Health Care Checkup: January 14, 2022

Health Care Checkup

January 14, 2022

THE BIG PICTURE

However, SCOTUS did uphold the CMS vaccine mandate, which requires that workers at health care facilities participating in Medicare and/or Medicaid be fully vaccinated against COVID-19. Following the ruling to uphold CMS’s mandate, CMS Administrator Chiquita Brooks-LaSure said, “CMS is extremely pleased the Supreme Court recognized CMS’s authority to set a consistent COVID-19 vaccination standard for workers in facilities that participate in Medicare and Medicaid. CMS’s vaccine rule will cover 10.4 million health care workers at 76,000 medical facilities. Giving patients assurance on the safety of their care is a critical responsibility of CMS and a key to combatting the pandemic.” The rulings can be found here.

Also on Thursday, the Senate HELP Committee voted 13-8 to advance Robert Califf's nomination as Commissioner of the Food and Drug Administration. The eight Senators who voted against his advancement include Bernie Sanders (I-VT), Maggie Hassan (D-NH), Bill Cassidy (R-LA), Mike Braun (R-IN), Roger Marshall (R-KS), Tim Scott (R-SC), Tommy Tuberville (R-AL) and Jerry Moran (R-KS). Califf previously served as the FDA Commissioner during former President Obama's second term.

This week, Senate Democrats worked on voting rights legislation and a vote is scheduled next week. However, the bill will likely fail as Senators Joe Manchin (D-WV) and Kyrsten Sinema (D-AZ) are opposed to it. On Thursday, lawmakers held a bipartisan gathering in which they discussed a potential government spending bill ahead of the current February 18 deadline when the CR expires. Congressional Democrats are considering adding additional COVID aid to the bill, but it is uncertain if that effort will succeed.

On Tuesday, CMS announced its plans for Medicare coverage of the expensive Alzheimer's drug, Aduhelm, but only for participants of clinical trials. The drug, which was approved conditionally last year by the U.S. Food and Drug Administration, is the only one of its kind due to its ability to remove amyloid, the substance that builds up in Alzheimer's patients. Aduhelm is priced at $28,200 a year and critics have been concerned that it could drain Medicare resources if approved for coverage by the program. According to CMS, to be approved, the clinical trials must be randomized, and participants must have a “clinical diagnosis of mild cognitive impairment (MCI) due to Alzheimer’s Disease (AD) or mild AD dementia and evidence of amyloid pathology consistent with AD.” CMS will accept public comment on the proposal for 30 days and a final decision is expected by April 11. More information can be found here.

Also on Tuesday, the Senate HELP Committee held a hearing on the federal response to the COVID-19 pandemic. The witnesses at the hearing included CDC Director Dr. Rochelle Walensky, NIAID Director Dr. Anthony Fauci, Acting FDA Commissioner Dr. Janet Woodcock, and HHS Assistant Secretary for Preparedness and Response Dawn O'Connell. The hearing delved into criticisms over COVID at-home-testing shortages, and confusion over public messaging. When asked about the current CDC guidelines for quarantining, Dr. Walensky said that exposed, asymptomatic individuals who have received a booster do not need to quarantine but should test five days after exposure. Further, she said that boosted individuals who do feel sick but feel better by day five can leave quarantine by day six but should wear a mask in public.

Beginning January 15, the Biden Administration will require insurance companies and group health plans to cover the cost of over-the-counter, at-home COVID-19 tests. Consumers will be able to either get the test for free at the store counter by showing their insurance card or by submitting a claim to their health plan for reimbursement. Insurers will be required to cover eight free over-the-counter tests per covered individual per month. Additional information can be found here.

What to Expect Next Week: Next week, the Senate was scheduled to be out for recess, but Senate Majority Leader Chuck Schumer announced that the recess would be canceled, and that the Senate will convene on Tuesday to work on voting rights legislation. It is expected that talks on the Build Back Better social spending bill will be tabled until February.

DEEP DIVE

SCOTUS Strikes Down OSHA’s COVID-19 Vaccine Mandate, Upholds CMS’s Mandate

On Thursday, the Supreme Court of the United States (SCOTUS) struck down the Occupational Safety and Health Administration’s (OSHA’s) testing and vaccine mandate. OSHA’s mandate required that companies with 100 or more employees require their personnel to either get fully vaccinated against COVID-19 or submit to weekly testing. In an unsigned opinion, the court’s conservative majority signaled that OSHA had overstepped its boundary in issuing the mandate. Three liberal Justices, Stephen Breyer, Sonia Sotomayor and Elena Kagan dissented. In response to the OSHA ruling, President Joe Biden said, “I am disappointed that the Supreme Court has chosen to block common-sense life-saving requirements for employees at large businesses that were grounded squarely in both science and the law.” However, SCOTUS did uphold the CMS vaccine mandate, which requires that workers at health care facilities participating in Medicare and/or Medicaid be fully vaccinated against COVID-19. Following the ruling to uphold CMS’s mandate, CMS Administrator Chiquita Brooks-LaSure said, “CMS is extremely pleased the Supreme Court recognized CMS’s authority to set a consistent COVID-19 vaccination standard for workers in facilities that participate in Medicare and Medicaid. CMS’s vaccine rule will cover 10.4 million health care workers at 76,000 medical facilities. Giving patients assurance on the safety of their care is a critical responsibility of CMS and a key to combatting the pandemic.” The rulings can be found here.

CMS Proposes Medicare Coverage of Alzheimer's Drug, Aduhelm, But Only for Clinical Trial Participants

On Tuesday, CMS announced its plans to cover the expensive Alzheimer's drug, Aduhelm, but only for participants of clinical trials. The drug, which was approved conditionally last year by the U.S. Food and Drug Administration, is the only one of its kind due to its ability to remove amyloid, the substance that builds up in Alzheimer's patients. Aduhelm is priced at $28,200 a year and critics have been concerned that it could drain Medicare resources if approved for coverage by the program. According to CMS, to be approved, the clinical trials must be randomized, and participants must have a “clinical diagnosis of mild cognitive impairment (MCI) due to Alzheimer’s Disease (AD) or mild AD dementia and evidence of amyloid pathology consistent with AD.” CMS will accept public comment on the proposal for 30 days and a final decision is expected by April 11. More information can be found here.

CMS Leaders Discuss Strategic Vision for the Medicare Program

On Tuesday, Health Affairs published a piece on the Biden Administration’s plans for the Medicare program, written by leaders of CMS, Meena Seshamani, Elizabeth Fowler, and Chiquita Brooks-LaSure. The blog, titled, “Building on the CMS Strategic Vision: Working Together for a Stronger Medicare” delves into the Administration’s goals for the program, including advancing health equity, expanding affordable health care, promoting high quality care, making care more affordable, and engaging with stakeholders. The post can be found here.

Biden Administration to Require Insurance Companies and Group Health Plans to Cover the Cost of At-Home COVID-19 Tests

CMS Announces 13.8 Million Americans Have Enrolled in Marketplace Plans Ahead of the Jan 15 Open Enrollment Deadline

CMS announced that enrollment numbers for ACA plans on HealthCare.gov and State-based Marketplaces (SBMs) have reached a record 13.8 million ahead of the January 15 enrollment deadline. So far, 9.7 million people have enrolled through HealthCare.gov and 4.1 million people have enrolled through SBMs. The press release can be found here, and the fact sheet can be found here.

HHS Updates the ACA Preventive Health Care Guidelines for Women and Children

HHS has updated preventive care and screening guidelines for women, infants, children, and adolescents. Among the updates, health insurers will now be required to provide coverage without a co-pay or deductible for double electric breast pumps. There are also new guidelines for assessing risks for cardiac arrest in individuals ages 11 to 21 and for assessing risks for hepatitis B virus infection in newborns to 21-year-olds. Additional information can be found here.

Senate HELP Committee Advances the Nomination of Robert Califf as FDA Commissioner

On Thursday, the Senate HELP Committee voted 13-8 to advance Robert Califf's nomination as Commissioner of the Food and Drug Administration. The eight Senators who voted against his advancement include Bernie Sanders (I-VT), Maggie Hassan (D-NH), Bill Cassidy (R-LA), Mike Braun (R-IN), Roger Marshall (R-KS), Tim Scott (R-SC), Tommy Tuberville (R-AL) and Jerry Moran (R-KS). Califf previously served as the FDA Commissioner during former President Obama's second term.

Senate HELP Committee Holds Hearing on Federal Response to Ongoing COVID Pandemic

The Senate HELP Committee held a hearing on the federal response to the COVID-19 pandemic. The witnesses at the hearing included CDC Director Dr. Rochelle Walensky, NIAID Director Dr. Anthony Fauci, Acting FDA Commissioner Dr. Janet Woodcock, and HHS Assistant Secretary for Preparedness and Response Dawn O'Connell. The hearing delved into criticisms over COVID at-home-testing shortages, and confusion over public messaging. When asked about the current CDC guidelines for quarantining, Dr. Walensky said that exposed, asymptomatic individuals who have received a booster do not need to quarantine but should test five days after exposure. Further, she said that boosted individuals who do feel sick but feel better by day five can leave quarantine by day six but should wear a mask in public. Also at the hearing, Dr. Fauci defended himself against aggressive questioning from Senator Rand Paul (R-KY). Dr. Fauci told the Committee that Paul’s website has a “fire Dr. Fauci” feature in which individuals can make donations. Fauci told Paul that he is “making a catastrophic epidemic for [his] political gain.”