April 11, 2022 This Week in Health Policy for April 11 This Week (April 11-15) Congress will be out of session next week for its two-week Easter recess. The next This Week in Health Policy will be Friday, April 29. Last Week (April 4-8) Health Care Highlights Congress (again) stalls on COVID-19 relief. Congress is expected to depart Friday (April 8) for its two-week recess without taking action on a new Senate negotiated COVID-19 relief bill. Under the nearly $10 billion deal announced Monday (April 4), the Biomedical Advanced Research and Development Authority (BARDA) would receive $9.25 billion, of which at least $5 billion would pay for COVID-19 therapeutics and $750 million would go toward developing vaccines for future coronavirus variants. However, despite reaching a compromise on funding offsets, the deal stalled after Republicans demanded a vote on an amendment to extend the use of Title 42, which restricted migrants' U.S. entry amid the pandemic. On April 1, the Biden administration announced the policy would end on May 23. It's likely Congress will take the COVID-19 relief package back up when lawmakers return from recess. Biden admin proposes 'family glitch' fix. On Tuesday (April 5), the Internal Revenue Service (IRS) issued a proposed rule to address the Affordable Care Act's so-called "family glitch," which prevents workers' spouses and dependents from qualifying for premium tax credits (PTCs) on the exchanges if the employee receives an offer of affordable self-only coverage, even if the cost of family coverage is unaffordable (>~10% of household income). Under the proposed rule, the IRS would change the definition of affordability for an employee's spouse and dependents, enabling them to qualify for PTCs if the employer does not offer an affordable family plan. The rule makes no changes to the affordability rule for employees. While the IRS did not include an estimate of the rule's potential impact on the coverage market, the Biden administration estimated 200,000 uninsured people would gain coverage and up to one million could see their coverage become more affordable. IRS will accept public comments for 60 days and hold a public hearing on June 27 to discuss the proposed changes. If finalized, the rule would go into effect on January 1, 2023, meaning the subsidies would be available to people during the annual open enrollment period. Biden signs EO to improve access to affordable, quality health coverage. On Tuesday (April 5), President Biden, joined by former President Barack Obama, signed an executive order (EO) that directs federal agencies to identify ways to expand access to affordable, quality health coverage. The order builds on Biden's Strengthening Medicaid and the Affordable Care Act EO signed on January 28, 2021. The order instructs agency heads to "identify ways to continue to expand the availability of affordable health coverage, to improve the quality of coverage, to strengthen benefits, and to help more Americans enroll in quality health coverage." CMS issues MA and Part D rates. On Monday (April 4), CMS announced the 2023 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies. CMS finalized a 4.88% boost to MA plan payments for 2023, up from the 4.75% increase proposed in February despite calls from lawmakers and the Medicare Payment Advisory Commission to stabilize the growth rate. CMS said it expects total change in revenue for MA plans to rise 8.5% in 2023. CMS did not finalize any proposed changes to the MA star rating system, including stratifying data on social risk factors, developing a Health Equity Index, and more. However, the agency said it will use feedback to inform future rulemaking. CMS publishes FAQ on No Surprises Act regulations. On Wednesday (April 6), CMS published a frequently asked questions (FAQ) document to help providers navigate regulations implementing the No Surprises Act. The FAQ outlines exceptions to certain requirements, clarifies the types of providers and insurers impacted by the rules, outlines patient-specific circumstances providers may have to navigate, and clarifies various aspects of the independent dispute resolution process. CMS limits coverage of Aduhelm. On Thursday (April 7), CMS announced its final coverage determination for Biogen's Alzheimer's drug Aduhelm. Despite pushback from advocacy groups, CMS finalized its proposal to only cover Aduhelm for patients enrolled in a clinical trial overseen by either the Food and Drug Administration (FDA) or the National Institutes of Health. However, the agency said it would not automatically apply the same coverage standard to future monoclonal antibodies targeting amyloid if FDA determines clear clinical evidence that the drug is beneficial through the traditional approval pathway. Aduhelm was approved through FDA's accelerated approval pathway and under CMS' coverage determination is subject to more stringent coverage requirements. CMS to delay Radiation Oncology model indefinitely. On Wednesday (April 6), CMS issued a proposed rule to indefinitely delay the mandatory Radiation Oncology (RO) model to give providers and the agency more time to prepare for the model's launch. The model was set to begin January 1, 2023. Medicare to provide no-cost COVID-19 tests. On Monday (April 4), CMS announced that Medicare Part B beneficiaries will now have access to up to eight over-the-counter COVID-19 tests per month at no cost. The announcement marks the first time Medicare has covered an over-the-counter medical test at no cost. CMS provided a list of participating pharmacies here. HHS reopens PRF reporting for Round 1 providers. On Friday (April 1), HHS' Health Resources and Services Administration (HRSA) said it would give certain providers who failed to meet reporting requirements for Provider Relief Funds (PRF) additional time to report and delay efforts to recoup the funding. The move comes after provider groups said that some providers were unaware of the reporting requirements. Providers will be able to submit a Request to Report Late Due to Extenuating Circumstances for Reporting Period 1 from Monday, April 11 to Friday, April 22, 2022. The request form will be available starting on April 11, 2022. Sequester Medicare payments resume. On Friday (April 1), a 1% sequester cut to Medicare payments took effect as CMS begins phasing back in the cuts, which have been delayed throughout the COVID-19 pandemic. Providers will see a 1% cut through the end of June, at which point the full 2% cut will resume. While provider groups have asked Congress for additional delays, there appears to be little appetite to postpone the sequester cuts further. Hearings The Senate Health, Education, Labor & Pensions Committee hearing on "FDA User Fee Agreements: Advancing Medical Product Regulation and Innovation for the Benefit of Patients." The hearing was the first of two the committee will hold on Food and Drug Administration (FDA) user fee agreements, which authorize the FDA to collect user fees from companies and requires congressional reauthorization every five years. During the hearing, committee members discussed a range of topics related to the Prescription Drug User Fee Amendments (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), Biosimilar User Fee Amendments (BsUFA III), and the Medical Device User Fee Amendments (MDUFA V), which would authorize new user fees for their respective industries for fiscal years 2023—2027. Witnesses at Tuesday's hearings included representatives from each industry, as well as the Pew Charitable Trusts who answered lawmakers' questions on ways the latest agreements would improve access to lower cost drugs and address longstanding concerns with FDA processes.
The House Energy and Commerce Committee's Subcommittee on Health hearing on "Communities in Need: Legislation to Support Mental Health and Well-being." During the hearing, lawmakers discussed 19 bipartisan bills that address mental health care in the United States. Lawmakers paid particular attention to bills that addressed pediatric mental health issues, the mental health workforce, and law enforcement response to mental health crises. Committee members heard from two panels: One consisting of representatives from the Biden administration and another panel of experts, including representatives from behavioral health provider groups and state mental health and alcohol and drug use directors. Panelists provided updates on federal agency efforts to address mental health and shared their support for various programs included in the legislation discussed during the hearing. The hearing is one of a series of hearings occurring across committees of jurisdiction on mental health care and marks the next stage in the Subcommittee's effort to advance a comprehensive mental health package.
The Senate Finance Committee and House Budget Committee hold separate hearings on the "Department of Health and Human Services FY 2023 Budget." During the hearings, Department of Health and Human Services Secretary Xavier Becerra answered lawmakers' questions on President Biden's recent FY 2023 budget request. Topics discussed during the hearings ranged widely and included mental health, long-term care challenges, health care and long-term care workforce shortages, maternal health, telehealth, and ways HHS and its agencies would use requested funds to address those and other issues. During both hearings, Becerra and discussed ways to permanently extend certain pandemic-related telehealth flexibilities. Becerra told lawmakers that HHS needs Congress to act on policies to lift Medicare's originating site restrictions, enable federally qualified health centers and rural health clinics to provide telehealth services, expand reimbursement for audio-only visits, and allow interstate licensing so medical providers can practice across stateliness. Democrats expressed their support for proposals in the budget that enhance access to care and expressed the need for urgent action on issues such a mental health parity. Senate Republicans expressed concern that proposals did not include efforts to stave off Medicare insolvency, among other items. Becerra said HHS is exploring ways to achieve savings through value-based care models but would like to work with Congress on other solutions that produce savings without reducing benefits. Reports, Studies, and Journals Commonwealth Fund. Medicaid and Safety-Net Providers: An Essential Health Equity Partnership. The report found safety-net providers play a key role in promoting health equity in Medicaid. The report proposed two strategies to strengthen the Medicaid safety net: ensuring safety-net providers are in-network for managed care organizations; and developing value-based payment strategies that create incentives around health equity. Health Affairs. Trends In Outpatient Mental Health Services Use Before And During The COVID-19 Pandemic. The retrospective observational study examined changes in outpatient mental health service use pre- and post-pandemic. The study found in-person mental health visits declined by 50% at the start of the pandemic, while telehealth encounters rose with use varying by patient groups. For example, people with schizophrenia were less likely to use telehealth compared with those with anxiety and fear-related disorders. BMJ. Efficacy of interventions to reduce long term opioid treatment for chronic non-cancer pain: systematic review and meta-analysis. The study conducted a systematic review and meta-analysis of research on interventions to reduce long-term opioid treatment for patients with chronic pain unrelated to cancer. They found most research was hampered by poor study design, which limits existing evidence on those interventions and potential harms and calls for better study design standards for research examining methods to reduce opioid use. ———————————————
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