This Week (December 6-10)

House Energy & Commerce hearing on "The Future of Biomedicine: Translating Biomedical Research into Personalized Health Care."

• Detail: Wednesday, December 8, 2021 at 10:30am ET.
• More information available here.

Last Week (November 29-December 3)

Health Care Highlights

Government funding extended through Feb. 18; Medicare cuts not addressed. Congress approved a Continuing Resolution (CR) to fund the government through February 18 this week, averting a government shutdown despite threats from Republican Senators Mike Lee (R-UT) and Roger Marshall (R-KS) to delay a vote over their concerns with President Biden's employer vaccine mandate. An amendment to defund the mandate was voted down during the process. The action takes one pressing item off the Senate's December agenda, which also includes the possible consideration of the Build Back Better Act (H.R. 5376) budget reconciliation bill by Christmas. Tensions over the vaccine amendment and a holdup on the defense authorization bill (H.R. 4350) demonstrated how one or two members can halt progress in the Senate. Majority Leader Chuck Schumer (D-NY) said passing the reconciliation bill won't be easy and there is increasing skepticism about enactment by the end of the year.

The CR includes a bump out of several other items along with government funding, including extension of a temporary scheduling order for fentanyl-related substances (discussed more below), however it does not address upcoming Medicare cuts set to take effect at the beginning of 2021, despite pushback from provider groups. Barring Congressional action, a 2% Medicare sequester cut — which was delayed via pandemic legislation — will go back into effect on January 1, 2021 and pending 4% PAYGO cuts (which have never been allowed to take effect) will also be triggered two weeks following the start of the next Congress. Democrats are "exploring all options to protect these vital programs from senseless cuts," House Budget Committee Chair John Yarmuth (D-KY) said in a statement. "Since the inception of PAYGO, Congress has come together repeatedly on a bipartisan basis to protect vital programs Americans rely on from painful sequestration cuts — and this time should be no different," he said. The House is currently working on a possible short-term package to address the impending cuts, which could also include other limited health priorities. According to the American Hospital Association (AHA), Medicare fee-for-service payments could be reduced by $14.1 billion in 2022 unless there's action by the end of the year to address mandatory spending sequestration and PAYGO requirements. Provider groups are also advocating for an extension of a 3.75% bump to Medicare payments provided during the pandemic period, also set to expire at year-end.

Administration update COVID-19 plan for winter, Omicron variant. On Thursday (Dec. 2), President Biden announced new actions aimed at combatting COVID-19 as the country faces an expected uptick in cases this winter and the emergence of a new variant, Omicron. President Biden called the new variant a "cause for concern, not a cause for panic" and said his administration will combat the pandemic this winter with extensive COVID-19 vaccinations and testing, "not with shutdowns or with lockdowns." The updated strategy largely builds on infrastructure set up over the last several months to accelerate vaccine distribution and encourage more people to get initial doses and booster shots, especially seniors and children. It also includes a new requirement for insurers to cover the cost of at-home COVID-19 tests through guidance the administration plans to issue in January. Earlier in the day, White House press secretary Jen Psaki told reporters that additional details, such as whether the government will reimburse insurers for the costs of at-home tests would be detailed in the January guidance. The plan also urges employers "to move forward expeditiously with requiring their workers to get vaccinated or tested weekly" amid a court-mandated pause in the enforcement of the administration's rule to require employers over 100 to mandate vaccinations or weekly testing. Other actions include requiring Medicaid to pay health care providers to talk to families about getting their kids vaccinated, a review of school COVID-19 prevention policies to avoid unnecessary closures, stricter testing rules for international travelers, and accelerated delivery of vaccines globally, among other items.

The Centers for Disease Control and Prevention (CDC) also updated its guidance on booster shots this week, now recommending that all adults get a booster dose and not just older Americans. An advisory panel to the Food and Drug Administration (FDA) this week also endorsed Merck & Co. and Ridgeback Biotherapeutics LP's COVID-19 antiviral pill for patients at high risk of severe illness, meaning the treatment could be available to patients within weeks if the agency authorizes it. The group's narrow 13-10 vote reflects concerns about the pill's effectiveness.

Biden health care worker vaccine mandate blocked. On Tuesday (Nov. 30), a federal court in Louisiana blocked the Biden administration's vaccine requirement for health care workers across the country, except in the 10 states where the rule has already been paused due to a federal district court ruling in Missouri the day before. The court found that the government lacked the statutory authority to issue the rule and denied the Biden Administration's request for a stay on the preliminary injunction pending an appeal to the Fifth Circuit. The court in Louisiana said it considered limiting the injunction to the 14 states that brought the lawsuit, but said that "there are unvaccinated healthcare workers in other states who also need protection." The lawsuit is one of four challenges to the rule.

CMS pulls "Seriously Ill Population" component to PCF. On Tuesday (Nov. 30), the Center for Medicare and Medicaid Service (CMS) announced that following review, it will no longer implement the Seriously Ill Population (SIP) Component of the Primary Care First (PCF) Model. The SIP Component was originally announced in April 2019 and scheduled to start one year later. However, the Biden Administration placed the implementation of this part of the PCF model on hold in March 2021 pending further review. According to CMS, the review found that the SIP component wouldn't bring in enough beneficiaries to be properly tested.

Hearings and Markups

Energy and Commerce Committee Hearing on the Overdose Crisis. On Thursday (Dec. 2), the Subcommittee on Health of the Committee on Energy and Commerce held a hearing entitled, "The Overdose Crisis: Interagency Proposal to Combat Illicit Fentanyl-Related Substances." In opening the hearing, Chairman Frank Pallone (D-NJ) said that the current temporary scheduling order for fentanyl-related substances will be extended through February 18, 2022 via the CR, but that "it is critical that Congress and this Committee work together in a bipartisan fashion, with the Administration, to put in place a long-term solution." Health Subcommittee Ranking Member Brett Guthrie (R-KY) expressed frustration with his Democratic counterparts on the issue and urged them "to permanently schedule fentanyl analogues" and said the Administration's proposal "misses the mark" due to its failure to impose mandatory minimums on fentanyl analogue traffickers. The Administration's proposal would create a class-wide definition of "fentanyl-related substances" and permanently place them into Schedule I while also creating a mechanism to expedite rescheduling or descheduling of substances as needed.

Education and Labor Committee Hearing on Workers Compensation Programs. On Thursday (Dec. 2), the Subcommittee on Workforce Protections of the Committee on Education and Labor held a hearing entitled, "Strengthening the Safety Net for Injured Workers." The Committee discussed four bills aimed at modernizing worker compensation programs:

• The Federal Fighters Fairness Act (H.R. 2499), which would provide that federal firefighters, who are diagnosed with certain long-term illnesses, would receive a presumption that their illness is deemed work-related under FECA.
• The Longshore and Harbor Workers' COVID-19 Compensation Act (H.R. 3114), which would establish a presumption that maritime workers who were diagnosed with COVID-19 received it at their place of work and ease eligibility for disability compensation and medical benefits.
• The Black Lung Benefits Improvement Act (H.R. 6102), which would help coal miners with disabilities access legal representation, improve access to evidence, adjust benefits for inflation, and reduce the backlog of claims.
• The Improving Access to Workers' Compensation for Injured Federal Workers Act (H.R. 6087), which would expand the number of qualified providers who can provide medical services under FECA.

Reports, Studies, and Journals

Office of the Assistant Secretary for Planning and Evaluation: Medicare Beneficiaries' Use of Telehealth in 2020: Trends by Beneficiary Characteristics and Location. This research report examines changes in Medicare fee-for-service Part B visits and use of telehealth in 2020 during the COVID-19 public health emergency (PHE) by beneficiary characteristics, provider specialty, and location.

Office of the Assistant Secretary for Planning and Evaluation: Evidence on Surprise Billing: Protecting Consumers with the No Surprises Act. This brief provides background information on surprise billing, describes some of the consumer protections in the No Surprises Act that will be available to those who have not been covered by previous state laws, and sketches out the process for resolving claims when there is a dispute between providers and payers.

Urban Institute: In the Years before the COVID-19 Pandemic, Nearly 13 Million Adults Delayed or Did Not Get Needed Prescription Drugs Because of Costs. Nearly 13 million adults delayed or did not get needed prescription drugs in the past year because of the cost, including 2.3 million elderly Medicare beneficiaries and 3.8 million nonelderly adults with private insurance, 1.1 million with Medicaid, and 4.1 million who were uninsured at any point during the year.

Health Affairs: Private Equity Acquisition And Responsiveness To Service-Line Profitability At Short-Term Acute Care Hospitals. As private equity firms continue to increase their ownership stake in various health care sectors in the US, questions arise about potential impacts on the organization and delivery of care. Using a difference-in-differences approach, researchers investigate changes in service-line provision in private equity-acquired hospitals.

———————————————