Update for November 28, 2012 · the RGA that guidance will be issued in the coming days and weeks....
Transcript of Update for November 28, 2012 · the RGA that guidance will be issued in the coming days and weeks....
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CMS Releases FY 2012 Financial Report; Misses Target for Reductions in Improper Payments
CMS missed an important goal
set by President Obama to slash
improper government reimbursements
by 50 percent by 2012, according to
the Agency’s financial report released
on November 21. In June 2010,
President Obama launched a national
campaign to combat fraud and to
reduce wasteful government
spending. The campaign included a
government-wide program designed
to implement programs that would
target and reduce waste, fraud and
abuse in the Medicare program.
According to the Office of www.polsinelli.com
Management and Budget (OMB), the
improper payment rate for CMS at
that time (FY 2009) was 10.8 percent,
or $30.8 billion. The Obama
Administration set a target rate of 5.4
percent by 2012 for reducing
improper payments – half of what it
was in 2009. According to CMS’
financial report, the improper
payment rate for FY 2012 was 8.5
percent, down slightly from FY 2011
(8.6 percent). Durable medical
equipment claims held the highest
percentage of improper payment rates
at 66 percent. Physicians, labs and
ambulances combined carried a 9.9
percent improper payment rate,
inpatient hospitals had a 6.8 percent
Update for November 28, 2012
Top News ….. 1
State News ….. 7
Regulatory News ….. 8
Additional Reading …..11
Federal Register ….. 12
For More Information ….. 18
Top News
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rate, non-inpatient hospitals had a 4.8 percent rate, and
Medicare Part D had a 3.1 percent payment rate.
However, according to the OMB’s blog, the government
cut wasteful spending across all agencies and programs
by $47 billion over the past three years, “almost hitting
the President’s ambitious goal of avoiding $50 billion in
improper payments by the end of FY 2012.” The report,
“CMS Financial Report Fiscal Year 2012,” is available
here. The OMB’s blog post is available here.
CMS Releases Guidance on Medicaid/CHIP Issues
CMS’ Center for Medicaid and CHIP Services
released guidance in the form of a “frequently asked
questions” document on November 19 that addresses a
number of questions related to Medicaid/CHIP
Affordable Care Act-related implementation issues. The
document is intended to provide guidance to states as to
their obligations with respect to upgrading their eligibility
and enrollment systems for Medicaid and the Children's
Health Insurance Program. CMS said that states that are
not building their own exchanges or opting to expand
their Medicaid programs must still coordinate with the
federal government under the federally-facilitated
exchange, which will determine eligibility standards and
exchange subsidies. CMS also said that while enhanced
funding is available to all states and not just to those who
choose to expand their Medicaid programs, in order to
qualify for the enhanced federal match rate, their system
upgrades must meet all requirements, standards, and
conditions that were addressed in a final rule published
by CMS in April 2011. The FAQ document is available
here.
HHS Secretary Extends Deadline for Decision on
Exchanges
In response to a request from the Republican
Governors Association (RGA), HHS Secretary
Kathleen Sebelius has pushed back the deadline for
states to decide on the issue of the establishment of
their health insurance exchanges. She told the RGA on
November 16 that states will be granted a one month
extension to decide whether to set up their own
exchanges, and that they have until December 14 to
submit their letters of intent and detailed exchange
blueprint plans. February 15, 2013 remains the
deadline for states to decide if they will operate in
partnership with the federal government. She reassured
the RGA that guidance will be issued in the coming
days and weeks. Sebelius had previously extended the
deadline to December 14 for states to submit their
blueprints to build state-based exchanges. While a
number of governors have already declared their
intentions, several still remain undecided. Sebelius’
letter to the RGA is available here.
Three House Republicans Consider Creating New
Health Care Committee
Three House Republicans circulated a “Dear
Colleague” letter that
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deficit reductions that would prevent cuts to hospitals
by shifting them to other providers and increasing
beneficiary cost-sharing. The Affordable Care Act
mandated $155 billion in cuts, and hospitals are
concerned that deeper cuts will be made as part of the
deficit reduction talks. Hospitals particularly are
concerned about the potential for cuts to hospital
evaluation and management service payments. Instead,
the AHA pointed to other plans and proposals that have
been offered from a variety of sources, such as
President Obama’s budget proposals and the National
Commission on Fiscal Responsibility and Reform. The
list includes options such as creating a combined
Medicare Part A and Part B deductible, increasing the
Part B premium from 25 percent to 50 percent,
changing the Medicare eligibility age to 67, and
imposing a tax on certain employment-based health
plans in 2014 instead of 2018. Other provider groups
oppose such proposals, arguing they would hurt
beneficiaries.
Senate HELP Committee Holds Hearing on NECC
Compounding Issues
The Senate Committee on Health, Education, Labor
and Pensions (HELP Committee) held a hearing on
proposed shifting jurisdiction over health care from the
Energy & Commerce and Ways & Means committees to
a new Committee on Health Care. Reps. Doc Hastings
(R-WA), Rob Woodall (R-GA) and Reid Ribble (R-WI)
said that the jurisdictions of the current committees are a
“relic of decades of Democratic control” and that a new
health care committee would provide an opportunity to
reform or repeal the Affordable Care Act. The
Committee on Health Care would be a permanent
standing committee with complete jurisdiction on health
care matters and would “elevate and ensure relentless
oversight of Obamacare.” The three Republicans
reportedly are suggesting Rep. Paul Ryan (R-WI) to chair
the proposed committee.
Burgess Open to Shifting Part B Drug into Part D
Rep. Michael Burgess (R-TX) recently said he would
be open to moving the Part B outpatient drug benefit into
the Part D outpatient prescription drug benefit. He said
he would like to “eliminate all the silos – A, B, C and D –
and treat Medicare as an integrated program.” Part B
typically pays more for drugs, since prices are set at 106
percent of the average sales price except for vaccines and
DME-infused drugs, which are paid at 95 percent of the
average wholesale price as of October 1, 2003. Instead
of moving Part B drugs into Part D, some industry
sources said it would be better to consolidate all Part B
services, including the DME and laboratory fee schedule,
into a program that is modeled similarly to Part D.
Provider Groups Differ on Medicare Reform, Deficit
Reduction Targets
The American Hospital Association (AHA) is
circulating a list of previously discussed options for
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House Leaders Demand Documents from FDA
In related news, House leaders recently called on
FDA Commissioner Margaret Hamburg to submit
internal documents related to the deadly meningitis
outbreak no later than November 30, 2012. While
testifying before the House Energy & Commerce
Oversight and Investigations Subcommittee on
November 14, Commissioner Hamburg repeatedly
assured members that the Agency would provide the
documents, originally requested one month ago, in a
timely manner. In a letter to Commissioner Hamburg
dated November 16, Committee Chairman Fred Upton
(R-MI), Oversight and Investigations Subcommittee
Chairman Cliff Stearns (R-FL), Chairman Emeritus Joe
Barton (R-TX), Health Subcommittee Chairman Joe
Pitts (R-PA), and Rep. Michael C. Burgess, M.D. (R-
TX) wrote, “In order to effectively and responsibly
address the question of clarifying or enhancing FDA’s
authority over compounding pharmacies, the committee
must identify what happened at the New England
Compounding Center (NECC), and why FDA did not
use its authority to take enforcement action against
NECC until October 2012, after the meningitis
outbreak. Your agency has not provided any internal
communications or memoranda in response to the
committee’s bipartisan request letter of October 17,
November 15 over the recent meningitis outbreak that to
date has resulted in over 30 deaths and more than 500
serious illnesses. Lawmakers pressed pharmacy groups
testifying before the committee to provide assurances that
they would cooperate fully with lawmakers as they work
to develop preventative measures and to clarify the
FDA’s role in oversight of compounding pharmacies.
Committee Chairman Tom Harkin (D-IA) said the
Committee intends to pursue legislation to ensure the
safety of compounding pharmacies. Senator Lamar
Alexander (R-TN), slated to take over the ranking spot on
the committee, said not to expect the introduction of any
legislation until early next year, dismissing any concerns
that lobbying groups would move in with efforts against
any bill. “I don’t think lobbying forces are going to have
any luck on this one,” he said to reporters after the
hearing. The current Ranking Member, Senator Mike
Enzi (R-WY), said in his opening statement that the
Committee would continue to investigate the New
England Compounding Center conduct and the oversight
of state and federal regulators and would “leave no stone
unturned.” Top officials from the FDA, the CDC, the
Massachusetts and Tennessee Departments of Health,
Barry Cadden, the owner and director of the NECC, as
well as leaders of several pharmacy coalitions all testified
at the hearing. Testimony from the hearing is available
here. The Committee’s report, “The New England
Compounding Center and the Meningitis Outbreak of
2012: A Failure to Address Risk to the Public Health,” is
available here
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available here.
Medical Device Excise Tax Estimated to Increase
Industry’s Tax Liability by 29 Percent
The Affordable Care Act’s excise tax on medical
devices will add 29 percent a year to what the medical
device industry pays in federal income taxes, according
to AdvaMed. The device tax will increase taxes for the
industry by about $2.5 billion. This is in addition to the
$8.7 billion in overall federal income taxes the medical
device industry will pay in 2013. AdvaMed President
and CEO Stephen Ubl said, “A dramatic tax increase on
a job-creating industry like medical technology makes
no sense. A tax bill this big will only lead to fewer
jobs, reduced investment in tomorrow’s treatment and
cures, or higher health care costs for the consumer.”
AdvaMed, along with other industry trade groups, is
urging Congress to repeal the tax. A statement from
AdvaMed is available here.
GAO Finds CMS Delinquent in Reporting
Progress of FPS
A recent GAO study found that despite the
apparent success of CMS’ Fraud Prevention System
(FPS), CMS has
2012. We need these documents to identify any possible
weaknesses in FDA’s regulatory system that can be
immediately corrected administratively or legislatively.
Without gaining insight into whether FDA used its
existing authority effectively, providing clearer or
additional authority to FDA may not solve the actual,
underlying problem…” The letter to Commissioner
Hamburg is available here. Testimony from the hearing
“The Fungal Meningitis Outbreak: Could It Have Been
Prevented?” is available here.
Nursing Homes Criticize OIG Report on Billing
Errors
The American Health Care Association (AHCA)
sharply criticized a recent OIG report that found that
approximately 25 percent of skilled nursing home claims
billed in 2009 were in error. The OIG conducted a
medical record review of a random sample of SNF claims
from 2009 and concluded that Medicare inappropriately
paid $1.5 billion for these claims. The report said that
SNFs were improperly upcoding to achieve higher
reimbursement. The AHCA criticized the OIG for
questioning treatment decisions made three years ago
without the considering the patients’ and the clinicians’
perspectives. “Bureaucrats questioning these services
after three years and saying they know what’s in the best
interest of patients is not good medicine and doesn’t
make sense,” said AHCA President and CEO Mark
Parkinson. He added that the OIG report goes too far by
implying that “clinical decisions made in consultations
with doctors and therapists at the time of treatment
somehow constitutes wrongdoing.” The OIG report,
Inappropriate Payments to Skilled Nursing Facilities
Cost Medicare More Than a Billion Dollars in 2009, is
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Studies Find Alarming Rise in Diabetes Diagnoses
in the U.S.
The CDC published the results of a study that
shows an alarming rise in the number of diagnosed
cases of diabetes in the U.S. and Puerto Rico.
According to the report, the number of cases of diabetes
rose by 50 percent or more in 42 states over the period
between 1995 and 2010 and by 100 percent or more in
18 states during that same period. The states with the
largest increases were Oklahoma (226 percent),
Kentucky (158 percent), Georgia (145 percent),
Alabama (140 percent), Washington (135 percent), and
West Virginia (131 percent), according to the study.
The region with the greatest increase was the South and
the Northeast had the fewest number of newly
diagnosed cases. The investigators who conducted the
study predicted that barring significant lifestyle
changes, the number of cases of diabetes will climb to
as many as 552 million by the year 2030. The CDC
report, published in the CDC’s November 16, 2012
Morbidity and Mortality Weekly Report, is available
here.
In related news, researchers from the CDC have
generated yearly forecasts on the incidence of diabetes
diagnoses on youth under 20 years of age. The
researchers found that the numbers of individuals
failed to provide Congress with statutorily-required
updates on the usefulness of the system. The FPS,
initially launched in July 2011, uses computer-generated
predictive modeling and data analytics to ferret out
fraudulent Medicare fee-for-service claims. The
investigation was conducted at the request of a group of
senators who have made repeated requests to CMS for a
report outlining performance metrics associated with the
FPS. CMS reported initial performance measurements
and targets in September 2011 and said it would submit a
new report in June 2012, but has not yet done so. The
GAO recommended that CMS define quantifiable
benefits of the system, create performance targets and
milestones for use in measuring the success of the FPS,
develop a timeline for when the FPS system will be
integrated with the claims payments systems, and review
the system to assess its viability. The GAO report, “CMS
Has Implemented a Predictive Analytics System, but
Needs to Define Measures to Determine its
Effectiveness,” is available here.
“Doc Fix” to Cost More than Previously Estimated
According to the latest estimates from the
Congressional Budget Office (CBO), the “doc fix” is
going to cost taxpayers nearly $7 billion more for a one
year “fix” than was previously estimated in its last
projection. The CBO now says that delaying the cut and
freezing pay for doctors will cost $25 billion, a sharp
increase from its last projection of $18.5 billion.
According to its report, freezing doctors pay for 10 years
will cost as much as $244 billion, and a two-year “fix”
will cost $41.5 billion. Additional information about the
physician fee schedule is available here.
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about the exchange until our state receives clear,
binding rules from your department,” he wrote.
Tennessee Governor Bill Haslam announced that he
will wait until the new December deadline to decide,
anticipating that in the coming weeks HHS will issue
appropriate guidances.
Other governors have opted for federally-run
exchanges. Nebraska Governor Dave Heineman said
that although Nebraska was ready to run its own
exchange, his state is opting for a federally-run
exchange. He said in a statement that “the reality is
that the federal health care law is being totally dictated
and totally controlled by the federal government.”
Governor Robert Bentley of Alabama said that he
would not impose a “tax burden of up to $50 million on
the people of Alabama,” despite the fact that the state
has been actively planning for its exchange. Others
remain dubious. Indiana Governor-elect Mike Pence
said that running a state-based exchange would be too
expensive and thus, the state will have to opt for a
federally-run exchange. However, he said he would not
rule out a hybrid system. Wyoming will start with a
federal system, but lawmakers there are considering
measures to study progress and may opt for a state-
based exchange in the future. In Florida, Governor
Rick Scott, one of the most outspoken critics of the
ACA, said that he wants to negotiate with the federal
diagnosed with types 1 and 2 diabetes at ages younger
than 20 years is expected to rise significantly by 2050 –
by as much as 178 percent. The largest increases are
expected to occur in youth of minority racial and ethnic
groups. The study, “Projections of Type 1 and Type 2
Diabetes Burden in the U.S. Population Aged <20 Years
Through 2050,” is available here.
State News
Governors Speak Out on Exchanges
Following HHS Secretary Sebelius’ announcement
that states would be granted an additional 30 days to
decide about their health care exchanges, a number of
governors are again calling on HHS to produce rules and
guidance before they will make a formal decision. South
Carolina Governor Nikki Haley sent HHS a letter stating
that the state will not establish an exchange because HHS
has not issued formal rules defining how the exchanges
will operate. Utah Governor Gary Herbert sent HHS a
letter listing 10 questions regarding federal exchanges.
He said that he planned to continue to pursue Utah’s
state-based reforms, including “our vision for an
exchange based on defined contribution, consumer
choice, and free markets,” but Utah remains uncommitted
at this point. In Iowa, Governor Terry Branstad told
HHS that while Iowa will continue to create a state-based
exchange, it still is dependent on rules and guidance and
could end up switching over to a federally-run exchange
if it does not receive more details soon. “I cannot
provide you with a set of timelines or complete details
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that for fiscal years 2003 through 2007, five hospitals
were ineligible to receive those payments in one or
more of those years. In order to qualify as a DSH, at
least 1 percent of the hospital’s total inpatient
population must be Medicaid recipients. Over the five-
year period, New Jersey claimed $6.2 billion in DSH
payments to 109 hospitals. State officials contend that
while at least one of the hospitals involved may have
been ineligible, New Jersey submitted valid claims for
the other hospitals. The OIG report, “The New Jersey
Department of Human Services Claimed Medicaid
Disproportionate Share Hospital Payments to Five
Hospitals That Did Not Meet Federal Eligibility
Requirements (A-02-09-01017)” is available here.
Regulatory News
HHS Releases Proposed Rules to Implement
ACA’s Market Rules, Essential Health Benefits,
Wellness Provisions
HHS on November 20 released three proposed rules
to implement provisions of the Affordable Care Act
regarding essential health benefits, employer-based
wellness programs, requirements for insurance
government. He said that he is responsible for the
families of Florida and wants to “get to yes,” though he
would not clarify exactly how he intended to get there.
Massachusetts Implements New Healthcare Cost
Containment System
A newly-formed commission in Massachusetts has
taken on the task of overseeing reductions in state health
care expenditures as established under the state’s health
reform law. The panel, known as the Health Policy
Commission (HPC) will enforce cost containment
measures required by a state law that established a health
care cost growth benchmark equal to the potential
economic growth rate of the state for each of the next five
years. The HPC will focus on “gross abuses” and target
health care entities identified as excessively contributing
to cost growth. Those identified will be required to file a
performance improvement plan or seek a waiver, and
may be subject to a fine of up to $500,000. The HPC will
be assisted by a new state agency, the Center for Health
Information and Analysis, that will assume many of the
duties of the former Division of Health Care Finance and
Policy. Additional information about the Health Policy
Commission is available here.
OIG Says NJ Owes Feds $5 Million in Improper
Payments
A recent investigation conducted by HHS’ Office of
the Inspector General found that New Jersey owes the
federal government $50 million in improper payments
made to disproportionate share hospitals (DSH) that did
not meet the criteria for DSH status. The study found
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will prevent insurance companies from charging
individuals and small employers higher premiums due
to enrollee’s health status or gender. The proposed rule
is available here.
HHS also issued a proposed rule regarding
nondiscriminatory wellness programs in group health
coverage. The ACA allows employers to provide
discounts on health insurance to workers who achieve
certain medical or fitness goals, such as weight,
cholesterol level and blood pressure level. The
proposed rule raises the level of the permissible reward,
discount or penalty from 20 percent to 30 percent of the
cost of the health coverage. The rule also proposes to
increase the maximum reward to 50 percent for
programs to reduce tobacco use. The rule requires that
wellness programs must offer alternatives to programs
for people with doctor-certified health conditions that
make it “unreasonably difficult” to meet the specified
health-related standard. The proposed rule is available
here.
CMS Issues Guidance on Coverage Requirements
for Medicaid Expansion
CMS issued guidance on November 20 that defines
the minimum standards with which state Medicaid
programs must
premiums, risk pools and guaranteed availability of
coverage.
The essential health benefits proposed rule details the
items and benefits that health plans in the small and
individual group market will be required to cover. The
rule also proposes the specific actuarial values that health
plans will be required to meet. The rule proposes to
allow states to select a benchmark plan from four types of
health plans: the largest plan by enrollment in any of the
three largest small group insurance products in the state’s
small group market; any of the largest three state
employee health plans by enrollment; any of the largest
three national Federal Health Benefits Program plan
options; or the largest insured commercial non-Medicaid
Health Maintenance Organization operating in the state.
The essential health benefits proposed rule broadens
earlier HHS guidance on how plans must structure
prescription drug coverage. The proposed rule would
require that plans either cover one drug in every category
and class or the same number of drugs in each category
and class as the selected benchmark plan. This proposal
does not include “protected classes” of drugs that some
advocates requested. Advocates for patients with HIV/
AIDS are concerned that plans will only cover one drug
per class, which they considered inadequate protection.
The proposed rule is available here.
The “market” rule proposes a number of
requirements on health insurance premiums, guaranteed
availability, guaranteed renewability, risk pools, and
other insurance reforms. The rule would require health
insurers to accept individuals or employees who apply for
coverage in the individual or group market. Such
coverage also would include guaranteed renewability,
except for non-payment of premiums or fraud. The rule
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premiums as well as modest increases in the Part A
deductible. Medicare Part A pays for inpatient
hospitals, skilled nursing facilities, and some home
health care. Medicare Part A monthly premiums will
be $441 for 2013, a decrease of $10 from 2012. The
Part A deductible paid by beneficiaries when admitted
as a hospital inpatient will be $1,184 in 2013, an
increase of $28 from last year's deductible of $1,156.
The notice entitled “Medicare Program; Part A
Premiums for CY 2013 for the Uninsured Aged and for
Certain Disabled Individuals Who Have Exhausted
Other Entitlement [CMS-8047-N]” is available here.
The notice entitled “Medicare Program; Medicare Part
B Monthly Actuarial Rates, Premium Rate, and Annual
Deductible Beginning January 1, 2013 [CMS-8048-N]”
is available here. The notice entitled “Medicare
Program; Inpatient Hospital Deductible and Hospital
and Extended Care Services Coinsurance Amounts for
CY 2013 [CMS-8046-N]” is available here.
CMS Announces Data Sharing Performance
Measurement Project
CMS announced on November 21 a new project
designed to help consumers get more information
regarding the performance of their local doctors,
hospitals, and other health care providers. The
comply as they design coverage options under the
Medicaid expansion. In a letter to state Medicaid
directors, Cindy Mann, Director of the Center for
Medicaid and CHIP, said that there are a number of
options states may use in designing plans for their states’
Medicaid expansion, but at a minimum, benefits must be
actuarially equivalent to one of the four benchmark plans
as defined under the Deficit Reduction Act of 2005.
These include: 1) the Standard Blue Cross/Blue Shield
preferred provider option offered through the Federal
Employees Health Benefit program; 2) state employee
coverage that is generally made available to state
employees; 3) the commercial health maintenance
organization with the largest insured commercial, non-
Medicaid enrollment in the state; and 4) HHS Secretary-
approved coverage, which can include the Medicaid state
plan benefit package offered in that state. States seeking
to expand their Medicaid programs must also ensure that
the option they choose meets the essential health benefit
requirements as established under the ACA. The state
Medicaid director letter is available here.
HHS Publishes Medicare Parts A and B Rates for
CY 2013
HHS posted on November 16 the Medicare Part A
and Part B premiums, deductibles and coinsurance
amounts for 2013. The Medicare Part B standard
premium in 2013 will be $104.90, an increase over last
year’s premium of $99.90, and the Part B deductible will
be $147.00. Medicare Part B covers physicians’ services,
outpatient hospital services, certain home health services,
durable medical equipment, and other items. HHS also
announced a decrease in Medicare Part A monthly
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• Kaiser Commission on Medicaid and the
Uninsured: The Role of Medicaid for Adults with
Chronic Illnesses
• Kaiser Commission on Medicaid and the
Uninsured: The Cost and Coverage Implications of
the ACA Medicaid Expansion: National and State-
by-State Analysis
• Kaiser Health News: Doctors' and Nurses'
Licenses Snagged by New Immigration Law in
Georgia
• Kaiser Health News: Effort to Curb Medicare
Spending Begins With Crackdown on Hospital
Readmissions
• Los Angeles Times: U.S. Panel Advises HIV Tests
for Everyone Ages 15 to 64
• MedPage Today: Repeat Testing Common in
Older Patients
• Office of the Inspector General: Fall 2012
Semiannual Report to Congress
• Office of the Inspector General: OIG Reports $6.9
Billion in Expected Recoveries Among FY 2012
Accomplishments
• Office of the Inspector General Report: 2012 Top
Management and
Medicare Data Sharing for Performance Measurement
Program, also known as the Qualified Entity Program,
makes Medicare claims data available under strict
privacy requirements to groups that HHS certifies as
qualified to handle this data and protect patient privacy.
These groups will combine Medicare and private
insurance data to create comprehensive, useful reports on
provider performance. The three organizations selected
to participate in this project are the Health Improvement
Collaborative of Greater Cincinnati, the Kansas City
Quality Improvement Consortium (serving the Greater
Kansas City area in Missouri and Kansas), and the
Oregon Health Care Quality Corporation. All
participants have certified that they can manage and
process consumer-focused data and can prevent breaches
of protected health information. The organizations must
also show that they are working with private insurers to
access other payer data in order to produce
comprehensive reports on provider performance.
Additional details about this program are available here.
Additional Reading
• AHRQ: Long-Term Care for Older Adults: A
Review of Home and Community-Based Services
Versus Institutional Care
• Becker’s Hospital Review: U.S. Primary Care
Physician Adoption of EMRs Increases 50%, Still
Lags Other Countries
• Bloomberg: Hospital Medicare Cash Lures Doctors
as Costs Increase
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CDC published a notice announcing an upcoming
public meeting of the Advisory Committee on Breast
Cancer in Young Women. The meeting will be held
via telephone conference on December 13, 2012. The
notice is available here and appeared in the November
16 Federal Register.
CDC published a notice that a proposed collection
of information project entitled “Emergency Epidemic
Investigations” has been submitted to the OMB for
review and approval. Comments will be accepted for
30 days following publication. The notice is available
here and appeared in the November 19 Federal
Register.
CDC published a notice that a proposed collection
of information project entitled “Determining Causes of
Sudden, Unexpected Infant Death: A National Survey
of U.S. Medical Examiners and Coroners” has been
submitted to the OMB for review and approval.
Comments will be accepted for 60 days following
publication. The notice is available here and appeared
in the November 19 Federal Register.
Performance Challenges
• Urban Institute: Cross Cutting Issues: Will There Be
Enough Providers to Meet the Need? Provider
Capacity and the ACA
• Washington Post: Medicaid Personal-Care Programs
are Targets for Fraud, Investigators Say
• Washington Post: Millions Will Qualify for New
Options Under the Health Care Law. Most Have No
Idea.
• Washington Post: Report Says States Can Get More
Than $9 from Feds for Every $1 They Spend to
Expand Medicaid
Federal Register
CDC published a notice that a proposed collection
of information project entitled “Nationally Notifiable
Sexually Transmitted Disease (STD) Morbidity
Surveillance” has been submitted to the OMB for review
and approval. Comments will be accepted for 30 days
following publication. The notice is available here and
appeared in the November 16 Federal Register.
CDC published a notice that a proposed collection
of information project entitled “Spectrum of Flavoring
Chemical-Related Lung Disease” has been submitted to
the OMB for review and approval. Comments will be
accepted for 60 days following publication. The notice is
available here and appeared in the November 16 Federal
Register.
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© 2012 Polsinelli Shughart Page 13 of 18
Federal Register Continued
CDC published a notice announcing an upcoming public meeting of the Advisory Board on Radiation and Worker
Health. The meeting will be held December 11-12, 2012 in Knoxville, TN. The notice is available here and appeared in
the November 19 Federal Register.
CMS published a notice that a proposed collection of information project entitled “Children's Health Insurance
Program (CHIP) Report on Payables and Receivables” has been submitted to the OMB for review and approval.
Comments will be accepted for 31 days following publication. The notice is available here and appeared in the
November 16 Federal Register.
CMS published a notice that a proposed collection of information project entitled “Medicaid Report on Payables
and Receivables” has been submitted to the OMB for review and approval. Comments will be accepted for 31 days
following publication. The notice is available here and appeared in the November 16 Federal Register.
CMS published a notice that a proposed collection of information project entitled “State Health Insurance
Assistance Program (SHIP) Client Contact Form, Public and Media Activity Report Form, and Resource Report Form”
has been submitted to the OMB for review and approval. Comments will be accepted for 31 days following publication.
The notice is available here and appeared in the November 16 Federal Register.
CMS published a notice that a proposed collection of information project entitled “Valve Therapy Registry and
KCCQ-10” has been submitted to the OMB for review and approval. Comments will be accepted for 31 days following
publication. The notice is available here and appeared in the November 16 Federal Register.
CMS published a notice entitled “Recognition of Entities for the Accreditation of Qualified Health Plans.” This
notice announces the recognition of the National Committee for Quality Assurance (NCQA) and URAC as recognized
accrediting entities for the purposes of fulfilling the accreditation requirement as part of qualified health plan
certification. This notice is effective as of November 23, 2012. The notice is available here and appeared in the
November 23 Federal Register.
CMS, the Department of the Treasury, Internal Revenue Service, and the Department of Labor, Employee Benefits
Security Administration published a notice of proposed rulemaking entitled “Incentives
for Nondiscriminatory Wellness Programs in Group Health Plans [CMS-9979-P].”
This document proposes amendments to regulations, consistent with the Affordable
Care Act, regarding nondiscriminatory wellness programs in group health coverage.
These regulations also include other proposed clarifications regarding the reasonable
design of health-contingent wellness programs and the reasonable alternatives they
must offer in order to avoid prohibited discrimination. Comments will be accepted for
60 days following publication. The notice is available here and appeared in the
November 26 Federal Register.
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CMS published a notice that a proposed collection of information project entitled “Initial Plan Data Collection to
Support Qualified Health Plan (QHP) Certification and Other Financial Management and Exchange Operations” has
been submitted to the OMB for review and approval. Comments will be accepted for 30 days following publication.
The notice is available here and appeared in the November 21 Federal Register.
CMS published a notice that a proposed collection of information project entitled “Information Collection
Requirements for Compliance with Individual and Group Market Reforms under Title XXVII of the Public Health
Service Act” has been submitted to the OMB for review and approval. Comments will be accepted for 60 days
following publication. The notice is available here and appeared in the November 21 Federal Register.
CMS published a notice that a proposed collection of information project entitled “Medicare Uniform Institutional
Provider Bill and Supporting Regulations in 42 CFR 424.5” has been submitted to the OMB for review and approval.
Comments will be accepted for 60 days following publication. The notice is available here and appeared in the
November 21 Federal Register.
CMS published a notice that a proposed collection of information project entitled “Medicare Plan Finder
Experiment” has been submitted to the OMB for review and approval. Comments will be accepted until January 10,
2013. The notice is available here and appeared in the November 26 Federal Register.
CMS published a notice that a proposed collection of information project entitled “CMS Enterprise Identity
Management System” has been submitted to the OMB for review and approval. Comments will be accepted for 60 days
following publication. The notice is available here and appeared in the November 26 Federal Register.
CMS published a notice that a proposed collection of information project entitled “The Medicare Advantage and
Prescription Drug Program: Part C Explanation of Benefits CFR 422.111(b)(12)” has been submitted to the OMB for
review and approval. Comments will be accepted for 60 days following publication. The notice is available here and
appeared in the November 26 Federal Register.
CMS published a final notice announcing its decision to approve the American Association for Accreditation of
Ambulatory Surgery Facilities for continued recognition as a national accrediting organization for ambulatory surgery
centers that wish to participate in the Medicare or Medicaid programs, effective November 27, 2012 through November
27, 2018. The notice is available here and appeared in the November 26 Federal
Register.
CMS published a notice announcing an upcoming public meeting of the Advisory
Panel on Hospital Outpatient Payment. The meeting will be held March 11-12, 2013 at
the CMS Central Office in Woodlawn, MD. Individuals interested in attending this
meeting must preregister online and may do so January 9 through February 22, 2013.
Please see the notice available here for registration information. This notice appeared
in the November 26 Federal Register.
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FDA published a notice that a proposed collection of information project entitled “Draft Guidance for Industry on
Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act” has been submitted to the OMB
for review and approval. Comments will be accepted for 30 days following publication. The notice is available here and
appeared in the November 16 Federal Register.
FDA published a notice announcing an upcoming public meeting of the Neurological Devices Panel of the Medical
Devices Advisory Committee. The meeting will be held on December 10, 2012 in Gaithersburg, MD. The notice is
available here and appeared in the November 16 Federal Register.
FDA published a notice announcing an upcoming public hearing and request for comments entitled “Establishing a
List of Qualifying Pathogens that have the Potential to Pose a Serious Threat to Public Health.” The hearing will be held
on December 18, 2012 at the FDA’s White Oak Campus in Silver Spring, MD. Preregistration no later than December 3,
2012 is required for individuals who intend to make an oral presentation. Comments will be accepted until December 3,
2012. The notice is available here and appeared in the November 16 Federal Register.
FDA published a proposed rule entitled “Unique Device Identification System [Docket No. FDA-2011-N-0090].”
The FDA is amending its July 10, 2012, proposed rule (77 FR 40736) to establish a unique device identification system as
required by recent amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act). On July 9, 2012, the Food
and Drug Administration Safety and Innovation Act (FDASIA) was signed into law; section 614 of FDASIA amends the
FD&C Act in ways that require modification of the timeframe for implementation of the proposed rule’s requirements as
they apply to devices that are implantable, life-saving (life-supporting), or life-sustaining. Comments will be accepted for
30 days following publication. The notice is available here and appeared in the November 19 Federal Register.
FDA published a notice entitled “Medical Devices; Custom Devices; Request for Comments.” The FDA is in the
process of developing an implementation strategy and policy for the custom device exemption criteria in the FD&C Act
amended by FDASIA. FDA is seeking information on appropriate uses of the custom device exemption. Comments will
be accepted for 60 days following publication. The notice is available here and appeared in the November 19 Federal
Register.
FDA published a notice announcing the availability of draft guidance entitled “Draft Guidance for IRBs, Clinical
Investigators, and Sponsors: IRB Responsibilities for Review the Qualification of Investigators, Adequacy of Research
Sites, and the Determination of Whether an IND/IDE is Needed.’ To ensure
consideration, comments must be submitted no later than 60 days following
publication. The notice is available here and appeared in the November 20 Federal
Register.
FDA published a notice announcing the availability of draft guidance entitled
“Draft Guidance for Industry on Electronic Source Data in Clinical Investigations.” To
ensure consideration, comments must be submitted no later than 60 days following
publication. The notice is available here and appeared in the November 20 Federal
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© 2012 Polsinelli Shughart Page 16 of 18
Register.
FDA published a notice announcing the availability of a guidance entitled “International Conference on
Harmonisation: Guidance on Q11 Development and Manufacture of Drug Substances.” The notice is available here and
appeared in the November 20 Federal Register.
FDA published two notices announcing an upcoming pubic meeting of the Pulmonary-Allergy Drugs Advisory
Committee. The meeting will be held January 29-30, 2013 at the FDA White Oak Campus in Silver Spring, MD. The
notices are available here and here and appeared in the November 20 Federal Register.
FDA published a notice and request for comments entitled “Development of Prioritized Therapeutic Area Data
Standards.” The FDA is announcing its intent to prioritize and develop therapeutic area data standards to facilitate the
conduct of clinical research and the regulatory review of medical products. Comments will be accepted for 60 days
following publication. The notice is available here and appeared in the November 20 Federal Register.
FDA published a notice announcing an upcoming public workshop entitled “Antiseptic Patient Preoperative Skin
Preparation Products; Public Hearing; Request for Comments.” The Agency is announcing a public hearing to obtain
input on how to address microbial contamination of patient preoperative skin preparation drug products. The public
hearing will be held December 12-13, 2012 in Silver Spring, MD. Preregistration no later than November 27 is required
of those wishing to make an oral presentation. Comments will be accepted until February 12, 2013. The notice is
available here and appeared in the November 21 Federal Register.
FDA published a notice entitled “Medical Device User Fee and Modernization Act; Notice to Public of Web Site
Location of Fiscal year 2013 Proposed Guidance Development. The FDA is announcing the website location where the
Agency will post two lists of guidance documents that the Center for Devices and Radiological Health is intending to
publish in FY 2013. In addition, FDA has established a docket where stakeholders may provide comments and/or
propose draft language for those topics, suggest new or different guidance documents, and comment on the priority of
topics for guidance. The notice is available here and appeared in the November 26 Federal Register.
FDA published a notice announcing an upcoming public meeting of the Risk Communication Advisory Committee.
The meeting will be held on February 12, 2013 at the FDA White Oak Campus in Silver Spring, MD. The notice is
available here and appeared in the November 26 Federal Register.
FDA published a notice announcing an upcoming public hearing and request for
comments entitled “FDA Actions Related to Nicotine Replacement Therapies and
Smoking-Cessation Products; Report to Congress on Innovative Products and
Treatments for Tobacco Dependence.” The hearing will be held on December 17,
2012 at the FDA White Oak Campus in Silver Spring, MD. Preregistration prior to
December 6 is required. Comments will be accepted until January 2, 2013. The notice
is available here and appeared in the November 28 Federal Register.
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© 2012 Polsinelli Shughart Page 17 of 18
FDA published a notice withdrawing guidance for industry entitled “Enforcement Policy Concerning Rotational
Warning Plans for Smokeless Tobacco Products.” The withdrawal is effective November 28, 2012. The notice is
available here and appeared in the November 28 Federal Register.
FDA published a notice announcing an upcoming public meeting and request for comments entitled “Framework for
Pharmacy Compounding: State and Federal Roles.” The meeting will be held on December 19, 2012 at the FDA White
Oak Campus in Silver Spring, MD and via live webcast. Registration is required and will begin onsite at 2:00 p.m.
Comments will be accepted until January 18, 2013. The notice is available here and appeared in the November 28
Federal Register.
FDA put on display a notice that a proposed collection of information project entitled “Revision of the Requirements
for Constituent Materials” has been submitted to the OMB for review and approval. Comments will be accepted for 60
days following publication. The notice is available here and is scheduled to appear in the November 29 Federal Register.
FDA put on display a notice announcing the availability of draft guidance for industry entitled “Preclinical
Assessment of Investigational Cellular and Gene Therapy Products.” To ensure consideration, comments must be
received no later than 90 days following publication. The notice is available here and is scheduled to appear in the
November 29 Federal Register.
FDA put on display a notice announcing an upcoming public meeting of the Orthopaedic and Rehabilitation Devices
Panel of the Medical Devices Advisory Committee. The meeting will be held on April 5, 2013 in Gaithersburg, MD. The
notice is available here and is scheduled to appear in the November 29 Federal Register.
HHS published a notice announcing an upcoming public meeting of the President’s Advisory Council on Faith-
Based and Neighborhood Partnerships. The meeting will be held on November 29, 2012 at a location yet to be
determined in the White House complex. Space is extremely limited. Photo ID and RSVP are required to attend this
event. The notice is available here and appeared in the November 16 Federal Register.
HHS published a notice announcing an upcoming public meeting of the Advisory Committee on Minority Health.
The meeting will be held November 29-30, 2012 in Washington, DC. Preregistration is required. The notice is available
here and appeared in the November 19 Federal Register.
HHS published a notice that a proposed collection of information project entitled
“Medical Reserve Corps United Profile and Reports” has been submitted to the OMB
for review and approval. Comments will be accepted for 30 days following
publication. The notice is available here and appeared in the November 26 Federal
Register.
HHS published a notice entitled “Office of the National Coordinator for Health
Information Technology; Health Information Technology; HIT Policy Committee:
HEALTH REFORM + RELATED HEALTH POLICY NEWS | E-ALERT November 28, 2012
© 2012 Polsinelli Shughart Page 18 of 18
For questions regarding any of the issues covered in this Alert, please contact:
� Matthew J. Murer | Practice Area Chair | 312.873.3603 | [email protected]
� Colleen M. Faddick | Practice Area Vice-Chair | 303.583.8201 | [email protected]
� Bruce A. Johnson | Practice Area Vice-Chair | 303.583.8203 | [email protected]
� Alan K. Parver | Practice Area Vice-Chair | 202.626.8306 | [email protected]
� Darryl Drevna | Editor | 202.626.8303 | [email protected]
For More Information
Additional Health Care Public Policy Professionals
Julius W. Hobson, Jr. Washington, D.C. 202.626.8354 [email protected]
Harry Sporidis Washington, D.C. 202.626.8349 [email protected]
Request for Comment Regarding the Stage 3 Definition of Meaningful Use of Electronic Health Records.” Comments
will be accepted until January 14, 2013. The notice is available here and appeared in the November 26 Federal Register.
HHS published a notice announcing an upcoming public meeting of the President’s Council on Fitness, Sports, and
Nutrition. The meeting will be held on December 13, 2012 via webinar. Preregistration is required. The notice is
available here and appeared in the November 28 Federal Register.
HHS published a notice announcing an upcoming public meeting of the World Health Organization’s Consultative
Expert Working Group on R&D Financing and Coordination. The meeting will be held on December 18, 2012 in
Washington, DC and via teleconference. Preregistration is required. The notice is available here and appeared in the
November 28 Federal Register.
NIH published a notice announcing an upcoming joint public meeting of the National Advisory Council on Alcohol
Abuse and Alcoholism, National Advisory Council on Drug Abuse, and the National Cancer Advisory Board. The
meeting will be held via telephone conference and webcast on December 13, 2012. The notice is available here and
appeared in the November 21 Federal Register.
HEALTH REFORM + RELATED HEALTH POLICY NEWS | ATTORNEYS November 28, 2012
© 2012 Polsinelli Shughart Page 19 of 18
Matthew J. Murer Practice Area Chair Chicago 312.873.3603 [email protected] Colleen M. Faddick Practice Area Vice-Chair Denver 303.583.8201 [email protected]
Bruce A. Johnson Practice Area Vice-Chair Denver 303.583.8203 [email protected] Alan K. Parver Practice Area Vice-Chair Washington, D.C. 202.626.8306 [email protected] Janice A. Anderson Chicago 312.873.3623 [email protected] Douglas K. Anning Kansas City 816.360.4188 [email protected]
Jack M. Beal Kansas City 816.360.4216 [email protected]
Cynthia E. Berry Washington, D.C. 202.626.8333 [email protected] Mary Beth Blake Kansas City 816.360.4284 [email protected] Gerald W. Brenneman Kansas City 816.360.4221 [email protected]
Teresa A. Brooks Washington, D.C. 202.626.8304 [email protected] Jared O. Brooner St. Joseph 816.364.2117 [email protected] Anika D. Clifton Denver
303.583.8275 [email protected] Lawrence C. Conn Los Angeles 310.203.5336 [email protected] Anne M. Cooper Chicago 312.873.3606 [email protected] Lauren P. DeSantis-Then Washington, D.C. 202.626.8323 [email protected] S. Jay Dobbs St. Louis 314.552.6847 [email protected] Thomas M. Donohoe Denver
303.583.8257 [email protected] Cavan K. Doyle Chicago 312.873.3685 [email protected] Meredith A. Duncan Chicago 312.873.3602 [email protected] Erin Fleming Dunlap St. Louis 314.622.6661 [email protected]
Fredric J. Entin Chicago 312.873.3601 [email protected] Jennifer L. Evans Denver 303.583.8211 [email protected] Colleen M. Fraddick Denver 303.583.8201 [email protected] T. Jeffrey Fitzgerald Denver 303.583.8205 [email protected] Kara M. Friedman Chicago 312.873.3639 [email protected] Rebecca L. Frigy St. Louis 314.889.7013 [email protected] Asher D. Funk Chicago 312.873.3635 [email protected] Randy S. Gerber St. Louis
314.889.7038 [email protected] Mark H. Goran St. Louis 314.622.6686 [email protected] Linas J. Grikis Chicago 312.873.2946 [email protected] Lauren Z. Groebe Kansas City 816.572.4588 [email protected]
Brett B. Heger Dallas 314.622.6664 [email protected] Jonathan K. Henderson Dallas 214.397.0016 [email protected] Margaret H. Hillman St. Louis 314.622.6663 [email protected] Jay M. Howard Kansas City 816.360.4202 [email protected]
Cullin B. Hughes Kansas City 816.360.4121 [email protected] Sara V. Iams Washington, D.C. 202.626.8361 [email protected] George Jackson, III Chicago 312.873.3657 [email protected] Bruce A. Johnson Denver 303.583.8203 [email protected]
HEALTH REFORM + RELATED HEALTH POLICY NEWS | ATTORNEYS November 28, 2012
© 2012 Polsinelli Shughart Page 20 of 18
Joan B. Killgore St. Louis 314.889.7008 [email protected] Anne. L. Kleindienst Phoenix 602.650.2392 [email protected] Chad K. Knight Dallas
214.397.0017 [email protected] Dana M. Lach Chicago 312.873.2993 [email protected] Jason T. Lundy Chicago 312.873.3604 [email protected] Ryan M. McAteer Los Angeles 310.203.5368 [email protected] Jane K. McCahill Chicago 312.873.3607 [email protected] Ann C. McCullough Denver
303.583.8202 [email protected]
Aileen T. Murphy Denver 303.583.8210 [email protected] Gerald A. Niederman Denver 303.583.8204 [email protected] Edward F. Novak Phoenix
602.650.2020 [email protected] Thomas P. O’Donnell Kansas City 816.360.4173 [email protected] Aaron E. Perry Chicago 312.873.3683 [email protected] Mitchell D. Raup Washington, D.C. 202.626.8352 [email protected] Daniel S. Reinberg Chicago 312.873.3636 [email protected] Donna J. Ruzicka St. Louis
314.622.6660 [email protected]
Charles P. Sheets Chicago 312.873.3605 [email protected] Kathryn M. Stalmack Chicago 312.873.3608 [email protected] Leah Mendelsohn Stone Washington, D.C.
202.626.8329 [email protected] Chad C. Stout Kansas City 816.572.4479 [email protected] Steven K. Stranne Washington, D.C. 202.626.8313 [email protected] William E. Swart Dallas 214.397.0015 [email protected] Tennille A. Syrstad Denver 312.873.3661 [email protected] Emily C. Tremmel Chicago
303.583.8263 [email protected]
Andrew B. Turk Phoenix 602.650.2097 [email protected] Joseph T. Van Leer Chicago 312.873.3665 [email protected] Andrew J. Voss St. Louis
314.622.6673 [email protected] Joshua M. Weaver Dallas 214.661.5514 [email protected] Emily Wey Denver 303.583.8255 [email protected] Mark R. Woodbury St. Joseph
816.364.2117 [email protected] Janet E. Zeigler Chicago 312.873.3679 [email protected]
HEALTH REFORM + RELATED HEALTH POLICY NEWS | ABOUT November 28, 2012
© 2012 Polsinelli Shughart Page 21 of 18
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