The Advancing Chronic Care, Extenders, and Social Services ...€¦ · TITLE IV—PART B...

Prepared by Health Policy Alternatives, Inc. February 16, 2018

The Advancing Chronic Care, Extenders, and Social Services (ACCESS) Act and other Healthcare-Related Provisions of the Bipartisan Budget Act of 2018

Summary

The Bipartisan Budget Act of 2018 (BBA 2018) was signed into law on February 9, 2018 (Public Law 115-123). Division E of the BBA 2018 is cited as the “Advancing Chronic Care, Extenders, and Social Services (ACCESS) Act.” The ACCESS Act contains 11 titles which cover a number of programs and policies under the jurisdiction of the Department Health and Human Services. This summary addresses the provisions that relate to the Medicare, Medicaid and Children’s Health Insurance Programs, as well as other provisions, but does not include title VII (Family First Prevention Services Act) and title VIII (Supporting Social Impact Partnerships to Pay for Results). The summary also describes the budget provision that extends the Medicare 2 percent sequestration requirement of the Budget Control Act of 2011 by another two years.

Table of Contents DIVISION E—HEALTH AND HUMAN SERVICES EXTENDERS 4 TITLE I—CHIP 4 Sec. 50101. Funding extension of CHIP through fiscal year 2027 4 Sec. 50102. Extension of pediatric quality measures program 4 Sec. 50103. Extension of outreach and enrollment program 5 TITLE II—MEDICARE EXTENDERS 5 Sec. 50201. Extension of work GPCI floor 5 Sec. 50202. Repeal of Medicare payment cap for therapy services; limitation to ensure appropriate therapy

5

Sec. 50203. Medicare ambulance services 6 Sec. 50204. Extension of increased inpatient hospital payment adjustment for certain low-volume hospitals

8

Sec. 50205. Extension of the Medicare-dependent hospital (MDH) program 8 Sec. 50206. Extension of funding for quality measure endorsement, input, and selection; reporting requirements

9

Sec. 50207. Extension of funding outreach and assistance for low-income programs; State health insurance assistance program reporting requirements

10

Sec. 50208. Extension of home health rural add-on 10 TITLE III—CREATING HIGH-QUALITY RESULTS AND OUTCOMES NECESSARY TO IMPROVE CHRONIC CARE

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Subtitle A—Receiving High Quality Care in the Home 11 Sec. 50301. Extending the Independence at Home Demonstration Program 11 Sec. 50302. Expanding access to home dialysis therapy 12 Subtitle B—Advancing Team-Based Care 13 Sec. 50311. Providing continued access to Medicare Advantage special needs plans for vulnerable populations

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Subtitle C—Expanding Innovation and Technology 16 Sec. 50321. Adapting benefits to meet the needs of chronically ill Medicare Advantage enrollees through telehealth

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Prepared by Health Policy Alternatives, Inc.

Sec. 50322. Expanding supplemental benefits to meet the needs of chronically ill Medicare Advantage enrollees

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Sec. 50323. Increasing convenience for Medicare Advantage enrollees through telehealth 17 Sec. 50324. Providing ACOs the ability to expand the use of telehealth 18 Sec. 50325. Expanding the use of telehealth for individuals with stroke 18 Subtitle D—Identifying the Chronically Ill Population 19 Sec. 50331. Providing flexibility for beneficiaries to be part of an ACO 19 Subtitle E—Empowering Individuals and Caregivers in Care Delivery 19 Sec. 50341. Eliminating barriers to care coordination under ACOs 19 Sec. 50342. GAO report on longitudinal comprehensive care planning services under Medicare part B

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Subtitle F—Other Policies to Improve Care for the Chronically Ill 20 Sec. 50351. GAO report on improving medication synchronization 20 Sec. 50352. GAO report on impact of obesity drugs on patient health and spending 21 Sec. 50353. HHS report on long-term risk factors for chronic conditions among Medicare beneficiaries

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Sec. 50354. Providing prescription drug plans with parts A and B claims data 21 TITLE IV—PART B IMPROVEMENT ACT AND OTHER PART B ENHANCEMENTS 22 Subtitle A—Medicare Part B Improvement Act 22 Sec. 50401. Home infusion therapy services temporary transitional payment 22 Sec. 50402. Orthotist’s and prosthetist’s clinical notes as part of the patient’s medical record 23 Sec. 50403. Independent accreditation for dialysis facilities and assurance of high quality surveys

23

Sec. 50404. Modernizing the application of the Stark rule under Medicare 23 Subtitle B—Additional Medicare Provisions 24 Sec. 50411. Making permanent the removal of the rental cap for durable medical equipment under Medicare with respect to speech generating devices

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Sec. 50412. Increased civil and criminal penalties and increased sentences for federal health care program fraud and abuse

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Sec. 50413. Reducing the volume of future EHR-related significant hardship requests 24 Sec. 50414. Strengthening rules in case of competition for diabetic testing strips 25 TITLE V—OTHER HEALTH EXTENDERS 26 Sec. 50501. Extension for family-to-family health information centers 26 Sec. 50502. Extension for sexual risk avoidance education 26 Sec. 50503. Extension for personal responsibility education 28 TITLE VI—CHILD AND FAMILY SERVICES AND SUPPORTS EXTENDERS 28 Subtitle A—Continuing the Maternal, Infant, and Early Childhood Home Visiting Program 28 Sec. 50601. Continuing evidence-based home visiting program 28 Sec. 50602. Continuing to demonstrate results to help families 29 Sec. 50603. Reviewing statewide needs to target resources 29 Sec. 50604. Improving the likelihood of success in high-risk communities 29 Sec. 50605. Option to fund evidence-based home visiting on a pay for outcome basis 30 Sec. 50606. Data exchange standards for improved interoperability 30 Sec. 50607. Allocation of funds 30 Subtitle B—Extension of Health Professions Workforce Demonstration 30


Sec. 50611. Extension of health workforce demonstration projects for low-income Individuals

30

Titles VII and VIII which pertain to foster care and adoption assistance (Sections 50711- 50802) are not included in this summary

TITLE IX—PUBLIC HEALTH PROGRAMS 31 Sec. 50901. Extension for community health centers, the National Health Service Corps, and teaching health centers that operate GME programs

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Sec. 50902. Extension for special diabetes programs 33 TITLE X—MISCELLANEOUS HEALTH CARE POLICIES 33 Sec. 51001. Home health payment reform 33 Sec. 51002. Information to satisfy documentation of Medicare eligibility for home health services

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Sec. 51003. Technical amendments to Public Law 114–10 35 Sec. 51004. Expanded access to Medicare intensive cardiac rehabilitation programs 36 Sec. 51005. Extension of blended site neutral payment rate for certain LTCH discharges; temporary adjustment to site neutral payment rates

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Sec. 51006. Recognition of attending physician assistants as attending physicians to serve hospice patients

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Sec. 51007. Extension of enforcement instruction on supervision requirements for outpatient therapeutic services in critical access and small rural hospitals through 2017

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Sec. 51008. Allowing physician assistants, nurse practitioners, and clinical nurse specialists to supervise cardiac, intensive cardiac, and pulmonary rehabilitation programs

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Sec. 51009. Transitional payment rules for certain radiation therapy services under the physician fee schedule

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TITLE XI—PROTECTING SENIORS’ ACCESS TO MEDICARE ACT 38 Sec. 52001. Repeal of the Independent Payment Advisory Board 38 TITLE XII—OFFSETS 38 Sec. 53101. Modifying reductions in Medicaid DSH allotments 38 Sec. 53102. Third party liability in Medicaid and CHIP 38 Sec. 53103. Treatment of lottery winnings and other lump-sum income for purposes of income eligibility under Medicaid

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Sec. 53104. Rebate obligation with respect to line extension drugs 40 Sec. 53105. Medicaid Improvement Fund 40 Sec. 53106. Physician fee schedule update 40 Sec. 53107. Payment for outpatient physical therapy services and outpatient occupational therapy services furnished by a therapy assistant

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Sec. 53108. Reduction for non-emergency ESRD ambulance transports 41 Sec. 53109. Hospital transfer policy for early discharges to hospice care 41 Sec. 53110. Medicare payment update for home health services 41 Sec. 53111. Medicare payment update for skilled nursing facilities 42 Sec. 53112. Preventing the artificial inflation of star ratings after the consolidation of Medicare Advantage plans offered by the same organization

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Sec. 53113. Sunsetting exclusion of biosimilars from Medicare part D coverage gap discount program

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Sec. 53114. Adjustments to Medicare part B and part D premium subsidies for higher 42


income individuals Sec. 53115. Medicare Improvement Fund 42 Sec. 53116. Closing the Donut Hole for Seniors 43 Note: Sec. 53117 (relating to child support enforcement fees) is not included in the summary Note: Sec. 53118 (relating to prison data reporting) is not included in the summary Sec. 53119. Prevention and Public Health Fund 43 DIVISION C-BUDGETARY AND OTHER MATTERS 43 Sec. 30101. Amendments to the Balanced Budget and Emergency Deficit Control Act 43 DIVISION E—HEALTH AND HUMAN SERVICES EXTENDERS Title I – CHIP Sec. 50101. Funding Extension of the Children’s Health Insurance Program (CHIP) through Fiscal Year 2027. CHIP Funding Funding for CHIP allotments is provided for fiscal years (FY) 2024 through 2027. A continuing resolution enacted on January 22, 2018 (Public Law 115-120) provided funds for CHIP for FYs 2018 through 2023.1 This legislation extends funding beyond FY 2023 by providing for “such sums as are necessary” for the program for FYs 2024 through 2026. For FY 2027, it provides for two semi-annual allotments that total $15.3 billion. Funding for other CHIP activities is also continued through FY 2027:

• Such sums as are necessary for the Child Enrollment Contingency Fund. The contingency fund is available for states experiencing a shortfall of CHIP funds and whose enrollment exceeds a target level.

• Funds for “qualifying states,” or those states that expanded Medicaid to children who would have qualified for CHIP before the CHIP program was enacted, and for Express Lane Eligibility are available through FY 2027.

Maintenance of Effort The provision extends the maintenance of effort (MOE) requirement established under the ACA for children’s coverage under the CHIP program through FY 2027. The MOE provision requires states to maintain income eligibility levels for CHIP children as a condition of receiving federal Medicaid payments. Under prior law, the MOE was in place through FY 2023. Sec. 50102. Extension of Pediatric Quality Measures Program. The ACCESS Act extends funding for the Pediatric Quality Measures Program by providing $60 million for the period FYs 2024 through 2027. In addition, it adds a change to the existing annual reporting requirements. Under existing law, states are required to submit an annual report to the Secretary on state-specific child health quality measures and the quality of health care for children under their Medicaid and CHIP plans. This provision requires that states use, beginning with the FY 2024 report, the initial core measurement set identified by the Secretary and requires states to provide those measures using the standardized format for reporting information and procedures as developed by the Secretary.

1 The amount provided for FY 2018 were $21.5 billion; FY 2019= $22.6 billion, FY 2020=$23.7 billion; FY 2021=$$24.8 billion; FY 2022=$25.9 billion; and FY 2023=$5.7 billion.

https://www.congress.gov/bill/115th-congress/house-bill/1892/text#toc-HE1B4AEF3C8A94B138D95CD923E45B8F4


Sec. 50103. Extension of Outreach and Enrollment Program. The provision extends funding for outreach and enrollment grants to states. It provides $48 million in funds for the period of FYs 2024 through 2027. Those grants were most recently extended in Public Law 105-120, under which $120 million was provided for the period of FYs 2018 – 2023. For the FYs 2024 – 2027 period, the provision also requires that 10 percent of those funds be used by the Secretary for evaluating and providing technical assistance to grantees. Further, the provision makes a change to the existing National Enrollment Campaign funded under CHIP. The campaign is intended to improve the enrollment of underserved child populations in CHIP and Medicaid. The existing program components of the campaign may be expanded to incorporate the development of materials, toolkits, and technical assistance for states regarding enrollment and retention strategies. TITLE II—MEDICARE EXTENDERS Sec. 50201. Extension of work GPCI floor. Medicare’s physician fee schedule relative value units are comprised of three components: physician work, practice expense and malpractice. Each component is adjusted separately for geographic cost variation through the geographic practice cost index (GPCI). If the GPCI is more than 1.0, costs in the area are greater than the average nationwide. If the GPCI is less than 1.0, costs in the area are less than the average nationwide. Since January 1, 2004, the statute has established a floor on the physician work GPCI of 1.0. The physician work GPCI floor expired on December 31, 2017. Section 50201 extends the physician work GPCI floor of 1.0 for services furnished on or after January 1, 2018 and before January 1, 2020. Sec. 50202. Repeal of Medicare payment cap for therapy services; limitation to ensure appropriate therapy. Effective with respect to therapy services furnished on or after January 1, 2018, the cap on the amount of payment that may be made for therapy services furnished to a Medicare beneficiary in a year is replaced by a targeted medical review process for certain therapy services when expenses exceed a new threshold of $3,000. The law also requires that claims for all therapy services above the amount that was previously the therapy cap under section 1833(g)(2) of the Act ($2010 for 2018) contain an appropriate modifier (such as the KX modifier) to indicate medical necessity and appropriate documentation in the medical record.

Under the targeted medical review process, the Secretary determines which therapy services to review considering such factors as a therapy provider who (i) has had a high claims denial percentage or is less compliant with applicable Medicare program requirements; (ii) has a pattern of billing for therapy services that is aberrant compared to peers or otherwise has questionable billing practices, such as billing medically unlikely units of services in a day; (iii) is newly enrolled or has not previously furnished therapy services under the Medicare program; (iv) provides services to treat a type of medical condition; or (v) is part of a group that includes another therapy provider identified by the preceding factors.

The new threshold will apply separately (i) to physical therapy and speech language pathology services and (ii) to occupational therapy services.


The new provisions also apply to therapy services furnished by hospitals to Medicare beneficiaries who are hospital outpatients and to certain hospital inpatients (i.e., those enrolled in Part B but not entitled to benefits under Part A or those who are entitled to Part A but who have exhausted benefits for Part A inpatient hospital services).

Beginning with fiscal year 2018, $5 million is transferred each fiscal year from the Medicare Part B Trust Fund, to remain available until expended, to implement the targeted medical review process. The funds may not be used for audits for medical review of therapy services by a Medicare recovery audit contractor (RAC).

Sec. 50203. Medicare ambulance services. Medicare pays for ambulance services on the basis of a fee schedule. For ambulance transports originating in a rural area or a rural census tract of an urban area, the fee schedule payment included a temporary increase of 3 percent for services furnished before January 1, 2018. For ambulance transports originating in counties designated as “super rural,” (those areas comprising the lowest 25th percentile of all rural populations arrayed by population density), the temporary increase was 22.6 percent for services furnished before January 1, 2018. For ambulance transports originating in all other areas, the temporary increase was 2 percent for services furnished before January 1, 2018. Section 50203 extends these increases to ambulance services furnished on or after January 1, 2018 and before January 1, 2023. By December 31, 2019, section 50203 also requires the Secretary to develop a data collection system (which may include use of a cost survey) to collect cost, revenue, utilization, and other information from providers and suppliers of ground ambulance services. The Secretary must collect:

• Information needed to evaluate how reported costs relate to ambulance fee schedule payment rates;

• Utilization of capital equipment and information on ambulance capacity, including: o The aggregate cost of operations and the aggregate volume of services; o The costs and volume of services for various functional accounts and

subaccounts; o Rates, by category of patient and class of purchaser; o Capital assets, including (as appropriate) capital funds, debt service, lease

agreements used in lieu of capital funds, and the value of land, facilities, and equipment; and

o Discharge and bill data; and • Information on different types of ground ambulance services furnished in different

geographic locations, including rural areas and super rural areas. By December 31, 2019, the Secretary is also required to identify a representative sample of providers and suppliers of ground ambulance services that will be required to submit information through the data collection system being developed by the Secretary. Information will be submitted for each year from 2020 through 2024. However, no ambulance provider or supplier will be required to submit information for two consecutive years. The sample shall be representative of:


• Different providers and suppliers of ground ambulance services (including those that are part of an emergency service or a government organization); and

• Geographic locations in which ground ambulance services are furnished (urban, rural, and low population density areas).

The law requires providers and suppliers of ground ambulance services to submit the required cost information in a form and manner, and at a time, specified by the Secretary. The Centers for Medicare and Medicaid Services (CMS) is required to post information from the data collection on its website as the Secretary determines appropriate. Beginning January 1, 2022, the Secretary may impose a 10 percent reduction to ambulance fee schedule payments to a provider or supplier for a year that is no more than 2 years after a year the Secretary found that the provider or supplier failed to sufficiently submit information. The Secretary may provide a hardship exemption from the payment reduction in the event of a natural disaster, bankruptcy, or other similar situation that the Secretary determines interfered with the ability of the provider or supplier of ground ambulance services to submit such information timely. The Secretary shall establish a process under which a provider or supplier of ground ambulance services may seek an informal review of a determination that the provider or supplier is subject to the payment reduction. The Medicare Payment Advisory Commission (MedPAC) is required to submit a Report to Congress by March 15, 2023 and as necessary thereafter. The Report shall assess the adequacy of ground ambulance payments and the geographic variations in the cost of furnishing such services and must contain:

• An analysis of information submitted through the data collection system; • An analysis of any burden on providers and suppliers of ground ambulance services

associated with the data collection system; • A recommendation as to whether information should continue to be submitted through

the data collection system or if the system should be revised; and • Other information determined appropriate by the Commission.

In order to continue to evaluate the extent to which reported costs relate to payment rates and for other purposes the Secretary deems appropriate, the Secretary shall require providers and suppliers of ground ambulance services to submit cost information no less often than once every three years for years after 2024. The Secretary may revise the data collection system as appropriate taking into account MedPAC’s recommendations, if available. The Secretary must implement this provision through notice and comment rulemaking and is exempted from having to comply with the Paperwork Reduction Act. The data collection system and the identification of respondents are precluded from administrative or judicial review. The Secretary is given $15 million for FY 2018 to administer this provision, and the funds shall remain available until expended.


Sec. 50204. Extension of increased inpatient hospital payment adjustment for certain low-volume hospitals. The law provides special Medicare payment adjustments for low-volume hospitals paid under the hospital inpatient prospective payment system (IPPS). Initially, low-volume hospitals qualified for the adjustment by having fewer than 800 total discharges2 and being more than 25 miles from another hospital. The adjustment was 25 percent for all qualifying hospitals. From FY 2011 through FY 2017, hospitals qualified for the low-volume adjustment by being more than 15 miles from another hospital and having fewer than 1,600 Medicare discharges. From FY 2011 through FY 2017, the adjustment was 25 percent for hospitals with fewer than 200 Medicare discharges and was a linearly declining amount for other low-volume hospitals up to 1,600 Medicare discharges. Section 50204 extends the FY 2011 through FY 2017 criteria through FY 2018. Section 50204 establishes a threshold of 3,800 total discharges (Medicare and non-Medicare) to be eligible for the low-volume hospital adjustment from FY 2019 through FY 2022. Section 50204 also establishes that the maximum adjustment will be 25 percent for hospitals with fewer than 500 total discharges and a linearly declining amount for other low-volume hospitals up to 3,800 total discharges. Eligibility for the low-volume adjustment returns to a maximum of 800 total discharges in FY 2023.3 In addition, MedPAC is required to provide a report on the low-volume adjustment by March 15, 2022 that evaluates the effect of this provision on:

• Medicare beneficiary utilization of inpatient hospital services; • The financial status of hospitals with a low volume of Medicare or total inpatient admissions; • Medicare program spending; and • Other relevant matters.

Sec. 50205. Extension of the Medicare-dependent hospital (MDH) program. MDHs are hospitals with no more than 100 beds that are treated as rural under the IPPS and have 60 percent or more of their inpatient days or discharges attributed to Medicare patients for their cost reporting period beginning in FY 1987 or two of the three most recently audited cost reporting periods. MDHs are paid the IPPS amount plus 75 percent of the difference between the IPPS amount and their per discharge costs from one of several different base years. Congress has repeatedly extended the MDH program since its inception in 1990. Section 50205 extends the MDH program from October 1, 2017 through September 30, 2022. Hospitals in states without any rural areas (Delaware, Rhode Island and New Jersey) were unable to qualify for MDH status. While there are provisions of the law that allow urban hospitals to be treated as rural for purposes of the IPPS and qualify for MDH status, hospitals in all-urban states

2 By statute, a hospital can qualify for the low-volume adjustment by having fewer than 800 total discharges. However, by regulation, CMS used its authority to make a 25 percent adjustment to the Medicare IPPS payment only for hospitals having fewer than 200 total discharges. 3 Similarly, while the law allows the low-volume adjustment for up to 800 total discharges, the policy will revert to the regulatory criteria for FY 2023 and subsequent years—25 percent to the Medicare IPPS payment only for hospitals having fewer than 200 total discharges.


could not qualify to do so because the states lack rural areas. Effective on or after date of enactment of the ACCESS Act, hospitals in all-urban states may qualify for MDH status by:

• Being located in a rural census tract of an urban county; • Being located in an area that is designated as rural by any state law or regulation; • Being a hospital that is designated as rural by any state law or regulation; • Qualifying as a rural referral center or sole community hospital were the hospital to be

located in a rural area. The requirement of the second or third of the above criteria may only be met for hospitals in all-urban states if the state law or regulation is effective as of January 1, 2018. Section 50205 also requires the General Accountability Office (GAO) to submit a report to Congress analyzing:

• MDH payor mix and how payor mix will trend in future years (based on current trends and projections), and whether or not the 60 percent utilization requirement should be revised.

• The characteristics of MDHs that qualify for MDH status based on a 1988 or 1987 cost report, including Medicare inpatient and outpatient utilization, payor mix, and financial status (including Medicare and total margins), and whether or not Medicare payments for such hospitals should be revised.

• Such other items that GAO determines appropriate. The report is due not later than 2 years after enactment and shall include recommendations for legislation or administrative action that GAO determines appropriate.

Sec. 50206. Extension of funding for quality measure endorsement, input, and selection; reporting requirements. This section transfers $7.5 million for each of fiscal years 2018 and 2019 from the Medicare Trust Funds to provide continued funding for the National Quality Forum (NQF), the Measure Applications Partnership (MAP) and related activities, with the funds remaining available until expended. This funding for fiscal years 2018 and 2019 is in addition to any remaining unobligated funds from fiscal years 2014 through 2017. This funding level represents a significant reduction from the previous three fiscal years which had provided for the annual transfer of $30 million for these purposes.

The Secretary is also required to begin providing annual reports to Congress (starting in 2019) that includes the following information: (i) a comprehensive plan to identify quality measurement needs of CMS programs and initiatives; (ii) a strategy for using the NQF and other contractors to carry out MAP and other related duties under section 1890A of the Social Security Act (the Act) to meet quality measurement needs; (iii) general funding information (specifically how much of the money transferred to the CMS Program Management Account has been obligated, expended, and remains unobligated); (iv) how much funding has been obligated or expended for work done by CMS, by the NQF, and by other contractors; (v) a description of activities (e.g., task orders) for which funds were used for activities done by CMS, by the NQF and by other contractors; and (vi) estimates of additional funding needed for the succeeding two years to carry out activities under section 1890 and 1890A of the Act.


The consensus-based entity (i.e., the NQF) must also provide more information to Congress and to the Secretary in its annual reports. Specifically, Congress wants an annual accounting of the annual revenues and expenses of the NQF as well as a breakdown of the amount awarded per contracted task order. The reports must also contain information on any updates or modifications of the NQF’s internal policies and procedures relating to the duties imposed under section 1890 of the Act; Congress is specifically interested in disclosure of interests and conflicts of interest for NQF committees, work groups, task forces, and advisory panels as well as information on the participation of external stakeholders. Within 18 months of enactment, the GAO must submit a report to Congress that examines the following matters: (i) the extent to which CMS has set and prioritized objectives for quality measurement activities, and the extent to which CMS has developed a comprehensive plan to meet those objectives; (ii) CMS efforts to meet those objectives, including how the agency has divided duties among CMS, the NQF and other contractors; (iii) whether there is any overlap among work undertaken by CMS, the NQF, the MAP, and other contractors; (iv) the total amount of funding to carry out sections 1890 and 1890A; the amount that has been obligated or expended and the amount remaining unobligated; and (v) funding allocations for work by CMS, the NQF and other contractors. Sec. 50207. Extension of funding outreach and assistance for low-income programs; State health insurance assistance program reporting requirements. Funding for low-income outreach and assistance activities is extended as follows:

• State Health Insurance Assistance Programs, $13 million for each of FYs 2018 and 2019. • Area Agencies on Aging, $7.5 million for each of FYs 2018 and 2019. • Aging and Disability Resource Centers, $5 million for each of FYs 2018 and 2019. • The National Center for Benefits and Outreach Enrollment, $12 million for each of FYs 2018 and

2019.

The provision adds a new reporting requirement; every 2 years, beginning with 2019, the Agency for Community Living must post information on its website that specifies the amount of federal funding provided to each state for State health insurance assistance programs, and the amount the state provided to entities to carry out such programs, as well as other information the Secretary may require. Sec. 50208. Extension of home health rural add-on. This section both extends and modifies the three percent add-on to payments made under the home health prospective payment system (HH PPS) for home health services provided to patients in rural areas. For 2018, the 3 percent add-on payment for such services is continued without change.

Beginning in 2019, the amount of the percentage add-on to payments, and the period for which the percentage add-on payment applies, differ based on the characteristics of the rural county as shown in the table.


Percentage Add-on to Payment by Type of Rural County and Year

Category of Rural County 2019 2020 2021 2022

1. Highest quartile of rural counties based on the number of Medicare home health episodes furnished per 100 individuals who are Medicare fee-for-service beneficiaries (the territories are excluded from this category)

1.5% 0.5% N/A N/A

2. Rural county not described in category 1 above with a population density of ≤ 6 individuals per square mile

4% 3% 2% 1%

3. Rural county not described in category 1 or 2 above

3% 2% 1% N/A

The Secretary determines the assignment of each rural county to one of the three categories described above. The assignment lasts for the duration of the 4-year period (2019 through 2022). In determining which counties are in the highest quartile based on the number of Medicare home health episodes furnished per 100 individuals who are Medicare fee-for-service beneficiaries, the Secretary must use 2015 data and must exclude data from the territories. The agency may exclude data from counties with a low volume of Medicare home health services; if the Secretary excludes those data, it must exclude those counties from the first category. The Secretary must use data from the 2010 Census to determine population density for category 2. Administrative or judicial review of these determinations is prohibited. Claims for home health services furnished on or after January 1, 2019 must contain the county code in which the services were furnished. TITLE III—CREATING HIGH-QUALITY RESULTS AND OUTCOMES NECESSARY TO IMPROVE CHRONIC CARE Subtitle A—Receiving High Quality Care in the Home Sec. 50301. Extending the Independence at Home Demonstration Program. The Independence at Home Medical Practice Demonstration Program was established by section 3024 of the ACA to test the provision of physician and nurse practitioner-directed home-based primary care to certain beneficiaries and coordinate health care across all treatment settings, beginning January 1, 2012. Eligible beneficiaries are defined as those having 2 or more chronic illnesses, a non-elective hospital admission within the past 12 months, previous acute or subacute rehabilitation services, and 2 or more functional dependencies. Participating practices must furnish services to at least 200 Medicare beneficiaries, must use electronic health information systems, remote monitoring, and mobile diagnostic technology, and may share savings in excess


of 5 percent. A participating practice that fails to generate 5 percent in savings must be terminated from the demonstration.

This provision extends the demonstration for an additional two years and increases the number of eligible beneficiaries that may participate from 10,000 to 15,000. Eligible beneficiaries that participate in the demonstration because of the increase in the limit under this provision are considered in the spending target estimates and in the incentive payment calculations for the sixth and seventh years of the demonstration. The rules for mandatory termination of medical practices from the demonstration program are modified; the threshold for termination is extended to failure to receive an incentive payment for three consecutive years as opposed to the previous requirement of two consecutive years. The final report to Congress on the demonstration must include information on the use of electronic health information systems by participating practices in the demonstration. Sec. 50302. Expanding access to home dialysis therapy. Before the enactment of the ACCESS Act, the law permitted coverage of home dialysis services for Medicare beneficiaries with end-stage renal disease (ESRD) under certain conditions specified in regulations. Those conditions include training and monthly home visits by qualified personnel to monitor how the patient is adapting to home dialysis pursuant to the plan of care developed by the patient’s physician and other qualified providers or ESRD facility personnel. This provision permits monthly visits to be conducted using telehealth from the beneficiary’s place of residence as long as the beneficiary has a face-to-face visit that is not done through telehealth (e.g., an in-home visit by the qualified personal) at least monthly during the first three months of home dialysis and at least once every three months thereafter. The Medicare fee-for-service telehealth statute is amended to permit the monthly visit to be done through telehealth in the case of an ESRD Medicare beneficiary. A renal dialysis facility is added to the list of originating sites for purposes of telehealth payments but only for purposes of home dialysis services and the monthly ESRD clinical assessments; a facility fee payment will be made to the renal dialysis facility. This provision also permits the ESRD beneficiary’s place of residence to be an originating site for this purpose; however, no facility fee payment applies when the telehealth service’s originating site is the beneficiary’s home. This section also amends the definition of remuneration that is used for purposes of the fraud and abuse laws (e.g., the anti-kickback law and the beneficiary inducement CMP) to exclude telehealth technologies provided by an institutional provider of services (e.g., a hospital, skilled nursing facility, etc.) or a renal dialysis facility to ESRD patients receiving Medicare Part B home dialysis if (i) the technologies are not offered as part of any solicitation or advertisement; (ii) the technologies are provided to furnish telehealth services related to the patient’s ESRD; and (iii) the provision of the technologies meets other regulatory requirements.


Subtitle B—Advancing Team-Based Care Sec. 50311. Providing Continued Access to Medicare Advantage Special Needs Plans for Vulnerable Populations. Reauthorization of the Special Needs Plans (SNPs) Section 50311(a) of the new law permanently reauthorizes the authority for SNPs by removing the January 1, 2019 expiration date. Medicare Advantage SNPs may restrict the enrollment of individuals under the plans to individuals who are within one or more classes of special needs individuals. Increased Integration of Dual SNPs Dual SNPs enroll beneficiaries who are entitled to both Medicare and Medicaid and offer the opportunity of enhanced benefits by combining the benefits available through those two programs. Under section 50311(b) of the new law, a Dual SNP must meet additional requirements intended to improve integration of Medicare and Medicaid benefits. Specifically, the Secretary, acting through the Federal Coordinated Health Care Office (created under section 2602 of the Affordable Care Act) is required to serve as a dedicated point of contact for states to address misalignments that arise with the integration of specialized MA plans for special needs dual eligible individuals and, consistent with such role, must establish: (i) a uniform process for disseminating to state Medicaid agencies Medicare information impacting contracts between such agencies and Dual SNPs and (ii) basic resources for states interested in exploring such plans as a platform for integration, such as a model contract or other tools to achieve those goals. Unified Grievances and Appeals Process. By April 1, 2020, the Secretary is required to establish a unified grievances and appeals process which brings together, to the extent feasible, procedures unifying grievances and appeals procedures under specified statutory provisions of Medicare and Medicaid for those programs’ items and services provided by Dual SNPs. These new procedures shall apply in place of otherwise applicable grievance and appeals procedures. The Secretary is required to solicit comment in developing these procedures from states, plans, beneficiaries and their representatives as well as from other stakeholders. These procedures must be included in the Dual SNP’s contract with the state Medicaid agency and must: (i) adopt the provisions for the enrollee that are most protective for the enrollee and, to the extent feasible as determined by the Secretary, are compatible with unified timeframes and consolidated access to external review under an integrated process; (ii) account for differences in state Medicaid plans; and (iii) be easily navigable by the enrollee and include specified elements. The elements include: (i) a single written notification of Medicare and Medicaid grievance and appeal rights; (ii) single pathways for resolution of any grievance or appeal; (iii) notices written in plain language and available in a language and format that is accessible to the enrollee; (iv) unified timeframes for grievances and appeals processes; and (v) requirements for how the plan must process, track, and resolve grievances and appeals, to ensure beneficiaries are notified on a timely basis of decisions that are made throughout the process and are able to easily determine the state of a grievance or appeal. The unified procedures must incorporate current law and regulations that provide continuation of benefits pending appeal under Medicare and Medicaid. Beginning for 2021, the Dual SNP contract with a state Medicaid agency must require the use of the unified grievance and appeals procedures.


Requirements for Integration. Beginning for 2021 and to the extent permitted under state law, a Dual SNP is required to meet one or more of the following for integration of Medicare and Medicaid benefits:

• It must contract with the state Medicaid agency and coordinate long-term services and supports or behavioral health services, or both, by meeting an additional minimum set of requirements. These requirements are to be determined by the Secretary through the Federal Coordinated Health Care Office based on input from stakeholders. Examples include notifying the state in a timely manner of hospitalizations, emergency room visits, and hospital or nursing home discharges of enrollees, assigning one primary care provider for each enrollee, or sharing data that would benefit the coordination of Medicare and Medicaid items and services. (These minimum requirements must be included in the contract of Dual SNP plan with the state Medicaid agency.)

• The Dual SNP must meet the requirements of a fully integrated plan described in section 1853(a)(1)(B)(iv)(II) of the Act (other than the requirement that the plan have similar average levels of frailty as the PACE program, as determined by the Secretary), or enter into a capitated contract with the state Medicaid agency to provide long-term services and supports or behavioral health services, or both.

• In the case of a Dual SNP offered by a parent organization that is also the parent organization of a Medicaid managed care organization providing long-term services and supports or behavioral services, the parent organization must assume clinical and financial responsibility for Medicare and Medicaid benefits with respect to any individual who is enrolled in both the Dual SNP and the Medicaid managed care organization.

Suspension of Enrollment for Failure to Meet Requirements During Initial Period. During plan years 2021 through 2025, if the Secretary determines that a Dual SNP has failed to comply with the above requirements for integration, the Secretary may suspend enrollment in the same manner as the Secretary may apply such remedy, and in accordance with the same procedures as would apply, in the case of an MA organization determined by the Secretary to have engaged in conduct described in section 1857(g)(1) of the Act (e.g., fails substantially to provide required medically necessary items and services; imposes higher premiums than allowed; misrepresents certain information, etc.). Study and Report to Congress. By March 15, 2022, and generally biennially thereafter through 2032, MedPAC in consultation with MACPAC must conduct and submit to the Secretary and to Congress a study to determine how Dual SNPs perform among each other based on data from Healthcare Effectiveness Data and Information Set (HEDIS) quality measures or other measures as specified by the Commissions that enable an accurate evaluation. The legislation specifies the comparison groups for the evaluation. Beginning with 2033 and every five years thereafter, MedPAC, in consultation with MACPAC, is required to conduct this same evaluation study. Conforming Amendments. The provision includes conforming amendments to the responsibilities of the Federal Coordinated Health Care Office, including to act as a designated contact for states; to develop regulations and guidance related to the implementation of a unified grievances and appeals process; and to develop regulations and guidance related to the integration or alignment of policy and oversight under the Medicare and Medicaid programs regarding Dual SNPs. (The Secretary has to approve these regulations and guidance.)


Improvements to Severe or Disabling Chronic Condition SNPs. Section 50311(c) of the new law amends section 1859(f)(5) of the Act to provide for new care management requirements for Severe or Disabling Chronic Condition SNPs (C-SNPs). These types of SNPs serve beneficiaries defined to have “severe or disabling chronic conditions who have one or more comorbid and medically complex chronic conditions that are substantially disabling or life threatening, have a high risk of hospitalization or other significant adverse health outcomes, and require specialized delivery systems across domains of care” (section 1859(b)(6)(B)(iii) of the Act). The provision revises this definition by providing that on or after January 1, 2022, beneficiaries are eligible if they have “one or more comorbid and medically complex chronic conditions that is life threatening or significantly limits overall health or function, has a high risk of hospitalization or other adverse health outcomes and require intensive care coordination and that is listed under subsection (f)(9)(A).” That refers to a newly added list of conditions for clarifying the definition of a special needs individual. This list is to be developed by December 31, 2020 and updated every 5 years thereafter by a panel of clinical advisors convened by the Secretary; the conditions have to meet criteria specified by the legislation. HIV/AIDS, end stage renal disease and disabling mental illness must be among the conditions included. In establishing and updating the list, the panel is required to take into account the availability of varied benefits, cost-sharing, and supplemental benefits under the C-SNP model. Beginning for 2020, C-SNPs must meet the following additional requirements: (i) Its interdisciplinary team (already required under the statute) must include a team of providers with demonstrated expertise, including training in an applicable specialty, in treating individuals similar to the targeted population of the plan; (ii) provide face-to-face encounters with individuals enrolled in the plan not less frequently than on an annual basis; (iii) as part of the evidence-based model of care that is already required, address in each enrollee’s individualized care plan the results of an initial assessment and annual reassessment; and (iv) as part of the annual evaluation and approval of the model of care, the Secretary shall take into account whether the C-SNP fulfilled the previous year’s goals (as required under the model of care). The Secretary is required to establish a minimum benchmark for each element of the model of care of a plan and only approve a plan’s model of care if each of its elements meets the minimum benchmark. Quality Measurement at the Plan Level for SNPs and Determination of Feasibility of Quality Measurement at the Plan Level for all MA Plans Section 50311(d) amends section 1853(o) of the Act relating to quality bonus payments for MA plans to provide for a new paragraph (6) Quality Measurement at the Plan Level for SNPs. In general, the Secretary may require plan level quality reporting for, and apply for the quality bonus payments, quality measures at the plan level for specialized MA plans for special needs individuals instead of at the contract level. Prior to applying plan level data, the Secretary must: (i) consider the minimum number of enrollees in a specialized MA plan for special needs individuals in order to determine if a statistically significant or valid measurement of quality at the plan level is possible; (ii) consider the impact of such application on plans that serve a disproportionate number of dually eligible individuals; (iii) if quality measures are reported at


the plan level, ensure that MA plans are not required to provide duplicative information; and (iv) ensure that such reporting does not interfere with the collection of MA organization encounter data or the administration of any changes to the program under this part as a result of the collection of such data. If the Secretary applies quality measurement at the plan level, such measurement may include Medicare Health Outcomes Survey (HOS), Healthcare Effectiveness Data and Information Set (HEDIS), Consumer Assessment of Healthcare Providers and Systems (CAHPS) measures and quality measures under part D. In addition, the Secretary must consider applying administrative actions, such as suspension of enrollment, civil money penalties, or suspension of payment, at the plan level. Further, the Secretary is required to determine the feasibility of requiring reporting of data under section 1852(e) of the Act (related to MA quality improvement programs) for, and applying for the quality bonus payments, quality measures at the plan level for all MA plans. After making this determination, the Secretary must consider requiring such reporting and applying the quality measures at the plan level. A GAO study is required of the state-level integration between specialized MA plans for dually eligible special needs individuals and the Medicaid program. Requirements for what GAO should include in the study are specified. Within two years of enactment, GAO is required to submit a report to Congress containing the results of the study together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate. Subtitle C—Expanding Innovation and Technology Sec. 50321 Adapting Benefits to Meet the Needs of Chronically Ill Medicare Advantage Enrollees. Under current program requirements, MA plans are required to offer the same benefits package to all of their enrollees. In 2017, CMS’ Innovation Center (CMMI) launched a pilot program that allows plans in 7 states greater flexibility in the benefit design for their plans so that they can provide for value-based benefit designs. CMS extended the demonstration to plans in three additional states for 2018 and planned to expand the pilot to 15 additional states in 2019.4 This provision amends section 1859 of the Act relating to MA program definitions and other miscellaneous provisions by adding subsection (h) National Testing of Medicare Advantage Value-Based Insurance Design Model (“the Model”). In implementing this model, the Secretary is required to revise its current demonstration to cover, effective not later than January 1, 2020, all states. Section 1115A(b)(3)(B) of the Act will not apply to the Model (as revised under this legislation) until January 1, 2022. (Under this “budget neutrality” subsection, a demonstration is expected to improve the quality of care without increasing spending, reduce spending without reducing the quality of care; or improve the quality of care and reduce spending.) The Secretary is required to allocate funds made available under section 1115A(f)(1) of the Act to design, implement, and evaluate the Model.

4 https://innovation.cms.gov/initiatives/vbid/

https://innovation.cms.gov/initiatives/vbid/


Sec. 50322 Expanding Supplemental Benefits to Meet the Needs of Chronically Ill Medicare Advantage Enrollees. Medicare Advantage plans may offer supplemental benefits as part of their plan design as long as the benefits meet certain conditions under the current program. Under this provision of the legislation, section 1852(a)(3) of the Act is amended to expand the types of supplemental benefits that can be offered to qualified individuals. Beginning for plan year 2020, an MA plan, including a specialized MA plan for special needs individuals, may provide supplemental benefits that, with respect to a chronically ill enrollee, have a reasonable expectation of improving or maintaining the health or overall function of the chronically ill enrollee and may not be limited to being primarily health related benefits. A chronically ill enrollee means in this context an enrollee in an MA plan that the Secretary determines has one or more comorbid and medically complex chronic conditions that is life threatening or significantly limits the overall health or function of the enrollee; has a high risk of hospitalization or other adverse health outcomes; and requires intensive care coordination. With respect to these new supplemental benefits, the Secretary may waive the program uniformity standard requiring that MA plans offer the same benefit package to all of their Medicare enrollees. In addition, GAO is required to conduct a study on supplemental benefits provided to MA plans, including specialized MA plans for special needs individuals. To the extent data are available, the study should include an analysis of the type of benefits provided, total numbers of enrollees receiving each and whether the benefit is covered by the standard benchmark cost of the benefit or with an additional premium. It should also address the frequency in which these benefits are utilized by each enrollee and the impact they have on quality indications, utilization of Medicare items and services and the amounts bid by MA organizations for their MA plans. In conducting the study, GAO is required to consult with CMS and MA organizations. Not later than 5 years after enactment, GAO must submit to Congress a report on the study’s results together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate.

Sec. 50323. Increasing Convenience for Medicare Advantage Enrollees through Telehealth. Medicare Advantage enrollees are eligible for the same limited set of telehealth services as those in original fee-for-service Medicare. The provision adds new subsection (m) to section 1852 of the Act (relating to MA benefits and beneficiary protections) to allow MA plans to offer expanded telehealth services as part of the basic benefit to chronically ill enrollees beginning in plan year 2020. For purposes of this new provision and section 1854 relating to MA premiums, “additional telehealth services” means services for which benefits are available under part B, including services for which payment is not made under section 1834(m) of the Act (relating to telehealth services under fee-for-service Medicare) due to the conditions for payment under that section; and that are identified for such year as clinically appropriate to furnish using electronic information and telecommunications technology when a physician or practitioner providing the services is not at the same location as the plan enrollee. This definition does not include capital and infrastructure costs and investments relating to telehealth benefits. The Secretary must solicit public comment before November 30, 2018, with respect to the types of additional telehealth services that should be considered and the requirements for providing those services. In addition, the Secretary must specify requirements for the provision of


additional telehealth benefits, including with respect to (i) physician or practitioner qualifications (other than licensure) and other requirements such as specific training; (ii) factors necessary for the coordination of such benefits with other items and services including those furnished in-person; and (iii) such other areas as determined by the Secretary. Enrollee Choice. If a MA plan provides a service as an additional telehealth benefit, it must also provide access to that benefit through an in-person visit (and not only as an additional telehealth benefit), and an enrollee must be given the option to receive such additional benefit through telehealth or in person. Treatment under MA. If a plan provides additional telehealth services, the benefits must be treated for purposes of the MA plan premium as if they were benefits under original fee-for-service Medicare. Clarification Regarding Inclusion in Bid Amount. The provision clarifies through an amendment to section 1854(a)(6)(A)(ii)(I) that the additional telehealth benefits become part of the MA plan bid for plan year 2020 and subsequent plan years. Sec. 50324. Providing ACOs the ability to expand the use of telehealth. Medicare fee-for-service program telehealth benefits are limited under the statute as to the types of facilities where the patient may be seen through telehealth (i.e., the originating site), the geographic area in which the facility is located (generally in a rural area), and the form of telehealth transmission. Beginning January 1, 2020, this provision permits accountable care organizations (ACOs) (either under the Medicare Shared Savings Program or under a CMMI ACO model) to provide telehealth services currently covered under the Medicare fee-for-service program in the beneficiary’s home (i.e., the beneficiary’s place of residence). These telehealth services may be furnished without regard to the geographic limitations that otherwise apply, including with respect to the beneficiary’s home. To qualify, the ACO must operate under a two-sided risk model and fee-for-service beneficiaries assigned to the ACO must be assigned prospectively. Services that are not appropriate to be furnished in a home (such as services furnished in inpatient hospital settings) are excluded from payment. Additionally, the patient’s home is not eligible for a facility fee payment that would otherwise apply to telehealth services furnished in a physician’s office or other health care setting. By not later than January 1, 2026, the Secretary must submit a report to Congress on this provision, including an analysis of utilization of and spending for these telehealth services furnished in the patient’s home. The Secretary is given the authority to collect the data the agency determines necessary for purpose of the report. Sec. 50325. Expanding the use of telehealth for individuals with stroke. Beginning January 1, 2019, Medicare fee-for-service telehealth benefits will cover services relating to the diagnosis, evaluation or treatment of symptoms of acute stroke furnished through telehealth. The provision waives limitations on originating sites (both the type and the geographic location of the facilities or offices) at which the eligible telehealth individual is


located at the time the service is furnished. The Secretary must determine the services that are covered under this authority. The list of originating sites is expanded to include mobile stroke units and other sites the Secretary determines to be appropriate; however, the facility fee is waived with respect to new categories of originating sites unless the site meets pre-existing requirements for originating sites (e.g., hospitals and critical access hospitals will receive the facility fee for these telehealth services while new sites may not). Subtitle D—Identifying the Chronically Ill Population Sec. 50331. Providing flexibility for beneficiaries to be part of an ACO. Assignment of Medicare fee-for-service beneficiaries to an ACO is important for the calculation of the ACO’s benchmark, determining the ACO’s financial performance after each performance year, and developing the ACO’s sample of beneficiaries for reporting on quality measures. Some Medicare Shared Savings Program (MSSP) ACO models provide for preliminary prospective beneficiary assignment with final retrospective beneficiary assignment. A criticism of this assignment model is that the ACO does not know which beneficiaries will ultimately be included in their financial performance assessment until the end of the performance year. For ACO agreement periods entered into or renewed on or after January 1, 2020, an MSSP ACO that is in a model that uses retrospective assignment may elect to use prospective assignment of beneficiaries to the ACO so the ACO knows the patient population for which it is responsible before the end of the year. Additionally, for performance year 2018 and subsequent performance years, fee-for-service beneficiaries may identify an ACO professional as his or her primary care provider for purposes of assignment to the ACO. The Secretary must provide notice to fee-for-service beneficiaries that they have the right to designate an ACO professional as their primary care provider for purposes of assignment to an ACO as well as the right to change that designation. The Secretary must also inform the beneficiaries of the manner in which they may make and change those designations. The provision clarifies that a beneficiary designation supersedes any claims-based designation that the Secretary may make. Subtitle E—Empowering Individuals and Caregivers in Care Delivery Sec. 50341. Eliminating barriers to care coordination under ACOs. The Federal prohibition on beneficiary inducements (i.e., an offer or transfer to a Medicare or Medicaid beneficiary of any “remuneration” that is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of Medicare or Medicaid covered items or services) may subject a provider of services, physician or other supplier to civil money penalties of up to $10,000 for each wrongful act. Remuneration includes transfers of items or services for free or for other than fair market value though there are a number of exceptions established pursuant to statute and regulations. Beginning as early as January 1, 2019 but no later than January 1, 2020, certain ACOs using a two-sided risk model (MSSP Tracks 2 and 3 and any successor two-sided risk track) may operate an ACO Beneficiary Incentive Program; incentive payments that meet certain requirements (described below) and that are provided under an incentive program are exempt from the prohibition on beneficiary inducements.


The incentive program applies to “qualifying services” which are Medicare Part B primary care services for which cost-sharing applies that are furnished through the ACO by a primary care physician (an MD or DO), a physician assistant, a nurse practitioner, a clinical nurse specialist, or an FQHC. The incentive payments may not exceed $20 for each qualifying service, and the incentive payment amount must be uniform for all attributed ACO beneficiaries. Incentive payments must be made no later than 30 days after the qualifying service is furnished. The Secretary may not reimburse the ACO for the costs of carrying out an ACO Beneficiary Incentive Program, but the ACO may use shared savings it receives under the MSSP ACO program to fund the incentive program. Additionally, incentive payments are disregarded in calculated ACO benchmarks, estimated average per capita Medicare expenditures, and shared savings. The ACO must provide the Secretary such information on the incentive program as the agency requires (including the amount and frequency of incentive payments). The Secretary may terminate an ACO Beneficiary Incentive Program “for reasons determined appropriate by the Secretary.” The provision exempts payments received under an incentive program for purposes of income tax laws or laws governing qualification for Federal or State assistance programs. The Secretary must evaluate the impact of the ACO Beneficiary Incentive Program on Medicare spending and beneficiary outcomes and submit a report by October 1, 2023. Sec. 50342. GAO study and report on longitudinal comprehensive care planning services under Medicare part B. Not later than 18 months after the date of enactment, GAO must submit a report to Congress on the establishment of a Medicare Part B payment code for a visit for longitudinal comprehensive care planning services furnished to a Medicare beneficiary by an institutional provider of services (including a hospice program) or by a physician or other health care practitioner. A longitudinal comprehensive care planning service is a voluntary shared decisionmaking process through an interdisciplinary team for beneficiaries with a diagnosis of a serious or life-threatening illness to discuss disease progression, treatment options, beneficiary preferences and available resources and social supports. The GAO must address a number of issues, including (i) the frequency with which similar services are currently furnished to Medicare beneficiaries and by whom; (ii) whether payment is made for such services and if so through which codes; (iii) whether these planning services overlap with other care planning services; (iv) any barriers providers of services or suppliers might face working with beneficiaries to furnish these planning services; (v) options for ensuring providers and suppliers are apprised of any existing longitudinal care plans; (vi) development of quality metrics; (vii) appropriate training for providers of services and suppliers; and (viii) the frequency with which such services should be provided. Subtitle F—Other Policies to Improve Care for the Chronically Ill Sec. 50351. GAO study and report on improving medication synchronization. Not later than 18 months after the date of enactment, the GAO must submit to Congress a report on the extent to which plans that provide Medicare Part D drug coverage (whether an MA-PD


plan or a stand-alone prescription drug plan) and private insurers or group health plans use synchronized pharmacy dispensing. Synchronized pharmacy dispensing is a program through which pharmacies dispense multiple prescriptions to enrollees at the same time in order to provide more comprehensive medication counseling for the patients. It has also been shown to improve medication adherence.

GAO must examine adoption rates by pharmacies of synchronized pharmacy dispensing programs, common characteristics across these dispensing programs, any impacts on patient medication adherence and overall health outcomes, and patient satisfaction. The study must also examine how these programs differ between Medicare and private payors, whether Medicare law supports these programs, and whether there are any barriers preventing MA-PD plans or prescription drug plan sponsors to use these programs. Sec. 50352. GAO study and report on impact of obesity drugs on patient health and spending. Not later than 18 months after the date of enactment, the GAO must submit to Congress a report on the use of prescription medicines to manage the weight of obese patients and the impact of the use of those medicines on patient health and on health care spending both for Medicare beneficiaries and for other patient populations. GAO must examine the prevalence of obesity in the Medicare and non-Medicare populations, use of obesity drugs, alternative approaches such as behavioral counseling, physician attitudes towards obesity drugs, insurance coverage limitations, obesity medication adherence, maintenance of weight loss; and spending rates for health services between patients who use such medicines and those who do not. Sec. 50353. HHS study and report on long-term risk factors for chronic conditions among Medicare beneficiaries. Not later than 18 months after the date of enactment, the Secretary must submit to Congress a report on long-term cost drivers to the Medicare program. Topics to be studied include the impact of obesity, tobacco use, mental health conditions, and other factors that contribute to deteriorating health conditions of Medicare beneficiaries with chronic conditions. The Secretary must also identify barriers to collecting and analyzing data on long-term cost drivers and suggestions to remove those barriers. Sec. 50354. Providing Prescription Drug Plans with Parts A and B Claims Data. Under a newly added subparagraph (6) to section 1860D-(4)(c) of the Act (relating to cost and utilization management, quality and medication therapy management), the Secretary is required to establish a process under which a Prescription Drug Plan (PDP) sponsor of a drug plan may submit a request to CMS to obtain on a periodic basis and in an electronic format, beginning in plan year 2020, Medicare Parts A and B claims data (for periods determined by the Secretary) with respect to the enrollees in its Part D plan. The sponsor could use these data to: optimize therapeutic outcomes through improved medication use; improve care coordination so as to prevent adverse health outcomes, such as preventable emergency department visits and hospital readmissions; and for any other purpose determined appropriate by the Secretary. A PDP sponsor will not be allowed to use these data to (i) inform Part D coverage determinations; (ii) conduct retroactive reviews of medically accepted indications determinations; (iii) facilitate enrollment


changes to a different PDP or an MA-PD of the same parent organization; (iv) inform marketing of benefits; or (v) for any other purpose that the Secretary determines is necessary to protect the identity of Part D enrollees of individuals entitled to Part D and to protect the security of personal health information. TITLE IV—PART B IMPROVEMENT ACT AND OTHER PART B ENHANCEMENTS Subtitle A—Medicare Part B Improvement Act Sec. 50401. Home infusion therapy services temporary transitional payment. Pharmacies providing home infusion drugs administered through an item of durable medical equipment provided additional services to patients with the margins they had on those drugs. The 21st Century Cures Act reduced payment for those home infusion drugs effective January 1, 2017, and created a separate home infusion benefit for those additional services. While the drug payment reductions were effective January 1, 2017, the new home infusion benefit was not effective until January 1, 2021. Section 50401 requires the Secretary to establish a home infusion therapy services temporary transitional payment system effective January 1, 2019. Payment is for professional services, including nursing services, training and education, remote monitoring, and monitoring services, as well as for “transitional home infusion drugs” (defined below). Payment may be made to an “eligible home infusion supplier.” The transitional payment system will be in effect until January 1, 2021 when a new home infusion benefit created by the 21st Century Cures Act is scheduled to go into effect for “qualified home infusion therapy suppliers.” A “transitional home infusion drug” is a parenteral drug or biological administered intravenously, or subcutaneously for an administration period of 15 minutes or more, in the home of an individual through a pump that is an item of durable medical equipment. A transitional home infusion drug may include a self-administered drug or biological if it is identified by a HCPCS code listed in the statute as of the date of enactment. The statute requires the Secretary to establish three categories of payment and specifies the HCPCS codes to include in each category. Each payment category requires payment for specific HCPCS codes covered under a local coverage determination associated with External Infusion Pumps (LCD number L33794) as of January 1, 2018. The categories are:

• Payment Category 1: J0133, J0285, J0287, J0288, J0289, J0895, J1170, J1250, J1265, J1325, J1455, J1457, J1570, J2175, J2260, J2270, J2274, J2278, J3010, or J3285.

• Payment Category 2: J1555 JB, J1559 JB, J1561 JB, J1562 JB, J1569 JB, or J1575 JB. • Payment Category 3: J9000, J9039, J9040, J9065, J9100, J9190, J9200, J9360, or J9370.

The Secretary is further provided with authority to assign drugs billed under “not otherwise classified” codes as of July 1, 2017 (or any successor codes created after date of enactment that are also covered under LCD L33794) to one of the three payment categories. The statute specifies that the payment amounts will equal the physician fee schedule payment without any geographic adjustments as of January 1, 2018 (or as subsequently modified by the Secretary) as follows:


• Payment Category 1: One unit of HCPCS code 96365 and three units of HCPCS code 96366. • Payment Category 2: One unit of HCPCS code 96369 and three units of HCPCS code 96370. • Payment Category 3: One unit of HCPCS code 96413 and three units of HCPCS code 96415.

The transitional home infusion drug payment system will be for all home infusion drugs and professional services furnished on a single date of service by eligible home infusion suppliers. If drugs in more than one payment category are furnished on the same date, Medicare will make a single payment at the rate of the payment category with the highest payment. An “eligible home infusion supplier” is a pharmacy enrolled in Medicare Part B that provides external infusion pumps and external infusion pump supplies, and that maintains all pharmacy licensure requirements in the state where the infusion drugs are being administered. The Secretary may implement the transitional home infusion drug payment system by instruction without going through notice and comment rulemaking. Sec. 50402. Orthotist’s and prosthetist’s clinical notes as part of the patient’s medical record. Section 50402 allows documentation created by an orthotist or prosthetist to be considered as part of the medical record for determining medical necessity of orthotics and prosthetics. Sec. 50403. Independent accreditation for dialysis facilities and assurance of high quality surveys. Section 50403 allows accreditation bodies to certify that End Stage Renal Disease (ESRD) facilities meet the conditions and requirements established by the Secretary that apply to ESRD facilities participating in Medicare. To provide that certification, the accreditation body must be recognized by the Secretary as qualified under provisions of current law and regulations. In addition, the Secretary is required (as appropriate) to conduct any or all of the following as frequently as is required of other accreditation bodies or other provider entities: validation surveys, accreditation programs, and performance reviews (as defined in sections 488.8(c) and 488.8(a) of title 42 of the Code of Federal Regulations, respectively, or successor regulations). Not later than 90 days after the date of enactment, the Secretary is required to begin accepting requests from accreditation organizations to certify ESRD facilities. Effective 180 days after the date of enactment, for new dialysis facilities, the Secretary is required to initiate a new survey within 90 days of receiving a provider enrollment form (even if the form is submitted prior to the date of enactment) if the enrollment form is complete and the provider’s enrollment status indicates approval is pending the results of a survey. Sec. 50404. Modernizing the application of the Stark rule under Medicare. Section 50404 codifies in statute certain recent clarification of requirements under the Prohibition on Physician Self-referral (Stark) law relating to writing and signature requirements as well as holdover arrangements. Parties to a compensation arrangement that is required to be in writing may satisfy the writing requirement through a collection of documents (including contemporaneous documents that


evidence the course of conduct between the parties) and through such other means as the Secretary may determine. Parties to a compensation arrangement that is required to be signed and in writing may satisfy the signature requirement by obtain the requisite signatures as late as 90 consecutive calendar days after the date the compensation arrangement became noncompliant as long as the compensation arrangement otherwise complies with all of the criteria of the applicable exception. Payments made by a lessee to a lessor under a holdover lease arrangement of office space or equipment shall not be considered a compensation arrangement where (i) the holdover lease arrangement immediately follows a lease of at least one year in length that met existing requirements under section 1877(e)(1)(A) or (B) of the Act, (ii) the holdover lease arrangement is under the same terms and conditions as the immediately preceding arrangement; and (iii) the holdover arrangement continues to meet requirements under such section 1877(e)(1)(A) or (B). Similarly, remuneration from an entity under a holdover personal service arrangement shall not be considered a compensation arrangement where (i) the holdover personal service arrangement immediately follows a personal service arrangement for a term of at least one year in length that met existing requirements under section 1877(e)(1)(A) of the Act, (ii) the holdover personal service arrangement is under the same terms and conditions as the immediately preceding arrangement; and (iii) the holdover arrangement continues to meet requirements under such section 1877(e)(1)(A). Subtitle B—Additional Medicare Provisions Sec. 50411. Permanent Removal of DME Rental Cap for Speech Generation Devices. This section amends section 1834(a)(2)(A)(iv) of the Act by striking “and before October 1, 2018,”. The elimination of the date makes permanent the removal of the rental cap for DME under Medicare with respect to speech generation devices. Sec. 50412. Increased civil and criminal penalties and increased sentences for Federal health care program fraud and abuse. This provision significantly increases (i.e., doubles or quadruples) the maximum amount of civil money penalties or criminal fines that may be imposed for a violation of the health care fraud and abuse laws. It also significantly increases (i.e., doubles) the maximum sentence of imprisonment that may be imposed for criminal violation of certain fraud and abuse laws (i.e., false statements or representations, the Anti-Kickback law, and excess charges) from 5 to 10 years. The increased penalties and sentences apply to acts committed on or after the date of the enactment of the ACCESS Act. Sec. 50413. Reducing the volume of future EHR-related significant hardship requests. Under the Medicare Electronic Health Record Incentive Program, eligible professionals, eligible hospitals and eligible critical access hospitals must demonstrate meaningful use of electronic health record (EHR) technologies. Statutory requirements for the program include using certified EHR technology in a meaningful manner; demonstrating that the technology is connected for the electronic exchange of health information to improve the quality of health care;


and using EHRs to submit certain performance measures to the Secretary. Over time, the Secretary is directed to require more stringent measures of meaningful use. Section 50413 strikes the language in the statute that mandates the use of more stringent measures over time under the Program. Thus the Secretary is no longer required to make measures more stringent over time (though technically the statute as amended does not prohibit the Secretary from doing so). Sec. 50414. Strengthening Rules in Case of Competition for Diabetic Testing Strips. Special Rule in Case of Competition for Diabetic Testing Strips This section, in general, codifies certain beneficiary protections regarding diabetic testing strips under CMS’ competitive bidding program. In addition, this section requires enhanced reporting intended to ensure beneficiaries are receiving the diabetic testing strips needed to manage their condition. Specifically, paragraph (10) of section 1847(b) of the Act is amended. Specifies more clearly what data elements should be used by the Secretary to determine the volume of diabetic testing strips. Requires the Secretary to use multiple sources of data (from mail order and non-mail order Medicare markets), including market-based data measuring sales of diabetic testing strip products. Clarifies that market-based data cannot be used that reflects diabetic testing strips exclusively sold by a single retailer from a particular market.

Requires an entity bidding to furnish diabetic testing strips (on or after January 1, 2019) to attest to the Secretary that it has the ability to furnish types and quantities of diabetic testing strips consistent with its bid. The entity can accomplish this in one of two ways: (1) provide letters of intent with manufacturers, wholesalers, or other suppliers, or other evidence that the Secretary may specify, or (2) demonstrate to the Secretary that it made a good faith effort to obtain such a letter of intent or other evidence.

Current law requires that winning bidders under the competitive bidding program must cover at least 50 percent, by volume, of all types of diabetes test strips on the market. This is generally referred to as the 50-percent rule. This section amends the current law by specifying that the Secretary may not use “unlisted” types of diabetic testing strips in the calculation. In other words, the Secretary may not attribute a percentage to types of diabetic testing strip products that are not identified by brand, model, and market share volume.

Stipulates that for entities furnishing diabetic testing strip products (on or after January 1, 2019), the Secretary establish an ongoing process to monitor whether the entity continues to cover the product types included in the entity’s bid. Allows the Secretary to terminate the entity’s contract if the entity fails to maintain an inventory or otherwise maintain ready access to a type of product included in the entity’s bid. This excludes circumstances in the involved market where there was a discontinuation of the product manufacturer, a market-wide shortage, or introduction of a newer model or version of the product.

Codifying and Expanding Anti-Switching Rule

This section sets forth additional rules in the case of competition of diabetic testing strips and amends section 1847(b) of the Act, by adding a new paragraph (11).5 In general, an entity 5 The current paragraph (11) is redesignated in this Section as paragraph (12).


furnishing diabetic testing strips under the competitive bidding program is required to furnish to each individual a brand compatible with the home blood glucose monitor selected by the individual.

Prohibits an entity from attempting to influence or incentivize an individual to switch the brand of glucose monitor or diabetic testing strip product selected by the individual. This includes persuading, pressuring, or advising the individual to switch, or furnishing unsolicited information about alternative brands.

Requires the Secretary to develop and make available (no later than January 1, 2019) to entities furnishing diabetic testing strips under the competitive bidding program standardized information that describes the rights of an individual. This information must include (1) information on requirements prohibiting entities from influencing and incentivizing; (2) the right of the individual to purchase diabetic testing strip products from another mail order supplier of such products or a retail pharmacy if the entity is not able to furnish the compatible testing strip with the home blood glucose monitor; and (3) the right of the individual to return diabetic testing strip products furnished to the individual by the entity. Also prohibits entities from communicate directly with the individual “until the entity has verbally provided the individual with such standardized information.” Thus, each entity that seeks to communicate directly with individuals (the nature of the communication is not specified) must first verbally provide individuals the standardized information describing their rights with regards to the entity.

With respect to order refills (on or after January 1, 2019), requires the entity furnishing diabetic testing strips to contact and receive a request (within a 14-day period) from the individual prior to dispensing a refill.

Implementation; Non-Application of the Paperwork Reduction Act.

Paperwork Reduction Act does not apply to this section or the amendments made by this section and thus can be implemented (notwithstanding any other provision of law) by program instruction or otherwise.

TITLE V—OTHER HEALTH EXTENDERS Sec. 50501. Extension for Family-to-Family Health Information Centers. The Family-to-Family Health Information Center is a program to provide grants for the development and support of centers which provide information, education, technical assistance, and peer support to families of children and youth with special health care needs and the professionals who serve them. Funding for the Family-to-Family Health Information Center program is extended for fiscal years 2018 and 2019 and increased to $6 million for each of those fiscal years. The legislation also requires the Secretary to establish Family-to-Family Health Information Centers in all the territories and at least one center for the Indian tribes. Sec. 50502. Extension for sexual risk avoidance education. The ACCESS Act makes a number of changes to the State Abstinence Education Grant Program under Title V of the Social Security Act. Under prior law, funding was provided through fiscal year 2017 to states and territories for abstinence education, and where appropriate, mentoring,


counseling and adult supervision to promote abstinence from sexual activity. Generally, abstinence education had to meet the following requirements:

• Have as its exclusive purpose, teaching the social, psychological, and health gains to be realized by abstaining from sexual activity;

• Teach abstinence from sexual activity outside marriage as the expected standard for all school age children;

• Teach that abstinence from sexual activity is the only certain way to avoid out-of-wedlock pregnancy, sexually transmitted diseases, and other associated health problems;

• Teach that a mutually faithful monogamous relationship in the context of marriage is the expected standard of human sexual activity;

• Teach that sexual activity outside of the context of marriage is likely to have harmful psychological and physical effects;

• Teach that bearing children out-of-wedlock is likely to have harmful consequences for the child, the child’s parents, and society;

• Teach young people how to reject sexual advances and how alcohol and drug use increases vulnerability to sexual advances; and

• Teach the importance of attaining self-sufficiency before engaging in sexual activity.

Section 50502 extends the fiscal year 2017 level of funding ($75 million) for the program for each of fiscal years 2018 and 2019; modifies the purposes and activities of the program; and changes the name of the program to the Sexual Risk Avoidance Education Program. Additionally, the Secretary may retain up to 20 percent of the funding to administer the program; conduct national evaluations of the program; and provide technical assistance to grant recipients. Not all states submitted applications for grants under the program under prior law. Section 50502 permits entities in a state that has not submitted an application for grant funding to separately submit applications under a competitive grant process for funding for sexual risk avoidance education programs for youth (which is defined as ages 10 through 19). In each of fiscal years 2018 and 2019, the Secretary must allot grants to entities in those states in an amount that would have been allotted to the state had the state submitted an application for funding. The purpose of a grant is to enable a state to implement education exclusively on sexual risk avoidance which is defined to mean voluntarily refraining from sexual activity. The education must address each of the following topics:

• The holistic individual and societal benefits associated with personal responsibility, self-regulation, goal setting, healthy decision-making, and a focus on the future.

• The advantage of refraining from non-marital sexual activity in order to improve the future prospects and physical and emotional health of youth.

• The increased likelihood of avoiding poverty when youth attain self-sufficiency and emotional maturity before engaging in sexual activity.

• The foundational components of healthy relationships and their impact on the formation of healthy marriages and safe and stable families.

• How other youth risk behaviors, such as drug and alcohol usage, increase the risk for teen sex. • How to resist and avoid, and receive help regarding, sexual coercion and dating violence,

recognizing that even with consent teen sex remains a youth risk behavior.


Each of the topics must (i) emphasize a message that normalizes optimal health behavior of avoiding non-marital sexual activity; (ii) be medically accurate and complete; (iii) be age appropriate; (iv) be based on age-group appropriate adolescent learning and development theories; and (v) be culturally appropriate. Additionally, any information on contraception must be medically accurate and complete and emphasize that contraception reduces physical risk but does not eliminate it. Up to 20 percent of an allotment to a state or an entity may be used for research to build the evidence base for sexual risk avoidance education; research must be rigorous, evidence-based and conducted by independent researchers with appropriate experience. States and entities receiving allotments must collect information on the programs and activities funded through the grants and submit reports to the Secretary. The Secretary must conduct a rigorous evaluation of sexual risk avoidance education and associated data under the program, and submit a report to Congress on the evaluation. Sec. 50503. Extension for personal responsibility education. The Personal Responsibility Education Program provides grants to state agencies to educate young people (ages 10 through 19) on abstinence and contraception to prevent pregnancy and sexually transmitted infections, including HIV/AIDS. The program targets youth who are homeless, in foster care, live in rural areas or in geographic areas with high teen birth rates, or come from racial or ethnic minority groups. The program also supports pregnant and parenting youth. This section of the ACCESS Act extends the fiscal year 2017 funding level ($75 million) for the program for each of fiscal years 2018 and 2019. Under prior law, $10 million in funding is reserved each year to award grants to entities to implement innovative youth pregnancy prevention strategies and target services to high-risk, vulnerable, and culturally under-represented youth populations, including youth in foster care, homeless youth, youth with HIV/AIDS, pregnant women who are under 21 years of age and their partners, mothers who are under 21 years of age and their partners, and youth residing in areas with high birth rates for youth. This is amended to add victims of human trafficking as an under-represented youth population and for which reserved funding is available. Local organizations and entities in a state that has not submitted an application for funding under the program may apply for that funding. Under the Access Act, the Secretary must continue to fund (through fiscal year 2019) those organizations and entities that received grants under the program for fiscal year 2015, 2016 or 2017. Title VI – Child and Family Services and Supports Extenders Subtitle A – Continuing the Maternal, Infant, and Early Childhood Home Visiting Program Sec. 50601. Continuing Evidence-based Home Visiting Program. Under the Maternal, Infant and Early Childhood Home Visiting Program, states, territories and tribal entities can receive grant funds to develop and implement evidence-based programs intended to improve maternal and child health, prevent child abuse and neglect, teach parenting skills and increase school readiness. The provision extends funding for the program for 5


additional years, providing $400 million for each of FYs 2018 through 2022. That amount is the same as has been made available for the program for each of FYs 2013 through 2017. Sec. 50602. Continuing to Demonstrate Results to Help Families. Demonstrating Improvement in Benchmark Areas at 3- and 5-years This provision will make it easier for grantees of funds under the Maternal, Infant and Early Childhood program to demonstrate, after 3-years and 5-years of being in effect, quantifiable and measurable improvements for those programs. Programs will no longer need to provide evidence of demonstrable improvement in each of the following areas (although they would continue to be required to provide evidence of demonstrable improvements in the listed areas.) The areas are improved maternal and newborn health; prevention of injuries, abuse, or neglect; school readiness; family self-sufficiency; coordination and referrals for other community resources; and supports reduction in crime or domestic violence. Demonstration of Improvement in Subsequent Years The ACCESS Act adds a requirement that grantees continue to track and report, beginning in 2020 and every three years thereafter, progress in benchmark areas, and that they must demonstrate improvements in at least 4 of the specified areas (listed above). If improvement cannot be demonstrated in at least 4 of the benchmark areas, the Act requires the entity to develop and implement a correction plan. Under the provision, the Secretary is required to conduct oversight of the program and provide technical assistance on the improvement plan. It also provides the Secretary with the authority to terminate the grant if he determines that the entity has failed to demonstrate improvement or failed to submit a corrective action plan. Sec. 50603. Reviewing Statewide Needs to Target Resources. Under prior law, each state was required to conduct a statewide needs assessment no later than September of 2010 as a condition of receiving grants under the Maternal, Infant, and Early Childhood Home Visiting program. This requirement is updated so that under the new law, each state is required, as a condition of receiving payments under this program, to conduct a statewide needs assessment (separate from the assessment required for the Maternal and Child Health Block Grant) no later than October 1, 2020. Sec. 50604. Improving the Likelihood of Success in High Risk Communities. Under prior law, a state receiving grant funds under the Maternal, Infant, and Early Childhood Home Visiting program is required to prioritize certain high-risk populations including:

• Eligible families who reside in communities in need of services as identified through the statewide needs assessment,

• Low-income families and pregnant women under age 21, • Families with a history of child abuse or substance abuse, and • Those with children who have developmental delays, disabilities, or low student

achievement, among others. The ACCESS Act modifies one of those priority populations. The group that includes certain high-risk populations residing in communities in need of services as identified through statewide needs assessment is modified so that the group is identified through a statewide needs assessment


that takes into account “staffing, community resource, and other requirements to operate at least one approved model of home visiting and demonstrate improvements for eligible families.” Sec. 50605. Option to Fund Evidence-Based Home Visiting on a Pay for Outcome Basis. This section provides a new option for grantees to use up to 25 percent of grant funds for payments tied to outcomes so long as the initiative doesn’t result in a reduction of funds available for home visiting services delivered by the entity. An outcomes initiative is defined to mean a “performance-based grant, contract, cooperative or other agreement in which a commitment to pay for improved outcomes achieved as a result of the intervention results in social benefits, direct cost savings, or cost avoidance to the public sector.” The initiative must include a feasibility study that describes how the proposed intervention would be based on evidence of effectiveness; a third party evaluation to determine if the initiative has met its proposed outcomes; and an annual report on the progress of the initiative which would be made publicly available. Under the initiative, payments could only be made when agreed upon outcomes are achieved (except for payments made to a third party for program evaluation). Outcomes payments under this section are available for expenditure for a period of no more than 10 years after the funds are made available. Sec. 50606. Data Exchange Standards for Improved Interoperability. Beginning February 9, 2020 (two years after the date of enactment of the ACCESS Act) programs funded by home visiting grants will be required to have in place data exchange standards that conform with the requirements listed below. The head of a department or agency administering a program funded by such grants will need to designate standards meeting the following requirements (if its existing standards are not effective and efficient). The standards, developed in consultation with an interagency work group, must, to the extent practicable, be

• Non-proprietary and interoperable; • Developed and maintained by an international voluntary consensus standards body,

intergovernmental partnership, and federal entities with authority over contracting and financial assistance;

• Used for federal reporting; • Consistent with applicable accounting principles; • Cost-effective and improve program efficiency and effectiveness; and • Capable of being upgraded as necessary.

In addition, they must incorporate a widely accepted, nonproprietary, searchable, computer-readable format. Sec. 50607. Allocation of Funds. This provision requires the Secretary to use the most accurate federal data available when making any grant under the Maternal, Infant, and Early Childhood Home Visiting Programs that is awarded based on relative population or poverty considerations. Subtitle B—Extension of Health Professions Workforce Demonstration Projects SEC. 50611. Extension of health workforce demonstration projects for low-income individuals. One component of the Social Service Block Grant Program is the health workforce demonstration project for low-income individuals. Under the project, the Secretary awards


grants to eligible entities to conduct demonstration projects designed to provide eligible low-income individuals the opportunity to obtain education and training for occupations in the health care field that pay well and are expected to either experience labor shortages or be in high demand. Eligible entities include states, Indian tribes or tribal organizations, institutions of higher education, local workforce investment boards, sponsors of apprenticeship programs registered under the National Apprenticeship Act, or community- based organizations. The legislation appropriates $85,000,000 for each of fiscal years 2018 and 2019 (which continues the same level of funding that applied for the preceding 8 fiscal years).

TITLE IX—PUBLIC HEALTH PROGRAMS Sec. 50901. Extension for community health centers, the National Health Service Corps, and teaching health centers that operate GME programs. Community Health Center (CHC) Funding The ACCESS Act extends funding for the CHC program under section 330(b) of the Public Health Service Act (PHSA) providing $3.8 billion for FY 2018 and $4 billion for FY 2019. The program was partially funded in an earlier continuing resolution legislation enacted on December 12, 2017 (Public Law 115-96) under which $550 million was provided for the first half of FY 2018. Other CHC Provisions. This provision swaps out the term “substance abuse” in exchange for the term “substance use disorder” and makes other changes to eliminate some of the purposes for which grants may be made. One of the purposes of the program it eliminates is to enable health centers to develop managed care plans and networks. The general purpose of CHC grants under prior PHSA section 330(c)(1) becomes new PHSA section 330(c) but otherwise remains the same -- to make grants to public and nonprofit private entities for projects to plan and develop health centers. Improving Quality of Care The section eliminates the authority for the Loan Guarantee program (under PHSA section 330(d)) for CHCs and replaces it with the authority for the Secretary to make supplemental grant awards to health centers to implement evidence-based models for increasing access to high quality services. The models can address care delivery for individuals with multiple chronic conditions, workforce, care coordination or integration, cost, telehealth, or treating substance use disorders. Such models are required to have an implementation plan. Under the new section the Secretary may give special consideration to applicants in areas with a shortage of health care providers or services. The ACCESS Act shortens the period of availability of operating grants that the Secretary is authorized (under PHSA section 330(e)) to provide to CHCs in medically underserved areas from two years to one year. It also requires that applicants for operating grants submit an implementation plan to the Secretary. It further provides authority for the Secretary, in making grants under section PHSA 330(e), to give special consideration to applicants expanding delivery sites or expanding services in underserved areas. For both new delivery sites and expanding service applicants, the Secretary is directed to approve applications ensuring that the ratio of those expected to use the services in rural areas versus urban areas would be no less than two to three or no greater than three to two. For expanded services applications, the Secretary would be


permitted to give special consideration to applications that seek to address emerging public health, behavioral health, and mental health or substance abuse issues in areas where there are significant barriers to accessing such care. Grant applications will need to demonstrate that the applicant has consulted with appropriate state and local government agencies and health care providers regarding the need for the proposed health care services or delivery site. The ACCESS Act expands the priority areas for grants addressing homeless populations authorized under PHSA section 330(h). In addition to grants for projects related to homeless individuals, homeless children and youth at risk of homelessness, grants may now address veterans and veterans at risk of homelessness. It adds a requirement that the Secretary may only use no more than 3 percent of section 330 grant funds for technical assistance provided under PHSA section 330(l). With respect to auditing requirements specified in PHSA section 330(q) applicable to grant recipients, the legislation adds limitations to the waivers that are available at the Secretary’s discretion. Going forward, waivers are only allowed for one year, may not be extended beyond that period, and an entity is not allowed more than one waiver in consecutive years. Under PHSA section 330(r), the Secretary is required to submit annual reports to Congress regarding the use of grant funds. The ACCESS Act adds specification to the existing reporting requirement by:

• Specifying the Committees of Congress to which annual reports must be submitted; • Adding that reports must address the distribution of awards for new or expanded services

in each of rural areas and urban areas; • With respect to establishing new access points, the number of new access points created; • The amount of unexpended funds for loan guarantees and loan guarantee authority

provided to facilities under PHSA Title XVI (Hill-Burton facilities); • The rationale for substantial changes in the distribution of funds; • Rate of closures of health centers and access points; • The number and reason for operating grants under section 330(e)(1)(b); and • The number and reason for waivers under section 330(q).

An additional $25 million is provided for FY 2018 to support the participation of health centers in the All of Us Research Program described under the Precision Medicine Initiative under section 498E of the PHSA. The ACCESS Act eliminates section 330(s) which provided for a pilot program for community health centers to test the use of individualized wellness plans. National Health Service Corps. This provision establishes funding for the National Health Services Corps of $310,000,000 for each of fiscal years 2018 and 2019. Teaching Health Centers that Operate Graduate Medical Education Programs This provision continues the Teaching Health Center Program by providing $126,500,000 for each of fiscal years 2018 and 2019. The Secretary shall make payments for direct expenses and


indirect expenses to qualified teaching health centers that are listed as sponsoring institutions by the relevant accrediting body for the purposes of: 1) maintaining filled positions; 2) expanding existing programs; or 3) establishing new graduate medical education training programs. A “new approved graduate medical residency training program” is an approved graduate medical residency training program for which the sponsoring qualified teaching health center has not received a Teaching Health Center payment for a previous fiscal year. In making payments, the Secretary is required to consider the cost of training residents at teaching health centers and the implications of the per resident amount on approved graduate medical residency training programs at teaching health centers. Funding priority shall be given to qualified teaching health centers that: 1) serve health professional shortage areas or medically underserved communities or 2) are located in rural areas. Teaching Health Centers are required to report annually on: 1) the number of patients treated by their medical residents; 2) the number of visits by patients treated by their medical residents; 3) the number and percentage of residents the Teaching Health Center trained who completed their residency training and entered primary care practice; and 4) the number and percentage of residents the Teaching Health Center trained who completed their residency training and who entered practice at a health care facility primarily serving a health professional shortage area or a medically underserved community or located in a rural area. The Secretary is required to provide a report to Congress by March 31, 2019 on the direct and indirect expenses of approved graduate medical residency training programs associated with the additional costs of teaching residents in qualified teaching health centers. Sec. 50902. Extension for special diabetes programs. Section 50902 extends funding for two Public Health Service Act special diabetes programs. The first program is for research into the prevention and cure of Type I diabetes. The second program provides services through the Indian Health Service or Indian Health Programs for the prevention and treatment of diabetes among Indians. Previously, the CHIP and Public Health Funding Extension Act (Division C of Public Law 115-96) provided funding for both these programs through the second quarter of fiscal year 2018. Funding for the Type I Diabetes program and the Indian Health Service program is increased for each program to $150,000,000 for each of fiscal years 2018 and 2019. TITLE X—MISCELLANEOUS HEALTH CARE POLICIES Sec. 51001. Home health payment reform. Currently under the home health prospective payment system (HH PPS), home health services furnished to Medicare fee-for-service beneficiaries are paid standardized prospective payment amounts for services furnished during a 60-day episode of care (or unit of service). Effective for home health services furnished on or after January 1, 2020, section 51001 requires payment for these services to be based on a 30-day unit of service. The Secretary must implement the transition from the 60-day to a 30-day unit of service in a budget neutral manner. The Secretary is required to calculate the standard prospective payment


amount so that estimated expenditures for 2020 under a 30-day unit of service are equal to estimated expenditures for 2020 if the law had not changed the unit of service from 60 to 30 days. This calculation is done before the application of the update to the standard prospective payment amounts. Additionally, in making this calculation for 2020, The Secretary is directed to make certain assumptions about changes in behavior of home health agencies (e.g., patterns of service delivery) that might occur due to the shorter unit of service as well as changes in case-mix adjustment factors (the Secretary is required to eliminate the use of therapy thresholds in case mix adjustment factors for 2020 and subsequent years). The Secretary must describe its assumptions on these issues in the proposed and final rules to implement the changes to the home health prospective payment system required by this section. Beginning in 2020 and ending in 2026, the Secretary must determine for each year the difference between the estimated impact of the behavior changes it assumed for 2020 (and included in the calculation of the standard prospective payment amount) and the actual impact of those behavior changes for that year. The Secretary is required to make one or more permanent prospective adjustments (increases or decreases) to the standard prospective payment amount to offset the difference between actual and estimated behavior changes for purposes of future payment. The Secretary must also make one or more temporary prospective adjustments (increases or decreases) to the payment amount for a unit of home health services to offset the difference between actual and estimated behavior changes for a previous year; these temporary adjustments are not taken into account in computing the payment amount for future years. During 2018, the Secretary must hold one or more sessions of a technical expert panel (composed of home health providers, patient representation and other relevant stakeholders) to identify and prioritize recommendations for the HH PPS on (i) the Home Health Groupings Model proposed but not finalized by the Secretary in the HH PPS 2018 rulemaking cycle, and (ii) other case-mix models that were submitted as comments to the HH PPS 2018 proposed rule. Not later than 2019, the Secretary must submit to Congress a report on the technical expert panel’s recommendations. Not later than December 31, 2019, the Secretary must “pursue” rulemaking on a case-mix system for the HH PPS. MedPAC must submit an interim report (due March 15, 2022) and a final report (due March 15, 2026) on the substitution of the 30-day unit of service under the HH PPS. MedPAC must analyze payment levels to home health agencies and compare those levels to the cost of delivering home health services; it must also examine any unintended consequences of the shorter unit of service, including with respect to behavior change and quality. Sec. 51002. Information to satisfy documentation of Medicare eligibility for home health services. In order for payment to be made for home health services furnished to Medicare beneficiaries, among other requirements, a physician must certify that the services are medically necessary. Claims review processes have led to payment denials for home health services because of insufficient evidence or inadequate medical record notes to document medical necessity.

Effective for certifications (or recertifications) for home health services furnished on or after January 1, 2019, the Secretary (and its contractors) are permitted to consider documentation in the medical record of the home health agency furnishing home health services as supporting


material if it is appropriate to the case. This new authority applies with respect to payments for home health services under Part A and Part B.

Sec. 51003. Technical amendments to Public Law 114–10. Section 51003 makes a number of changes to the Merit-Based Incentive Payment System (MIPS) for Medicare physicians’ services that was enacted as part of Medicare Access and CHIP Reauthorization Act of 2015 (Public Law 110-14). Scope of Services. As enacted in 2015, MIPS payments apply to payments for Medicare Part B “items and services” furnished on or after January 1, 2019. Effective for MIPS performance periods beginning on or after January 1, 2018, MIPS payments will apply to “covered professional services” as that term is applied under the Physician Quality Reporting System (PQRS). The elimination of the term “items” from MIPS payment calculations is significant; the Secretary may implement this provision by eliminating Part B drugs from those calculations since Part B drugs were not included as covered professional services under the PQRS. Resource Use Category This section makes a number of modifications with respect to the resource use category in the calculation of the composite performance score. The composite scoring methodology uses a scoring scale of 0-100 with weights assigned to each performance category and each underlying measure or clinical practice improvement activity (with a continuous distribution of performance scores, resulting in differential payments). The statute specifies for the resource use performance category a weight of not more than 10 percent in year 1, 15 percent in year 2, and 30 percent in later years. The weights are changed for years 2 through 5; the resource use category weight may not be less than 10 percent and not more than 30 percent in each of those years. Under the composite score methodology, beginning in year 2 of the MIPS program, the Secretary must take into account improvement for the resource use performance category and for the quality performance category. The statute is modified to direct the Secretary not to take into account improvement for the resource use performance category in years 2 through 5 of the MIPS program. Before the end of each year, beginning with 2018, the Secretary is also directed to post on its website information on resource use measures used in MIPS as well as resource use measures under development, potential future resource use measure topics, a description of stakeholder engagement, and the percent of expenditures under Parts A and B that are covered by resource use measures. Performance Threshold. The Secretary must establish performance standards for measures and activities. Performance thresholds must be set at the mean or median (as selected by the Secretary) of the composite performance scores for all MIPS eligible professionals with respect to a prior period specified by the Secretary (the use of the mean or median may be reassessed by the Secretary every 3 years). For the first two years of the MIPS program, performance thresholds must be based on available data from a prior period with respect to performance on measures and activities incorporated into MIPS and other factors determined appropriate by the Secretary; this is amended to apply for the first five years of the MIPS program. However, the Secretary must also increase the performance threshold for the third, fourth and fifth MIPS


program years to ensure a gradual and incremental transition to the sixth year where the thresholds are set at the mean or median of all composite performance scores. Physician-Focused Payment Model Technical Advisory Committee (PTAC). The PTAC reviews proposals for physician-focused payment models submitted by stakeholders to determine whether they meet criteria developed by the Secretary. PTAC submits comments and recommendations to the Secretary on the issue of whether models submitted to the PTAC meet the criteria; the Secretary must respond to PTAC comments and recommendations. This section amends the statute to permit the PTAC to provide initial feedback to stakeholders who submit models on whether the models meet the criteria and why the PTAC finds that the model does (or does not) meet those criteria. Sec. 51004. Expanded access to Medicare intensive cardiac rehabilitation programs. This section would expand the number of qualifying conditions for a Medicare beneficiary to be eligible to receive items and services under an intensive cardiac rehabilitation program. Before the amendments made by this section, the beneficiary must have had one of the following conditions: (i) an acute myocardial infarction within the preceding 12 months; (ii) coronary bypass surgery; (iii) stable angina pectoris; (iv) heart valve repair or replacement; (v) percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting; or (vi) a heart or heart-lung transplant. Effective on the date of enactment of the ACCESS Act, a patient with stable, chronic heart failure (which is defined as patients with left ventricular ejection fraction of 35 percent or less and New York Heart Association (NYHA) class II to IV symptoms despite being on optimal heart failure therapy for at least 6 weeks) is eligible for coverage of an intensive cardiac rehabilitation program. Additionally, a condition which would qualify a beneficiary for a cardiac rehabilitation program (i.e., a non-intensive cardiac rehabilitation program) would also qualify for an intensive cardiac rehabilitation program unless the Secretary determines that it would not be supported by clinical evidence. Sec. 51005. Extension of blended site neutral payment rate for certain LTCH discharges; temporary adjustment to site neutral payment rates. Certain long-term care hospital (LTCH) discharges that do not meet specified criteria are paid the lesser of (i) an amount comparable to Medicare’s Inpatient Prospective Payment System per diem rate for the same type of discharge, including any applicable outlier payments, or (ii) 100 percent of the cost of the case, whichever is lower. This payment rate is referred to as the site-neutral payment rate. When first enacted, the site neutral payment rate was phased in over a two-year period so that for discharges occurring during cost reporting periods beginning in fiscal years 2016 and 2017, the site neutral payment rate is a blend of (i) one-half the standard LTCH prospective payment system payment rate and (ii) one-half the site-neutral payment rate. Section 51005 extends the blended site neutral payment rate for an additional two fiscal years so that qualifying discharges occurring during cost reporting periods beginning in fiscal year 2018 and fiscal year 2019 are paid for those discharges at the blended rate.


To offset the cost of the two-year extension of the blended site neutral payment rate, the otherwise applicable IPPS comparable per diem rate for discharges occurring during cost reporting periods beginning during fiscal years 2018 through 2026 will be reduced for each such fiscal year by 4.6 percent. Sec. 51006. Recognition of attending physician assistants as attending physicians to serve hospice patients. Hospice care may be provided to a Medicare beneficiary when the patient’s attending physician and the medical director of the hospice program each certify that the patient is terminally ill (generally a medical prognosis of life expectancy of 6 months or less). Additionally, the patient’s attending physician and the hospice program’s medical director establish and review the patient’s plan of care for hospice services. Section 51006 permits an attending physician assistant to carry out the same functions as an attending physician with respect to the furnishing of hospice care to a terminally ill Medicare beneficiary, including the certification of terminal illness and the establishment and review of the hospice plan of care. Sec. 51007. Extension of enforcement instruction on supervision requirements for outpatient therapeutic services in critical access and small rural hospitals through 2017. In 2009, the Secretary clarified its physician supervision policy for outpatient therapeutic services that a physician must be immediately available to furnish assistance and direction throughout the performance of an outpatient therapeutic procedure (i.e., direct supervision). Critical access hospitals (CAHs) and rural hospitals commented that the direct supervision requirement may limit beneficiary access to care in their hospitals due to difficulty recruiting physicians to practice in rural areas. The Secretary instructed all Medicare administrative contractors not to evaluate or enforce the supervision requirements for therapeutic services in CAHs and rural hospitals with 100 or fewer beds from 2010 to 2013. Congress extended this instruction not to enforce supervision requirements from 2013 to 2016. The Secretary is continuing its non-enforcement instruction for 2018 and 2019; however, there is a statutory and regulatory gap in the enforcement instruction for 2017. The legislation extends the enforcement instruction through 2017 to address that legal gap. Sec. 51008. Allowing physician assistants, nurse practitioners, and clinical nurse specialists to supervise cardiac, intensive cardiac, and pulmonary rehabilitation programs. By statute, for the Medicare benefit categories of cardiac rehabilitation programs, intensive cardiac rehabilitation programs, and pulmonary rehabilitation programs, supervision of these programs may only be carried out by a physician. Effective for items and services furnished on or after January 1, 2024, this provision permits physician assistants, nurse practitioners, and clinical nurse specialists to provide that supervision. Additionally, the provision also clarifies that physicians who may supervise these programs are doctors of medicine or osteopathy; the other Medicare physician categories (i.e., dentists, podiatrists, optometrists and chiropractors) may not.


Sec. 51009. Transitional payment rules for certain radiation therapy services under the physician fee schedule. Section 3 of the Patient Access and Medicare Protection Act (Public Law 114-115) required the Secretary to use the same code definitions, work relative value units, and the direct inputs for the practice expense relative value units under the Medicare physician fee schedule for radiation treatment delivery and related imaging services (identified in 2016 by HCPCS G-codes G6001 through G6015) furnished in 2017 and 2018 as the agency used for those services furnished in 2016. It also directed the agency not to treat those services as potentially misvalued for purposes of making adjustments for misvalued codes under the fee schedule. The legislation extends these provisions for another year through 2019. TITLE XI—PROTECTING SENIORS’ ACCESS TO MEDICARE ACT Sec. 52001. Repeal of the Independent Payment Advisory Board. The Affordable Care Act established the “Independent Medicare Advisory Board” known as the IPAB. Under the IPAB provision currently, Medicare spending is limited to a target forecast by the Medicare Actuary. If Medicare spending exceeds the target, the IPAB is required to recommend spending reductions. The Secretary of Health and Human Services is required to implement IPAB’s recommendations unless Congress enacts legislation to achieve equivalent savings. If the IPAB does not recommend spending reductions, the Secretary is authorized to implement spending reductions to achieve the target. Section 52001 repeals the IPAB as well as GAO reporting requirements related to the IPAB, MedPAC provisions requiring it to comment on the IPAB’s recommendations, and post-IPAB lobbying restrictions on former IPAB members. TITLE XII—OFFSETS Sec. 53101. Modifying Reductions in Medicaid DSH Allotments. Reductions to disproportionate share hospital (DSH) payments to states are modified. Instead of reductions beginning in 2018 and totaling $43 billion through 2025, reductions will begin in 2020 and total $44 billion through 2025. The specific annual reductions are $4 billion for fiscal year 2020 and $8 billion for each of fiscal years 2021 through 2025. Sec. 53102. Third Party Liability in Medicaid and CHIP. “Pay and Chase” Changes Federal law requires that each state Medicaid program have procedures for determining the legal liability of third parties to pay for medical assistance provided by the state’s Medicaid plan, and for recovery from third parties of the cost of medical assistance provided, whenever recovery is feasible. For certain services, however, states are required to provide and pay for those services first and then seek repayment from any liable third party. The ACCESS Act makes several changes to these so-called “pay and chase” requirements. Under prior law, with respect to prenatal and preventive pediatric care services, a state is required to pay for those services first without regard to the liability of a third party and then later pursue repayment from the liable third party. The ACCESS Act eliminates “prenatal care” from this requirement so that upon enactment, the pay and chase requirement applies only to preventive pediatric care services.


This provision also changes the effective date of two related third party liability provisions that affect pay and chase requirements. Beginning on October 1, 2017, a state was able to withhold payment for services provided to children for whom a child support enforcement order was in effect and for prenatal or pediatric preventive care services for 90 days after the provider submitted the claim to the liable third party. After that, the state would then have been required to pay and chase. The ACCESS Act changes the effective date of this provision so that starting October 1, 2019, the state will have the choice of delaying their payments for a 90-day period after the third party is billed. Taking into account the ACCESS Act provision described above, this delay applies to preventive pediatric care services and to services provided to children for whom a child support enforcement order is in effect. Repeal of Provisions Related to Beneficiary Settlements The ACCESS Act repeals a provision that enabled states to be reimbursed from portions of personal injury recoveries beyond the portion of the settlement that is directly designated for payment for past medical expenses. Under the ACCESS Act, a state will no long be deemed to have the right to take its repayment from “any payment by [a] third party” and reverts to being limited to reimbursements from amounts provided under the settlement specifically for medical expenses. Also repealed is the requirement that beneficiaries assign to the state their rights for “any payment for a third party that has a legal liability to pay for care and services under the plan” (as opposed to simply assigning their rights to payment for portions of settlements specifically for medical expenses). These provisions are effective as if enacted on September 30, 2017 and apply to any open claims, including claims pending, generated, or filed after that date. GAO Report The GAO must submit a report to the House Committee on Energy and Commerce and the Senate Finance Committee about the impact of the amendments made by this section. The report must be provided no later than 18 months after enactment and will include an evaluation of the impact on access to prenatal and preventive pediatric care, access to services for children with a child support enforcement order in effect, and on providers of such services. Sec. 53103. Treatment of Lottery winnings and other lump-sum income for purposes of income eligibility under Medicaid. This provision requires States to count lottery winnings (for lotteries occurring on or after January 1, 2018) or other lump sum income received after that date when determining eligibility for Medicaid based on modified adjusted gross income. States are required to count income in the month in which it is received if the amount of the lump sum or lottery income is less than $80,000; over a period of 2 months if the amount is equal to $80,000 or over, up to but less than $90,000; over a period of 3 months if the amount is equal to $90,000 or over, up to but less than $100,000; over a period of 3 months plus 1 additional month for each increment of $10,000 received, not to exceed a period of 120 months for amounts greater than or equal to $100,000. Amounts over $80,000 are to be counted in equal monthly installments over the number of months specified.


The state Medicaid program and the Secretary of HHS may establish hardship standards to provide an exemption to these rules if the denial of Medicaid on account of counting such income would cause an undue medical or financial hardship. If an individual loses eligibility for Medicaid because of the treatment of lottery winnings or other lump-sum income, a state must notify the individual before the date they are to lose eligibility (i) that they may enroll in an Exchange plan, and (ii) the date on which they would no longer be ineligible, and reapply, for medical assistance. The state must also provide technical assistance to an individual seeking to enroll in an Exchange plan. Qualified lump sum payments are defined as income received from gambling or income received as liquid assets from the estate of a deceased individual. The bill specifies that this provision is not intended to prevent states from intercepting lottery winnings to recover amounts paid for Medicaid for an individual and is not intended to affect the determination of eligibility for any other member of the household other than the individual who received the funds or their spouse. Sec. 53104. Rebate obligation with respect to line extension drugs. Treatment of new formulations of brand name drugs (oral solid dosage form) under the Medicaid drug rebate program is modified. Beginning with rebate periods effective on or after October 1, 2018, for a drug that is a line extension of a single source drug or an innovator multiple source drug that is an oral solid dosage form, the rebate obligation is the greater of two amounts.

• The first amount is the basic rebate calculated for single source drugs and innovator multiple source drugs (23.1 percent) plus the additional rebate for those drugs for the rebate period (i.e., the difference between the average manufacturer price (AMP) and the best price per unit and adjusted by the Consumer Price Index-Urban (CPI-U) based on launch date and current quarter AMP).

• The second amount is the basic rebate calculated for single source drugs and innovator multiple source drugs (23.1 percent) plus an amount equal to the product of:

(1) the AMP of the line extension of a single source drug or an innovator multiple source drug that is an oral solid dosage form;

(2) the highest additional rebate (calculated as a percentage of AMP) for any strength of the original single source drug or innovator multiple source drug; and

(3) the total number of units of each dosage form and strength of the line extension product paid for under the state plan in the rebate period (as reported by the State).

Sec. 53105. Medicaid Improvement Fund. Funding for the Medicaid Improvement Fund is reduced to $0. (Funding was previously set to be $5 million a year beginning in 2021.) In addition, the $980 million in funding for state activities relating to mechanized claims systems beginning in fiscal year 2023 is reduced to $0. That now-eliminated funding was provided in the continuing appropriations law just enacted on January 22, 2018 (P.L. 115-120). Sec. 53106. Physician fee schedule update. The physician fee schedule update for 2019 is reduced from 0.5 percent to 0.25 percent. Updates for subsequent years are unchanged.


Sec. 53107. Payment for outpatient physical therapy services and outpatient occupational therapy services furnished by a therapy assistant. Claims for outpatient physical or occupational therapy services furnished to Medicare beneficiaries by therapy assistants under the supervision of a physical or occupational therapist are paid at the same rate that applies when those same therapy services are furnished by a physical or occupational therapist. Beginning January 1, 2022, the payment rate for those services when furnished by a therapy assistant will be paid at a reduced rate (viz., 85 percent of the rate that would otherwise apply to the service when furnished by a physical or occupational therapist). The provision also requires that the reduced payment rate applies whether the therapy service is furnished in whole or in part by the therapy assistant. CMS must define in regulations what that phrase “in whole or in part” means and how it will be implemented; the agency may also define the term therapy assistant since there is no definition in statute. Additionally, this provision contains a rule of construction intended to clarify that applicable requirements for coverage of therapy services when furnished by therapy assistants are not changed. By not later than January 1, 2019, CMS must develop a modifier to identify when a therapy service is furnished in whole or in part by a therapy assistant. Beginning January 1, 2020, claims for therapy services furnished in whole or in part by a therapy assistant must include that modifier. CMS must implement these changes through notice and comment rulemaking. Sec. 53108. Reduction for non-emergency ESRD ambulance transports. The reduction in the fee schedule amount for non-emergency ambulance services provided to beneficiaries with end stage renal disease for renal dialysis services is increased from 10 percent to 23 percent for services furnished on or after October 1, 2018. Sec. 53109. Hospital transfer policy for early discharges to hospice care. Effective October 1, 2018, discharges from an inpatient hospital to hospice care by a hospice program are treated as transfer cases for purposes of payment under the inpatient hospital prospective payment system (IPPS). The Secretary must include in a description of the impact of this provision in the IPPS proposed rule for FY 2019. MedPAC is directed to conduct an evaluation of the effects of this provision, including effects on the number of discharges from an inpatient setting to a hospice program; the length of stay of patients who are discharged from an inpatient setting to a hospice program; total Medicare spending; and other areas determined appropriate by the Commission. The evaluation must consider factors such as whether changes in hospital policies or behavior in response to the provision have affected beneficiary access to hospice care. Preliminary results of the evaluation are due to Congress by March 15, 2020 and the evaluation report itself is due on March 15, 2021. Sec. 53110. Medicare payment update for home health services. The market basket increase under the prospective payment system for home health services is set to be 1.5 percent for 2020; no productivity adjustment will apply in that year.


Sec. 53111. Medicare payment update for skilled nursing facilities. The net effect of the market basket increase and the productivity adjustment under the prospective payment system for skilled nursing services is set to be 2.4 percent for 2019. Sec. 53112. Preventing the artificial inflation of star ratings after the consolidation of Medicare Advantage plans offered by the same organization. The calculation of Medicare Advantage (MA) Star Ratings is modified when there is consolidation of MA plans offered by a single Medicare Advantage Organization (MAO) under one or more contracts with plans offered under a separate contract. The Star Ratings and any quality increase and rebate amounts for the continuing contract will be adjusted using an enrollment-weighted average of scores or ratings for the continuing and closed contracts, as determined appropriate by the Secretary. The adjustment may not apply for any year for which the quality rating of the continuing contract is based primarily on a measurement period that precedes the first year for which the closed contract is no longer offered. Sec. 53113. Sunsetting Exclusion of Biosimilars from Medicare Part D Coverage Gap Discount Program. The provision amends section 1860D-14A(g)(2)(A) of the Act to eliminate the exclusion of biosimilars from the Part D coverage gap discount program beginning with plan year 2019. As background, Part D reimbursement for a covered prescription drug is not available to an enrollee in the Part D benefit’s coverage gap (also known as the “donut hole”). Under the Medicare Coverage Gap Discount Program, which was established by the ACA, the manufacturer of the brand drug or original biologic provides a 50 percent discount for its drug when obtained by a Part D enrollee who is in the coverage gap. The manufacturer’s discount counts towards the enrollees’ total out-of-pocket Part D spending (i.e., TrOOP). Under the ACA, however, biosimilar drugs were excluded from the manufacturer discount program. Sec. 53114. Adjustments to Medicare part B and part D premium subsidies for higher income individuals. Income-related premium amounts under Medicare Parts B and Part D are increased beginning in 2019 for individuals with a modified adjusted gross income equal to $500,000 or more and couples filing a joint tax return with a modified adjusted gross income equal to $750,000 or more. Instead of paying premiums set to equal 80 percent of Part B (or Part D) costs, these beneficiaries will pay a premium set to equal 85 percent of Part B (or Part D) costs. That is, the federal premium subsidy for these individuals will be reduced from 20 percent to 15 percent. Although the income-related premium income levels are generally adjusted each year for inflation6 (the Consumer Price Index for All Urban Consumers, or CPI-U), the new $500,000/ $750,000 income category will not be indexed to the CPI-U until 2028. Sec. 53115. Medicare Improvement Fund. Funding for the Medicare Improvement Fund is reduced to $0. (Funding was previously set to be $220 million for services furnished during and after fiscal year 2021.) 6 The law provides that CPI-U indexing does not apply to the income related premium thresholds for 2018 and 2019.


Sec. 53116. Closing the Donut Hole for Seniors. Under Part D coverage, enrollees enter into the coverage gap (“donut hole”) once their out-of-pocket spending hits a certain threshold (in 2018, that amount is $3,750) but before they receive full coverage after spending $5,000 (the applicable amount for 2018). The ACA provided that this coverage gap be phased out so that enrollee coinsurance would be 25 percent by 2020. Under the provision, the current timeline for closing the coverage gap accelerates by reducing the enrollee’s coinsurance for covered Part D drugs to 25 percent in 2019 rather than 2020. In addition, the provision increases the percentage discount that the manufacturer must apply, increasing from 50 percent as currently required to 70 percent starting in 2019. Note: Sections 53117 (Modernizing child support enforcement fees) and 53118 (Increasing efficiency of prison data reporting) are not summarized. Sec. 53119. Prevention and Public Health Fund. This section modifies amounts provided for the Prevention and Public Health Fund for 2019 and later years. The specific amounts total $13 billion for fiscal years 2019 through 2028 as follows:

2019 $900 million 2020 $950 million 2021 $950 million 2022 $1.0 billion 2023 $1.0 billion 2024 $1.3 billion 2025 $1.3 billion 2026 $1.8 billion 2027 $1.8 billion 2028 $2.0 billion

This replaces amounts that would have totaled $14.35 billion for fiscal years 2019 through 2028. DIVISION C-BUDGETARY AND OTHER MATTERS Sec. 30101. Amendments to the Balanced Budget and Emergency Deficit Control Act. Extension of Medicare Sequestration. The 2 percent sequestration of Medicare expenditures, which was established initially under the Budget Control Act of 2011 for FYs 2013 through 2021 and subsequently extended through FY 2025, is further extended for an additional 2 years, through fiscal year 2027. Because under this provision Medicare sequestration for a fiscal year begins on April 1st, the practical effect of this provision is to extend Medicare sequestration through March 31, 2028. Increase in Discretionary Spending Caps. This section provides for increases in the security and nonsecurity discretionary spending caps for fiscal years 2018 and 2019, and directs OMB to ignore these increases for the purpose of determining the level of sequestration for FYs 2018 and 2019. This direction has no effect on the level of Medicare sequestration, however, which is limited to 2 percent.

The Advancing Chronic Care, Extenders, and Social Services ...€¦ · TITLE IV—PART B...

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