The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from April 26 – May 1. 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 April 28, the Ways & Means Health Subcommittee held a hearing entitled Charting the Path Forward for Telehealth. Many members emphasized the need for bipartisan work to expand telehealth and broadly supported extending current flexibilities around telehealth, though there was some disagreement around whether expansions should be temporary to allow Congress to gather more data or permanent to ensure stability. Witnesses included: Sinsi Hernández-Cancio, Vice President for Health Justice, National Partnership for Women and Families; Ellen Kelsay, President & CEO, Business Group on Health; Thomas Kim, MD, Chief Behavioral Health Officer, Prism Health North Texas; Ateev Mehrotra, MD, Associate Professor of Health Care Policy, Department of Health Care Policy, Harvard Medical School; and Joel White, Executive Director, Health Innovation Alliance.
On April 29, the Judiciary Antitrust, Commercial, and Administrative Law Subcommittee held a hearing entitled Treating the Problem: Addressing Anticompetitive Conduct and Consolidation in Health Care Markets. The hearing examined three proposals to lower pharmaceutical drug prices and address consolidation in the markets for hospital care, health insurance, prescription drugs and other health care products and services. Members advocated for bipartisan, bicameral work to address anticompetitive practices in the health care industry and reducing drug prices. Witnesses included: Sens. Chuck Grassley (R-IA), Amy Klobuchar (D-MN); John Cornyn (R-TX), Richard Blumenthal (D-CT), and Mike Lee (R-UT); Rep. Carolyn Maloney (D-NY); Leemore Dafny, MD, Bruce V. Rauner Professor of Business Administration, Harvard Business School, Faculty Member, John F. Kennedy School of Government; Michael Carrier, Distinguished Professor of Law Rutgers, School of Law-Camden; and Robin Feldman, Arthur Goldberg Distinguished Professor of Law, Albert Abramson ’54 Distinguished Professor of Law Chair, Director of the Center for Innovation, University of California, Hastings College of Law.
On April 30, the Blue Dog Coalition announced its policy task forces for the 117th Congress, including a task force on Strengthening Rural America to focus increasing access to health care and other topics, chaired by Rep. Tom O’Halleran (D-AZ).
Senate
On April 25, 17 senators led by Bernie Sanders (I-VT), urgedPresident Biden Administration to lower the Medicare eligibility age; expand Medicare benefits to include hearing, dental, and vision care; implement a cap on out-of-pocket expenses under traditional Medicare; and allow the program to negotiate lower drug prices in the American Families Plan.
On April 27, the Senate voted 81-13 to approve Jason Miller to be Office of Management and Budget (OMB) Deputy Director for Management
On April 29, Health, Education, Labor, & Pensions (HELP) Committee Chair Patty Murray (D-WA) and Ranking Member Richard Burr (R-NC) released a Dear Colleague letter to announce the beginning of bipartisan discussions to consider how to better prepare the nation for future public health emergencies in light of the COVID-19 pandemic.
On April 28, the Appropriations Military Construction, Veterans Affairs, and Related Agencies Subcommittee held a hearing entitled VA Telehealth Program: Leveraging Recent Investments to Build Future Capacity. Subcommittee Chairman Martin Heinrich (D-NM) committed to improving access to telehealth services, including expanding telehealth capacity, bridging the digital divide and increasing broadband access. Witnesses included: Steven Lieberman, MD, Acting Deputy Under Secretary for Health, Veterans Health Administration (VA); Kevin Galpin, MD, Executive Director, Telehealth VA; and Jack Galvin Associate, Deputy Assistant Secretary, Development, Security And Operations Office of Information and Technology.
NON-CORONAVIRUS REGULATORY UPDATE
On April 26, Health & Human Services (HHS) partnered with 22 national organizations to support Black American outreach and enrollment efforts during the HealthCare.gov Special Enrollment Period during COVID-19. During the Black American Week of Action, April 25 – May 1, HHS and its partnership organizations will combine social media efforts to inform Black American consumers and spur enrollment in affordable, quality health plans through HealthCare.gov
On April 26, HHS issued a notice entitled Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder.The notice exempts eligible providers from certification requirements for prescribing buprenorphine to 30 or fewer patients. A summary of the notice is available here.
On April 26, the Food & Drug Administration (FDA) announced it is concluding the Quality in 510(k) Review Pilot Program, which allows the FDA to direct more effort on the review of higher risk devices, which helps reduce total time to decision, and promotes consistency in 510(k) reviews. After May 30, 2021, the FDA will no longer accept Quality in 510(k) Review Files.
On April 28, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled Hospital Inpatient Prospective Payment Systems (IPPS) for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year (FY) 2022 Rates etc. Under the rule, acute-care hospitals would see an overall 2.8% increase in Medicare reimbursements in FY 2022 and long-term care hospitals would receive an extra 1.4%. Notably, CMS is proposing to repeal the Trump-era policy requiring hospitals to report on the Medicare cost report the median payer-specific negotiated charge that the hospital has negotiated with all of its Medicare Advantage (MA) organization payers, by MS-DRG, for cost reporting periods ending on or after January 1, 2021. CMS is also proposing to repeal the market-based MS-DRG relative weight methodology that was adopted effective for FY 2024, and to continue using the existing cost-based MS-DRG relative weight methodology to set Medicare payment rates for inpatient stays for FY 2024 and subsequent fiscal years. A fact sheet on the rule is available here. A fact sheet on changes to enhance the medical workforce in rural and underserved communities is available here.
On April 28, CMS updated its Overall Hospital Quality Star Ratings. 50% of hospitals received the same rating, 45% moved up or down by one star, and 5% shifted up or down by two or more stars.
On April 30, FDA approved a higher dose naloxone hydrochloride nasal spray product to treat opioid overdose. The newly approved product delivers 8 milligrams (mg) compared to previously approved 2 mg and 4 mg products
On April 30, HHS issued a final rule entitled HHS Notice of Benefit and Payment Parameters for 2022 and Pharmacy Benefit Manager Standards. The rule lowers maximum consumer out-of-pocket costs by $400, improves competition and stability, elevates the consumer experience, expands transparency, ensures state flexibility, and promotes program integrity. A fact sheet on the Notice of Benefit and Payment Parameters for 2022 is available here. A fact sheet on the changes to Federal Marketplace Plans is available here.
On April 29, CMS issued a final rule entitled Comprehensive Care for Joint Replacement Model Three-Year Extension and Modifications to Episode Definition and Pricing (CMS-5529).
On April 30, HHS withdrew a notice Regarding the Food and Drug Administration Drug Review Timeline Transparency, which required the agency to annually report its drug review timelines.
On April 30, CMS announced the Artificial Intelligence (AI) Health Outcomes Challenge winner and runner-up. The challenge aims to accelerate the development of AI solutions for predicting patient health outcomes for Medicare beneficiaries for potential use by the CMS’ Center for Medicare & Medicaid Innovation.
NON-CORONAVIRUS WHITE HOUSE UPDATE
On April 26, President Biden issued an Executive Order (EO) to create a Task Force on Worker Organizing and Empowerment to support for workers organizing unions and bargaining collectively with their employers. A summary of EO is available here.
On April 27, President Biden issued an EO increasing the hourly minimum wage for federal contractors to $15.
On April 27, President Biden made a joint address to Congress and formally released the $1.8 trillion American Families Plan, the second “infrastructure” package. While the package was initially expected to contain sweeping health policy initiatives, “letting Medicare negotiate prices” and “creating a public option and the option for people to enroll in Medicare at age 60,” those issues have been punted to a future package. The American Families Plan invests $200 billion to make permanent the ACA premium subsidy expansions. The White House plans to offset the package through increased taxes. A fact sheet on the package is available here.
CORONAVIRUS UPDATE
House
On April 25, India Caucus Vice Chair Ro Khanna (D-CA) called on the U.S. to share its stockpile of AstraZeneca vaccines with India, seek one year intellectual property waiver from Pfizer and Moderna for their COVID-19 vaccines, and take other emergency actions to address the COVID-19 pandemic. Rep. Raja Krishnamoorthi (D-IL) also called on the Administration to release doses of the AstraZeneca vaccines to countries currently being hit by COVID-19 outbreaks, including India and Argentina.
On April 28, the Energy & Commerce Health Subcommittee held a hearing entitled The Long Haul: Forging a Path through the Lingering Effects of COVID-19. Chairman Frank Pallone (D-NJ) called for further research to better understand the impact of long COVID on individuals and population health, and identify how to prevent or treat long COVID. Witnesses included: Francis Collins, M.D., Director National Institutes of Health (NIH); John Brooks, M.D., Chief Medical Officer, Centers for Disease Control and Prevention (CDC) COVID-19 Response, CDC; Steven Deeks, M.D. Professor of Medicine University of California; Jennifer Possick, M.D. Associate Professor, Section of Pulmonary, Critical Care and Sleep Medicine, Yale School of Medicine Director, Post-COVID Recovery Program Winchester Center for Lung Disease, Yale-New Haven Hospital; Natalie Hakala, Patient; Lisa McCorkell, Patient; Chimere Smith, Patient
Senate
On April 28, HELP Committee held a hearing entitled Examining Our COVID-19 Response: Using Lessons Learned to Address Mental Health and Substance Use Disorders. Chair Murray highlighted the importance of investing in the recruitment and training of mental health care professionals. Witnesses included: Jonathan Muther, Vice President, Medical Services-Behavioral Health, Advisor, Salud Family Health Centers & Clinical Integration Eugene Farley, Jr. Health Policy Center; Tami Benton, M.D., Psychiatrist-in-Chief, Executive Director, Chair, Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children’s Hospital of Philadelphia; Sara Goldsby, Director, South Carolina Department of Alcohol and Other Drug Abuse Services; and Andy Keller, President, CEO, Linda Perryman Evans Presidential Chair, Meadows Mental Health Policy Institute.
On April 29, Sens. Warren, Ed Markey (D-MA), Tammy Baldwin (D-WI), Jeff Merkley (D-OR), and Chris Murphy (D-CT) called for Pfizer, Moderna and Johnson & Johnson to increase global access to COVID-19 vaccines, but specifically increase India’s access to vaccines. The senators proposed sharing COVID-19 vaccine technology, such as through the COVID-19 Technology Access Pool, and temporarily waiving intellectual property rights.
Regulatory
On April 26, U.S. Trade Representative Katherine Tai met with AstraZeneca and Pfizer to discuss the companies’ roles in increasing vaccine production, global health issues and the potential waiver for relaxing intellectual property protections around COVID-19 vaccines patents.
On April 26, OMB received a final rule from OSHA entitled Subpart U – Emergency Temporary Standard – COVID-19. The rule details emergency workplace safety rules to prevent the spread of the COVID-19.
On April 27, CDC updated its guidance allowing people who have been fully vaccinated against COVID-19 to go outdoors without masks except in certain crowded settings and venues, gather indoors with fully vaccinated people without wearing a mask or staying 6 feet apart, and gather indoors with unvaccinated people from one other household without masks or staying 6 feet apart, unless others are at increased risk for severe illness from COVID-19.
On April 27, HHS Secretary Xavier Becerra encouraged former President Trump to make a public service announcement promoting COVID-19 vaccines to his supporters
On April 28, CDC released data that found that fully vaccinated adults 65 years and older that received the Pfizer or Moderna COVID-19 vaccine were 94% less likely to be hospitalized with COVID-19 than people of the same age who were not vaccinated.
On April 30, HHS held a virtual COVID-19 Health Equity Task Force meeting discussing interim recommendations specific to mental and behavioral health.
White House
On April 25, the Biden Administration announced that it will send India raw materials for COVID-19 vaccines, therapeutics, rapid diagnostic test kits, ventilators, and Personal Protective Equipment, and increase financing aid for COVID-19 shot production.
On April 26, the Biden Administration announced it is looking at options to share up to 60 million doses of AstraZeneca’s COVID-19 vaccine with other countries, once it clears federal safety reviews. AstraZeneca’s vaccine has not been authorized in the U.S. The Administration said it is prioritizing the needs of Americans and is building supply for potential booster shots. There is no clear timeline for shipping those doses abroad.
On April 26, Vice President Harris urged the United Nations to begin work into how it will respond to the next global pandemic.
Other
On April 26, Sanofi announced that it will produce up to 200 million doses of Moderna’s COVID-19 vaccine starting in September to increase supply to meet current global demand.
On April 26, World Health Organization Assistant Director-General Mariângela Batista Galvão Simão said the organization expects to decide whether to give emergency approval for China's two COVID-19 vaccines in the next two weeks.
On April 27, the National Bureau of Economic Research released a working paper entitled Medicaid and Fiscal Federalism During the COVID-19 Pandemic analyzing the effects of COVID-19 on state and local government finances, specifically health spending needs and the role of Medicaid. The report found that enhanced federal matching funds are of roughly the same magnitude as expected increases in state Medicaid costs, there is substantial variation in states’ exposure to increases in Medicaid program costs, and enhanced Medicaid matching funds are quite weakly correlated with variations in states’ cost increases.
On April 27, Pfizer CEO Albert Bourla predicted that an oral drug for COVID-19 could be ready next year.
On April 29, Moderna announced new funding commitments to increase COVID-19 vaccine supply, increasing the global 2022 capacity from 700 million to up to 3 billion doses of its COVID-19 vaccine. Moderna said its vaccine supply in 2022 would likely include both its current shot and new vaccines it is developing to target coronavirus variants.
As of May 1, over 146 million people have received the first dose of COVID-19 vaccines (more than 103 million have received both doses) and more than 312 million doses have been distributed, according to the CDC COVID Data Tracker.
As of May 1, the U.S. had 32,377,645 confirmed COVID-19 cases resulting in 576,606 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center.
RULES AT THE WHITE HOUSE OMB
HHS-CMS
Modification of Limitations on Redesignation by the Medicare Geographic Classification Review Board (CMS-1762); Interim Final Rule; Received 2/26/21
COVID-19 Vaccine Immunization Requirements for LTC Residents and Staff (CMS-3414); Interim Final Rule; 3/29/21
CY 2022 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1751); Proposed Rule; Received 3/30/21
REPORTS
HHS Office of Inspector General (OIG)
On April 27, OIG released a report entitled Louisiana Appropriately Claimed Most Balancing Incentive Payment Program Funds. OIG found that Louisiana appropriately claimed most of its State Balancing Incentive Payment Program (BIPP) expenditures in accordance with Federal requirements but mistakenly included ineligible procedure codes as noninstitutional long-term services and supports expenditures on the CMS-64, resulting in $1.3 million at the enhanced Federal Medical Assistance Percentage rate for ineligible expenditures. OIG recommended that Louisiana refund $1.3 million to the Federal Government in BIPP funding that it received for ineligible expenditures. A summary of the report is available here.
On April 28, OIG released a report entitled Medicare Home Health Agency Provider Compliance Audit: Visiting Nurse Association of Maryland (VNA). The report found that VNA did not always comply with Medicare billing requirements for home health claims, resulting in at least $2.1 million in overpayments from 2015 to 2016. OIG found that VNA incorrectly billed Medicare for services provided to beneficiaries who were not homebound, services provided to beneficiaries who did not require skilled services, services that were not delivered in accordance with the beneficiary's plan of care, and claims that were assigned with incorrect Health Insurance Prospective Payment System payment codes. OIG recommended that VNA exercise reasonable diligence to identify, report, and return any overpayments, and ensure that the homebound statuses of Medicare beneficiaries are verified and continually monitored and the specific factors qualifying beneficiaries as homebound are documented, beneficiaries are receiving only reasonable and necessary skilled services, services are provided in accordance with beneficiaries' plans of care, and the correct HIPPS payment codes are billed. VNA disagreed with the majority of OIG’s findings. A summary of the report is available here.
Government Accountability Office (GAO)
On April 27, GAO released a blog posting entitled Gene Sequencing Can Track COVID Variants, But High Costs and Security and Privacy Concerns Present Challenges. The blog explained what gene sequencing is, how new technologies are changing, what opportunities genomic sequencing present, and highlighted challenges that limit the use of genomic sequencing technologies.
On April 29, GAO released a report entitled Prescription Drugs: U.S. Prices for Selected Brand Drugs Were Higher on Average than Prices in Australia, Canada, and France. GAO estimated that U.S. prices for 20 selected brand-name prescription drugs paid at the retail level by consumers and other payers were more than two to four times higher than prices in Australia, Canada, and France. GAO predicted that the actual differences between U.S. prices and those of the other countries were likely larger than estimates. GAO found similar differences in estimated prices paid by final payers at the manufacturer level. The GAO analysis found consumers' out-of-pocket costs for prescription drugs varied across and within all four countries but were likely more within the U.S. and Canada where multiple payers had a role setting prices and designing cost-sharing for consumers, and not all consumers had prescription drug coverage. GAO provided a draft to HHS for review. This report was commissioned by Sen. Bernie Sanders (I-VT). A summary of the report is available here.
On April 30, GAO released a report entitled Behavioral Health: Patient Access, Provider Claims Payment, and the Effects of the COVID-19 Pandemic. GAO identified that shortages of qualified behavioral health professionals, due to provider reimbursement rates and health system capacity, pose a barrier to accessing care. The report also found increases in anxiety or depression, and Emergency department visits for overdoses and suicide attempts from April 2020 through Feb. 2021. A summary of the report is available here.
HEARINGS
House
Oversight and Reform Economic and Consumer Policy Subcommittee
May 4, 11:00 a.m.
Witnesses include: Tonya Ingram, Patient Waiting for a Transplant; Dara Kass, Living Donor and Mother of Transplant Recipient; LaQuayia Goldring, Patient Waiting for a Transplant; Steve Miller, CEO, Association for Organ Procurement; Joe Ferreira, President Association for Organ Procurement; Matt Wadsworth, President, CEO, Life Connection of Ohio; Seth Karp, MD, Director, Vanderbilt Transplant Center; and Donna Cryer, President, CEO, Global Liver Institute.
House Energy and Commerce Health Subcommittee
Negotiating a Better Deal: Legislation to Lower the Cost of Prescription Drugs
May 4, 11:30 a.m.
Legislation to be considered:
· H.R. 3, the "Elijah E. Cummings Lower Drug Costs Now Act"
· H.R. 19, the "Lower Costs, More Cures Act of 2021"
· H.R. 153, the "Protecting Consumer Access to Generic Drugs Act of 2021"
· H.R. 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" or the "BIOSIM Act"
· H.R. 2831, the "Prompt Approval of Safe Generic Drugs Act"
· H.R. 2843, the "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" or the "STOP GAMES Act"
· H.R. 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under Part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes
· H.R. 2853, the "Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021" or the "BLOCKING Act"
Witnesses include: Therese Ball, patient; Michael Carrier, Distinguished Professor of Law, Rutgers Law School; Rachel Sachs, Associate Professor of Law, Washington University in St. Louis School of Law; Gaurav Gupta, M.D., Founder, Ascendant BioCapital; and Khrystal Davis, Rare Disease Caregiver & Patient Advocate, Texas Rare Alliance Founding President.
Education & Labor HELP Subcommittee
Lower Drug Costs Now: Expanding Access to Affordable Health Care
May 5, 12:00 p.m.
Energy & Commerce Communications and Technology Subcommittee
Broadband Equity: Addressing Disparities in Access and Affordability
May 6, 11:30 a.m.
Oversight and Reform Committee
May 18, 10:00 a.m.
Senate
None of note.
OTHER HEALTH POLICY NEWS
On April 26, 100 investor groups called for nursing home companies to increase staffing levels, boost staff pay, offer paid sick leave, improve resident safety programs and allow staff members to unionize.
On April 26, Colorado Governor Jared Polis (D) signed S.B. 123 which would allow the state to expand the state’s drug importation program to other nations other than Canada, if the federal government authorizes it.
On April 27, Kaiser Family Foundation (KFF) issued two reports entitled How Lowering the Medicare Eligibility Age Might Affect Employer-Sponsored Insurance Costs and Health Spending for 60-64 Year Olds Would Be Lower Under Medicare Than Under Large Employer Plans. The analysis found that lowering Medicare eligibility age from 65 to 60 could significantly reduce health spending for employers and could also have a downward effect on total national health spending due to the lower prices paid in Medicare versus private insurance.
On April 27, United States of Care released recommendations for CMMI, including: testing whether using doulas or midwives reduces maternal mortality, investigating whether more providers would accept Medicaid if it could pay at Medicare rates, and developing models for more in-home care for people with disabilities
On April 27, the American Clinical Laboratory Association called for the Biden Administration to strengthen public-private partnerships to prepare for future public health threats, support return to care, address persistent health disparities, protect seniors’ access to testing, and establish appropriate and clear pathways for test development and regulation.
On April 28, Pew Charitable Trusts urged the Administration and HHS to permanently rescind the Securing Updated and Necessary Statutory Evaluations Timely rule and other HHS policies do very little to advance transparency, efficiency, or accountability within FDA, including: the final rule mandating job reviews be conducted every five years for FDA Center Directors, and the inability for FDA could not require premarket review of lab-developed tests. Pew called for legislation to update FDA’s regulatory oversight of diagnostic tests and to provide regulatory certainty.
On April 29, KFF and the Purchaser Business Group on Health released a report surveying corporate executives on their view on the costs of health care and health coverage, and the potential advantages and disadvantages of increasing the government’s role in providing health coverage and reducing costs. The report found significant concerns regarding health care costs and identified varying factors contributing to rising costs, including the cost of prescription drugs, provider market consolidation and increased market power, volume-based payments, and unhealthy behaviors. A majority of respondents advocated for greater government roles in providing coverage and addressing health care costs, including creating a public option for employees and lowering the Medicare eligibility age. The survey also found that a majority of respondents supported capping hospital prices in non-competitive markets, limiting out-of-network charges, negotiating or limiting drug prices in certain cases, increasing transparency of prices and costs, and increasing antitrust enforcement or otherwise address non-competitive conduct.