Health Care Watch: September 20, 2021
The following FHP Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from September 13 – September 18. 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 September 13-15, the Energy & Commerce Committee held a markup of its legislative proposals in $3.5 trillion budget reconciliation bill, S. Con. Res. 14 the Build Back Better Act. Reps. Scott Peters (D-CA) and Kurt Schrader (D-OR) offered an amendment to the package to include the Reduced Costs and Continued Cures Act, which would limit the subset of drugs in Medicare Part B that would be subject to price controls, relative to H.R. 3, the Lower Drug Costs Now Act, which was under consideration by the committee. Reps. Kathleen Rice (D-NY), Peters, and Schrader opposed H.R. 3’s inclusion in the committee’s package, dealing a significant setback to Democrat chances to move the reconciliation bill and likely delaying its consideration for six to eight weeks. The committee’s health legislative language is available here:
Subtitle E: Recommendations Relating to Drug Pricing;
Subtitle F: Recommendations Relating to the Affordable Care Act (ACA);
Subtitle G: Recommendations Relating to Medicaid;
Subtitle H: Recommendations Relating to the Children’s Health Insurance Program (CHIP);
Subtitle I: Recommendations Relating to Medicare;
Subtitle J: Recommendations Relating to Public Health; and
Subtitle N: Recommendations Relating to Manufacturing Supply Chain.
All amendments and bill texts are available here. A summary of the legislation can be found here.
On September 14, the Select Subcommittee on the Coronavirus Crisis released additional documents from the Committee’s investigation into the former Trump Administration’s response to COVID-19, including emails showing that the Administration failed to heed early warnings of COVID-19 and emails from personal accounts pushing unproven scientific treatments and other White House related business. The Committee also sent a letter to former White House Office of Manufacturing and Trade Policy Director Peter Navarro regarding the federal government’s response to COVID-19 and issues obtaining critical supplies.
On September 14-15, the Ways & Means Committee continued to markup its legislative proposals in S. Con. Res. 14 the Build Back Better Act, the $3.5 trillion budget resolution. Following the Energy & Commerce Committee failing to pass H.R. 3 out of committee, the Ways & Means Committee successfully advanced the legislation and voted to make expanded ACA premium subsidies permanent. Health care related sections are available here:
Part 1 of Subtitle E: Budget Reconciliation Legislative Recommendations Relating to Pathways to Health Careers
Part 3 of Subtitle E: Budget Reconciliation Legislative Recommendations Relating to Skilled Nursing Facilities
Part 4 of Subtitle E: Budget Reconciliation Legislative Recommendations Relating to Medicare Dental, Hearing, and Vision Coverage
Committee Print Consisting of Subtitles F, G, H, and J: Budget Reconciliation Legislative Recommendations Relating to Infrastructure Financing, Green Energy, Social Safety Net, and Prescription Drugs
Amendment in the nature of a substitute to add Subtitle I, Legislative Recommendations Relating to Funding Our Priorities
House returns for votes on September 20.
Senate
On September 13, Sen. Joe Manchin (D-WV) voiced his support for a $1 trillion to $1.5 trillion reconciliation package. Budget Chair Bernie Sanders (I-VT) disagreed with the $1.5 trillion ceiling, saying that progressives had already compromised enough. Sen. Kyrsten Sinema (D-AZ) also voiced concern with the package’s price tag. Sen. Sanders noted that the Senate Democrats are considering including $1,000 Medicare vouchers to be used for dental care as the benefit would take time to implement. Sen. Mark Warner (D-VA) also threatened that he could vote against the budget package if additional housing assistance funding is not added.
On September 15, Sens. Raphael Warnock (D-GA), Tammy Baldwin (D-WI), and Jon Ossoff (D-GA) called for Senate leadership to include provisions to address the Medicaid coverage gap and provide a fix for non-expansion states in the Senate version of the budget reconciliation package.
The Senate will return for votes on September 20.
NON-CORONAVIRUS REGULATORY UPDATE
On September 13, the Centers for Medicare & Medicaid Services (CMS) announced that it will withdraw the Notice of Funding Opportunity for the Emergency Triage, Treat, and Transport (ET3) Model due to an insufficient number of applications.
On September 13, CMS issued a notice of proposed rulemaking entitled Medicare Coverage of Innovative Technology (MCIT) and Definition of Reasonable and Necessary. The rule proposes to fully repeal the Trump-era final rule that created a new MCIT expedited coverage pathway for Breakthrough Devices and codified the definition of “reasonable and necessary.” Comments are due October 15.
On September 13, the Substance Abuse and Mental Health Services Administration (SAMHSA) awarded $123 million in grant funding to support communities and health care providers in combating the overdose epidemic.
On September 14, the U.S. Census released a report finding that private health insurance coverage declined during the COVID-19 pandemic for adults aged 19 to 64. Americans with private insurance decreased by one percentage-point to 54.5% of adults and Americans with Medicaid increased slightly to 17.8% in 2020. The report found that 8.6% of Americans did not have health insurance in 2020. The Census noted that disparities in insurance coverage between racial and ethnic groups widened. A summary of the report is available here.
On September 15, the Federal Trade Commission (FTC) held a meeting discussing privacy breaches by health apps and other connected devices, large technology platforms’ unreported acquisitions, procedural rules and processes to receive public input on rulemaking petitions by external stakeholders, and rescinding the Vertical Merger Guidelines and the Commentary on Vertical Merger Enforcement. The FTC voted 3-2 to rescind 2020 vertical merger guidelines, allowing the FTC to challenge mergers between companies that are not direct competitors. The FTC will work with the Justice Department to create updated guidelines.
On September 15, the U.S. Department of Health & Human Services (HHS) released a report that more than 2.8 million people enrolled in health insurance during the 2021 Special Enrollment Period through HealthCare.gov and State-based Marketplaces. Total ACA enrollment since 2014 reached 12.2 million. A summary infographic is available here. A summary of the report is available here.
On September 15, CMS published the Long-Term Care Hospital September 2020 to September 2021 Continuity Assessment Record and Evaluation Data Set Quarterly Q&As and the Inpatient Rehabilitation Facility Patient Assessment Instrument Quarterly Q&A to clarify existing guidance.
On September 15, the Food & Drug Administration (FDA) and the European Medicines Agency (EMA) launched a pilot program to expand the Parallel Scientific Advice program for new drugs and biological products and provide parallel scientific advice to applicants of abbreviated new drug applications for FDA’s complex generic drug products and of marketing authorization applications for EMA’s hybrid products.
On September 15, CMS published three FAQs maintaining that CMS will not take enforcement action against payers for the payer-to-payer data exchange provision of the May 2020 Interoperability and Patient Access final rule until future rulemaking is finalized.
On September 16, Health Resources & Services Administration (HRSA) awarded $48 million through the HHS’ Ending the HIV Epidemic in the U.S initiative, to expand HIV prevention and treatment, including pre-exposure prophylaxis related services, outreach, and care coordination.
On September 16, a study published in the JAMA Internal Network found that 60% of nursing home staff and 81.4% of residents were fully vaccinated, on average. The study noted that nonprofit and nonchain nursing homes, facilities with higher Medicare star ratings, and facilities with longer-tenured staff had greater vaccine coverage.
On September 16, the Justice Department filed a motion to block the Purdue Pharma bankruptcy settlement due to the legal immunity the settlement allows.
On September 17, the FDA issued guidance entitled Questions and Answers on Biosimilar Development and the Biologics Price Competition and Innovation Act of 2009.
On September 17, CMS extended the open enrollment period an extra 30 days which will run from November 1, 2021 through January 15, 2022, on HealthCare.gov. CMS also expanded services provided by Federally-facilitated Marketplace Navigators and will re-launch its Champions for Coverage program to support organizations providing outreach and education about the Health Insurance Marketplace and how consumers can enroll in coverage through HealthCare.gov, Medicaid, or CHIP. A fact sheet regarding these extensions is available here.
The Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) will hold a public meeting on September 22 to examine relevant health outcomes in studies for cerebrovascular disease treatment, with a particular focus on new technologies of interest to CMS.
The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices will hold a meeting on September 29 and 30 to review and revise the list of vaccines for administration to vaccine-eligible children through the Vaccines for Children program.
NON-CORONAVIRUS WHITE HOUSE UPDATE
On September 13, President Biden nominated Alvaro Bedoya as a FTC Commissioner.
On September 16, President Biden nominated Robert Otto Valdez as HHS Assistant Secretary for Planning and Evaluation.
CORONAVIRUS UPDATE
House
On September 14, Select Subcommittee on the Coronavirus Crisis Ranking Member Steve Scalise (R-LA) and Oversight and Reform Committee Ranking Member James Comer (R-KY) sent a letter to FDA Acting Commissioner Janet Woodcock regarding potential political interference with FDA and CDC by the Biden Administration regarding COVID-19 vaccine booster shots.
On September 15, Oversight Reform Committee Ranking Member Comer requested that the Office of the Director of National Intelligence publicly release documents regarding the origins of COVID-19.
Senate
None of note.
Regulatory
On September 12, U.S. Surgeon General Vivek Murthy argued that the new Occupational Safety and Health Administration COVID-19 vaccine requirements for companies with 100 workers or more are an appropriate legal measure that follow traditional safety requirements in schools and workplaces.
On September 13, HHS published a notice entitled Ninth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19. This notice allows licensed pharmacists, qualified pharmacy technicians and pharmacy interns to administer COVID-19 therapeutics authorized, approved or cleared by the FDA under the Public Readiness and Emergency Preparedness Act. Pharmacists may also order these therapies in addition to administering them.
On September 14, the Army announced that all active-duty units are to be fully vaccinated by December 15. Reserve and National Guard members must be fully vaccinated by June 30, 2022.
On September 14, HHS and the Department of Defense bought 1.4 million additional doses of Regeneron's COVID-19 monoclonal antibody treatments and took over the state distribution to more evenly distribute the 150,000 doses that the government makes available each week to states.
On September 15, the CDC awarded the Association of Public Health Laboratories $282 million over five years to help strengthen the capacity of U.S. public health laboratories.
On September 15, the National Institutes of Health (NIH) announced $470 million in funding for the NIH REsearching COVID to Enhance Recovery (RECOVER) Initiative to support a national network of large-scale studies on “long-COVID”, aligning efforts by new studies and expanding existing long-running studies.
On September 16, FDA revised the emergency use authorization (EUA) for COVID-19 monoclonal antibody therapy bamlanivimab and etesevimab to allow the treatment to be used as a preventative therapy for those over 12 years old who are at high risk for progression to severe COVID-19.
On September 16, the FDA issued revised guidance on the enforcement of policy for face masks, barrier face coverings, face shields, surgical masks, and respirators during COVID-19.
On September 17, the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) held a meeting to discuss Pfizer’s COVID-19 vaccine boosters for those 16 and older. VRBPAC members voted 16-3 to advise the agency against approving the booster dose for the 16 and older group. The Committee then reconvened to consider whether the data support administering a booster to individuals 65 years and older and people who are at high risk of severe COVID-19. VRBPAC members voted 18-0 in favor of authorizing boosters for the 65 and older group and indicated they would consider boosters for additional populations as more data is collected. A briefing document on the meeting is available here.
On September 17, the CDC announced $2.1 billion in funding to strengthen state, local, and territorial public health departments and other health care organizations to improve infection prevention and control activities, including combating COVID-19 and other known and emerging infectious diseases.
On September 17, the CDC released a study that found a range of vaccine effectiveness against COVID-19 hospitalization: the Moderna vaccine reached 93% efficacy, the Pfizer vaccine reached 88% efficacy, and the Johnson & Johnson vaccine reached 71% efficacy.
The CDC Advisory Committee on Immunization Practices is holding a meeting on September 22 and 23 to discuss COVID-19 vaccine boosters.
White House
Reports indicate that at the upcoming Global COVID-19 Summit hosted by the U.S. on September 22, President Biden will urge world leaders to pledge to expand the COVID-19 vaccine supply and essential medical supplies; solve logistical challenges; support administration arms; reduce vaccine hesitancy; and provide sustainable financing, capacity, and global leadership to improve prevention, detection, and response of COVID-19 and for future biological threats.
On September 14, the Biden Administration announced that federal employees and contractors must be fully vaccinated against COVID-19 no later than November 22.
Other
On September 13, a study published in the Lancet by two senior FDA officials and the World Health Organization concluded that COVID-19 vaccine boosters are not needed for the general public at this time, referencing studies that support continued efficacy of COVID-19 vaccines.
On September 14, Pfizer’s Chief Financial Officer Frank D'Amelio predicted that Pfizer could apply for FDA approval of its COVID-19 vaccine for kids under five in November.
On September 14, Arizona Attorney General (AG) Mark Brnovich filed a lawsuit against the Biden Administration regarding the COVID-19 vaccine mandate for private employers with 100 or more employees. On September 16, 24 AGs voiced their opposition to vaccine mandates.
On September 15, additional data was released that found that the Moderna COVID-19 vaccine is highly effective against circulating variants but found a higher rate of breakthrough cases in those who received shots early. Moderna announced that it will pursue EUA for its COVID-19 booster, rather than full FDA approval.
On September 15, a study published in the New England Journal of Medicine on the Pfizer COVID-19 vaccine booster’s effectiveness in Israel for those 60 and older found that the booster dose significantly decreased COVID-19 infections and severe illness for a few weeks following the third dose, but may not indicate long-term benefit.
On September 16, Canada fully approved Moderna’s COVID-19 vaccine for children 12 and older.
As of September 18, nearly 212 million people in the U.S. have received the first dose of COVID-19 vaccines (more than 180 million have received both doses) and more than 464 million doses have been distributed, according to the CDC COVID Data Tracker.
As of September 18, the U.S. had more than 42 million confirmed COVID-19 cases resulting in 671,883 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center.
RULES AT THE WHITE HOUSE OMB
HHS-CMS
Patient Protection and Affordable Care Act; Updating Payment Parameters and Improving Health Insurance Markets for 2022 and Beyond (CMS-9906); Final Rule; 8/19/21
HHS-FDA
Medical Device De Novo Classification Process; Final Rule; 6/28/21
Medical Devices; Ear, Nose and Throat Devices; Establishing Over-the-Counter Hearing Aids and Aligning Other Regulations; Proposed Rule; 8/18/21
Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Notice; 8/18/21
Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Revised Draft Guidance for Industry; Availability; Notice; 8/31/21
Rescission of the Final Rule entitled "Implementation of Executive Order on Access to Affordable Life-Saving Medications"; Final Rule; 9/9/21
HHS-Office of the Secretary
Securing Updated and Necessary Statutory Evaluations Timely; Proposed Rule; 8/31/21
Streamlining HHS Guidance Practices; Proposed Rule; 6/28/21
Department of Labor-Employee Benefits Security Administration
Requirements Related to Surprise Billing, Part 2; Interim Final Rule; 8/2/21
REPORTS
HHS Office of Inspector General (OIG)
On September 16, OIG released an audit entitled HHS Needs to Improve Contingency Planning Oversight of its IT Systems. Due to the COVID-19 public health emergency (PHE) and increased cyber-activity, OIG is only posting the title of cybersecurity audits.
Government Accountability Office (GAO)
On September 16, GAO released a report entitled Chronic Health Conditions: Federal Strategy Needed to Coordinate Diet-Related Efforts. The report found that preventable chronic health conditions, including cardiovascular diseases, cancer, diabetes, and obesity, are linked to diet and are prevalent, deadly, and costly. For example, 42% of adults had obesity in 2018, a 19% increase from 2009. Cardiovascular diseases, cancer, and diabetes accounted for 50% of all annual deaths in the U.S. Government spending, including health care spending through Medicare and Medicaid, to treat cardiovascular disease, cancer, and diabetes, accounted for 54% of the $383.6 billion in spending to treat these conditions. GAO identified 200 federal efforts related to diet across 21 agencies for reducing Americans' risk of chronic health conditions, which fall into the following categories: research, education and clinical services, food assistance and access, and regulatory action. GAO recommended for Congress to consider identifying and directing a federal entity to lead development and implementation of a federal strategy for diet-related efforts aimed at reducing Americans' risk of chronic health conditions. A summary of the report is available here.
UPCOMING CONGRESSIONAL HEARINGS
House
Energy & Commerce Oversight and Investigations Subcommittee
Hearing on “Putting Kids First: Addressing COVID-19’s Impacts on Children”
September 22, 10:30 a.m., 2123 Rayburn House Office Building
Energy & Commerce Committee
TBD
Hearing on the Future of Biomedicine: Translating Biomedical Research into Personalized Health Care
Senate
Finance Committee
September 22, 10:00 a.m., 215 Dirksen Senate Office Building
OTHER HEALTH POLICY NEWS
On September 14, the Kaiser Family Foundation released a report estimating that between June and August 2021, over 280,000 COVID-19 hospitalizations among unvaccinated adults cost the health care system over $5.7 billion. These estimates do not include the cost of outpatient treatment.
On September 15, the Urban Institute released a report estimating that by the end of 2021, 17 million more nonelderly people will be enrolled in Medicaid than before COVID-19, and that the number of Medicaid enrollees could decline by about 15 million people in during 2022 after the PHE is expected to expire.