Hart Health Strategies provides a comprehensive policy briefing on a weekly basis. This in-depth health policy briefing is sent out at the beginning of each week. The health policy briefing recaps the previous week and previews the week ahead. It alerts clients to upcoming congressional hearings, newly introduced bills, regulatory announcements, and implementation activity related to the Patient Protection and Affordable Care Act (PPACA) and other health laws.


Supreme Court Rules on Vaccine Mandates

Last week, the Supreme Court blocked the enforcement of the administration’s vaccine-or-testing mandate for large employers, while allowing the Centers for Medicare and Medicaid Services (CMS) to implement a rule requiring vaccination among health care workers at federally funded facilities for the 25 states subject to the preliminary injunction. Many Republicans on Capitol Hill were quick to praise the Supreme Court’s decision, including Senate Minority Whip John Thune (R-S.D.) and Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Richard Burr (R-N.C.), who highlighted the pressure placed by the vaccine mandate on an already strained supply chain and labor market. These remarks were echoed by House Energy and Commerce Committee Ranking Member Cathy McMorris Rodgers (R-Wash.), who also stated that GOP Energy and Commerce panel members still plan to lead a Congressional Review Act (CRA) resolution to nullify the health care worker mandate. The resolution was introduced by Rep. Jeff Duncan (R-S.C.) on December 9.

Concerning the health care mandate, Texas is the only state in the country that does not have to comply with the rule. In light of that, the Biden administration has filed a notice to appeal a preliminary injunction granted by the U.S. District Court for the Northern District of Texas. Through its ruling, the Supreme Court lifted injunctions in two separate cases that had blocked the mandate from the Centers for Medicare and Medicaid Services (CMS) in 24 states, determining that Congress has authorized the agency to protect the health and safety of Medicare and Medicaid recipients. Facilities in the 24 states impacted have until March 15 to implement the vaccine requirement for their employees, while facilities in the 25 states not involved in the litigation have until February 28 to ensure employees are fully vaccinated.

Please see here for a resource document related to the mandates that Hart Health Strategies will continue to update as new information becomes avaialble.

Senate to Consider Voting Legislation this Week

Majority Leader Chuck Schumer (D-N.Y.) announced last week that the Senate would postpone its scheduled recess to vote on voting rights legislation in the coming days. If the measure is blocked by Republicans, as expected, the chamber will vote on changing the Senate’s rules. Sens. Joe Manchin (D-W.Va.) and Kyrsten Sinema (D-Ariz.), however, remain opposed to the elimination of the 60-vote threshold to enable passage of this legislation with a simple majority. President Joe Biden called on the Senate to change its rules to allow a simple majority to pass voting rights legislation during a trip to civil rights landmarks in Atlanta last week.

HELP Advances FDA Commissioner Nomination

The Senate Health, Education, Labor, and Pensions (HELP) Committee advanced the nomination of Robert Califf to serve as commissioner of the Food and Drug Administration (FDA) in a 13-8 vote. Sens. Bernie Sanders (I-Vt.) and Maggie Hassan (D-N.H.) were the only Democratic members to vote against Califf. Ranking Member Richard Burr (R-N.C.) and Sens. Susan Collins (Maine), Lisa Murkowski (Alaska), and Mitt Romney (Utah) were the only GOP members to back the nominee. Sen. Rand Paul (R-Ky.) was not present for the vote.

Sen. Edward Markey (D-Mass.) has added himself to the list of Democratic senators – which also includes Sens. Richard Blumenthal (D-Conn.), Joe Manchin (D-W.Va.), Bernie Sanders (I-Vt.), and Maggie Hassan (D-N.H.) – who plan to vote against Califf ’s confirmation. Markey cited concerns about the nominee’s ability to address the current substance misuse epidemic and effectively regulate opioid products. Among those currently serving in the Senate are 69 lawmakers who previously voted to confirm Califf to head the FDA during the Obama administration in 2016. His first appointment was approved in an 89-4 vote.

WH Under Pressure from Democrats to Step Up COVID Response

Agroup of more than 40 Democrats have sent a letter to President Joe Biden calling on him to use the power of the executive branch to manufacture enough COVID-19 tests for each American to take one every week. The letter was led by Sen. Bernie Sanders (I-Vt.) and Reps. Adam Schiff (D-Calif.) and Ro Khanna (D-Calif.). A separate group of Senate Democrats penned a letter to the President about the administration’s current state of preparedness and response to the COVID-19 pandemic and the omicron variant. The letter was led by Sen. Jacky Rosen (D-Nev.) and signed by Sens. Joe Manchin (D-W.Va.), Kyrsten Sinema (D-Ariz.), Jon Ossoff (D-Ga.), and Mark Kelly (D-Ariz.). “We ask that you address the steps you have taken to prepare the country for the increase in cases, why the administration failed to take more significant steps earlier to increase access to at-home tests, and how you plan to mitigate the impact of the current and future variants moving forward,” the letter states. The lawmakers also ask the administration if any additional funding is necessary to contain the pandemic. The White House is also under pressure to close the global vaccine gap. Seven Democrats led by Sen. Elizabeth Warren (D-Mass.) and Rep. Jan Schakowsky (D-Ill.) sent a letter last week encouraging the President to immediately mandate transfer of mRNA vaccine technology and to create publicly owned manufacturing facilities to accelerate global production of COVID-19 vaccines. The Biden administration announced that starting on Wednesday, January 19 each residential address can order 4 home tests on a new website, www.COVIDTests.gov.

Lawmakers Praise Aduhelm NCD

The Centers for Medicare and Medicaid Services (CMS) would limit Medicare coverage of Biogen’s Alzheimer’s treatment Aduhelm to patients enrolled in qualifying clinical trials under the agency’s proposed National Coverage Determination (NCD). The move was praised by House Energy and Commerce Committee Chair Frank Pallone (D-N.J.) and Oversight and Reform Committee Chair Carolyn Maloney (D-N.Y.), who are investigating the approval of Aduhelm amidst concerns about the treatment’s safety, efficacy, and cost. The lawmakers also expressed support for the re-evaluation of Medicare Part B premiums based on the NCD and a recent change in the medication’s price. Medicare Part B monthly premiums in 2022 were set to increase, in part due to the originally set annual price of $56,000 for Aduhelm. Biogen recently announced that it would reduce the price by 50% to $28,200.

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