The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from March 15 - March 21. 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.
NON-CORONAVIRUS LEGISLATIVE UPDATE
House
On March 17, Rep. Pramila Jayapal, 14 committee chairs, and several key leadership Members introduced H.R.1976, To establish an improved Medicare for All national health insurance program.
On March 19, the House passed H.R. 1868 to extend the Medicare sequester moratorium that expires on March 31 through the end of the year and to waive the PAYGO scorecard for the newly signed American Rescue Plan Act of 2021 so that it does not create an additional sequester cut, including $36 billion in cuts to the Medicare program. Twenty-nine Republicans joined the Democrats to pass this measure. The Senate may consider similar legislationintroduced by Sens. Jeanne Shaheen (D-NH) and Susan Collins (R-ME) the week of March 22. This bill would likely extend relief from the 2% Medicare sequester cut through the end of the year but not address the potential cuts in 2021 as a result of PAYGO. Sens. Shelly Moore Capito (R-WV) and John Boozman (R-AR) have cosponsored S. 748, which means seven more Republicans are needed to advance the bill.
Senate
On March 17, the Health, Education, Labor, & Pensions (HELP) Committee held a hearing entitled Nomination of Vivek Hallegere Murthy to serve as Medical Director in the Regular Corps of the Public Health Service and Surgeon General of the Public Health Service, and Rachel Levine to serve as Health & Human Services (HHS) Assistant Secretary. The committee voted 16-6, including all Democrats and five Republicans, to forward Murthy’s nomination, and 13-9, including all Democrats and two Republicans, to forward Levine’s nomination to the full Senate.
On March 18, the Senate confirmed California Attorney General Xavier Becerra as HHS Secretary in a 50-49 vote. All Democrats and Sen. Susan Collins (R-ME) voted in favor of Becerra’s confirmation.
NON-CORONAVIRUS REGULATORY UPDATE
On March 15, the Food & Drug Administration (FDA) launched the FDA Adverse Event Reporting System (FAERS) Public Dashboard to expand access of FAERS data to the general public to search for information related to human adverse events reported to the FDA by the pharmaceutical industry, healthcare providers, and consumers.
On March 16, CMS announced updates to the CY2022 Part D Payment Modernization Model, including eliminating two Trump-era design elements from the Model: (1) the Part D Formulary Flexibilities (i.e., flexibility around “protected class” and 2-drug per class requirements), and (2) removal of downside risk for CY 2022. In recent weeks, patient advocacy groups aggressively pushed to remove the “protected class” flexibilities allowed under the Model. An updated fact sheet on the model is available here.
On March 16, CMS released the RFA for Cohort 2 of the Primary Care First Model. Practices that participate will have flexibility in care delivery and the opportunity to increase practice revenue through performance-based model payments. The deadline for practice applications is April 30, 2021; the deadline for payer applications is May 28, 2021.
On March 16, the Federal Trade Commission (FTC), Canadian Competition Bureau, European Commission Directorate General for Competition, U.K.’s Competition and Markets Authority, U.S. Department of Justice Antitrust Division, and Offices of State Attorneys General launched a working group to update the FTC approach to analyzing the effects of pharmaceutical mergers.
On March 16, the U.S. District Court for the Southern District of Indiana granted Lilly’s request for a preliminary injunction putting the 340B administrative dispute resolution (ADR) final rule on hold while the lawsuit on the regulation proceeds. The court opinion indicated that HHS likely did not go through the proper notice and comment procedure on the ADR rule as the Trump-era HHS had announced in the Unified Agenda that the proposal was “withdrawn” leading a “reasonable observer to believe the ADR rule had in fact been withdrawn.”
On March 17, Acting CMS Administrator Elizabeth Richter issued letters to Arkansas and New Hampshire withdrawing approval of the states’ Medicaid work requirement waivers.
On March 18, HHS issued a delay of effective date and correction of the final rule entitled Securing Updated and Necessary Statutory Evaluations Timely, also known as the Sunset Rule, delaying the rule until March 22, 2022.
On March 18, HHS further delayed the effective date for certain provisions in the final rule entitled, Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals And Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees (“Rebate Rule”) until January 1, 2023. These provisions had previously been delayed until March 22, 2021 pursuant to the Biden Administration’s “regulatory freeze” memo. The latest delay follows a March 15 court order that also holds litigation about the rule in abeyance pending a review by HHS. Part of the rule was already delayed until January 1, 2023 – pursuant to an earlier court order – the most recent court order delays the entire rule until January 1, 2023.
The FDA will host a meeting entitled Roadmap to 2030 for New Drug Evaluation in Older Adults on March 23.
The FDA will host meetings entitled Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards on April 7.
NON-CORONAVIRUS WHITE HOUSE UPDATE
On March 2, President Biden announced a series of appointments and nominations:
Gene Sperling to oversee the implementation of the American Rescue Plan;
Sarah Lovenheim for HHS Assistant Secretary for Public Affairs; and
Dawn O’Connell for HHS Assistant Secretary for Preparedness and Response.
The Administration is considering an extension of the Federal Marketplace Special Enrollment period beyond the current deadline of May 15.
CORONAVIRUS UPDATE
House
On March 17, the Energy and Commerce Oversight and Investigation Subcommittee held a hearing entitled Leading the Way Forward: Biden Administration Actions to Increase COVID-19 Vaccinations. The committee and witnesses discussed vaccine supply and distribution plans, new vaccines and vaccine boosters, how to address vaccine equity and hesitancy, and other topics. Witnesses included: Anthony Fauci, MD, Director, National Institute of Allergy and Infectious Diseases (NIAID); Rochelle Walensky, MD, Director, Centers for Disease Control and Prevention (CDC); and Peter Marks, Director, Center for Biologics Evaluation and Research, FDA.
Senate
On March 18, the HELP committee held a hearing entitled Examining Our COVID-19 Response: An Update from Federal Officials. Chair Patty Murray (D-WA) noted how the Biden Administration has improved the federal COVID response but emphasized the need to address vaccine hesitancy, accessibility, and equity that are impacting communities of color, the disability community, and others. Ranking Member Richard Burr (R-NC) urged the CDC, NIH, FDA, and HHS to take stock of COVID-19 preparedness and response shortfalls and to keep pace with science by utilizing private sector partners and innovators. Witnesses included: Anthony Fauci, MD, Director, NIAID, National Institutes of Health; David Kessler, MD, Chief Science Officer, COVID Response, HHS; Peter Marks, MD, Director, Center for Biologics Evaluation and Research, FDA: Rochelle Walensky, MD, Director, CDC.
Regulatory
On March 15, CMS increased the Medicare payment amount for administering the COVID-19 vaccine. The national average payment rate for physicians, hospitals, pharmacies, and other immunizers will be increased from $28 to $40 to administer each dose of a COVID-19 vaccine, effective March 15.
On March 15, the CDC released a report finding that 95.6% of people receive their COVID-19 vaccine second dose within the recommended interval.
On March 16, the FDA issued a new supplemental template for test developers seeking emergency use authorization (EUA) of certain tests for screening with serial testing, as well as at-home tests. The agency also issued a fact sheet that outlines considerations for selecting a test for use in a screening testing program.
On March 17, HHS announced $10 billion in funding to increase testing to reopen schools, $2.25 billion to increase testing in underserved populations, and new CDC guidance on asymptomatic screening testing in schools, workplaces, and congregate settings. These measures are part President Biden’s National Strategy for the COVID-19 Response and Pandemic Preparedness.
On March 17, HHS announced $150 million in funding to increase access to COVID-19 monoclonal antibody therapeutic treatments for patients in vulnerable communities.
On March 17, the FDA granted BioFire Diagnostics LLC marketing authorization for its BioFire Respiratory Panel 2.1 diagnostic test.
On March 17, the FDA authorized revised fact sheets on the effects of COVID-19 variants on COVID-19 treatments including Bamlanivimab, Bamlanivimab and Etesevimab, and REGEN-COV.
On March 19, FDA issued an EUA for the first machine learning-based COVID-19 non-diagnostic screening device that identifies certain biomarkers that are indicative of some types of conditions, such as hypercoagulation.
HHS will hold a COVID-19 Health Equity Task Force virtual meeting on March 26.
White House
On March 16, White House COVID-19 Task Force Adviser Andy Slavitt advocated for private sector and nonprofit organizations to take the lead on COVID-19 vaccine “passports,” not the federal government.
On March 16, the Biden Administration purchased 500,000 additional doses of AstraZeneca’s COVID-19 antibody cocktail for $205 million.
On March 18, White House Press Secretary Jen Psaki confirmedplans to share 4 million surplus doses of the AstraZeneca COVID-19 vaccine with the Canadian and Mexican governments.
On March 19, President Biden reached his goal of administering 100 million COVID-19 doses, earlier than his projected 100-day deadline.
Other
On March 15, Cardinal, AmerisourceBergen, and Henry Schein urged the Federal Emergency Management Agency to increase the resiliency and efficiency of the COVID-19 vaccine distribution system by utilizing the entire commercial medical supply and pharmaceutical distribution system.
On March 15, AstraZeneca predicted that the company’s COVID-19 Phase III trial data should be available soon and the company’s vaccine should be authorized in April.
On March 15, Sanofi announced the Phase I/II clinical trial for MRT5500, the company’s second COVID-19 vaccine after the first vaccine candidate did not produce strong enough efficacy. The company expects interim results from this trial in the third quarter of 2021.
On March 15, Moderna dosed the first participants in the company's Phase I next generation COVID-19 vaccine candidate, mRNA-1283. On March 16, Moderna announced the company has begun COVID-19 vaccine Phase II/III clinical trials with children six months to 12 years old. Moderna is the first trial including children this young.
On March 16, Former President Trump publicly recommended for Americans to get vaccinated and advocated for the safety of the vaccines.
On March 18, the European Medicines Agency concluded that the AstraZeneca COVID-19 vaccine is “not associated with an increase in the overall risk of thromboembolic events or blood clots,” after many European countries halted AstraZeneca vaccine administration.
On March 18, the Ad Council launched a COVID-19 vaccine campaign featuring pharmacists from CVS, Walgreens, and Walmart to address vaccine misconceptions for consumers and prepping pharmacists around the country to assuage their own patients’ concerns.
As of March 20, more than 77 million people have received the first dose of COVID-19 vaccines (nearly 42 million have received both doses) and more than 154 million doses have been distributed, according to the CDC COVID Data Tracker.
As of March 20, the U.S. had 29,730,639 confirmed COVID-19 cases resulting in 541,145 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center.
RULES AT THE WHITE HOUSE OMB
HHS-CMS
FY 2022 Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals, and the Long-Term Care Hospital Prospective Payment System (CMS-1752); Proposed Rule; Received 2/16/21
FY 2022 Skilled Nursing Facility (SNFs) Prospective Payment System Rate Update and Quality Reporting Requirements (CMS-1746); Proposed Rule; Received 2/25/21
FY 2022 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS-1750); Proposed Rule; Received 2/25/21
FY 2022 Inpatient Rehabilitation Facility (IRF) Prospective Payment System Rate Update and Quality Reporting Requirements (CMS-1748); Proposed Rule; Received 2/25/21
Modification of Limitations on Redesignation by the Medicare Geographic Classification Review Board (CMS-1762); Interim Final Rule; Received 2/26/21
FY 2022 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS-1754); Proposed Rule; Received 2/26/21
REPORTS
HHS Office of Inspector General (OIG)
On March 18, OIG released a report entitled North Mississippi Medical Center: Audit of Medicare Payments for Polysomnography Services. The report found that North Mississippi submitted Medicare claims for some polysomnography services that did not comply with Medicare billing requirements, resulting in at least $67,038 of overpayments. OIG recommended that North Mississippi Medical Center refund overpayment for incorrectly billed claims, educate its staff on properly billing for polysomnography services, and revise policies and procedures to ensure that claims are coded correctly and that sleep technicians have the required credentials before billing claims for polysomnography services to ensure full compliance with Medicare requirements. North Mississippi concurred with our findings and recommendations and described actions that it had taken to address them. A summary of the report is available here.
On March 19, the OIG released a report entitled Medicaid Fraud Control Units Fiscal Year 2020 Annual Report. The report found that in FY 2020, the Medicaid Fraud Control Units contributed to total recoveries of $1 billion, with a return on investment of $3.36 for every $1 spent.
Government Accountability Office (GAO)
On March 17, the GAO released a report entitled COVID-19 In Nursing Homes: HHS Has Taken Steps in Response to Pandemic, but Several GAO Recommendations Have Not Been Implemented. The report found that winter 2020 was marked by a significant surge in the number of COVID-19 cases and deaths in nursing homes but as of February 2021, both cases and deaths have declined by more than 80% since their peaks in December 2020. GAO identified that HHS has not implemented several relevant GAO recommendations, including for HHS to develop an implementation plan and to fill COVID-19 data voids. Implementing GAO's recommendations could help address some of the challenges nursing homes continue to face and fill important gaps in the federal government's understanding of, and transparency around, data on COVID-19 in nursing homes. A summary of the report is available here.
On March 17, GAO released a report entitled Puerto Rico: Efforts to Improve Competition for Medicaid Procurement. The report found that Puerto Rico continues to develop and carry out its planned reforms, implementing GAO’s recommendation for ongoing, risk-based oversight of Puerto Rico’s Medicaid procurement process. GAO recommended that CMS take steps to implement ongoing, risk-based oversight of Puerto Rico’s Medicaid procurement process. A summary of the report is available here.
HEARINGS
House
Appropriations Labor, HHS, Education and Related Agencies Subcommittee
Addressing the Maternal Health Crisis
March 23, 10:00 a.m. Webex
Witnesses include: Lisa Asare, Assistant Commissioner, Division of Family Health Services, New Jersey Department of Health; Wendy Gordon, MD, Associate Professor and Chair, Department of Midwifery, Bastyr University; Carol Sakala, MD, Director for Maternal Health, National Partnership for Women and Families; and Stacey Stewart, President and CEO, March of Dimes.
Energy & Commerce Health Subcommittee
Building on the Affordable Care Act: Legislation to Expand Health Coverage and Lower Costs
March, 23, 11:00 a.m. Webex
Witnesses include: Katie Keith, Associate Research Professor, Georgetown University; Dean Cameron, Director, Idaho Department of Insurance; Cindy, Mann Partner Manatt, Phelps & Phillips; Marni Jameson Carey, Executive Director, Association of Independent Doctors; and Laura LeBrun Hatcher, Board Vice President, Little Lobbyists.
Ways & Means Committee
March 23, 10:00 a.m.
Ways & Means Oversight Subcommittee
Hearing on Examining Private Equity’s Expanded Role in the U.S. Health Care System
March 25, 1:00p.m.
Senate
HELP Primary Health and Retirement Security Subcommittee
Why Does the US Pay the Highest Prices in the World for Prescription Drugs?
March 23, 10:00 a.m., 430 Dirksen Senate Office Building
Witnesses include: Aaron Kesselheim, MD, Professor Of Medicine, Brigham and Women’s Hospital and Harvard Medical School; Nav Persaud, MD, Canada Research Chair In Health Justice, University of Toronto; Elia Spates; and Alex Brill, Resident Fellow, AEI.
HELP Committee
March 25, 10:00 a.m. 430 Dirksen Senate Office Building
Witnesses include: Consuelo Wilkins, MD, Vice President For Health Equity, Vanderbilt University Medical Center; Abigail Echo-Hawk (Pawnee), Executive Vice President, Seattle Indian Health Board; Taryn Mackenzie Williams, Managing Director, Poverty To Prosperity Center for American Progress; and Gene Woods, President, Chief Executive Officer, Atrium Health.
OTHER HEALTH POLICY NEWS
On March 15, the Medicare Payment Advisory Commission releasedits March 2021 Report to the Congress: Medicare Payment Policy.The report includes chapters on the following topics:
Providing a broader context for the report, including the near-term consequences of the coronavirus pandemic and the longer-term effects of Medicare spending on the federal budget and the program’s financial sustainability;
Describing the Commission’s analytic framework for assessing payment adequacy;
Describing the Commission’s recommendations on fee-for-service payment rate updates and related issues including, as mandated by the Congress, a report on the expansion of the hospital post-acute care transfer policy to include discharges to hospice;
Updating the trends in enrollment, plan offerings, and payments in Medicare Advantage plans;
Updating the trends in enrollment and plan offerings for plans that provide prescription drug coverage under Part D; and
Presenting an option for Medicare’s coverage of telehealth services after the coronavirus public health emergency.
A summary of the report is available here.
On March 16, a study released in Health Affairs found that a majority of the largest hospitals are not complying with the November 2019 CMS final rule entitled “Price Transparency Requirements for Hospitals to Make Standard Charges Public.”
On March 18, the Commonwealth Fund released a report entitled Managing Medicare Beneficiaries with Chronic Conditions During the COVID-19 Pandemic. The report found that the COVID-19 pandemic has made the management of chronic conditions more challenging for Medicare beneficiaries but the CMS waivers that expanded telemedicine services and shifted more services toward outpatient and home-based care settings helped alleviate this issue.