Health Care Watch: September 23, 2023
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from September 17 – September 23. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
LEGISLATIVE UPDATE
House
On September 18, Energy & Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Health Subcommittee Chairman Brett Guthrie (R-KY), and Oversight and Investigations Subcommittee Chairman Morgan Griffith (R-VA), sent letters to the Centers for Disease Control and Prevention (CDC) and U.S. Department of Agriculture as part of the Committee’s ongoing investigation into federal laboratory biosafety practices and the handling of dangerous pathogens in bioresearch.
On September 19, House GOP leaders canceled a planned vote on a Republican-led health care package that included provisions relating to hospital transparency, site-neutral payments, and pharmacy benefit managers (PBMs). The bill was pulled because it would not have passed because of the necessary two-thirds voting in favor of the bill, as required for bills on the expedited suspension calendar. Leaders were hoping to avoid a lengthy amendment process which is why the bill did move under regular order. There is no indication of when the vote will be rescheduled.
On September 19, the Energy & Commerce Health Subcommittee held a hearing entitled Examining Policies to Improve Seniors’ Access to Innovative Drugs, Medical Devices, and Technology. The hearing examined roadblocks faced by Medicare beneficiaries when trying to access innovative treatments. A hearing memo can be found here.
During the week of September 25, the House is slate to consider H.R. 4368, the Agriculture, Rural Development, Food & Drug Administration, and Related Agencies Appropriations Act. for fiscal year 2024.
Unless Congress reaches an agreement by October 1, federal government funding will lapse. It is becoming increasingly likely that a shutdown will occur.
Senate
On September 19, the Finance Health Subcommittee held a hearing entitled Aging in Place: The Vital Role of Home Health in Access to Care. The hearing examined the current home health Medicare benefit, payment models, and overall health of the marketplace.
On September 21, the Health, Education, Labor & Pensions (HELP) Committee advanced S.2840, the Bipartisan Primary Care and Health Workforce Act in a 14-7 vote. The $26 billion package aims to strengthen access to primary care providers by increasing funding for community health centers and working to strengthen the doctor, nursing, and dentist workforces.
REGULATORY UPDATE
On September 18, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that aims to simplify processes for eligible individuals to enroll and retain eligibility in the Medicare Savings Programs (MSPs), and to better align enrollment into the MSPs with requirements and processes for other public programs. The rule is effective November 17, 2023. A fact sheet detailing the final rule can be found here.
On September 18, the Department of Health & Human Services (HHS) announced the launch of a nation-wide HHS Environmental Justice Community Innovator Challenge to support disadvantaged communities and Tribes facing the brunt of environmental injustices, including health harms due to climate change. This Challenge aims to uplift community-level solutions to address health inequities with prizes totaling $1,000,000 that will be awarded in two phases.
On September 18, the Food & Drug Administration (FDA) issued draft guidance on Labeling for Biosimilar and Interchangeable Biosimilar Products. If finalized, this guidance will revise and replace the current guidance on labeling for biosimilars issued in July 2018. Significant changes from the July 2018 guidance include recommendations on: labeling for interchangeable biosimilar products; product identification when the reference product labeling describes a clinical study conducted with a non-U.S.-approved biological product; pediatric use statements; and incorporating relevant immunogenicity data and information from the reference product labeling in the biosimilar or interchangeable biosimilar product labeling. Comments on the draft guidance are due November 17, 2023.
On September 18, Secretary of State Antony Blinken announced that the U.S. will name an envoy to work with foreign governments to combat fentanyl and other illicit synthetic drugs. The U.S. and the U.N. Office on Drugs and Crime will partner with tech companies to stop drug trafficking online and to help people seeking substance use disorder treatment.
On September 20, HHS, the Department of the Treasury, and the Department of Labor issued a proposed rule outlining the fees established in the No Surprises Act for the Federal Independent Dispute Resolution (IDR) process. The rule would amend existing regulations to provide that the administrative fee amount charged by the Departments to participate in the Federal IDR process, and the ranges for certified IDR entity fees for single and batched determinations, will be established annually in notice and comment rulemaking rather than guidance. The rule also proposes the amount of the administrative fee and the certified IDR entity fee ranges for disputes initiated on or after January 1, 2024. Comments on the proposed rule are due by October 26.
On September 20, HHS, through the Agency for Healthcare Research and Quality (AHRQ), announced nine grant awards of $1 million each for up to five years to support existing multidisciplinary Long COVID clinics across the country. The grants will help clinics expand access to comprehensive, coordinated, and person-centered care for people with Long COVID, particularly underserved, rural, vulnerable, and minority populations that are disproportionately impacted by the effects of Long COVID.
On September 20, FDA declined to approve an epinephrine nasal spray that would have been the first needle-free treatment for anaphylaxis, according to the manufacturer ARS Pharmaceuticals. Earlier in the summer, the agency’s outside experts, the Pulmonary-Allergy Drugs Advisory Committee, voted in favor of approval for the product, concluding that data presented by ARS showed the benefits of the product outweighed the risks. The company expressed surprise and disappointment about the FDA’s action and said it would file an appeal with the agency over the decision.
On September 21, HHS, through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced that it had awarded $127.7 million to expand Certified Community Behavioral Health Clinics (CCBHCs) across the country. The awards will work with provisions of the Bipartisan Safer Communities Act (BSCA) to expand access to the CCBHC model across the United States. Under BSCA, HHS will enable up to 10 additional states to create state CCBHC programs under Medicaid every two years starting in 2024, providing sustainable funding for CCBHC services to Medicaid beneficiaries.
On September 21, HHS announced that it has helped half a million children and families regain their Medicaid and Children’s Health Insurance (CHIP) coverage. On August 30, CMS issued a call to action and issued letters to states about a potential state systems issue where systems were inappropriately disenrolling children and other enrollees, even when the state had information indicating the person remained eligible. HHS notes as a result of CMS outreach, nearly 500,000 children and other individuals who were improperly disenrolled from Medicaid or CHIP will regain their coverage.
WHITE HOUSE
On September 20, the Biden Administration, through the Administration for Strategic Preparedness and Response (ASPR), announced an investment of $600 million across 12 domestic COVID-19 test manufacturers and the reopening of COVIDTests.gov to deliver COVID-19 tests for free to households across the country. The program will begin accepting orders for free at-home COVID-19 tests on September 25. Additional information about the program can be found here.
On September 21, the Biden Administration outlined plans to develop federal rules that would erase medical debt from consumers’ credit scores. The rules, if proposed, would: ban credit-reporting companies from including medical debt and collection information on consumer reports; prevent lenders from considering medical bills when deciding on loan applications; and stop debt collectors from using credit ratings to pressure people with health-care-related debt.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories (CMS-3326); Final Rule; 7/31/23
CMS Enforcement of State Compliance with Reporting and Federal Medicaid Renewal Requirements Under Section 1902(tt) of the Social Security Act (CMS-2447); Interim Final Rule; 8/16/23
Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions (CMS-3367); Proposed Rule; 12/27/22
Independent Dispute Resolution Operations (CMS-9897); Proposed Rule; 8/29/23
Request for Information Regarding Coverage of Over-the-Counter Preventive Products (CMS-9891); Notice; 9/6/23
Appeal Rights for Certain Changes in Patient Status (CMS-4204); Proposed Rule; 9/18/23
Disclosures of Ownership and Additional Disclosable Parties Information for Skilled Nursing Facilities and Nursing Facilities (CMS-6084); Final Rule; 9/19/23
FDA
Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, Neutral Manner in Advertisements in Television and Radio Format; Final Rule; 5/19/23
Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Certain Legally Marketed Medical Products: Questions and Answers (CDER, 2023-155); Notice; 7/13/23
Medical Devices; Laboratory Developed Tests; Proposed Rule; 7/26/23
Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act; Proposed Rule; 8/29/23
Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations; Final Rule; 9/7/23
Stimulant Use Disorders: Developing Drugs for Treatment; Draft Guidance for Industry; Availability; Notice; 9/15/23
OCR
Safeguarding the Rights of Conscience as Protected by Federal Statutes; Final Rule; 9/15/23
REPORTS
Office of Inspector General (OIG)
On September 18, OIG released a report examining New York’s Medicaid managed care organizations’ (MCOs) compliance with requirements for denying prior authorization requests. OIG examined denials made by one MCO, Centers Plan for Healthy Living (CPHL), because it was among the Medicaid MCOs with the highest percentage of denials overturned by New York for services requested during the period from April 1, 2018, through March 31, 2020 (audit period). OIG found that for 35 of 70 sampled denials, New York's oversight ensured that CPHL complied with Federal and State requirements when it initially denied prior authorization requests for services and items. However, for the remaining 35 sampled denials, OIG determined that CPHL justified the denials by citing incorrect information in denial notices. OIG recommends that New York: 1) use the finding in this report to determine whether CPHL was noncompliant and determine whether a corrective action plan or other sanctions are appropriate; 2) review CPHL's appeal process and ensure that CPHL makes any necessary changes to comply with requirements for denying services; and 3) implement procedures to obtain and review information related to MCOs' initial denials and internal appeals.
On September 20, GAO released a review of key strategies used for managing Medicaid and Marketplace enrollment during the COVID-19 public health emergency (PHE). GAO found that states used several successful strategies for addressing Medicaid and Marketplace enrollment challenges. These strategies included: expanded outreach efforts; improved applications and support; simplified eligibility determination processes; and adapted program operations.
Government Accountability Office (GAO)
On September 19, GAO released a report examining CMS’ monitoring of the effects of rebates on drug coverage and spending. GAO found that plan sponsors received $48.6 billion in rebates from manufacturers in 2021. Three therapeutic drug classes accounted for 73% of rebates: 1) endocrine metabolic agents, including antidiabetic drugs; 2) blood modifiers, including anti-stroke drugs; and 3) respiratory agents, including anti-asthma drugs. GAO stated that CMS should monitor drug rebates as such monitoring of rebates will be particularly important as the agency implements the provisions of the Inflation Reduction Act, which will change Part D plan sponsor, beneficiary, and Medicare drug spending responsibility and may affect formulary design and rebates.
UPCOMING HEARINGS
House
Ways & Means Committee
September 25; TBD
Markup of Health Savings Account legislation
October; TBD
Markup of drug and device legislation and hearing on the status of CMS’ Center for Medicare & Medicaid Innovation
Senate
Budget Committee
September 27; 10:00 AM; 106 Dirksen
Medicare Forever: Protecting Seniors by Making the Wealthy Pay Their Fair Share
Witnesses: Marilyn Moon, Visiting Scholar, Center for Medicare Advocacy, & Former Public Trustee of the Medicare and Social Security Trust Funds; Ms. Chye-Ching Huang, Executive Director, Tax Law Center, New York University School of Law.
OTHER POLICY NEWS
On September 18, the Kaiser Family Foundation (KFF) released a report examining the impacts of the Biden Administration’s nursing home minimum staffing requirements. KFF found that among all nursing facilities, fewer than 1-in-5 could currently meet the required number of hours for registered nurses and nurse aides, which means over 80% of facilities would need to hire nursing staff. Additionally, 90% of for-profit facilities would need to hire additional nursing staff compared with 60% of non-profit and government facilities.
On September 21, the Medicaid and CHIP Payment and Access Commission (MACPAC) met to discuss Medicaid payment policy, managed care denials and appeals, and nursing facility staffing and payment transparency, and Medicare savings programs, among other topics.