Carter L. Alleman, J.D.
Week of December 21, 2020
Pfizer COVID Vaccine Receives EUA
Pfizer Inc.’s coronavirus vaccine has received an emergency use authorization (EUA) from the Food and Drug Administration (FDA). Operation Warp Speed official Army Gen. Gustave F. Perna stated over the weekend that the first vaccines will be distributed today, echoing earlier remarks by U.S. Department of Health and Human Services (HHS) Secretary Alex Azar.
The FDA’s advisory panel voted to back the Pfizer shot by a vote of 17 to 4, with one abstention, earlier in the week – signaling that the benefits of the product outweigh the risks for individuals age 16 and older. Much of the panel’s discussion centered on whether there was enough evidence to support the vaccine’s use in 16 and 17 year olds. The Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) voted during an emergency meeting on Saturday to recommend that people age 16 and older receive the Pfizer vaccine. ACIP recommended that care providers monitor people with a history of anaphylaxis for 30 minutes after giving them a shot. The group also recommended letting pregnant women, lactating women, and immunocomprised people decide whether to get a vaccine given the lack of specific data on how it performs in these populations.
Defense officials announced that a group of senior leaders, including Defense Secretary Chris Miller, will be the first in the military to receive a COVID-19 vaccine as a part of an effort to build confidence in a vaccine and encourage other personnel to get the shot. The Pentagon is currently preparing to accept the first doses of the Pfizer vaccine and to distribute it to high priority officials, who are likely to include Deputy Defense Secretary David Norquist, Joint Chiefs Chairman Gen. Mark Milley, Vice Chairman Gen. John Hyten, and Senior Enlisted Adviser Ramón Colón-López. While the vaccine will initially be voluntary while it is under EUA, Pentagon officials have stated that once full approval is granted by the FDA that the department may require mandatory vaccination.
The FDA’s advisory panel will meet on December 17 to evaluate Moderna’s vaccine, and ACIP will next meet on December 18 and 20 to discuss vaccine distribution.
Compromise Reached on Surprise Billing Fix
Last Friday, key congressional lawmakers released legislative text and a summary of their negotiated agreement to protect patients from surprise insurance gaps and end surprise medical billing. All four health care committees of jurisdiction – led by House Ways and Means Chair Richard Neal (D-Mass.), House Energy and Commerce Chair Frank Pallone (D-N.J.), House Education and Labor Chair Bobby Scott (D-Va.), and Senate Health, Education, Labor, and Pensions (HELP) Chair Lamar Alexander (R-Tenn.) – have agreed to the proposal, which would use an independent dispute resolution (IDR) process without benchmark pay rates to resolve disputes over out-of-network bills between providers and payers. The arbiter would be directed to consider the median in-network payment rate for the service in question, information related to the providers’ experience, the complexity of the service, and the market share of the parties and their previous contracting history. The IDR would be binding, and there would be no monetary threshold for seeking arbitration.
Patients would be held harmless from surprise medical bills and only be responsible for the in- network payment rate, unless they are notified about receiving out-of network services 72 hours before receiving care. The agreement includes provisions to improve the accuracy of provider directory information. Also, a ban on air ambulance surprise bills is included in the deal. The legislation would extend mandatory funding for community health centers, the National Health Service Corps, and the Teaching Health Center Graduate Medical Education Program at current levels through fiscal year (FY) 2024. House Speaker Nancy Pelosi (D-Calif.) has said she will push for the measure’s passage before the end of the year, but it remains unclear whether Senate Majority Leader Mitch McConnell (R-Ky.) will support the inclusion of the measure in a year-end legislative package.
Government Funding Deadline Extended to Dec. 18; Ongoing Negotiations on COVID Package
In advance of the December 11 deadline, Congress passed a one-week stop-gap spending bill, extending the deadline for funding the federal government for fiscal year (FY) 2021 until December 18. Negotiators are still trying to reach a deal on a roughly $1.4 trillion omnibus package that would include all 12 appropriations bills. Lawmakers also continue to negotiate a bipartisan coronavirus relief bill, which may be attached to the appropriations package. An agreement was reportedly reached on Sunday evening to vote on employer liability protections and state and local government aid provisions as a separate bill. If the agreement holds, the larger of the two proposals would include $748 billion for enhanced unemployment insurance, small business relief, and vaccine distribution funding, while the separate $160 billion measure would contain liability protections and state and local government aid. Complete details of each measure are expected to be released soon. Treasury Secretary Steven Mnuchin made his own $916 billion proposal on behalf of Republicans last week that was rejected by Democrats for failing to include additional money for supplemental unemployment benefits.
Senators Josh Hawley (R-Mo.) and Bernie Sanders (I-Vt.) have warned that they will use the funding deadline to force a vote on a second round of stimulus checks for individuals. Their proposal would provide a $1,200 check to individuals making up to $75,000. House Majority Leader Steny Hoyer (D-Md.) has advised members that pending an agreement on the omnibus and further coronavirus relief legislation, votes in the House could occur as early as 6:30 p.m. on Tuesday. No votes are expected in the House until agreement has been reached on the omnibus or coronavirus legislation.
HHS Finalizes Rule on 340B Disputes
HHS published a final rule instructing the Secretary to assemble representatives from key agencies, including the Centers for Medicare and Medicaid Services (CMS) and the Health Resources and Services Administration (HRSA), to resolve disputes in the program between hospitals or clinics and pharmaceutical manufacturers. The Affordable Care Act (ACA) called for the development of a process to address such disputes, but this is the first effort that has been taken to fulfil that requirement.
President Continues Push for $200 Drug Discount Cards
Work continues on a revised version of President Trump’s proposal to send Medicare beneficiaries $200 in drug discount cards. The plan would send a letter to 39 million beneficiaries within the next week, with the drug-discount cards being distributed later in December and in January. The plan was circulated inside the administration last week with instructions to expedite its approval. The Special Interest Group for Inventory Information Approval System Standards (SIGIS), which works with the Internal Revenue Service (IRS) to set the standards for health benefit cards, has raised concerns that the plan is not aligned with other regulated discount cards used for medical goods and services because the White House intends the cards to be used exclusively for drugs. The Trump administration, however, continues to urge SIGIS to reconsider its position and disregard the regulations in question.
New Bipartisan Stimulus Plan Gains Momentum; Congress Likely to Pass a Stopgap CR
A bipartisan group of lawmakers from the House and Senate have drafted a $908 billion coronavirus stimulus plan that they are pushing to pass before the end of the year. The legislation is designed to provide coronavirus relief through March. It includes nearly $300 billion in support for small businesses and the Paycheck Protection Program (PPP), $160 billion in aid for state and local governments, and $180 billion to extend pandemic unemployment benefits. Vaccines, testing, and tracing would get $16 billion, and $35 billion is allocated to the provider relief fund. An additional $5 billion would be set aside for opioid treatment. The proposal includes a short-term moratorium on COVID-19 related liability lawsuits.
The proposal is supported by House Speaker Nancy Pelosi (D-Calif.) and Senate Minority Leader Chuck Schumer (D-N.Y.), who have backed down from their prior insistence on a much larger $2.4 trillion relief bill. They have characterized the bipartisan proposal as the baseline for negotiations with congressional Republicans and the White House. The Democratic leaders hope to combine the relief measure with a fiscal year (FY) 2021 omnibus spending package.
Senate Majority Leader Mitch McConnell (R-Ky.) responded by circulating his own package, a slightly revised update of his previously introduced $500 billion plan. The bill includes $333 billion in spending on business subsidies, plus funding for schools, vaccines, and agriculture. It also includes legal liability protections and a one-month extension of pandemic unemployment relief followed by a two-month phase out. Neither proposal has been released in legislative form. It is not clear whether President Trump would sign any measure beyond the $500 billion bill proposed by Senate Majority Leader Mitch McConnell (R-Ky.). President-elect Joe Biden has endorsed passage of the $908 billion package during the lame-duck session as a “down payment” on a more comprehensive bill he wishes to sign into law next year.
ACIP Makes Recommendations for COVID Vaccine Prioritization; Other Key Vaccination Plans
The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has made its formal recommendations for determining the allocation of an eventual coronavirus vaccine, deciding that health care workers and residents of long-term care facilities should be first in line to receive the vaccine. The recommendations for phase 1a of vaccine distribution passed by a vote of 13-1. On Thursday, CDC Director Robert Redfield accepted the recommendations, making them officially CDC guidance. ACIP will discuss other high-priority groups – phase 1b – later this month, after the FDA reviews the emergency use authorization (EUA) for its first vaccine and late-stage trial data is available for review. The panel expects most jurisdictions to be able to vaccinate every health care worker within three weeks of receiving initial vaccine doses. The first doses will be targeted toward those with direct patient contact.
The Food and Drug Administration (FDA) is targeting authorization of the Pfizer/BioNTech and Moderna vaccines about a week after they are reviewed by the agency’s advisory committee. The Pfizer/BioNTech vaccine will be reviewed by the advisory panel on December 10, followed by Moderna’s vaccine on December 17. A CDC official told ACIP that there will likely be 5 to 10 million doses a week once a vaccine is authorized. The first shipments of Pfizer’s vaccine could be delivered as early as December 15, while the first shipment of Moderna’s vaccine could be delivered on December 22.
States will still have the authority to make their own prioritizations in determining their vaccine distribution plans. Some states have decided to defer to health care providers about who should receive the initial doses of coronavirus vaccine, arguing that hospitals and the health care industry best understand the populations most at risk for the virus. Kentucky, Mississippi, and New York are asking hospitals to develop a tiering system to decide which employees will be first to receive the vaccine.
Lawmakers Push to Make Telehealth Changes Permanent; Other Telehealth Information
A bipartisan, bicameral group of more than four dozen lawmakers have sent a letter to congressional leadership calling for legislation to make permanent expanded coverage of Medicare telehealth services. The letter argues that extending temporary coverage expansions instituted in response to the COVID-19 pandemic would provide much-needed certainty about Medicare telehealth coverage for health care providers and improve access to care for patients. The letter was led by Senator Brian Schatz (D-Hawaii). The members of congress express support for the inclusion of immediate action to permanently waive geographic restrictions for originating sites, authorize health centers in rural and underserved areas to provide telehealth, and to allow beneficiaries to use telehealth in their homes in end of the year legislation.
In related news, the U.S. Department of Health and Human Services (HHS) has decided that telehealth services can be offered across state lines during the COVID-19 public health emergency (PHE), regardless of state and local regulations. The declaration, which was made under the Public Readiness and Emergency Preparedness Act (PREP Act), gives immunity to health care providers using treatments authorized by the Food and Drug Administration (FDA) to combat COVID-19. It also expands the number of providers able to administer vaccines by modifying and clarifying the training requirements for pharmacists, pharmacy interns, and pharmacy technicians pursuant to the PREP Act.
Democratic Staff Report on COVID-19 in Behavioral Health Centers
House Oversight and Reform Chair Carolyn Maloney (D-N.Y.), Representative Katie Porter (D-Calif.), and Senator Elizabeth Warren (D-Mass.) have released a staff report investigating coronavirus outbreaks in behavioral health and addiction treatment programs. The probe found that 14 percent of facilities had experienced COVID-19 outbreaks of 10 or more cases, which is comparable to the rate of infection for the general population. The report expresses concerns, however, about the limited testing capabilities in such facilities.
GAO Releases Latest Report on COVID-19
The Government Accountability Office (GAO) has released a report detailing the concerns of many states that they will not have adequate supplies to administer an eventual COVID-19 vaccine. The report also details the issues states continue to face regarding a deficit of testing materials. The GAO makes recommendations for states to ensure an adequate supply of coronavirus testing and personal protective equipment (PPE), improve safety in nursing home settings, and to make decisions around vaccines and public-health guidance more transparent. The report makes 11 recommendations and one suggestion for Congress to consider.
CDC Updates Coronavirus Guidance
The Centers for Disease Control and Prevention (CDC) has updated its guidance to reduce the quarantine time for individuals exposed to the coronavirus. The agency previously recommended that people who have been exposed should stay home for 14 days after their last contact with a COVID-19 positive individual. The new recommended quarantine time would be seven days for those who test negative (with the test performed on day 5 after exposure or later), and 10 days for those who do not take a test. The CDC also issued new guidance recommending universal face mask use to mitigate the impact of COVID-19, as well as guidelines for reducing travel risks.
HHS Issues Regulation on Significant Guidance Documents
The U.S. Department of Health and Human Services (HHS) has finalized a rule in line with current law underscoring that regulatory guidance cannot impose binding legal obligations. Under the final rule, HHS must publish significant guidance documents – those with an annual effect of at least $100 million on the economy, or those raising a new legal or policy issue – through notice-and-comment rulemaking. Guidance must include certain uniform information, including the entities to which it applies, the issue date, and the applicable statutes or regulations. All guidance documents will be posted in an online, searchable portal, and the guidance documents that are not included in the portal within 30 days of publication of the rule will be considered rescinded. The Department will also establish a process through which to petition the correction of unlawful guidance.
Democratic leadership of the House Ways and Means Committee have sent a letter criticizing a regulation from the U.S. Department of Health and Human Services (HHS) that would require older regulations to be reviewed or automatically expire. “This sweeping and improper change would waste resources, undermine smooth program operation, and force the next administration to divert resources away from addressing the COVID-19 pandemic,” Health Subcommittee Chair Lloyd Doggett (D-Texas), Oversight Subcommittee Chair Bill Pascrell (D-N.J.), and Worker and Family Support Subcommittee Chair Danny Davis (D-Ill.) write. They ask Secretary Alex Azar to immediately rescind the notice of proposed rulemaking (NPRM).