased number of live fetuses, and decreased fetal body weight) when pregnant rabbits were given oral doses of ≥10 mg/kg rivaroxaban during the period of organogenesis. This dose corresponds to about 4 times the human exposure of unbound drug, based on AUC comparisons at the highest recommended human dose of 20 mg/day. Fetal body weights decreased when pregnant rats were given oral doses of 120 mg/kg. This dose corresponds to about 14 times the human exposure of unbound drug.
Labor and Delivery: Safety and effectiveness of XARELTO during labor and delivery have not been studied in clinical trials. However, in animal studies maternal bleeding and maternal and fetal death occurred at the rivaroxaban dose of 40 mg/kg (about 6 times maximum human exposure of the unbound drug at the human dose of 20 mg/day).
Nursing Mothers: It is not known if rivaroxaban is excreted in human milk. Rivaroxaban and/or its metabolites were excreted into the milk of rats. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from rivaroxaban, a decision should be made whether to discontinue nursing or discontinue XARELTO, taking into account the importance of the drug to the mother.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: Of the total number of patients in the RECORD 1-3 clinical studies evaluating XARELTO, about 54% were 65 years and over, while about 15% were >75 years. In ROCKET AF, approximately 77% were 65 years and over and about 38% were >75 years. In the EINSTEIN DVT, PE and Extension clinical studies approximately 37% were 65 years and over and about 16% were >75 years. In clinical trials the efficacy of XARELTO in the elderly (65 years or older) was similar to that seen in patients younger than 65 years. Both thrombotic and bleeding event rates were higher in these older patients, but the risk-benefit profile was favorable in all age groups [see Clinical Pharmacology (12.3) and Clinical Studies (14) in full Prescribing Information].
Females of Reproductive Potential: Females of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician.
Renal Impairment: In a pharmacokinetic study, compared to healthy subjects with normal creatinine clearance, rivaroxaban exposure increased by approximately 44 to 64% in subjects with renal impairment. Increases in pharmacodynamic effects were also observed [see Clinical Pharmacology (12.3) in full Prescribing Information].
Nonvalvular Atrial Fibrillation: In the ROCKET AF trial, patients with CrCl 30 to 50 mL/min were administered XARELTO 15 mg once daily resulting in serum concentrations of rivaroxaban and clinical outcomes similar to those in patients with better renal function administered XARELTO 20 mg once daily. Patients with CrCl 15 to 30 mL/min were not studied, but administration of XARELTO 15 mg once daily is also expected to result in serum concentrations of rivaroxaban similar to those in patients with normal renal function [see Dosage and Administration (2.3) in full Prescribing Information].
Treatment of DVT and/or PE, and Reduction in the Risk of Recurrence of DVT and of PE: In the EINSTEIN trials, patients with CrCl values <30 mL/min at screening were excluded from the studies. Avoid the use of XARELTO in patients with CrCl <30 mL/min.
Prophylaxis of DVT Following Hip or Knee Replacement Surgery: The combined analysis of the RECORD 1-3 clinical efficacy studies did not show an increase in bleeding risk for patients with CrCl 30 to 50 mL/min and reported a possible increase in total venous thromboemboli in this population. Observe closely and promptly evaluate any signs or symptoms of blood loss in patients with CrCl 30 to 50 mL/min. Avoid the use of XARELTO in patients with CrCl <30 mL/min.
Hepatic Impairment: In a pharmacokinetic study, compared to healthy subjects with normal liver function, AUC increases of 127% were observed in subjects with moderate hepatic impairment (Child-Pugh B).
The safety or PK of XARELTO in patients with severe hepatic impairment (Child-Pugh C) has not been evaluated [see Clinical Pharmacology (12.3) in full Prescribing Information].
Avoid the use of XARELTO in patients with moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment or with any hepatic disease associated with coagulopathy.
OVERDOSAGE: Overdose of XARELTO may lead to hemorrhage. Discontinue XARELTO and initiate appropriate therapy if bleeding complications associated with overdosage occur. A specific antidote for rivaroxaban is not available. Rivaroxaban systemic exposure is not further increased at single doses >50 mg due to limited absorption. The use of activated charcoal to reduce absorption in case of XARELTO overdose may be considered. Due to the high plasma protein binding, rivaroxaban is not expected to be dialyzable [see Warnings and Precautions and Clinical Pharmacology (12.3) in full Prescribing Information]. Partial reversal of laboratory anticoagulation parameters may be achieved with use of plasma products.
Active Ingredient Made in Germany
Finished Product Manufactured by:Janssen Ortho, LLCGurabo, PR 00778
or
Bayer Pharma AG51368 Leverkusen, Germany
Manufactured for:Janssen Pharmaceuticals, Inc.Titusville, NJ 08560
Licensed from:Bayer HealthCare AG51368 Leverkusen, Germany
© Janssen Pharmaceuticals, Inc. 2011
038576-150812
XARELTO® (rivaroxaban) tablets XARELTO® (rivaroxaban) tablets
MedicalEconomics.com MEDICAL ECONOMICS ❚ JUNE 10, 2016 33
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codes (99495 and 99496)
in the CPT codebook. It
the first required visit can
be billed separately, you
should only have to worry
about billing the first office.
Q: Can TCM services
be reported under the
primary care excep-
tion? Can the services
be reported with the
GC modifier?
A: TCM services are not on
the primary care exception
list, so the general teaching
physician policy would not
apply.
Therefore, do not use
modifier GC (Service has
been performed in part by
a Resident under the direc-
tion of a teaching physician).
When a physician places
the GC modifier on the
claim, he/she is certifying
that the teaching physi-
cian has complied with the
Teaching Physician require-
ments.
explains what to do if you
aren’t able to fulfill the codes’
direct-contact requirement.
Specifically, it reads:
“If two or more separate
attempts are made in a
timely manner but are
unsuccessful and other
transitional care manage-
ment criteria are met, the
service may be reported.”
Since the coding tip
seems to only be focused
on the use of modifier 54 in
a post-op period, it’s easy to
miss this piece of informa-
tion. However, it can be
very helpful when trying to
bill these codes.
However, make sure
you check with your local
Medicare Administrative
Contractor (MAC) to see
whether they adhere to the
CPT policy. While this rule
covers you for commercial
payers, it’s important to
remember that Medicare
Learning Network fact
sheet 908628 states,
“For Medicare purposes,
attempts to communicate
should continue after the
first two attempts in the
required two business days
until they are successful.”
Q: Can TCM services
be reported if the
patient dies prior to
the 30th day following
discharge?
A: Because the TCM codes
describe 30 days of care,
in cases when the patient
dies prior to the 30th day,
you should not report TCM
services. However, you can
report any face-to-face visits
that occurred under the
appropriate evaluation and
management (EM) code.
Since all EM codes after
Transitional care managementBilling and coding it the right way
Renee Dowling, is a billing and coding consultant with VEI Consulting in Indianapolis, Indiana. Send your billing and coding questions to: [email protected].
by RENEE DOWLING Contributing author
Our office is having a
difficult time reaching
patients within the
required two business
days from discharge
for transitional care management
(TCM) codes. Will this preclude
us from billing the codes when
all of the other criteria are met?
The fate of Obamacare: What the candidates will do to healthcare reform Page 54MORE AHEAD
Q
MedicalEconomics.com34
IN DEPTH
MEDICAL ECONOMICS ❚ JUNE 10, 2016
by CHARLOTTE HUFF Contributing author
Understand the clinical and legal risks surrounding these plans that require patients to pay more up front
How physicians can dealwith high-deductible plans
HIGH-DEDUCTIBLE PLANS are more com-mon in Lloyd Van Winkle’s practice these days and the South Texas family physician has also noticed more monetary pushback from patients to some of his treatment rec-ommendations as a result.
In one case, Van Winkle referred a patient for a colonoscopy to check out the source of rectal bleeding. But the patient put off scheduling the test citing the upfront out-of-pocket costs, his staff learned when they followed up. Th ree months later the patient called, describing a toilet bowl fi lled with blood, and was sent to the emergency de-partment. Th e problem turned out to be a vascular abnormality in the patient’s colon, says Van Winkle, who practices in Castro-ville, Texas.
Th e result, he says, was a partial colec-tomy and a hospital admission that “could have probably been prevented or at least managed less emergently if [the patient] had been seen early on.”
Hefty deductibles, relatively scarce a de-cade ago, have become a familiar feature on insurance policies off ered by employers or sold through the Aff ordable Care Act (ACA)
exchanges. Increasingly doctors describe related fi nancial resistance. Patients might balk at once routine preventive visits or postpone additional testing to either iden-tify or rule out a medical problem. While fi nancial diffi culties are nothing new, high deductible plans add a new cadre of patients who might take risks that delay diagnosis, potentially exposing the doctor to a mal-practice suit. How can physicians do best by their patients medically while still protect-ing themselves legally?
Th e deductible “creates an economic dis-incentive to get treatment for the patient,” says Rob Francis, MBA, chief operating of-fi cer of Th e Doctors Company, a medical malpractice insurer. “But yet the physician is held to the same standards of care that they always were.”
Along with educating patients about why a particular treatment recommendation is important, doctors should be extra careful to document that conversation in the medi-cal record, Francis says. Th at note should include why a test or referral is being recom-mended, and that the patient declined due to economic or in-
HIGHLIGHTS
Practices should
standardize their
procedures and policies
for circumstances
when a patient declines
treatment due to cost
concerns.
Operations
37
MedicalEconomics.com 37 MEDICAL ECONOMICS ❚ JUNE 10, 2016
surance reasons, Francis says. “What the patient’s response
was is the important part here,” he says.Practices also should standardize their
procedures for such circumstances, says Ericka Adler, JD, a Chicago-based partner at Roetzel & Andress who focuses on regu-latory and transactional healthcare law. Pa-tients should routinely be asked about the extent of their deductible, financial hard-ship should be documented if relevant and new doctors and other staff educated about these procedures as they join the practice, she says. “The only thing that can protect you is having a game plan.”
RISKING PREVENTATIVE CARE?In 2015, 24% of people with employer-pro-vided insurance were enrolled in a high-deductible plan with some sort of savings option, such as a health savings account, compared with 13% in 2010, according to the latest annual benefits survey by the Kaiser Family Foundation and the Health Research & Educational Trust (HRET). De-ductibles also figure on the exchanges, par-ticularly in the bronze plans as a tradeoff for lower monthly premiums.
As these high-deductible plans—some of which don’t include a savings account option— are becoming more prevalent, the treatment fallout is still being gauged. But signs of financial discomfort are emerging. Two out of every five adults with a deduct-ible considered to be high—defined as 5% or more of their total income—reported curtailing medical care in some way, accord-ing to a Commonwealth Fund 2015 analysis based on data from slightly more than 1,600 insured adults. Slightly more than one-fourth of patients struggling with deduct-ibles had skipped a medical test, treatment
or other follow-up measure recommended by their doctor. One-fifth reported not get-ting a medical problem checked out.
Among emergency physicians, 70% said they had treated patients who have delayed care due to high out-of-pocket costs, ac-cording to 1,432 surveyed last fall for the American College of Emergency Physicians (ACEP). “We see them in the emergency department once they start to decompen-sate because they haven’t been able to get that care,” says Ryan Stanton, MD, an ACEP spokesman and emergency physician in Lexington, Kentucky.
David Margolius MD, an internist in Cleveland, Ohio, wonders about those pa-tients who rarely cross his office threshold in the first place. “I know that these folks exist,” says Margolius, medical director of the outpatient internal medicine practice at MetroHealth, the county-operated hospi-tal system. “But they come much less often to primary care because they’d probably be paying for the entire visit out of pocket.”
Late in 2015, Margolius noticed an uptick in patients who he hadn’t seen previously, who he assumed had run through their de-ductible by then. But if they couldn’t be re-ferred for additional care until after January 1, they didn’t want to pursue it, he says. “Be-cause then their deductible starts all over.”
In Van Winkle’s experience, patient choic-es depend on how familiar they are with the deductible. If they are new to the insurance design, he says, they will wince the first time or two that they have to pay the full bill for the office visit. As those office visit bills stack up, and patients realize by mid-year that they’ve already exceeded their total out-of-pocket expenses for the entire prior year, he says, “they start to try to fall off the standard of care for monitoring different disease pro-
High-deductible plans Operations
34
[The deductible] creates an economic disincentive to get treatment for the patient. But yet the physician
is held to the same standards of care that they always were.”—ROB FRANCIS, MBA, CHIEF OPERATING OFFICER, THE DOCTORS COMPANY
MedicalEconomics.com38 MEDICAL ECONOMICS ❚ JUNE 10, 2016
Operations High-deductible plans
cesses. And they’re just not showing.” What’s particularly ironic is that patients
are being asked to pay a lot more upfront to see the doctor at the same time that federal officials and other leaders are promoting concepts such as patient-centered medical homes or accountable care organizations in an effort to boost the cost-effectiveness of primary care, says Peter V. Lee, JD executive director of Covered California, California’s healthcare insurance exchange.
“It’s totally backwards from the direction that we want to go,” says Lee, who co-au-thored a related perspective piece published March 10 in the New England Journal of Medicine (NEJM). The result, he says, is that doctors will be “swimming upstream to con-vince their patients to not skip visits.”
One approach, Lee says, is to describe to the patient how they might risk a much steeper bill if they postpone visits or care in the short term. For example, a patient
with diabetes might be reluctant to return for quarterly foot exams at more than $100 per office visit, he says. On the doctor’s part, it’s worth an attempt to explain that a little money invested upfront in office visits ide-ally will avoid landing in the hospital with a painful and costly foot amputation, Lee says.
But fight the temptation to waive fees in the face of high deductibles, Adler cautions. Doctors might do so with the best of inten-tions, she says, but they risk violating either their insurance contracts or federal and state laws. “Doctors are kind of caught in the middle between wanting to do a good thing and not wanting to violate the law,” she says.
NEGOTIATING DEDUCTIBLE DETERRENTSWhen high deductibles emerged, Adler ad-vised her clients to get some paperwork in place and make it a routine part of their practice. First, patients should be asked to
THE RISE OF HIGH-DEDUCTIBLES Percentage of patients with employer-sponsored health plans with a deductible greater than $1,000
Source: Employer Health Benefits: 2015 Annual Survey; Kaiser Family Foundation and Health Research & Educational Trust
10%
20%
30%
40%
50%
60%
70%
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
Employees of small firms, 3 to 199 workers
Employees of large firms, more than 200 workers
Employees of all firms
MedicalEconomics.com 39 MEDICAL ECONOMICS ❚ JUNE 10, 2016
OperationsHigh-deductible plans
sign a document verifying that they are re-sponsible for co-pays and deductibles. Pa-tients who realize upfront they can’t handle the expense can be referred to publicly fund-ed programs and charitable institutions.
If an existing patient hits a rough patch fi-nancially, doctors can waive fees if they doc-ument financial hardship for that patient, Adler says. But that entails the patient pro-viding financial information and that hard-ship status should be reviewed periodically as circumstances might change, she says.
When a doctor must refer a patient to an-other specialist or for a test, they lose any in-fluence over the out-of-pocket costs, Francis says. In cases where patients resist, doctors should be sure to document the differential diagnosis and why the additional care is rec-ommended, he says.
One approach is to draft a separate note, including the reason for the patient’s refusal, and request that the patient sign a printed copy or indicate in the electronic health re-cord that it’s been read, Francis says. “I think it would be a pretty strong defense if a phy-sician has made the appropriate note that the patient had the choice, and chose not to pursue that particular test,” he says. “And the patient has had an opportunity to review that note, and didn’t disagree with it.”
The practice also should regularly follow up to encourage the patient to get the ap-propriate test or other recommended care, Adler says. But she cautions against relying on electronic notifications, such as through a patient portal, to communicate with the patient. There’s no guarantee, she notes, that the electronic messages will ever be opened.
AVOIDING FISCAL MALPRACTICEAs patients and doctors discuss care op-tions, it’s important that they don’t make erroneous assumptions about how the de-ductible works for specific plans, Lee says. Not all deductibles require out-of-pocket payment for all services except for an annual physical and a few tests, such as a vaccine or a mammogram, he says.
More than 80% of consumers who pur-chased plans on the ACA exchanges in 2015 chose policies in which some health services (beyond preventive care like cancer screen-ings) were covered before meeting the de-ductible, including 53% of consumers on bronze plans, according to the Centers for Medicare & Medicaid Services. In Covered
California, all bronze plan enrollees can get one free primary care visit and three other visits that aren’t subject to the deductible, according to the NEJM perspective piece.
Lee maintains that physicians also are engaging in a form of fiscal malpractice if they don’t make a concerted effort to iden-tify more affordable locations for common tests and referrals. Otherwise a patient who is referred for a CT scan might blanch at the cost and skip it entirely. That decision not only undermines the patient’s care, but po-tentially his or her relationship with the doc-tor, Lee says. How can you think your doctor is looking out for you, he asks, if they send you to a place that you can’t afford?
Meanwhile, doctors like Van Winkle do their best to navigate this new high-deduct-ible landscape with their patients. He re-counts another story, one involving a man with a basal cell skin cancer on his ear. The typical approach would be to refer him to a dermatologist for Mohs surgery. But the pa-tient couldn’t afford the $1,000-plus derma-tology bill: the cancer was frozen instead in Van Winkle’s office.
Although it’s a less-costly procedure, the cancer is more likely to recur, so Van Winkle is very closely following the patient. In cases where Van Winkle hits high-deductible re-sistance, he says, “the obvious thing is you have to document the fact that you made the assessment, and you made the referral.”
Patients are free to refuse treatment for whatever reason, Van Winkle says. But with these high-deductible plans, he says, it’s not the patient’s choice. “That’s disturbing. That goes against the grain of most docs.”
I know that these folks exist. But they come much less often
to primary care because they’d probably be paying for the entire visit out of pocket.”— DAVID MARGOLIUS MD, INTERNIST, CLEVELAND, OHIO
MedicalEconomics.com 41
IN DEPTH
MEDICAL ECONOMICS ❚ JUNE 10, 2016
Technology
by KEN TERRY Contributing author
Experts explore the operational requirements, from care coordination to patient engagement
POPULATION HEALTH
Making it work
AS VALUE-BASED reimbursement grows in importance, physicians must learn how to manage the health of their patient popula-tions to lower costs and improve quality. While a small or medium-sized practice can do only part of this on its own, there are sev-eral core competencies that all practices and ACOs must master in order to manage population health.
Th ey must be able to:
❚ proactively address the health needs of their
whole patient population or at least all high-
risk patients,
❚ manage and coordinate care both during and
between visits,
❚ engage patients in their own care and reach
out to those with care gaps,
❚ measure quality and effi ciency and report on
quality measures, and
❚ develop a viable business model that will
eventually produce a return on investment.
PHM BASICSAll of the organizations in our sample have concentrated on building patient-centered medical homes (PCMHs). Th is is partly because primary care is central to PHM, and because a PCMH recognized by the National Committee on Quality Assurance (NCQA) must include several basic PHM components. Among these are expanded access to providers, the use of care teams, care coordination across care settings,eff ective management of care transitions and performance measurement.
THE FUTURE OF MEANINGFUL USE
While the program will end, another electronic health record incentive program will take its place. [51]
HIGHLIGHTS
Population health
management turns
the business model
of fee-for-service
medicine upside down.
Every service that a
practice provides and
every facility and piece
of equipment is a cost
center when a group
takes fi nancial risk for
care.
Third in a series This is the last of three parts on population health management (PHM). Part one, which ran in the May 10 issue of Medical Economics, discussed the challenges facing physicians. Part two, featured in the May 25 issue, explored the technological tools available to support PHM, how to select the right solutions, and what to do with them. Here, experts explore the operational requirements for PHM, especially in the areas of health monitoring, care coordination, and patient engagement.
MedicalEconomics.com42 MEDICAL ECONOMICS ❚ JUNE 10, 2016
Technology
Beacon Health Partners, a 700-doctor ACO on New York’s Long Island has helped about 20 primary care practices transform themselves into PCMHs and achieve NCQA recognition. “Whether you become an NCQA-recognized medical home or not, what’s important is to use some of those [PCMH] principles: coordinate care in a practice, have huddles, have care team mem-bers work to the top level of their license, em-power MAs [medical assistants] and other people to deliver care,” points out Simon Prince, MD, the ACO’s cofounder and its for-mer president and chief executive officer.
The groups we interviewed tried to ad-dress the needs of their entire patient population to varying extents. Beacon, for example, has focused its care management resources on high-risk patients, because it hasn’t had the “bandwidth” to coordinate care for patients who are less sick, notes Prince. (Catholic Health Services, a local healthcare system, recently acquired Bea-con, so that might change.)
In contrast, Bon Secours Virginia Medi-cal Group (BSVMG) in Richmond, Virginia, a 624-provider group that includes an ACO, uses care coordinators and information technology to reach out to its entire patient population. Robert Fortini, PNP, the group’s chief clinical officer, says this not only im-proves care but also leads to better financial outcomes under value-based contracts.
MULTI-DISCIPLINARY CARE TEAMSCare teams are generally defined as prac-tice units that include clinicians and other staff members. But an increasing number of healthcare organizations recognize that to perform PHM effectively, their care teams must integrate other professionals both with-in their practices and in other care settings.
Fortini is a proponent of multidisciplinary care teams, including pharmacists, dieti-
cians, physician assistants and nurse prac-titioners. “There are many aspects of health-care you could do more effectively with such teams,” he says.
Along with a growing number of health-care leaders, Fortini also sees the value of co-locating behavioral health specialists in primary care practices. “If you put a clini-cal psychologist into a primary care office and you attack diabetes from the behavioral health component and the medical com-ponent of that condition, your success rate goes up exponentially,” he says.
Some practices are also incorporating so-cial workers to help patients overcome the social, economic and physical environmen-tal factors that contribute to their illnesses and their inability to get better. According to the World Health Organization, these social determinants of health account for up to half of the variance in individual health.
Jennifer Brull, MD, a family physician who practices with four colleagues in Plain-ville, Kansas, notes that her group, a recog-nized PCMH, has hired a care coordinator who is also a licensed social worker. She finds solutions for patients who can’t afford their medications, assists them in finding transportation, and even helped one wom-an get state aid so she could heat her house. “That’s been very helpful for us,” Brull says.
CARE MANAGEMENTNurse care managers, sometimes called care coordinators or care navigators, are the linchpin of PHM. But this important role varies a great deal from one practice or healthcare organization to another. PHM participants disagree on how best to use care coordinators and how many of them are needed.
At New West Physicians, a 100-provider primary care group in Denver, Colorado, physicians function
Population health, part 3
47
In the new world order, [nurse practitioners or case managers] could be incredibly important team members.
They could help you on the road from volume to value.”DAVID NASH, MD, DEAN, THE COLLEGE OF POPULATION HEALTH, THOMAS JEFFERSON UNIVERSITY, PHILADELPHIA, PENNSYLVANIA
Introducing FLUAD™, a next-generation fl u shot for the 65+ generation. Because people 65 and older can have weakened immune systems, they could benefi t from a fl u vaccine created especially for their generation.1,2 FLUAD was shown in clinical trials to provide a strong immune response and have an acceptable safety profi le.2 Today, the 65+ generation is less concerned about being hip and more concerned about being healthy. FLUAD was designed specifi cally to help them stay that way.2 Right on!
Get in the groove, choose FLUAD for your patients 65+.
INDICATIONS
FLUAD is an inactivated infl uenza vaccine indicated for active immunization against infl uenza disease caused by infl uenza virus subtypes A and type B contained in the vaccine. FLUAD is approved for use in persons 65 years of age and older.
CONTRAINDICATIONS
Severe allergic reaction to any component of the vaccine, including egg protein, or after a previous dose of any infl uenza vaccine.
WARNINGS AND PRECAUTIONS
• If Guillain-Barré Syndrome (GBS) has occurred within six weeks of previous infl uenza vaccination, the decision to
give FLUAD should be based on careful consideration of the potential benefi ts and risks.
• The tip caps of the prefi lled syringes contain natural rubber latex which may cause allergic reactions in latex sensitive individuals.
ADVERSE REACTIONS
• The most common (≥10%) local (injection site) adverse reactions observed in clinical studies were injection site pain (25%) and tenderness (21%).
• The most common (≥10%) systemic adverse reactions observed in clinical studies were myalgia (15%), headache (13%) and fatigue (13%).
IMPORTANT SAFETY INFORMATION2
Please see Brief Summary of Prescribing Information for FLUAD adjacent to this ad.
To learn more, visit www.fluad.com.
References: 1. What you should know and do this fl u season if you are 65 years and older. Centers for Disease Control and Prevention website. http://www.cdc.gov/fl u/about/disease/65over.htm. Updated 2015. Accessed November 11, 2015. 2. FLUAD [package insert]. Cambridge, MA: Novartis Vaccines and Diagnostics, Inc.; 2015.
Novartis Vaccines and Diagnostics, Inc.East Hanover, New Jersey 07936-1080 © 2015 Novartis Vaccines and Diagnostics, Inc. November 2015 GMCC-643_2015-11-23
FLUAD (Influenza Vaccine, Adjuvanted) Suspension for Intramuscular Injection 2015-2016 Formula Initial U.S. Approval: 2015
BRIEF SUMMARY: See package insert for full prescribing information.
1 INDICATIONS AND USAGE
FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is approved for use in persons 65 years of age and older. Approval is based on the immune response elicited by FLUAD. Data demonstrating a decrease in influenza disease after vaccination with FLUAD are not available. [see Clinical Studies (14)]
4 CONTRAINDICATIONS
Do not administer FLUAD to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine, including egg protein [see Description (11)], or to a previous influenza vaccine.
5 WARNINGS AND PRECAUTIONS
5.1 Guillain-Barré Syndrome
If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FLUAD should be based on careful consideration of the potential benefits and risks. The 1976 swine influenza vaccine was associated with an elevated risk of GBS. Evidence for a causal relationship of GBS with other influenza vaccines is inconclusive; if an excess risk exists, it is probably slightly more than 1 additional case per 1 million persons vaccinated. [see References (1)]
5.2 Preventing and Managing Allergic Reactions
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
5.3 Latex
The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions in latex sensitive individuals. [see Description (11)]
5.4 Altered Immunocompetence
The immune response to FLUAD in immunocompromised persons, including individuals receiving immunosuppressive therapy, may be lower than in immunocompetent individuals. [see Concurrent Use With Immunosuppressive Therapies (7.2)]
5.5 Syncope
Syncope (fainting) may occur in association with administration of injectable vaccines including FLUAD. Ensure procedures are in place to avoid injury from falling associated with syncope.
5.6 Limitations of Vaccine Effectiveness
Vaccination with FLUAD may not protect all vaccine recipients against influenza disease.
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect rates observed in clinical practice.
Solicited adverse reactions were assessed in a multicenter, observer-blind, randomized controlled study (Study 1) conducted in the United States, Colombia, Panama and the Philippines. The safety analysis set included 3545 FLUAD recipients and 3537 AGRIFLU (Influenza Vaccine) recipients. The enrolled subject population in Study 1 was 65 to 97 years of age (mean 72 years) and 64% were female. Within each treatment group, 53% were Asian, 28% were Caucasian, 18% were Hispanic, 1% were Black, and fewer than 1% each were Native American/Alaskan, Pacific Islander/Hawaiian, or Other.
Solicited local (injection site) and systemic adverse reactions were collected from subjects in Study 1 who completed a symptom diary card for seven days following vaccination. The reported frequencies of solicited local and systemic adverse events from Study 1 are presented in Table 1.
Table 1. Percentages of Subjects ≥ 65 Years of
Age With Solicited Local and Systemic Adverse
Reactions in Days 1-7 After Administration of
FLUAD or AGRIFLU (a U.S. Licensed Comparator)
NCT01162122
Study 1
FLUAD
(Na=3418-3496)
Percentage
AGRIFLU
(Na=3420-3488)
Percentage
Local
Injection site
Pain
Any 25.0 12.2
Moderateb 3.9 1.9
Severec 0.3 0.2
Tenderness
Any 21.1 11.2
Moderate 3.0 1.0
Severe 0.1 0.2
Erythema
Any 1.2 0.5
25 to ≤ 50 mm 1.1 0.5
51 to ≤ 100 mm 0.2 <0.1
> 100 mm 0.0 0.0
Induration
Any 1.3 0.5
25 to ≤ 50 mm 1.0 0.5
51 to ≤ 100 mm 0.3 0.0
> 100 mm 0.0 0.0
Swelling
Any 1.2 0.4
25 to ≤ 50 mm 1.0 0.4
51 to ≤ 100 mm 0.2 <0.1
> 100 mm <0.1 0.0
a N = number of subjects with safety data.
b Moderate: pain, tenderness, myalgia, fatigue, headache,
arthralgia, chills, nausea, vomiting defined as “some limitation in
normal daily activity”, diarrhea defined as “4 to 5 stools a day”.
c Severe: pain, tenderness, myalgia, fatigue, headache,
arthralgia, chills, nausea, vomiting defined as “unable to
perform normal daily activity”, diarrhea defined as “6 or more
watery stools a day”.
d Potentially life threatening (PLT) reaction defined as requiring
emergency room visit or hospitalization.
Unsolicited Adverse Events (AEs): The clinical safety of FLUAD was assessed in fifteen (15) randomized, controlled studies. The total safety population in these trials included 10,952 adults 65 years
of age and older, comprising 5,754 who received FLUAD and 5,198 who received other US licensed influenza vaccines. The percentage of subjects with an unsolicited AE within 30 days following vaccination was similar between vaccine groups (16.9% FLUAD vs. 18.0% active comparator).
Serious Adverse Events (SAEs) and Deaths: In Study 1, in which subjects were followed for SAEs and deaths for one year following vaccination (N=3,545 FLUAD, N=3,537 AGRIFLU), the percentages of subjects with an SAE were similar between vaccine groups (7% FLUAD vs. 7% AGRIFLU). Four SAEs (1 FLUAD and 3 AGRIFLU) were assessed as related to study vaccination over one year of observation and 2 of these occurred (1 FLUAD and 1 AGRIFLU) within 21 days following study vaccination. There were 98 deaths (n=52 FLUAD, n=46 AGRIFLU) over one year of which none occurred within the first 21 days following vaccination.
In 14 additional randomized, controlled studies, SAEs were collected over a 3 to 4-week period in 4 studies, over a 8-week period in 1 study, and over a 6-month period in 9 studies (N= 2,209 FLUAD, N=1,661 US licensed influenza vaccines). The percentages of subjects with an SAE within 30 days (1.1% FLUAD vs. 1.8% AGRIFLU) or within 6 months (4.3% FLUAD vs. 5.9% AGRIFLU) were similar between vaccine groups. The percentages of deaths within 30 days (0.3% FLUAD vs. 0.6% active comparator) or within 6 months (1.0% FLUAD vs. 1.5% active comparator) were also similar.
Adverse Events of Special Interest (AESIs): Rates of new onset neuroinflammatory and immune mediated diseases were assessed in a post hoc analysis of the 15 randomized controlled studies over the time periods specified above for SAEs. The percentage of subjects with an AESI at any time after vaccination was similar between vaccine groups (0.9% FLUAD vs. 0.9% active comparator). There were no notable imbalances for specific AESIs.
Safety of Annual Revaccination: In 5 of the randomized, controlled trials, subjects were followed for SAEs and deaths for 6 months following revaccination (N=492 FLUAD, N=330 US licensed and non-US licensed influenza vaccines). After the second annual vaccination, the percentages of subjects with an SAE were similar between vaccine groups (6.1% FLUAD vs. 5.5% comparator influenza vaccines); 23 deaths (n=17 FLUAD, n=6 comparator influenza vaccines) were reported. Causes of death included cardiovascular events, malignancy, trauma, gastrointestinal disorders, and respiratory failure. Clinical characteristics of the deaths, including the variable causes, timing since vaccination, and underlying medical conditions, do not provide evidence for a causal relationship with FLUAD.
6.2 Postmarketing Experience
The following adverse events have been spontaneously reported during post-approval use of FLUAD in Europe and other regions since 1997.
Systemic
Myalgia
Any 14.7 9.7
Moderate 2.6 1.8
Severe 0.3 0.7
Fatigue
Any 13.3 10.4
Moderate 3.1 2.4
Severe 0.4 0.6
PLTd 0.0 <0.1
Headache
Any 13.2 11.2
Moderate 3.0 2.6
Severe 0.4 0.6
PLT 0.0 <0.1
Arthralgia
Any 8.5 7.8
Moderate 1.6 1.6
Severe 0.2 0.6
Chills
Any 6.7 4.7
Moderate 1.5 1.2
Severe 0.3 0.3
PLT <0.1 0.0
Diarrhea
Any 4.8 4.5
Moderate 1.3 0.9
Severe 0.3 0.2
PLT <0.1 <0.1
Fever
Any 3.6 3.4
≥ 38.0°C to ≤ 38.4°C
1.8 1.7
≥ 38.5°C to ≤ 38.9°C
1.3 1.3
39.0°C to ≤ 40.0°C
0.4 0.4
≥ 40.0°C 0.1 0.0
Nausea
Any 2.9 2.8
Moderate 0.4 0.6
Severe 0.1 0.1
PLT <0.1 0.0
Vomiting
Any 1.4 1.7
Moderate 0.4 0.5
Severe <0.1 0.1
PLT <0.1 0.0
Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine.
Blood and lymphatic system disorders:
Thrombocytopenia (some cases were severe with platelet counts less than 5,000 per mm3), lymphadenopathy
General disorders and administration site
conditions:
Extensive swelling of injected limb lasting more than one week, injection site cellulitis-like reactions (some cases of swelling, pain, and redness extending more than 10 cm and lasting more than 1 week)
Immune system disorders:
Allergic reactions including anaphylactic shock, anaphylaxis and angioedema
Musculoskeletal and connective tissue disorders:
Muscular weakness
Nervous system disorders:
Encephalomyelitis, Guillain-Barré Syndrome, convulsions, neuritis, neuralgia, paraesthesia, syncope, presyncope
Skin and subcutaneous tissue disorders:
Generalized skin reactions including erythema multiforme, urticaria pruritus or non-specific rash
Vascular disorders:
Vasculitis with transient renal involvement
7 DRUG INTERACTIONS
7.1 Concomitant Use With Other Vaccines
There are no data to assess the concomitant administration of FLUAD with other vaccines. If FLUAD is to be given at the same time as other injectable vaccine(s), the vaccine(s) should be administered at different injection sites.
Do not mix FLUAD with any other vaccine in the same syringe.
7.2 Concurrent Use With Immunosuppressive
Therapies
Immunosuppressive or corticosteroid therapies may reduce the immune response to FLUAD.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category B: A reproductive and developmental toxicity study has been performed in rabbits with a dose level that was approximately 15 times the human dose based on body weight. The study revealed no evidence of impaired female fertility or harm to the fetus due to FLUAD. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this vaccine should be used during pregnancy only if clearly needed.
In a reproductive and developmental toxicity study, the effect of FLUAD on embryo-fetal and post-natal development was evaluated in pregnant rabbits.
Animals were administered FLUAD by intramuscular injection twice prior to gestation, during the period of organogenesis (gestation day 7) and later in pregnancy (gestation day 20), 0.5 mL (45 mcg)/rabbit/occasion (approximately 15-fold excess relative to the adult human dose based on body weight). No adverse effects on mating, female fertility, pregnancy, embryo-fetal development, or post-natal development were observed. There were no vaccine-related fetal malformations or other evidence of teratogenesis.
8.4 Pediatric Use
The safety and effectiveness of FLUAD in the pediatric population has not been established.
8.5 Geriatric Use
Safety and immunogenicity of FLUAD have been evaluated in adults 65 years of age and older. [See Adverse Reactions (6.1) and Clinical Studies (14)]
FLUAD is a registered trademark of Novartis Vaccines and Diagnostics, Inc.
Manufactured by: Novartis Vaccines and Diagnostics Limited.
An affiliate of: Novartis Vaccines and Diagnostics, Inc., 350 Massachusetts Avenue, Cambridge, MA USA 02139 1-855-358-8966
MedicalEconomics.com 47 MEDICAL ECONOMICS ❚ JUNE 10, 2016
OPTIMIZING CARE MANAGEMENTealthcare organiza-
tions are divided
on whether they
should base care
managers centrally
or embed them in
practices. Some of
them do one or the
other, and some do
both.
New York’s
Beacon Health Partners, for instance,
has a centralized care management
function that it provides to member
practices. The care managers make
calls to high-risk patients whom they
have identified from claims data and
have confirmed with physicians or
whom ACO physicians have referred
to them.
But this approach has a draw-
back: patients don’t know who the
care managers are when they re-
ceive the calls. As a result, “the pa-
tients who are used to dealing with
us feel like they’re dealing with a
stranger,” notes Christopher Berard,
DO, an ACO member who practices
in Babylon, New York. Some patients
have dis-enrolled from the program
for that reason, he says.
The ACO pays for the care
managers by taking about half of
the physicians’ fees from Medicare’s
Chronic Care Management (CCM)
program, Berard says. He believes
there would be better patient compli-
ance with the program if he brought
it in-house, but then the practice
would have to hire its own care coor-
dinator. He and his two partners are
reluctant to do that because it would
push their overhead too high.
Emerald Physicians, a
50-provider group in Hyannis,
Massachusetts, is also using care
managers in the CCM program. Its
15 nurse care managers can each
take care of 400-500 patients, says
Carmac Coyle, MD, the group’s
founder and medical director. With
20,000 Medicare patients in the
practice, he believes that Emerald’s
providers can enroll 10,000-12,000
patients in CCM. That will require
the group to hire another 10 or so
care managers, he says, but they’re
worth it.
Emerald took on nurses with
acute care experience, so they would
understand the problems of patients
with complex conditions. They all
have knowledge of the local health-
care community as well, so they
can steer patients toward the best
resources for them, Coyle says.
By having the nurses call each
patient involved in the program once
a month, he notes, “we’re creating
new bonds with the patients, and
a new ability to access care in the
organization. This has proved to be a
very positive thing for most patients.
We’re listening to their concerns,
going over their medications, and
preparing them for upcoming office
visits that they’re having with us or
with their specialists. We’re review-
ing their documents with them, and
generally providing a helping hand for
them in a new way.”
TechnologyPopulation health, part 3
as care managers in the office, explains Ken Cohen, MD, the
group’s medical director. Medical assistants, he notes, address care gaps, immunizations, medication adherence and compliance, and COPD and asthma screenings. They also perform chronic care tasks such as conduct-ing diabetes foot exams and creating flow sheets to document progress. “With the MAs providing all of those functions, it al-lows the physician to focus on patient man-agement issues,” he says.
New West also has case managers who manage high-risk patients, but they work mostly in hospitals and post-acute-care set-tings. Cohen says that it’s too expensive to hire case managers for ambulatory care. “I don’t think you’ll solve population health
management by throwing a lot of case man-agers into the mix,” he argues. “You need to use case managers judiciously with very well defined functions.”
At the other end of the spectrum, BSVMG has embedded 52 care managers in its pri-mary care practices and another dozen in a central location, Fortini says. These care managers call sick patients who need help and guide them through the healthcare system. “A nurse care manager can perform 100% of preventive management and almost 50% of chronic disease management with good protocols and physician oversight,” he says.
How an organization allocates work to its care managers can make a big difference in its efficiency, notes Lawrence Casalino, MD,
42
MedicalEconomics.com48 MEDICAL ECONOMICS ❚ JUNE 10, 2016
Technology Population health, part 3
professor of public health and chief of the division of health policy and economics at Weill-Cornell College in New York. Instead of having nurse care managers call diabetic patients to remind them to get their HbA1c tests, the nurses should be managing only high-risk patients, he says. Less-skilled em-ployees or even college students could make the routine calls.
BSVMG has solved this problem with technology. It uses third-party automation software that includes a patient registry to trigger robocalls, emails and texts to pa-tients who have care gaps. The messages tell patients to make an appointment with their provider for necessary care. With the help of those tools, Fortini says, two full-time care managers can contact thousands of patients.
PATIENT OUTREACH AND ENGAGEMENTBefore an organization contacts its patients, it must stratify its population by health risk and identify individual care gaps. The data must be timely and actionable, as well as comprehensive. That means practices and ACOs should not only use their own EHR data, but should also try to obtain claims data from their payers.
Once the care gaps have been identified, practices must reach out to patients who need to be seen but have not scheduled vis-its. The leading EHRs can generate letters to patients and have patient portals that can be used to alert people about their care gaps.
The problem with portals is that not enough patients use them in many practic-es. For example, Cohen says only about 5% of New West’s patients use the portal, which has been online for five years. In contrast, Gretchen Hoyle, MD, of Twin City Pediatrics in Winston-Salem, North Carolina, says that
many of her patients’ parents use the prac-tice’s portal, through which she alerts them to their children’s care gaps.
Cohen thinks that patient engagement is less important than “building a well-functioning infrastructure and taking care of patients’ problems. In an ideal world, an engaged patient is much easier to care for than a non-engaged patient, and outcomes will be better.”
Both Cohen and Casalino emphasize the importance of a good doctor-patient relationship in getting patients to adhere to their care plans. “Patients are more likely to do something if they trust their physician and their physician has asked them to do it,” says Casalino. However, he adds, practices must find ways to enhance that relationship to engage patients with chronic conditions.
QUALITY MEASUREMENTMost physicians are already accustomed to quality reporting because of CMS’ Mean-ingful Use program and its Physician Qual-ity Reporting System (PQRS). In the coming years, value-based payment systems will stress quality reporting even more, and pro-viders’ efficiency will be measured, in most cases with claims data.
Because of PHM’s emphasis on making sure that most patients receive recommend-ed care, it offers a mechanism to improve quality scores. And, by requiring groups to measure their clinical performance, PHM gives practices data that they can use to pro-vide feedback to their own physicians.
Beacon Health Partners works closely with its member physicians to improve their performance, says Prince. The ACO uses a population risk management software application to analyze claims data and produce information 50
I don’t think you’ll solve population health management by throwing a lot of case managers into the mix. You need
to use case managers judiciously with very well defined functions.”—KEN COHEN, MD, GROUP MEDICAL DIRECTOR, NEW WEST PHYSICIANS, DENVER, COLORADO
LAYERCOMPLIANCby
TM
MedicalEconomics.com50 MEDICAL ECONOMICS ❚ JUNE 10, 2016
Technology Population health, part 3
on both the quality and the efficiency of providers. The
ACO sends them quarterly reports on their metrics and dispatches provider relations people or medical leaders to speak with the physicians who are outliers, he notes.
New West Physicians measures not only the performances of its primary care physi-cians, but those of the specialists they refer to. These measurements include the use of evidence-based medicine, Cohen notes. The group has a “bench-to-bedside” program in which the primary care doctors and spe-cialists periodically agree on new practice guidelines. Compelling new evidence is translated into practice within 12 weeks, and all doctors are expected to follow the new protocols.
FINANCIAL SUSTAINABILITYPHM turns the business model of fee-for-service medicine upside down. As Cohen notes, every service that a practice provides and every facility and piece of equipment is a cost center when a group takes financial risk for care. That is why New West Physi-cians has not invested in a surgery or imag-ing center.
Conversely, activities that are not rev-enue producing in traditional practices can help groups generate revenue by support-ing PHM and optimizing value-based reim-bursement. Cohen cites New West’s diabetes and nutrition centers. “Those two centers lose money every year, but they recoup their investment in terms of quality of care and population health benefits that more than offset their losses,” he says.
David Nash, MD, founding dean of the College of Population Health at Thomas Jefferson University in Philadelphia, agrees that these kinds of activities can be helpful in PHM. Whereas before a diabetes nurse practitioner or a care manager represented
a cost to a practice, he says, “In the new world order, these people could be incred-ibly important team members. They could help you on the road from volume to value.”
On the other hand, practices must find ways to continue to generate fee-for-service income during the period when they are building the infrastructure for PHM and risk contracting. That’s why it’s so important to use government programs such as Medi-care’s Chronic Care Management and Tran-sitional Care Management programs to help pay for care managers.
In addition, targeted patient outreach can help practices increase fee for service revenue by increasing visits from patients who need preventive and chronic care.
Keith Hoerning, MD, a member of Bea-con Health Partners, says the transition to PHM and value-based reimbursement is “crazy. To be honest, it’s fun to be in the early stages, yet it’s very frustrating. Because the hurdles are right in your face, and it defi-nitely is a difficult process in which you’re not always going to see the revenue stream that’s going to match the efforts you’re put-ting forward.”
48
To be honest, it’s fun to be in the early stages, yet it’s very frustrating. Because the hurdles are right in your face.”
—KEITH HOERNING, MD, BEACON HEALTH PARTNERS
Population health’s impact on private practicesbit.ly/pophealthprivate
Tackling the population health challengebit.ly/pophealthchallenge
Doctors must combat healthcare changes with professionalismbit.ly/pophealthopinion
MORE ON POPULATION HEALTH
MedicalEconomics.com MEDICAL ECONOMICS ❚ JUNE 10, 2016 51
New Health IT program continues legacy of Meaningful Useby GABRIEL PERNA Contributing author
The words “Meaningful Use” will no longer be applicable but
that doesn’t mean the remnants of the program will be gone. In
fact, “Advancing Care Information,” the new term for Meaningful
Use, as part of implementation of the Medicare Access and CHIP
Reauthorization Act of 2015 (MACRA), has a familiar look to it.
clarification on the meaning
of that line in the proposal.
Meanwhile, a lot isn’t
left up to interpretation in
terms of what’s carrying
over from Meaningful Use
to Advancing Care Informa-
tion. As stated, the Stage
3 rules of meaningful use
will carry over to MACRA
implementation, under
less demanding thresh-
olds. This includes asking
eligible professionals (EPs)
to get patients to view,
download and transmit
their health information;
to securely message pa-
tients; to exchange health
information with other pro-
viders; to send EHR data
to public health registries,
to secure patient data, to
integrate patient-generated
data, and much more. In
Advancing Care Informa-
tion, EPs will be able to
select measures that best
fit their practice. There are
bonus points available in
the performance aspect of
Advancing Care Informa-
tion, meaning if EPs do
particularly well on one
category, it can make up
for lacking in another.
One of the more
significant holdovers from
Meaningful Use that has
been incorporated into
Advancing Care Informa-
tion is the reporting period
requirements, says Tennant.
“There is a one-year report-
ing period [under MIPS].
That’s problematic,” he
says. “One-year reporting is
overkill. Quarterly reporting
is more than fair.”
He notes that physicians
aren’t going to turn off a
module of their EHR, such
as e-prescribing, from one
quarter to another just to
satisfy reporting require-
ments. In the proposed
rule, CMS reasons that the
full-year reporting period
aligns Advancing Care
Information with the other
MIPS categories and gets
them all on a “common
timeline.”
policy for the Medical Group
Management Association
(MGMA), says upon looking
deeper into the 962-page
proposed rule for MACRA
implementation from CMS,
this might not actually be
the case.
“When you read the
proposed rule, page 210, it
says, ‘Failure to meet the
submission requirements,
or measure specifications
for any measure in any of
the objectives would result
in a score of zero for the
Advancing Care Informa-
tion performance category
base score.’ I don’t see
that as anything other than
all or nothing. Yes, they’ve
decreased the number of
requirements, but they’ve
made it clear, at least to
me, if you miss out on any
[measure], you get a com-
plete zero for this category,”
he says. CMS did not
comment on requests for
IN OTHER WORDS, Mean-
ingful Use isn’t dead, it’s
reinvented.
It’s not a complete
carbon copy, as there are
changes to Meaningful
Use reporting. “They’ve
eliminated the need for
[physicians] to report clinical
quality measures, because
that’s already being done
through the quality portion
of MIPS,” says Tom Lee,
Founder and CEO of SA
Ignite, a Chicago-based
software firm that provides
assistance to providers
on reporting for federal
programs.
Also gone is the “all
or nothing” approach of
Meaningful Use. Providers
will be given half credit for
simply attesting and the
performance scores will be
weighted based on percent-
ages. However, Robert Ten-
nant, the director of health
information technology
Tech Talk
This article was first published in our partner publication, Physicians Practice. Send your technology questions to: [email protected].
Financial Strategies
MEDICAL ECONOMICS ❚ JUNE 10, 2016 MedicalEconomics.com52
COMPLYING WITH HIPAA is not a one-time event. By
taking a deliberate and forward-thinking approach, medical
practices can ensure they continually meet the various re-
quirements, and more importantly, keep patient data private
and secure.
Understand the scopeA practice should first get a handle on what the
requirements entail. The U.S. Department of Health
and Human Services’ health information privacy website
offers an overview, but organizations can quickly become
swamped with too much information if they don’t know what
to look for and what questions to ask. Therefore, it can be
helpful to obtain guidance from professional associations or
third-party vendors to learn which rules apply and when.
Quantify the gapPerform a gap analysis to compare current
performance with where future performance
needs to be. This will involve an in-depth review of existing
policies, visual observations of operations and conversations
with staff members about how they maintain the security
of patient health information. Again, practices may want to
leverage a third-party resource, such as a software program
or other side-by-side comparison tool, to streamline the
process of correlating the actual state of data security with
the requirements of HIPAA.
Craft the policiesAlthough creating
these documents may seem
like a tall order, don’t start
from scratch. Consult credible
internet sources or software
vendors. Customize any
policies to make sure they
address the practice’s specific
characteristics, risks and needs.
Auditors will not take kindly to a small practice that has a
HIPAA policy designed for a large health system.
Provide trainingA practice should then turn its attention to training.
Once a year, they should offer a comprehensive
HIPAA refresher course that reacquaints staff members
with the legislation’s pertinent elements and describes staff
members’ roles in preserving patient data privacy and security.
In addition, practices should include a HIPAA education
session in any new staff orientation. Consider offering
quarterly educational activities that improve information
retention and help staff members apply their knowledge.
Plan for the unexpectedEven with the best planning, incidents can—
and do—still occur, so practices must have a
defined response protocol. This should include how the
practice will document a breach and address root causes
to prevent future occurrences. It should also describe how
the organization will communicate about the incident with
patients, staff, the public and regulatory authorities. Locking
down these details before an incident occurs can ensure an
adequate and appropriate response.
by LYNN TRIFFLETTI, CPC Contributing author
There are more than 50 policies that medical practices may have
to implement to comply with the Health Insurance Portability
and Accountability Act (HIPAA), so it’s no wonder meeting these
requirements may appear overwhelming, especially for smaller
practices with limited time and resources. The good news is that
compliance might not be as difficult as it first appears.
Take a step-by-step approach to HIPAA compliance
Lynn Triffletti, CPC, is the vice president of coding/compliance at Stericycle, Inc. Send your financial questions to: [email protected].
1
2
4
3
5
MedicalEconomics.com54
IN DEPTH
MEDICAL ECONOMICS ❚ JUNE 10, 2016
Illus
tratio
ns b
y Ni
klas
Ask
er
by JORDAN ROSENFELD Contributing author
As the 2016 election heads for the home stretch, what will a new administration mean for the ACA?
THE FUTURE OF THE AFFORDABLE CARE ACT
THIS NOVEMBER the Aff ordable Care Act (ACA)—aka Obamacare—will face its
next great test: Can it survive beyond its namesake’s time in offi ce?
Six years after the legislation was enacted, it faces an uncertain future as the
presidential election looms. Candidates in both the Democratic and Republican
parties have made bold promises to revise or repeal the hard-won healthcare
reform law should they be elected, even though the Supreme Court upheld the
legislation in 2012. Here, health economists weigh in on the fate of the ACA.
HIGHLIGHTS
Real estate
developer Donald
Trump, the top
contender for the
Republican nomination,
has said he would
repeal the ACA outright.
Under a Democratic
president, particularly if
that is former Secretary
of State Hillary Clinton,
the most likely outcome
is that the ACA will
remain with some
tweaks.
Policy
Senator Bernie Sanders (D-Vermont) has taken the idea of single-payer healthcare out of its bottle in the form of an expanded “Medicare-for-all” plan, and it’s unlikely the idea will be easy to remove from voters’ minds.
Medicare for all would mean dismantling the ACA; there would be no more private in-surance companies or healthcare exchang-es. Instead the government would manage one fund that everyone pays into. Sanders
suggests that once the system no longer depends on multiple insurance companies and their individual rules, the government could recapture that administrative spend-ing and invest it in paying for healthcare for everyone, and broaden the scope of servic-es. Many praise this kind of plan because it would insure everyone equally and reduce insurance companies’ ability to jack up rates at will. But others worry about the ripples such a change would have on our economy.
RADICAL REVISIONTHE REALITIES OF SINGLE-PAYER HEALTHCARE
MedicalEconomics.com 55MEDICAL ECONOMICS ❚ JUNE 10, 2016
Real estate developer Donald Trump, the top contender for the Republican nomina-tion, has said he would repeal the ACA out-right.
Trump is promoting healthcare reform based on “free market principles.” He favors reducing barriers to purchasing insurance across state lines, making insurance premi-ums tax deductible. Fahrati doubts Trump’s plan to create competition among health-care providers will be eff ective because it is not based on any other existing model, and is short on specifi cs.
Kominksi is more alarmed by Trump’s plan to allow purchasing of healthcare in-surance across state lines. “Under Trump’s plan, you could incorporate, say, in Nevada, and sell products in California, and Cali-fornia couldn’t regulate that. We’d sacrifi ce all those [individual state law] protections. Th e model for that is the banking laws. All
the banks locate their headquarters in Dela-ware, because it has the least regulations of the industry.”
However, he understands why Trump’s plan appeals to some voters since the U.S. economy’s reliance on free markets is in-grained in the national consciousness. “Mar-kets do work very well in many areas.”
But markets are also subject to severe dysfunction, Kominski points out. He feels there’s a “natural monopoly” in hospitals and among doctors that doesn’t always work in patients’ favor. “In what other mar-ket would you go and buy a service and be told, if you ask the cost, ‘We don’t know, but we’ll send you a bill.’ Can you imagine buying a car that way?” he asks.
However, wholesale revisions to repeal the ACA do not seem realistic. “Repealing the ACA is way easier said than done,” Anthony Lo Sasso, PhD,
Senior health economist Farah Farahati, PhD, with the University of Maryland School of Public Health, does not believe single-payer healthcare will come to pass after the 2016 election, but she admires the model. “Most of the successful cost-eff ective health-care systems around the world have single-payer healthcare systems,” she says.
Putting single-payer into eff ect, how-ever, would be “a fundamental change in healthcare fi nancing,” according to Gerald Kominski, PhD, director of UCLA’s Center for Health Policy Research. “I genuinely be-lieve a single-payer system is where we have to get to maximize the value of our health-care system, and to end unnecessary waste in this current patchwork system.”
Even if Congress were to approve such a system, Kominski says it poses problems. “We have a lot of evidence from the past 30 years that doing away with cost sharing will result in an increased use of services. I’m not a big fan of high-deductible plans and signifi cant cost sharing, but some cost shar-ing and some level of deductibles helps keep
our spending from being even greater than it is,” he says. What’s clear is that we can’t have both the ACA and single payer.
Kominski does see one smaller-scale way to achieve single-payer insurance, however, which is at the state level. States could apply for a federal waiver where ev-eryone hospitalized would be covered by Medicare Part A. “A system like that could pass nationally as hospitalization is one of the most expensive components of care, and it would stabilize the hospital indus-try,” he says. He imagines such a system could be paid for through an increase in payroll taxes, and says it’s much like what Senator John Kerry proposed when he ran for president in 2004.
“I think it is stunningly unlikely to get radical change,” says Michael Chernew, PhD, professor of health economics at Harvard Medical School. “I don’t think you’re going to have a Congress that will be amenable to single-payer. We have a series of checks and balances in our system and the president doesn’t always get what they want.”
Fate of the ACA Policy
57
EFFORTS TO REPEAL
“I genuinely believe
a single-payer
system is where
we have to get
to maximize the value
of our healthcare
system, and to end
unnecessary waste
in this current
patchwork system.”
— GERALD KOMINSKI, PHD, DIRECTOR,
UCLA’S CENTER FOR HEALTH POLICY RESEARCH
MedicalEconomics.com 57MEDICAL ECONOMICS ❚ JUNE 10, 2016
PolicyFate of the ACA
professor of health policy and administration at the Univer-
sity of Illinois at Chicago, says. “First it re-quires legislation. You can’t just executive order it away. Even assuming [the House] was inclined, in all likelihood it wouldn’t fl y in the Senate.”
Chernew feels that eff orts to dismantle parts of the ACA would have far-reaching fi scal repercussions, such as adding to the defi cit. “Although it would lower taxes, some of the ACA is paid for by reforms in Medi-care,” he says.
Moreover, Chernew says Republicans might be surprised to fi nd out how reluc-tant their own voters are to lose the benefi ts they acquired under the ACA. Seventy-four percent of newly-insured Republicans were happy with their insurance acquired under
the ACA, according to a 2014 Common-wealth Fund report. Kominksi also cites the case of Kentucky, which implemented its own healthcare exchange under a Demo-cratic governor after the ACA passed. “Now that a Republican has come into offi ce who campaigned on a platform to roll back the Medicaid expansion, he’s fi nding it is not as easy to do,” he says. “It will be diffi cult to turn back the clock on the more than 20 million people who have insurance now than did back in 2013.”
“No matter whether you like or dislike the ACA, I think it’s relatively clear that there was a problem the ACA was trying to ad-dress,” says Chernew. However, as of yet, no candidate has provided a coherent, compre-hensive alternative in the context of repeal-ing the ACA.
55
STAYING THE COURSEUnder a Democratic president, particularly if that is former Secretary of State Hillary Clinton, the most likely outcome is that the ACA will “stay the course,” Lo Sasso says, with some tweaks. Chernew agrees, “If the Democrats win, particularly if they pick up seats in Congress, the ACA will be much more about modifying and refi ning going forward.”
Clinton championed a version of health-care reform in the 1990s, which was quite a bit more ambitious than the ACA.
Now, Clinton proposes to defend the Af-fordable Care Act and build on it to slow the growth of out-of-pocket costs.
One of the most burdensome of these out-of-pocket costs is prescription drugs. “Th ere’s been a long, ongoing debate about prescription drug prices in a variety of ways, since there have been egregious examples of pricing that are hard to swallow. We re-ally like our prescription drugs, we just want them cheaper,” says Chernew.
Despite mistrust of drug companies, Chernew says, profi tability encourages inno-vation, though he doesn’t feel this means we
should write blank checks to drug compa-nies, but should consider the consequences to innovation to any policy changes.
Small changes may be the best either par-ty can hope for, says Chernew. “Once regula-tions get set, those are hard to budge. Laws have to be rewritten.”
Kominski agrees. “Th e conclusion I’ve drawn from 30 years of studying U.S. health-care is that incremental change seems to be the fundamental strategy.” After all, even Medicare and Medicaid were built on incre-mental compromises to help people who were being left behind: namely the poor and elderly. “We have Medicare because we couldn’t get a single-payer system for every-one,” he says.
Ultimately, the next president must pay attention to the delicate balance of health-care, and consider that the ACA helps sup-port other aspects of the healthcare system. “Th is is not to say we should keep the ACA exactly as it is,” says Lo Sasso. “But people have to understand that what happens in the healthcare system in one area tends to reverberate through the system.”
“No matter
whether you like
or dislike the ACA,
I think it’s
relatively clear
that there was
a problem the
ACA was trying
to address.”— MICHAEL CHERNEW, PHD,
PROFESSOR OF HEALTH ECONOMICS, HARVARD
MEDICAL SCHOOL
MEDICAL ECONOMICS ❚ JUNE 10, 2016 MedicalEconomics.com58
Legally Speaking
The role of private counsel in medical malpractice casesby ANDREW M. KNOLL, MD, JD Contributing author
It’s been said that there are two types of doctors: those who have been sued and those
who are going to be sued. If there is one saving grace in the process, your professional
liability carrier will appoint and pay for your lawyer and you will not incur any out-of-
pocket expenses in your defense. Given that, why would you consider paying for another
lawyer to act as your private counsel?
Medical malpractice defense is a legal
specialty and carriers are very selective
regarding who they will assign as defense
counsel. Accordingly, I have found the
lawyers that I work with to be highly
competent in the law and knowledgeable
about the underlying medicine.
Sometimes, however, it’s good to get a
second opinion.
Private counsel needs to be able to
analyze the case from both the medi-
cal and legal perspectives, integrate
the two analyses and discuss with the
defendant-physician the strengths and
weaknesses of the case, the process (i.e.,
the anatomy of a malpractice case), liaison
with appointed counsel and advise her
client accordingly. A case can be medically
defensible while being legally problematic
and vice versa, and these determinations
go to the heart of a case, especially the
question of whether to settle. Even if none
of the situations discussed below exist,
peace of mind may make it worthwhile to
pay your own lawyer out-of-pocket for his
opinion and guidance.
As both a physician
and lawyer, I am often
asked to be private
counsel. Private counsel
is separate from the
lawyer appointed by the
insurance carrier and
works directly for the
defendant-physician.
My retention usually
comes about in one of
two ways. Sometimes
the physician seeks me
out directly for essen-
tially a second opin-
ion. More commonly,
someone involved in
the case, which may
be the carrier, defense
counsel or sometimes
even plaintiff’s counsel,
has suggested that the
physician retain private
counsel at his own
expense. Here are the
types of circumstances
that might warrant con-
sulting private counsel. 60
I have noticed a growing trend among plaintiff
attorneys to plead claims that are not covered
by insurance. Examples include claims for
punitive damages or for actions provided in
an administrative capacity (e.g., as medical
director of a facility). I think the plaintiffs’ bar
believes it can force settlements by scaring
the doctor into believing she has personal
exposure. In my experience, it almost never
works, but it does cause considerable
consternation to the physician and rest of the
defense team.
When faced with an uncovered claim,
carriers are required by law to notify the
insured—in writing—that the claim is uncov-
ered and the insured should consider retain-
ing private counsel. This does not necessarily
mean you need private counsel, however.
Awarding punitive damages is virtu-
ally unheard of in medical malpractice. The
standard—rightfully—is extremely high
and, according to case law, requires that
the defendant manifest evil or malicious
conduct beyond any breach of professional
duty, fraudulent or evil intent or
such a conscious and deliberate
Second opinion Uncovered claims
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MEDICAL ECONOMICS ❚ JUNE 10, 2016 MedicalEconomics.com60
disregard of
the interests
of others that the conduct
may be called willful or
wanton. It is conduct that
is sanctionable by licensing
boards and if a physician is
involved in such a case, the
medical malpractice case
is probably the least of his
worries.
Most often the inclusion
of a demand for punitive
damages is an idle threat.
On occasion, such as when
a prescribed drug violated
a black box warning, I have
been retained, but the
inclusion of a demand for
punitive damages did not
change management of
the case. (A case where
a patient was injured after
being prescribed a contra-
indicated drug in violation
of a black box warning is
going to get settled with
insurance money at some
point.)
Uncovered claims for
administrative services,
such as those performed
by the medical director of a
facility, are more interest-
ing. (As an aside, physi-
cians who perform these
services should ensure that
the facility’s malpractice
insurance policy will cover
them for such claims.)
Under New York case law,
a payer stating it would
only cover some of the
claims in the lawsuit, but
not all, creates a conflict
of interest for appointed
counsel whose “duty to
the insured would require
that he defeat liability on
any ground and his duty to
the insurer would require
that he defeat liability only
upon grounds which would
render the insurer liable.”
Under these circum-
stances, the carrier not
only has the duty to notify
the defendant-physician
that the claim is not cov-
ered but also that she has
the right to a different attor-
ney of her own choosing at
the carrier’s expense. This
duty is not limited to New
York. Many other states,
including California, Texas
and Illinois, have similar
case law. This is the type
of situation where private
counsel may become
explicitly involved. When
called upon, I have been
able to resolve this conflict
by effecting a settlement,
taking over the case
completely or negotiating
with the carrier to cover the
claim.
Legally Speaking
Andrew M. Knoll, MD, JD, is a partner and member of the healthcare law practice area for Cohen Compagni Beckman Appler & Knoll in Syracuse, New York. He was a board certified internisr for 20 years. Send legal questions to: [email protected].
58
The bad faith doctrine is best explained by analogizing
to a motor vehicle accident, where drivers typically
have lower policy limits than a medical malpractice
policy. Assume a driver, with a policy limit of
$50,000, causes an accident and the plaintiff sustains
$1 million in damages. Further assume that the
plaintiff’s attorney has demanded the policy limit
in compensation for his client. The carrier might be
tempted to chance a jury trial, because it doesn’t have
anything more to lose than the $50,000 it would be
required to pay anyway. The bad faith doctrine says
that where liability is clear and an offer has been made
to settle within the policy limit, the carrier’s refusal
to settle is considered bad faith, in which case the
carrier’s liability becomes infinite. In other words, the
carrier can still decide to roll the dice with the jury, but
now it’s gambling with its money, not its insured’s.
The doctrine applies in medical malpractice if the
physician was clearly negligent, the damages are very
high and the plaintiff has offered to settle within the
policy limits. Often the carrier will want to continue
to negotiate a lower settlement and a so-called “bad
faith” letter from private counsel will help protect the
doctor, as well as pressure the carrier to settle.
Note that there is no bad faith on the carrier who
refuses to settle if: 1) liability is not clear (i.e., the
case is defensible); or 2) the award is not likely to
exceed the policy limits. That is often the case when
I’m consulted because the doctor wants to settle but
the carrier does not. In that circumstance, private
counsel’s role is often to reassure the physician that
notwithstanding his/her desire to get the case over
with, the best course is to go the distance and allow
defense counsel to defend the case.
Another significant role for private
counsel is to mediate a settlement
informally. As private counsel, I would
typically have frank and confidential
separate discussions with plaintiff’s
counsel, defense counsel, the
defendant-physician and the claims
adjuster for the carrier. This does not
necessarily result in a settlement.
Sometimes the case needs to proceed
further, especially if depositions have
not yet been completed. However,
when the case needs to be settled,
performing this function—like shuttle
diplomacy—can often result in a
meeting of the minds and resolution of
the case.
In summary, there are situa-
tions where it is worthwhile for a
physician in a malpractice lawsuit
to engage private counsel at his or
her own expense. Private counsel’s
role may run the gamut from pro-
viding a second opinion and peace
of mind that appointed counsel is
handling the case appropriately to
becoming actively involved in set-
tling a case.
Bad faith doctrine
Informal mediation
MedicalEconomics.com 61 MEDICAL ECONOMICS ❚ JUNE 10, 2016
Policy
he newly amended rule from the Centers for Medicare & Medic-aid Services (CMS) governing how physicians and hospitals need to report and return Medi-care overpayments has sparked a range of concerns and emo-tions among providers.
They find the rule’s language vague and confusing, see the scope of what they’re being asked to do as burdensome on a number of levels and complain that the rule’s requirements add to the layers of regu-lations that they already face.
“It’s emotionally taxing as well as resource-taxing to the practice,” says Wanda Filer, MD, president of the American Academy of Fam-ily Physicians (AAFP). “They’re out there taking care of people. They don’t necessarily keep their ears attuned to everything CMS is throwing at them. They’re trying to keep their heads above water with Meaningful Use and other rapid changes that are underway.”
Promulgated by CMS in February, the final rule requires healthcare providers and suppliers to report and return overpay-ments under Medicare Parts A and B within 60 days of the date the overpayment is iden-tified, whether internally or by CMS or its contractors, or the date any corresponding cost report is due if that comes later.
CMS scaled back the “look back period” during which providers must retroactively
report and return overpayments from 10 to six years, which many in the healthcare field view as a step in the right direction—but still unduly onerous.
Providers are expected to exercise what CMS terms “reasonable diligence” in at-tempting to uncover and return overpay-ments. The potential consequences of not doing so remain the same as in the past: criminal charges, civil liability and exclusion from federal healthcare programs.
“The duty to identify and return overpay-ments is not a new one,” says Tony Salters, a CMS spokesperson. To avoid the penalties, he says, providers should adhere to the re-quirements by instituting proactive analyt-ics processes that identify and calculate all overpayments going back the full six years, and then reporting and returning the money in question in a timely manner.
The term “reasonable diligence” means that providers should undertake both proac-tive compliance activities to monitor claims themselves, as well as reactive investigations in response to receiving “credible informa-tion” about a potential overpayment, Salters says.
The rule itself says that these require-ments “are meant to ensure compliance with applicable statutes, promote the furnishing of high quality care, and to protect the Medi-care Trust funds against fraud and improper payments.”
HIGHLIGHTS
CMS requires
healthcare providers
and suppliers to
report and return
overpayments under
Medicare Parts A and
B within 60 days of the
date the overpayment is
identified.
by ED FINKEL Contributing author
The government wants physicians to identify overpayments, but many say the responsibilities remain unclear
Medicare overpayment rule leaves practices scrambling
MedicalEconomics.com62 MEDICAL ECONOMICS ❚ JUNE 10, 2016
Policy
IMPACT ON SMALL PRACTICESWhile perhaps no one disagrees with those goals, some physicians and organizations that represent them continue to have ques-tions about the particulars like, for example, what the rule means when it says providers have a “clear duty” to report and return over-payments.
Th e AAFP, which signed a 2012 letter that circulated to dozens of specialty societies and advocated for a three-year look-back period, is encouraging members to return overpayments as soon as they’re identifi ed but understands the burden that poses, Fil-er says. “Th e vast majority of these overpay-ments are due to inadvertent billing errors,” she says. “It’s a little unclear how CMS is go-ing to defi ne ‘clear duty.’ Th e clear duty of a provider is to care for your patients.”
Mark Silberman, JD, partner at Duane Morris LLP in Chicago, also isn’t certain what CMS means by “clear duty” on the part of providers. “It is not clearly defi ned, and I would hope they are gentle in their interpre-tation of that duty—at least until the practi-cal impact can be evaluated,” he says.
Filer has primarily heard from smaller family practices that they fi nd these Medi-care audits to be burdensome. “Th at said, I’m hopeful that as CMS continues to moni-tor this, if they fi nd this is not the best place to put their resources, three years might start to look more attractive,” she says.
Th e AAFP does not plan to issue general advice on how its members should comply with the rule given their vast diff erences in resources, size and overhead, Filer says. “Practices are going to have to look at their own resources and what are the best prac-tices for them,” she says. “Family medicine tends to run on quite thin margins. It’s not one where they’re going to be able to spend a huge amount of capital on doing this work.”
Nonetheless, given the potential penal-ties, she adds that as a general rule, “we’re telling practices that self-audits are a form of preventive care for your practice.”
Th e American College of Physicians has heard about the rule change but hasn’t tak-en a defi ned position and hasn’t heard much feedback from members to date, spokes-woman Jacquelyn Blaser told Medical Eco-
nomics via email. Kenneth Kubitschek, MD, chief execu-
tive offi cer of Carolina Internal Medicine Associates in Asheville, North Carolina, be-lieves the new rule mostly stemmed from problems with hospital providers and their employed physicians—and that the rule’s requirements are more realistic to expect from such large entities than a small prac-tice like his, which has nine physicians, fi ve non-physician providers and more than 50 total employees.
“[Hospitals] fi ddled around for long peri-ods instead of paying back millions of dol-lars,” he says. “Th at’s why [CMS] said, ‘OK, you’ve got 60 days.’ For a practice like ours, 60 days actually sounds kind of short. Be-cause we’re busy, everybody’s busy, and try-ing to set aside time to dive into those kinds of things, to fi nd out if it’s really a problem or just isolated—it’s a real challenge.”
Th e 60-day clock begins when a practice identifi es a problem, and Kubitschek, an editorial advisory board member of Medi-cal Economics, says he’s not sure precisely how that time requirement is determined by CMS. He’s also not sure how a practice like his can be expected to turn back the clock six years when, for example, the person re-sponsible for the overpayment might have retired.
Kubitschek and his colleagues at Caro-lina Internal Medicine Associates are begin-ning to sort that out, thinking about ques-tions like whether fi nding one overpayment should trigger a full investigation of that doctor’s billing going back six years, or an
Medicare overpayments
A Medicare overpayment is a payment you receive in excess of
amounts properly payable under Medicare statutes and regulations.
Once Medicare identifi es an overpayment, the overpayment
amount becomes a debt you owe the Federal government. Federal
law requires CMS try to recover all identifi ed overpayments.
In Medicare, overpayments commonly occur due to:
What is a Medicare Overpayment?
❚ Duplicate submission of the same service or claim;
❚ Furnishing and billing for excessive or non-covered services;
❚ Payment for excluded or medically-unnecessary services; or
❚ Payment to the incorrect payee.
Source: CMS
MedicalEconomics.com 63MEDICAL ECONOMICS ❚ JUNE 10, 2016
PolicyMedicare overpayments
investigation of how the practice has billed the particular code in question, Kubitschek says. But the road ahead will be littered with such questions.
“I guess we’re going to have to learn how to do it,” he says. “I’m casting about trying to fi gure it out.” Typically the practice refunds any overpayments it fi nds, but what if it billed for a lab the patient missed? He’s not sure whether to simply refund that one fee or attempt to extrapolate. “How do I apply that to a six-year window? I’m a little con-fused, and I’m hoping for more clarifi cation.”
For now, the practice does not have a plan in place, and Kubitschek isn’t sure how it will comply within the rule’s time require-ments. “I think they should graduate this in, and they should diff erentiate between misinterpretation of a rule and fraud, and if it’s fraud the look-back period should be longer,” he says.
Kubitschek also believes that the look-back period should be shorter for small practices because practices the size of his “don’t have the same capacity for applying the large numbers of personnel.”
LEGAL RAMIFICATIONSHealthcare attorneys empathize with their clients’ state of mind but say they’re well-ad-vised to practice what one calls “preventative law” in ensuring that their auditing practices err on the side of being as cautious and thor-ough as possible. Th ey say that documenta-tion of reasonable diligence can be critical to convincing CMS that a practice has not en-gaged in fraud, and that it has done all it can to root out inadvertent overbilling.
Th e fi nal rule is an improvement over the original and not that diff erent from the typical four-year “reopening period” that providers already deal with from other con-tractors, says Tony Maida, JD, partner with the health industry advisory group at Mc-Dermott, Will & Emery in New York. Some of those audits happen so long after the dates of service that the reopening period actually extends back closer to six years, adds Maida, a former deputy chief at the U.S. Depart-ment of Health and Human Services Offi ce of the Inspector General.
Maida believes that CMS has hinted between the lines that practices should in-stitute such compliance programs to be in Medicare. “Th ere is no regulation and no law that applies to everyone that says you have
to,” he says. “But that said, CMS thinks every-body should have one, and they’re probably right about that at some level. Given the en-forcement environment we have grown up in during the last 10 or 20 years, you would be ill-advised not to have one at this point.”
In addition to staying in CMS’ good graces, the new rule will make a compliance program more important to potential inves-tors—whether hospitals, other practices or anyone in the private equity sector—looking to buy into physician practices, Maida pre-dicts. “A buyer is going to kick the tires on your compliance program and see if the rev-enue from that practice is reliable,” he says.
A tight compliance program need not au-dit every claim, Maida says. “Th ere’s always a risk you will have overpayment in an area you haven’t looked,” he says. But providers need to be able to show that they have a year-in, year-out assessment process that plans the internal audit around both areas where CMS has expressed concerns and the practice’s own experience with overpayments.
Among the processes that providers should evaluate is what sort of “hotline” they have to receive complaints of over-billing, Maida says. “Th is rule is probably a good time to reassess that process and make sure it is tight, that things don’t get lost in the cracks, that decisions are made about whether to investigate something.”
If a provider has received several com-plaints and did not respond, he adds, “Th at takes on more importance under this rule. Th e government says you got credible infor-mation about this issue, and you didn’t do
You may choose from the following options when responding
to an initial demand letter:
Your options if you received an overpayment
Source: CMS
❚ Make an immediate payment;
❚ Request immediate
recoupment;
❚ Request the standard
recoupment process
(Automatic Offset/Withholding);
❚ Request an extended
repayment schedule;
❚ Submit a rebuttal; or
❚ Request a redetermination
to appeal the overpayment.
MedicalEconomics.com64 MEDICAL ECONOMICS ❚ JUNE 10, 2016
Policy Medicare overpayments
anything, or you did an incomplete job, and that is another strike against you.”
The ability of CMS to mine data and find practices that seem like outliers means that physicians need to invest more in their in-ternal auditing function, Maida says. “It’s very easy to find out now, in a way it wasn’t 10 years ago, who the top 10 billers are and pick a place [to audit],” he says.
Silberman of Duane Morris LLP agrees with Maida that providers need to be able to demonstrate they have attempted to root out and report overpayment errors. That makes some sense to him because other-wise, he figures, practices could spend time mired in denial about such errors if they suddenly see a spike in revenue from over-billing without asking why.
The lack of an adequate internal auditing function provides an opening for the gov-ernment to second-guess your processes, Silberman says. “What I try to tell my clients is, whatever you do, have a reason,” he says. “If you have a reasonable basis and explana-tion for why you did what you did, you can always have someone advocate for you. If you can’t explain it, the government fills in their own explanation.”
Silberman recommends that physicians practice what they preach to their patients: get regular checkups and take preventative steps. Approach the matter as a triage, start-ing with current auditing practices and then looking backward. “There’s no point in look-ing for what caused the injury if the patient dies on the table,” he says, extending the medical metaphor.
The next step is to decide whether you want to perform the audit yourself or hire an outside auditor. Doing so would increase costs but likely provide a more objective judgment. “We all know the government is
doing it, data mining and trying to find pat-terns,” he says, adding that if you’re going to have what he calls an “unpleasant discus-sion” with the government, it’s very impor-tant to show you’ve been diligent about root-ing out and trying to fix the problem.
Silberman extends the analogy to pre-ventive medicine by noting that taking a better-late-than-never approach and wait-ing to look for a problem might only mean it grows biger “Some people find problems and decide they’re going to wait to see if it’s ever discovered. The risk to that is, the gov-ernment can establish you didn’t use rea-sonable diligence, you’re outside the 60-day window and then you’re going to start look-ing at some pretty serious penalties.”
While most overpayments are handled in civil court, Silberman adds, there’s no guarantee, particularly when a practice doesn’t seem like it has been exercising due diligence. “Find me a federal prosecutor who will verify that it’s not going to cross over into the criminal [realm],” he says. “Their an-swer is, ‘We’re going to have to wait and see what our investigation yields.’ ”
Silberman is concerned that physicians are leaving medicine, shifting to payer-less arrangements or pursuing employed rela-tionships rather than more entrepreneurial paths because they find the administrative burden of actually running a practice that takes Medicare overwhelming.
But he suspects CMS requirements will not be easing any time soon, especially since the federal government has collected $47 billion in fines in just the last two years.
“They’re actually budgeting the recovery for fraud that hasn’t been committed yet,” Silberman says. “You know if you put forth the enforcement efforts, there is going to be a return on that investment.”
If you have a reasonable basis and explanation for why you did what you did, you can always
have someone advocate for you. If you can’t explain it, the government fills in their own explanation.”— MARK SILBERMAN, JD, PARTNER, DUANE MORRIS LLP, CHICAGO, ILLINOIS
MedicalEconomics.com 65
IN DEPTH
MEDICAL ECONOMICS ❚ JUNE 10, 2016
Money
by JANET KIDD STEWART Contributing author
11 tips to get the most for your continuing medical education spending
Getting the most out of CME on a budget
CONTINUING EDUCATION is taking on greater importance amid new quality measures, but it comes at a time when practices already are having to budget for pricey new electronic health record and technical upgrades called for under health reform. Getting the most bang for the buck when it comes to continu-ing medical education (CME) is critical.
Th e pressures on physicians go beyond just keeping up with the pace of knowledge expansion. New requirements to demon-strate quality of care that can be document-ed and quantifi ed, observers say, further drives up demand for CME.
“With the movement from volume to value it has become imperative for physicians to perform at a higher level, and CME will be-come even more important,” says Michael Ro-mano, MD, chief medical offi cer for Nebraska Health Network, a health system with 1,300 providers. Romano last year won an award from the Accreditation Council for Continu-ing Medical Education (ACCME) for his work on broad CME initiatives that improved phy-sician performance and patient care.
In a 2011 paper for the American Clini-cal and Climatological Association, Peter Densen, MD, a professor at the University of Iowa, discussed estimates that the doubling
time of medical knowledge fell from 50 years in 1950 to 3.5 years in 2010, with a forecast of just 73 days by 2020.
“Knowledge is expanding faster than our ability to assimilate and apply it eff ectively,” Densen wrote. “Clearly, simply adding more material and/or time to the curriculum will not be an eff ective coping strategy—funda-mental change has become an imperative.”
1 NEW CME CAN BE LOWER COSTTh e good news from a fi nancial perspec-tive, say physicians and other CME experts: Some of the most eff ective learning opportu-nities are coming from lower cost, informal and often online channels. And even in the live world of medical conferences, there are ways to stretch a CME budget.
“When people used to say ‘CME,’ I would think of lecture halls, dark rooms and a sage on the stage, much the way I was educated in medical school,” says Graham McMahon, MD, an internist and president and chief exrcutive offi cer of ACCME in Chicago. “Now that’s anachronistic and there’s such a variety of approaches that are more engag-ing, interesting and accessible.”
HIGHLIGHTS
Some of the most
effective learning
opportunities are
coming from lower
cost, informal and often
online channels. And
even in the live world of
medical conferences,
there are ways to
stretch a CME budget.
MedicalEconomics.com66 MEDICAL ECONOMICS ❚ JUNE 10, 2016
How do you quantify the learning that happens in these less formal engagements? We used to sign up for an activity,
fill out an application and collect documentation of attendance. Now education is happening on the fly and it’s difficult to quantify.”—MICHAEL ROMANO, MD, CHIEF MEDICAL OFFICER, NEBRASKA HEALTH NETWORK
Money
Hospitals are boosting investments in continuing education as a way to satisfy quality initiatives, and physicians them-selves are attending a much broader array of programming than they did even just a few years ago, McMahon says.
Rather than simply attending a specialty society’s annual conference, more physi-cians are participating in local, informal case presentations and online learning.
“The currency of education today is not necessarily information exchange, but get-ting together to problem solve, develop cog-nitive skills or learn a specific new technique in a hands-on way,” McMahon says.
Rather than going back to the same con-ference every year, physicians are thinking about a specific skill they need to develop this year, and finding that activity or course that delivers that, McMahon says.
Clearly, lecture-style education taught at live conferences still has its place.
2 GET INVOLVEDImparting new research information quickly is better suited to more didactic teaching styles, for example, and informal learning through face-to-face interaction with col-leagues is still valuable, experts say.
“My sense is that physicians really enjoy going to meetings for the social aspects,” says Daniel Carlat, MD, a psychiatrist in Newburyport, Massachusetts, and publisher of the Carlat CME Institute, which advo-cates for CME that is free of conflicts of in-terest from drug companies and healthcare industry entities.
“It’s easier to sit in a chair and view slides” than to engage in pro-active case studies or learning groups, he says.
For some applications, however, newer—and often cheaper—methods can work bet-ter. The trick, experts say, is choosing which method is best for each continuing educa-tion opportunity.
3 AVOID ‘CREDIT SHOPPING’When training budgets are tight, it’s tempt-ing to choose a CME course by picking the lowest-cost course per credit hour. Experts urge physicians to think about the actual value a given course generates, however.
“The key to stretching the CME dollar is to be much more deliberative about choos-ing courses,” McMahon says. He recom-mends physicians avoid “credit shopping,” or basing course selection on the lowest cost per credit hour delivered. Instead, think about the ongoing education benefits of any CME opportunity.
Repeated engagement with a subject over time can often drive much higher per-formance improvements than traditional one-off didactic lecture sessions, experts say.
4 FIND THE GAPSAnother way to stretch the CME dollar is through self-assessment tools, typically on-line through individual specialty associations that can identify the most critical areas physi-cians need to improve. In other words, physi-cians should skip CME programs that simply reinforce knowledge they already have.
“You want to identify gaps in yourself and then search for activities that plug that gap,” McMahon says.
Finding true knowledge gaps can be tricky, however. While board certification ex-
CME on a budget
MedicalEconomics.com 67 MEDICAL ECONOMICS ❚ JUNE 10, 2016
There’s still a role for live meetings because they provide networking, interacting with experts and being able to ask
about the subtleties among clinical colleagues.”— TODD DORMAN, MD, ASSOCIATE DEAN FOR CONTINUING MEDICAL EDUCATION, JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE
MoneyCME on a budget
ams often give physicians feedback on what questions were missed, for example, the length of time between exams (often a de-cade) make them impractical as an ongoing learning guide, notes Elizabeth Grace, MD, medical director for the Center for Person-alized Education for Physicians in Denver, Colorado, which offers re-entry programs for physicians coming back to practice after a hiatus and those who have been placed in performance improvement programs. In ad-dition, CME credit courses will often have a pre-test, but that is to demonstrate before-and-after knowledge on a very narrow topic, she says.
Physicians are sometimes blind to the gaps in their own knowledge and skill base, she says.. And the more deficient a physician is, the less likely he is to know he needs help. Physicians tend to choose CME programs that focus on content they already like and feel comfortable with, as opposed to where they see a real need, she says. As more medi-cal associations develop programs to assist with quality-based practice measures, how-ever, that will change, she says.
Competency-based education, with de-fined benchmarks for skill development, will make it easier for physicians to inventory their strengths and work on weaknesses, she says. She advocates educational programs that address topics of importance to physi-cians’ patient population as a way to acquire skills that can be immediately put to use in practices and demonstrate value to payers.
5 DON’T GO ALL-IN FOR ONLINEOnline education can certainly save costs on airfare, hotels and restaurants—and evi-
dence suggests younger physicians tend to prefer online to live meetings anyway —but having the ability to engage in impromptu conversations around the buffet line can’t be overlooked as a way to boost the perceived value of attending a conference.
“You want to balance online with peer learning,” McMahon says. Both are valuable to a physician’s life-long education, he says.
The face-to-face interaction with col-leagues from within a given specialty is still critical, and can help alleviate pent-up career stress, which can in turn prolong ca-reers, says Romano, a family physician also certified in hospice and palliative care.
“What gets lost in the conversation [about online alternatives and budget short-falls] is the collegial interaction with col-leagues from the same specialty, and that’s a very important part of these activities. As we deal with physician burnout, the ability to take a week, go to a vacation spot and un-wind for a week is really helpful in avoiding some of these burnout issues,” he says.
That’s an investment worth making, he says.
6 ONE FOR THE TEAMIncreasingly, experts say, physicians are eval-uating CME as it relates to an overall practice. Some of the newest courses, for example, in-volve teams of nurses, physician assistants, pharmacy professionals and doctors. Course-work centers on, among other things, how to function better as professionals.
“This one will take awhile to develop, but everyone recognizes this is important,” Ro-mano says. “More gatherings will begin to include the entire team.”
MedicalEconomics.com68 MEDICAL ECONOMICS ❚ JUNE 10, 2016
There can be some sticker shock involved with maintenance of certification, so anytime you can make it do double-duty
[as CME], that’s good.” — DANIEL CARLAT, MD, PUBLISHER, CARLAT CME INSTITUTE
Money CME on a budget
7 SKIP THE CONFLICTSCarlat advocates skipping conferences that are labeled as CME but are sponsored by drug or device makers, though industry-funded CME is rarer today than it was a few years ago, he says.
“A lower percentage of CME is financed by corporations, but it’s still an issue,” he says.
Commercial funding accounted for 25% of CME investment in 2014, down from 37% in 2010, according to ACCME.
8 DOUBLE DIPCarlat also suggests taking advantage of CME that can also serve as part of a physi-cian’s maintenance of certification (MOC) requirements. Increasingly, CME providers have dovetailed their offerings to serve both goals, experts say.
“There can be some sticker shock in-volved with maintenance of certification, so anytime you can make it do double-duty, that’s good,” he says.
The American Board of Internal Medicine and ACCME inked a deal in 2015 to stream-line the process for using approved CME coursework as part of the MOC process. (A list of joint programs can be found at bit.ly/ABIM-ACCME-courses. )
As part of that agreement, accredited CME providers can use a single, shared sys-tem for registering CME and MOC activities, among other areas of interoperability, the groups say.
Another example is thinking about lever-aging CME as a career advancement tool.
“In talking with hospital CEOs about the value of CME, one thing we recognized is that CME is rarely used strategically,” says John Combes, MD, an internist and chief
medical officer for the American Hospi-tal Association. “There’s a need to develop physician leaders and this is an activity to engage physicians and also get a benefit to organizations,” he says.
In a 2014 report, “Continuing Education as a Strategic Resource,” the association said hospital-provided CME programs account for nearly 40% of credit hours offered. The report urged hospital associations to pro-mote partnerships with medical societies and others on CME, another way to stretch dollars a practice commits to education.
The association also advocates more ac-commodative policies on accepting project work and other non-traditional activities as CME, another form of “double dipping” that can lower overall CME costs for a given prac-tice.
Replacing time-based credit with per-formance-based CME should be a key part of adapting new learning methods into physicians’ ongoing training, the report concludes, while acknowledging some prac-titioners’ concerns about loosening CME guidelines too much.
9 THINK ‘OUTCOMES’Looking forward, be aware that increasingly, CME may be measured more by outcomes than credit hours.
As less formal gatherings for skill de-velopment become more popular, look for newer ways of measuring continuing educa-tion, experts say.
“How do you quantify the learning that happens in these less formal engagements? We used to sign up for an activity, fill out an application and collect documentation of attendance. Now education is happening on the fly and it’s difficult to quantify,” Romano says.
MedicalEconomics.com 69 MEDICAL ECONOMICS ❚ JUNE 10, 2016
MoneyCME on a budget
Looking at outcomes may be the best indicator, he says, though he acknowledges the dilemma that some outcomes mea-sures take many years to come to fruition. Performance-based measures after CME occasions—tracking, for example, a physi-cian’s ordering of mammograms for over-50 patients—is easier to quantify over a shorter period of time, he says.
And practices can measure evidence-based processes of care that should result in good final outcomes, he says, such as physi-cians’ performance on keeping diabetic pa-tients’ blood pressure and cholesterol under control.
10 LEVERAGE COLLEAGUESJoining with a few other local practices to tackle issues in a similar format to a grand rounds or a cancer care team review is an-other way to promote learning in a lower-cost environment.
“The thing we found most useful is gath-ering physicians around one table to talk about activities,” Romano says. Physicians informally sharing opinions on treatment plans and discussing clinical cases are the most effective ways of learning, he says.
“When you get a group together to talk about patient care, patients definitely ben-efit. The sharing of the clinical experience is one of the more powerful ways to do edu-cation, not to mention the cost savings in-volved when you can bring a larger group together to lower the administrative costs,” of the meeting, he says.
This can be done even in a more tradition-al, didactic conference environment, says McMahon. To boost the take-away value of these sessions, he says, consider digging in when a presenter pauses a lecture and asks the audience to pause and think of a case that relates to the topic, says McMahon. Those are great opportunities to turn to a peer and ask how they handled a case, he says.
“It creates opportunities to become more self-aware and to be honest about not know-ing an answer or struggling with a difficult issue,” he says, another way to get more value out of a conference rather than simply absorbing presented information.
Traditional, presentation-based confer-ences still have value, argues Todd Dorman, MD, FCCM, associate dean for continuing
medical education at Johns Hopkins Univer-sity School of Medicine.
Didactic education shouldn’t be seen as weak cousin, he says. “There’s still a role for live meetings because they provide network-ing, interacting with experts and being able to ask about the subtleties among clinical colleagues.” He does expect nearly week-long, multi-faceted meetings to constrict down to smaller workshop sessions targeted to engaging physicians on areas of specific expertise.
Already, he says, physicians can extend the value of these sessions by being ac-countable for their own engagement. Asking questions at the end of presentations and sending follow-up emails to presenters after a conference with more detailed questions are all ways to boost what physicians take away, he says.
“I’ve had attendees write me about spe-cific patients after a conference where I have presented and have gladly and happily got-ten back to them,” he says.
11 GO OUTSIDE THE NORMIt’s important, also, to look for expertise at conferences that brings in knowledge that is a bit outside a physician’s core specialty, Dorman says.
“It might mean reaching out for activities that might be put on by other specialists. A pulmonologist might identify a weakness in expertise in certain aspects of kidney dis-ease, for example, so maybe once every few years he might look for a session on that,” he says.
The jury is in on CME in general, Dorman says, noting that CME has proven its value in moving the profession forward. But the issues involving how physicians can learn more and get increased value out of each op-portunity are still on the table, he says.
“The present question is, ‘Can we learn more about which methods are cost effec-tive under which circumstances?’ And, ‘How can we be more effective?’”
Maintenance of certification:Inside the physician revoltbit.ly/mocrevolt
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READ MORE How to gain power over payers PAGE 22
ast year, U.S. represen-tatives Phil Roe, MD, (R-Tennessee) and John C. Fleming, MD, (R-Louisi-ana) learned an important
lesson about the power of the GOP Doctors Caucus to aff ect legislation.
Eff orts by caucus members helped to kill the onerous Medicare Sustain-able Growth Rate formula. Th is year, the 18 member caucus has a more ambitious agenda, including repeal-ing and replacing the Aff ordable Care Act (ACA), supporting eff orts to curb opioid abuse, improving health care for veterans, and making health IT less onerous.
All of these issues are important but secondary to repealing and replacing the ACA, says Fleming, a family physi-cian who represents Louisiana’s Fourth Congressional District.
Last year, the caucus supported the eff ort to repeal the ACA, which President Obama vetoed. “But we expect that after the next president takes offi ce, we’ll vote to repeal it again and, if we have a Republican in the White House, it will be signed into law,” Fleming told Medical Economics. “So until then, our main agenda is to put in place a replacement bill that would be market driven and patient centered.”
Th e co-chairmen of the caucus, Fleming and Roe expect the ACA replacement bill will combine ele-
ments of the American Health Care Reform Act, which Roe introduced in 2013, and the Empowering Patients First Act, which caucus member Tom Price, R-Georgia, introduced in 2009. Th e bills would establish insurance pools for individuals, expand health savings accounts, provide tax credits for individuals who buy insurance and reform medical liability laws to curb the practice of defensive medicine.
To address opioid abuse, the doc-tors invited U.S. Surgeon General Vice Admiral Vivek H. Murthy, MD, to a caucus meeting. To Murthy, the mem-bers expressed their concern about the addiction epidemic, the rising number of deaths due to overdose and neonatal abstinence syndrome. Also, they encouraged Murthy to pursue his idea of producing a report on addiction this year.
Under the Veterans Access, Choice and Accountability Act of 2014, Congress added residency slots for students in order to serve the nation’s growing number of veterans.
On Meaningful Use, the caucus met with Karen B. DeSalvo, MD, national coordinator for health information technology. “She got an earful from us about how we believe CMS over-reached on Meaningful Use,” Roe says.
Fleming’s experience with Meaning-ful Use in his practice is similar to that of many physicians. “Th e frustration
and the anger among doctors about Meaningful Use is palpable, and I understand why,” he said. His family practice clinic in Minden, Louisiana, is about to implement its third EHR system to meet Meaningful Use re-quirements even though the fi rst one—installed in 1997—boosted practice effi ciency quite well.
“We were happy with it until Mean-ingful Use came along. Th en, it became about satisfying government require-ments rather than meeting physician and patient needs,” Fleming says.
Looking back on what the caucus gained from its experience opposing the SGR, Roe and Fleming learned they had leverage in the house. Dur-ing deliberations over the SGR, Roe and Fleming wrote to John Boehner (R-Ohio), who was the Speaker of the House at the time, indicating the cau-cus’ support to eliminate the SGR.
Th e letter was instrumental in helping Boehner get other members of Congress and Minority Leader Nancy Pelosi (D-California) to sup-port eff orts to end the SGR. “Without that letter and their full support, I believe the bill wouldn’t have passed,” he says.
Joseph Burns is an independent journalist in Falmouth, Massachusetts. What would you like to see the GOP Doctors Caucus take on in 2016? Tell us at [email protected].
L
GOP Doctors Caucus looking at ambitious 2016
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