04 April 2022 This Week in Health Policy for April 4 The Senate Health, Education, Labor & Pensions Committee will hold a hearing on “FDA User Fee Agreements: Advancing Medical Product Regulation and Innovation for the Benefit of Patients.”
The Senate Finance Committee will hold a hearing on the “The President’s Fiscal Year 2023 Health and Human Services Budget.”
The House Energy and Commerce Committee’s Subcommittee on Health will hold a hearing on “Communities in Need: Legislation to Support Mental Health and Well-being.”
The House Ways and Means Committee will hold a hearing on the “Proposed Fiscal Year 2023 Budget with Health & Human Services Secretary Becerra.”
The House Budget Committee will hold a hearing on the “Department of Health and Human Services FY 2023 Budget.”
House passes bill to cap insulin costs. On Thursday (March 31), the House voted 232-193 to pass a bill (HR 6833) that would cap monthly out-of-pocket insulin costs at $35 for people with health insurance. The Congressional Budget Office on Wednesday (March 30) said the bill would increase government spending by $6.6 billion over a decade and reduce government revenues by $4.8 billion. AHIP has come out against the bill, saying instead of lowering the price of insulin the bill shifts costs to others. The bill’s prospects in the Senate are unclear as Sens. Jeanne Shaheen (D-NH) and Susan Collins (R-ME) are working on a separate insulin cost cap bill that could include other provisions aimed at reducing drug list prices. Biden unveils FY 2023 budget request. On Monday (March 28), President Joe Biden released his fiscal year (FY) 2023 budget, requesting $127.3 billion in discretionary funding for the Department of Health and Human Services (HHS), a $26.8% increase from the 2021 enacted level. The National Institutes of Health (NIH) would get $49 billion, which includes a $5 billion investment in the Advanced Research Projects Agency for Health (ARPA-H). The Food and Drug Administration (FDA) would receive a $2.1 billion increase over FY 2022 appropriations to total $8.4 billion. The Centers for Disease Control and Prevention (CDC) budget would increase by $2.3 billion over FY 2022 appropriations to total $10.675 billion. Biden’s budget request also includes investments across multiple agencies to support several priority initiatives, including preparing for future pandemics and other biological threats ($81.7 billion), improving public health infrastructure and domestic and global threat surveillance ($28 billion), increasing public health capacity at CDC and state and local levels ($9.9 billion), addressing the nation’s mental health ($51.7 billion) and opioid ($10.4 billion) epidemics, reducing new cases of HIV/AIDS ($850 million), and reducing maternal mortality and race-based disparities ($470 million). In addition, the budget includes $92 million to support the president’s goal of reducing the cancer death rate by 50% over the next 25 years. CMS expects health spending to slowdown. On Tuesday (March 28), the Centers for Medicare and Medicaid Services’ (CMS) Office of the Actuary’s projected that national health spending grew by 4.2% to $4.3 trillion in 2021, down from 9.7% in 2020 as federal supplemental funding for the COVID-19 pandemic declined. CMS said hospital spending, which accounted for the largest percentage of national health spending in 2021, grew 5.7% to $1.3 trillion in 2021, while pharmaceutical spending increased 4.7%, Medicare spending grew 11.3%, and Medicaid spending grew 10.4%. CMS projected Medicaid enrollment grew 8.2% in 2021, up from 5.1% in 2020. However, CMS said health care use is expected to normalize between 2020 and 2024, and health insurance enrollment will decline to more closely reflect pre-pandemic distributions. Congress working toward COVID-19 relief. A bipartisan group of senators has been working on a new COVID-19 relief package after the House lawmakers pulled a $15.6 billion package from the omnibus bill earlier this month over disagreements about the offsets. Details of the new bill are still unclear, but the latest reports indicate the package now includes about $10 billion in funding for vaccines and treatments. The senators are still working out disagreements over funding offsets, but House Majority Leader Steny Hoyer (D-MD) on Wednesday (March 30) said he is optimistic a new package will pass before Congress leaves for Easter recess next week. The White House has warned without additional funds it will not be able to purchase more COVID-19 vaccines in the event of another surge in cases, and HHS’ Health Resources and Services Administration (HRSA) as of March 22 stopped accepting COVID-19 claims for testing, treatment, and vaccine administration for the uninsured due to insufficient funds. In related news, the White House on Wednesday (March 30) announced the launch of a new website, COVID.gov, where people can access information on where to find COVID-19 vaccines, tests, treatments, masks, and more. HHS wants $100M in PRF money back. Earlier this month, HRSA sent notices to certain round one Provider Relief Funding (PRF) recipients, giving them 30 days to return the funds for not complying with federal reporting requirements. The Medical Group Management Association (MGMA) said some providers were unaware of the reporting requirements and reminder emails were lost in spam folders or sent to employees who no longer worked at the practices. As such, MGMA is asking HRSA to re-open the reporting portal and give providers 60 days to comply before taking enforcement action. The American Medical Association also has asked HHS for a delay to give providers more time to comply with reporting requirements. The move comes as provider groups have asked for additional PRF relief to cover care costs from the omicron COVID-19 variant. CMS issues FY 2023 proposed rule for hospice payment. On Wednesday (March 30), CMS published a proposed rule that would increase payment rates for hospices in FY 2023 by 2.7%, or $580 million. The proposed rule would put in place a permanent solution to limit annual changes in the hospice wage index. CMS also proposed updates to the Hospice Quality Reporting Program (HQRP). Hospices that do not meet quality reporting requirements will see a 2-percentage point reduction in payments for FY 2023. CMS in the proposed rule noted that under statutory requirements the penalty is slated to rise to 4% in FY 2024. CMS also included a request for information on equity-based hiring and retention strategies; barriers to care and hospices’ localized solutions; and methodologies for collecting demographic data. CMS will accept public comments until May 31. CMS issues FY 2023 proposed rule for inpatient psychiatric facilities. On Thursday (March 31), CMS published a proposed rule that would increase payment rates for inpatient psychiatric facilities (IPFs) by 1.5%, or $50 million, for FY 2023. CMS included requests for comments on ways to update the IPF prospective payment system, which is still based on adjustment factors created in 2005, as well as ways to measure health care quality disparities through the IPF Quality Reporting Program. CMS will accept public comments until May 31. CMS issues FY 2023 proposed rule for inpatient rehabilitation facilities. On Thursday (March 31), CMS published a proposed rule that would increase payment rates for inpatient rehabilitation facilities (IRFs) by 2%, or $170 million, for FY 2023. The proposed rule would put in place a permanent solution to limit annual changes in the IRF wage index. In addition, CMS proposed expanding IRF quality data reporting requirements to include all IRF residents, not just those with traditional Medicare and Medicare Advantage plans. CMS also included requests for comments on ways to track the development of a new C. difficile infection among IRF patients, ways to track health equity initiatives at IRFs, and ways to implement a health equity measure to the quality reporting program. CMS will accept public comments until May 31. CMS announces new funding for Money Follows the Person Program. On Thursday (March 31), CMS announced more than $110 million in grants to encourage more states to participate in Medicaid’s Money Follows the Person Program. The program enables Medicaid beneficiaries to receive care in their homes and local communities. CDC recommends fourth COVID shot. On Tuesday (March 29), the Centers for Disease Control and Prevention (CDC) recommended people ages 50 and older and immunocompromised adults receive a fourth COVID-19 vaccine. CDC said immunocompromised teens could get an additional dose of the Pfizer vaccine. The recommendation came after the FDA authorized an additional booster shot for those 50 and older and immunocompromised patients age 12 and older. Hospital groups ask for PHE renewal. On March 28, a group of hospital associations sent a letter asking HHS Secretary Xavier Becerra to renew the public health emergency, which is currently set to expire April 16. The Biden administration has promised to give at least 60-days’ notice before allowing the PHE to lapse, meaning it’s likely the PHE will continue at least through July. House Oversight and Reform Committee Hearing on Examining Pathways to Universal Health Coverage. On Tuesday (March 29), the House Oversight and Reform Committee held a hearing entitled, “Examining Pathways to Universal Health Coverage.” During the hearing, Democrats discussed proposals to build on the Affordable Care Act (ACA) and achieve universal health coverage in the United States, as well as legislation to create a single-payer health insurance program in the United States. Republicans during the hearing lambasted such proposals, saying they would increase federal spending without addressing core inefficiencies of the current system and called on Democrats to consider market-based competitive policy solutions.
Senate Finance Committee Hearing on Behavioral Health Care When Americans Need It: Ensuring Parity and Care Integration. On Wednesday (March 30), the Senate Finance Committee held a hearing entitled, “Behavioral Health Care When Americans Need It: Ensuring Parity and Care Integration.” During the hearing, lawmakers and witnesses discussed health insurer compliance with mental health parity laws and models to integrate behavioral and primary care. Lawmakers asked specific questions on ways to improve parity enforcement and remove barriers to integrated care models, while witnesses provided examples of successful models and policy solutions to improve parity enforcement, such as centralizing enforcement authority. The hearing is one in a series the Senate Finance Committee plans to have as it works on bipartisan legislation to improve access to mental health care and substance use disorder treatment. As part of that effort, the Committee on Tuesday (March 29) released bipartisan report on mental health care, “Mental Health Care in the United States: The Case for Federal Action.”
House Committee on Energy and Commerce Hearing on FDA User Fee Reauthorization: Ensuring Safe and Effective Medical Devices. On Wednesday (March 30), the House Committee on Energy and Commerce held a hearing entitled “FDA User Fee Reauthorization: Ensuring Safe and Effective Medical Devices.” The Medical Device User Fee Amendments (MDUFA) authorizes the Food and Drug Administration (FDA) to collect user fees from companies producing medical devices and must be reauthorized by Congress every five years. The most recent MDUFA reauthorization expires on September 30, 2022. During the hearing, committee members expressed dismay that the Department of Health and Human Services has missed the statutory deadline for transmitting a final performance goals letter for MDUFA V, emphasizing the role of MDUFA in enabling access to innovative medical devices and stressing the importance of authorizing MDUFA V by the September 30 deadline. Center for Devices and Radiological Health Food and Drug Administration (CDRH) witness Dr. Jeff Shuren apologized for the delay, citing the significant burden that the COVID-19 pandemic had placed on his team and noting that the MDUFA V draft agreement would substantially improve their ability to meet these challenges and ensure patient access moving forward.
House Appropriations Committee Hearing on FY 2023 Budget Request for the Department of Health and Human Services. During the hearing, HHS Secretary Xavier Becerra asked committee members to advance President Biden’s budget request of $127.3 billion in discretionary funding and $1.7 trillion in mandatory budget authority for HHS. During the hearing, Becerra informed lawmakers that the Advanced Research Projects Agency for Health (ARPA-H) will be housed within the National Institutes of Health, rather than create an independent agency within HHS – a decision that drew criticism from both Democrats and Republicans on the committee. Becerra also asked lawmakers to pass legislation to allow medical professionals to obtain interstate licensing to facilitate telehealth visits across state lines when the pandemic ends.
CDC’s Morbidity and Mortality Weekly Report: Adolescent Behaviors and Experiences Survey —United States, January–June 2021. A new CDC report found 44.2% of U.S. high school students reported “persistent feelings of sadness or hopelessness” during the pandemic, while 19.9% reported “seriously contemplating suicide” and 9% reported attempting suicide. According to the report, LGBTQ youth were more likely than heterosexual youth to report poorer mental health and suicide attempts. JAMA. Racial Disparities in COVID-19 Outcomes Among Black and White Patients With Cancer. A new cohort study of 3,506 patients with cancer and COVID-19, found black patients were more likely to experience more severe COVID-19 outcomes, than white patients. The study also found the all-cause mortality rate for black cancer patients was 19%, compared with 17% among white cancer patients. Health Affairs. The Effectiveness of Government Masking Mandates On COVID-19 County-Level Case Incidence Across The United States, 2020. In this observational cohort study, the researchers examined data from 394 U.S. counties between March 21, 2020 an October 20, 2020 and found the daily COVID-19 case incidence per100,000 people in masked counties declined by an average of 23% at four weeks, compared with non-masked counties. The researchers said the benefit of masking varied across regions by population density and political leanings.
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