This Week: Congress Returns to Deal With Tax Bill… HHS Nominee Has First Hearing… Administration Kills Obama-era Payment Bundles
FDA Says It Will Expedite Review Programs for Drugs
Testifying before the House Energy and Commerce Committee on implementation of the 21st Century Cures Act on Nov. 30, FDA Commissioner Scott Gottlieb said the FDA will take new steps to more quickly approve new drugs and new uses for existing drugs.
The agency wants to extend its expedited review programs to drugs that show a clinical benefit in a small number of patients.
Rep. Pallone And Sen. Wyden Raise Concerns Over Iowa 1115 Waiver
On Nov. 28, Senate Finance ranking Democrat Ron Wyden (OR) and House Energy & Commerce ranking Democrat Frank Pallone (NJ) wrote CMS Administrator Seema Verma they are worried a recently approved amendment to Iowa’s 1115 waiver would eliminate retroactive Medicaid coverage. The pair believe this could have “devastating consequences” for the state’s elderly and disabled.
The Iowa Health and Wellness Plan, which became effective Nov. 1, waives previously mandated three-month retroactive Medicaid coverage for beneficiaries except pregnant women and infants under one year of age. The state will continue to operate its presumptive eligibility program, and Iowa will continue to provide outreach and education on Medicaid coverage.
“Instead of seeking to test new or innovative delivery system models that improve access to care, this amendment would threaten the medical and financial wellbeing of thousands of individuals, including seniors and individuals with disabilities who rely on Medicaid for essential long-term care such as nursing and home-based care,” Wyden and Pallone wrote. “By jeopardizing access to critical services for many of the most vulnerable individuals in the state, Iowa’s amendment contravenes the fundamental objectives of the Medicaid statute and congressional intent.”
When CMS approved the waiver, the agency said Iowa’s proposal to remove retroactive coverage promotes the goals of Medicaid because it encourages beneficiaries “to obtain and maintain health coverage, even when healthy.”
Senate Tax Bill Passes Repealing Individual Mandate
On Dec. 1, the Senate passed its tax bill which included repeal of the individual mandate. In addition, the bill maintained the medical expense deduction but changed the threshold to 7.5% threshold. Sen. Susan Collins (R-ME) announced she had a deal to ensure passage of her legislation to provide funding to states for invisible high risk pools and for the Alexander-Murray bill which is also focused on short-term market stabilization. The Congressional Budget Office wrote a letter last week to Sen. Murray (D-WA) stating that none of those provisions would counteract the impact of repealing of the individual mandate. Sen. Collins took issue with a number the points raised in the letter.
Hatch Pledges to Pass CHIP Funding
In a floor statement Nov. 30, Senate Finance Chairman Orrin Hatch (R-UT) pledged not to let the Children’s Health Insurance Program run out of money. CHIP’s current funding expired Sept. 30. Since then states have used contingency measures to finance their programs.
Hatch said on the Senate floor that “there’s no question” the program’s federal funding will be extended, but he did not set a timetable for getting it done. The Finance Committee has approved a five-year extension for CHIP, but there have been no final decisions on how to pay for it.
HHS Secretary Nominee Gets First Hearing
HHS Secretary-nominee Alex Azar went before the Senate Health, Education, Labor and Pensions Committee Nov. 29. The Senate Finance Committee has jurisdiction over Azar’s nomination and will vote on him once committee members review his paperwork, but the HELP committee also typically holds courtesy hearings on HHS secretary nominations.
In the hearing, Azar:
- Declined comment on pushing Congress to appropriate at least $45 billion to fight the opioid epidemic
- Affirmed he would uphold the Affordable Care Act as long as it is law while also backing efforts to repeal the individual mandate
- Supported reinsurance and market stabilization measures
- Defended the Trump administration’s decision to shorten the ACA enrollment period by half, saying data may show the move improves enrollment
- Wanted to stop brand drug companies from stalling generic competition
- Considered applying design aspects of Part D to Part B drug coverage
- Opposed gag orders that keep pharmacies from telling customers when drugs are cheaper out pocket than when bought with insurance
- Opposed drug importation and government price negotiation
Azar was in line with FDA Commissioner Gottlieb regarding increasing generic competition to bring down drug prices, but he appeared to break from the commissioner by questioning whether REMS are needed after patents have expired. The need for generics to join brands in a single-shared REMS system has been seen as a sticking point blocking generic competition. Gottlieb has pursued making it easier to reach a single-shared system, as opposed to waiving the REMS as a whole.
Support for Senate Proposals on Reinsurance And Market Stabilization
To gain more support for the Senate tax legislation, which repeals the Affordable Care Act’s individual mandate, President Donald Trump threw his support behind a short-term federal reinsurance program proposed by Sens. Susan Collins (R-ME) and Bill Nelson (D-FL) as well as the Alexander-Murray bill that funds cost-sharing reduction payments for two years, during Tuesday’s Senate GOP luncheon, according to several senators who attended the meeting. Collins affirms that if these two bills were to pass she could see herself supporting a tax bill that includes removal of the Affordable Care Act’s individual mandate, a repeal measure she had previously balked at supporting.
The Collins-Nelson amendment would add $2.25 billion in funding to the federal budget in both 2018 and 2019 to help states adopt reinsurance programs. The Alexander-Murray bipartisan stabilization plan would require that Congress pay certain subsidies to insurers to help low-income people with the costs associated with health care. Collins said she has secured a deal where both the Alexander-Murray and Collins-Nelson bills would be considered and signed into law before the conference report on the tax bill comes back.
Trump Donates Salary to HHS Opioid Efforts
President Donald Trump has donated his third-quarter presidential salary to HHS’s efforts to combat the opioid crisis, the department and the White House announced on Nov. 30. Trump has vowed to donate his entire annual salary of $400,000 while he is in office. His first-quarter earnings were donated to the National Park Service.
CMS Eliminates Bundled Payment Programs
CMS, in a final rule released Nov. 30, eliminated programs that would have held providers accountable for the cost of certain joint replacement surgeries and care for heart attacks and cardiac surgeries. It also made a previously mandatory hip and knee replacement program voluntary for hospitals in some areas.
The Trump administration believes making the programs voluntary will attract more participation, while also easing the regulatory burden on hospitals.
CMS Administrator Seema Verma said in a statement that the agency will announce a new set of voluntary payment bundles in the near future.
For a technical fact sheet on the changes in this final rule and interim final rule with comment period, please visit: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2017-Fact-Sheet-items/2017-11-30.html .
For more information on the Comprehensive Care for Joint Replacement Model, please visit: https://innovation.cms.gov/initiatives/cjr .
The final rule and interim final rule with comment (CMS-5524-F and IFC) can be downloaded from the Federal Register at https://www.federalregister.gov/public-inspection .
CMS Releases Its Measures Under Consideration List for 2018 Pre-rulemaking
CMS posted the Measures under Consideration (MUC) List for 2018 pre-rulemaking on the CMS website Nov. 30, and has sent it to the National Quality Forum (NQF) in preparation for multi-stakeholder input.
CMS recently announced the “Meaningful Measures” initiative to identify the most impactful areas for quality measurement and improvement and reflect core issues that are most vital to high-quality care and better individual outcomes. Each year, CMS publishes a list of quality and cost measures that are under consideration for Medicare quality reporting and value-based purchasing programs, and collaborates with the NQF to get input from multiple stakeholders, including patients, families, caregivers, clinicians, commercial payers and purchasers, on the measures that are best suited for these programs. Ultimately, these measures may help patients choose the nursing home, hospital or clinician that is best for them, and can help providers to provide the highest quality of care across care settings.
This year’s MUC List contains 32 measures. CMS is considering new measures to help quantify health care outcomes and track the effectiveness, safety and patient-centeredness of the care provided. At the same time, CMS is taking a new approach to coordinated implementation of meaningful quality measures focused on the most critical, highly impactful areas for improvement while reducing the burden of quality reporting on all providers so they can spend more time with their patients.
CMS considered 184 measures submitted by stakeholders during an open call for measures. Considering the meaningful measurement areas, CMS narrowed the list to 32 measures (17 percent of the original submissions) that focus CMS efforts to achieve goals of high-quality health care and meaningful outcomes for patients, while minimizing burden. CMS will continue to use the Meaningful Measures approach to strategically assess the development and implementation of quality measure sets that are the most parsimonious and least burdensome, that are well understood by external stakeholders and that are most likely to drive improvement in health outcomes.
This year, approximately 40 percent of measures on the MUC List are outcome measures, including patient-reported outcome measures, which will help empower patients to make decisions about their own health care and help clinicians to make continuous improvements in the care provided. In addition, this year there are eight episode-based cost measures proposed that were developed by incorporating the insight and expertise of clinicians and specialty societies..
CMS is inviting review of the list and participation in the public process. For more information regarding the NQF Measure Applications Partnership public stakeholder review meeting purpose, meetings, 2017 MUC List deliberations and voting, visit the NQF website at http://www.qualityforum.org/map/ .
Medicare Paying More for Part B Drugs HHS IG Reports
The HHS inspector general has found that CMS’s decision to include self-administered versions when setting prices for two Part B drugs caused Medicare to pay an extra $366 million from 2014 to 2016. At issue are two drugs, Cimzia and Orencia, which are used to treat rheumatoid arthritis and other autoimmune diseases. Part B, which covers drugs administered by physicians and in other outpatient settings, generally does not cover drugs that are self-administered by patients. But OIG said there are a small number of cases in which self-administered drugs that typically would be used in situations not covered by Part B are nonetheless being included when CMS sets payment amounts.