Health Care Checkup
December 11, 2020
THE BIG PICTURE
What Happened This Week
 
The House of Representatives and Senate voted on a one-week stopgap measure this week to extend the government funding deadline from December 11 to December 18. Thus far, President Donald Trump has indicated that he will sign the bill. The bill, H.R. 8900, will extend several Medicare, Medicaid and public health provisions from prior legislation. The one-week extension is intended to give lawmakers additional time to negotiate an omnibus spending package for the remainder of fiscal year 2021 and to potentially add another round of COVID relief funding into the package. Stay tuned as negotiations will continue into next week.

On December 7, President-elect Joe Biden formally announced the head members of his health team. The nominees and appointees include top health and infectious disease experts. Xavier Becerra, current Attorney General of California, was nominated to be the Secretary of Health and Human Services. The full list of the team can be found in the Deep Dive section below.

On Thursday, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) held a virtual meeting to discuss whether to recommend to the FDA that it should authorize Pfizer’s vaccine for emergency use. In a vote of 17-4, the team of outside experts voted to recommend that the FDA issue an emergency use authorization (EUA) for Pfizer’s coronavirus vaccine. Following the VRBPAC meeting, the FDA issued a statement, stating that it would “rapidly work toward finalization and issuance of an [EUA]” for the vaccine. On Friday, the CDC’s Advisory Committee on Immunization Practices (ACIP), also held a virtual meeting to review data on Pfizer’s vaccine. On Sunday, ACIP will vote on whether to recommend the vaccine for public distribution. On December 17, advisers to the FDA will meet to discuss Moderna Inc’s COVID vaccine, which is also under review for emergency use.

On Thursday, December 10, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) announced proposed changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. This proposal aims to “support individuals’ engagement in their care, remove barriers to coordinated care, and reduce regulatory burdens on the health care industry.”
 
Also this week, the House passed four health care bills: (1) H.R. 2477, (2) H.R. 3797, (3) H.R. 1570 and (4) H.R. 7898.
What to Expect Next Week: Congress will continue negotiations to complete legislation to appropriate Federal funds for fiscal year 2021. After passing the one-week stopgap measure this week, they will now be up against the deadline of December 18. While it remains to be seen whether COVID-19 relief will be tied to the funding package, these efforts remain the primary focus among lawmakers as we enter the year’s end. The outcome of these negotiations should be apparent by the end of next week.
DEEP DIVE
House and Senate Pass One-Week Stopgap Bill to Fund Federal Government Past December 11 Deadline
The House of Representatives and Senate voted on a one-week stopgap measure this week to extend the government funding deadline from December 11 to December 18. Thus far, President Donald Trump has indicated that he will sign the bill. The bill, H.R. 8900, will extend several health provisions from prior legislation. The one-week extension is intended to give lawmakers additional time to negotiate an omnibus spending package for fiscal year 2021 and to potentially add another round of COVID relief funding into the package. As reported, a group of bipartisan lawmakers introduced a $908 billion coronavirus aid package last week in an effort to bridge differences between GOP and Democratic leaders. President-elect Joe Biden and Democratic leaders Chuck Schumer (D-NY) and Nancy Pelosi (D-CA) announced their support for the bipartisan deal as a starting point for additional negotiations. However, differences still remain as Republican negotiators led by Senate Leader Mitch McConnell (R-KY) continue to push for a slimmer relief package that includes less funding for state and local governments. While McConnell said this week he would be willing to drop his top policy priority of liability protections if Democrats dropped their demand for robust state and local funding, the Trump Administration would prefer to sign a package that includes both robust liability protections and state and local aid. This week, Treasury Secretary Steven Mnuchin proposed his own $916 billion coronavirus relief package that would include direct payments of $600 to individuals and $1,200 per couple. However, House Speaker Nancy Pelosi (D-CA) and Senate Democratic Leader Chuck Schumer (D-NY) are continuing to push for inclusion of more robust unemployment benefits and other priorities. Stay tuned as negotiations will continue into next week. 

President-elect Joe Biden Announces Key Members of Health Team
On December 7, President-elect Joe Biden formally announced the head members of his health team. The nominees and appointees include top health and infectious disease experts. Xavier Becerra was nominated to be the Secretary of Health and Human Services, Dr. Vivek Murthy was nominated to be the Surgeon General, Dr. Rochelle Walensky was appointed to be the Director of the Centers for Disease Control and Prevention, Dr. Marcella Nunez-Smith was selected to be the COVID-19 Equity Task Force Chair, Dr. Anthony Fauci was chosen to be the Chief Medical Adviser to the President on COVID-19 (and will also continue in his role as Director of the National Institute of Allergy and Infectious Diseases), Jeff Zients was selected to be the Coordinator of the COVID-19 Response and Counselor to the President, and Natalie Quillian will serve as Deputy Coordinator of the COVID-19 Response. Additional details can be found here.
COVID-19 Vaccine Updates
On Tuesday, the U.S. Food and Drug Administration (FDA) released documents stating that Pfizer’s COVID vaccine is both safe and effective. On Thursday, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) held a virtual meeting to discuss whether to authorize Pfizer’s vaccine for emergency use. In a vote of 17-4, the team of outside experts voted to recommend that the FDA issue an emergency use authorization (EUA) for Pfizer’s coronavirus vaccine. Following the VRBPAC meeting, the FDA issued a statement, stating that it would “rapidly work toward finalization and issuance of an [EUA]” for Pfizer’s vaccine. On Friday, the CDC’s Advisory Committee on Immunization Practices (ACIP), also held a virtual meeting to review data on Pfizer’s vaccine. On Sunday, ACIP will vote on whether to recommend the vaccine for public distribution. ACIP is also expected to vote on specific recommendations for which populations and ages should receive the vaccine. On December 17, advisers to the FDA will meet to discuss Moderna Inc’s COVID vaccine, which is also under review for emergency use.

Also this week, in Wilmington, Delaware, President-elect Joe Biden spoke about the pandemic and promised he would get “at least 100 million COVID vaccine shots into the arms of the American people” during his first 100 days in office. Since the Pfizer vaccine requires two doses to be fully effective, approximately 50 million people would receive a vaccination during this time frame. Currently, the U.S. has an agreement with Pfizer for 100 million doses of its vaccine, but additional doses are unlikely to come to the U.S. until late summer. In addition, the distribution and transportation of the vaccine is proving to be a logistical challenge, as the vaccine must be maintained at around minus-94 degrees Fahrenheit. The vaccine must further be packed in a special container with dry ice to retain its cold temperature while it is transported around the world.

On Tuesday, the White House held its “vaccine summit.” At the event, President Trump praised “Operation Warp Speed” and called the development of the vaccine “a monumental national achievement.” He also signed an executive order that prioritizes access to the vaccine in the U.S. The Trump administration has previously stated that it has plans to vaccinate 300 million Americans within six months. Both Pfizer and Moderna turned down invitations to this event.
FDA Authorizes First Direct-to-Consumer COVID-19 Test                        
The FDA announced on December 9 that it had approved the first “direct-to-consumer” COVID-19 test. The test, which is produced by LabCorp’s Pixel, can be used by individuals aged 18 and over without a prescription. Individuals can collect their own nasal swab and send it back to LabCorp for testing. Positive and invalid test results would be delivered to individuals over the phone by a health care provider, while negative results would be sent to individuals via email or an online system. The home collection kit can be purchased online or in stores. Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement, “While many home collection kits can be prescribed with a simple online questionnaire, this newly authorized direct-to-consumer collection kit removes that step from the process, allowing anyone to collect their sample and send it to the lab for processing.”
HHS Announces Proposal to Modify the HIPAA Privacy Rule
On Thursday, December 10, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) announced proposed changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. This proposal aims to “support individuals’ engagement in their care, remove barriers to coordinated care, and reduce regulatory burdens on the health care industry.” Proposed changes to the HIPAA Privacy Rule include giving patients broader access to their health information, including electronic information; enhancing information sharing to bolster care coordination among providers; allowing for increased family and caregiver involvement for those experiencing health emergencies; giving greater flexibilities for disclosures in cases of life-threatening events; and reducing administrative burdens. In a statement, HHS Secretary Alex Azar stated, “As part of our broader efforts to reform regulations that impede care coordination, these proposed reforms will reduce burdens on providers and empower patients and their families to secure better health.” There will be a 60-day comment period for this proposed rule. 
House Passes Several Health Care Bills
This week, the House passed four health care bills. The first, H.R. 2477, titled the “Beneficiary Enrollment Notification and the Eligibility Simplification (BENES) Act of 2019,” was introduced by Reps. Raul Ruiz (D-CA), Jackie Walorski (R-IN), Brad Schneider (D-IL), and Gus Bilirakis (R-FL). The bill changes Medicare’s general enrollment period from January 1 – March 31 to October 15 – December 31, and it requires coverage to begin on the first day of the month following one’s enrollment. This legislation also would require that Social Security account statements include information about Medicare eligibility for individuals aged 60 – 64.

Another bill passed in the House, H.R. 3797, the “Medical Marijuana Research Act of 2019,” was introduced by Reps. Earl Blumenauer (D-OR), Andy Harris (R-MD), Zoe Lofgren (D-CA), Morgan Griffith (R-VA), Rob Bishop (R-UT), and Debbie Dingell (D-MI). This bill creates a new registration process to facilitate medical marijuana research. Additionally, it requires that HHS continue producing marijuana through the National Institute on Drug Abuse Drug Supply Program and offer any “immature plants” or seeds to researchers until manufacturers are able to provide adequate supplies of marijuana for medical research.

H.R. 1570, the “Removing Barriers to Colorectal Screening Act,” was introduced by Rep. Donald Payne, Jr. (D-NJ). This bill waives coinsurance requirements for Medicare beneficiaries for colorectal cancer screening tests. The coinsurance will be waived regardless of the code billed for the diagnosis or procedure.

Lastly, H.R. 7898, was passed by the House. This bill aims to provide the Inspector General of HHS with new authorities to investigate information blocking, among other responsibilities. It was introduced by Reps. Michael Burgess (R-TX) and Peter Welch (D-VT). It also creates incentives for health care providers to take up cybersecurity best practices. 
SENATE HEARINGS AND EXECUTIVE SESSIONS
WHAT: Senate Commerce, Science and Transportation Subcommittee on Manufacturing, Trade, and Consumer Protection (Hybrid) Hearing: "Examining the Impact of COVID-19 on the Live Event Entertainment Industry."   
WHEN: Tuesday, December 15 at 10:00 AM
 
WHAT: Senate Finance Subcommittee on Health Care (Virtual) Hearing: "The Alzheimer’s Crisis: Examining Testing and Treatment Pipelines and Fiscal Implications."
WHEN: Wednesday, December 16 at 2:30 PM
HOUSE HEARINGS AND EXECUTIVE SESSIONS
N/A
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