Health Care Checkup
December 10, 2021
THE BIG PICTURE
In a vote of 222 to 212, the House voted on Tuesday to postpone Medicare payment cuts, which were slated to go into effect on January 1. The bill, the Protecting Medicare and American Farmers from Sequester Cuts Act, was then sent to the Senate, where it passed on Thursday in a vote of 59-35. 14 Republican Senators (John Thune, Mitch McConnell, John Barrasso, Roger Wicker, Shelley Moore Capito, Susan Collins, Roy Blunt, Thom Tillis, Lisa Murkowski, Richard Burr, Joni Ernst, John Cornyn, Mitt Romney, and Rob Portman) crossed the aisle to advance the legislation.
 
The bill also created a one-time fast-track process for a joint resolution to increase the debt limit. As a reminder, the deadline to raise the debt limit is Wednesday, December 15. It is expected that Congress will vote early next week to raise the limit ahead of the deadline.
 
Regarding the Medicare program, the legislation made several changes to postpone payment cuts. Now, the 2% cuts from Medicare sequestration will be delayed until March 31, 2022. Beginning in April, the sequester cuts will be reduced to 1% until June 2022. PAYGO cuts will be postponed until 2023. Additionally, the 3.75% cut to physician payments under the Medicare PFS will be reduced to 0.75%. The bill also delays cuts to the clinical lab fee schedule and Medicare radiation oncology demonstration for one year.
 
On Thursday, the American Hospital Association (AHA) and American Medical Association (AMA) filed a suit against the federal government over its implementation of the No Surprises Act. The lawsuit challenges the Department of Health and Human Services September 30 final rule. The groups wrote that while they support “a patient-first solution to surprise billing,” HHS’s implementation of the Act “deviates from Congress’s balanced design in a critical respect: the Rule places a heavy thumb on the scale during the independent arbitration process in a way that directly conflicts with the statutory text.” The AHA and AMA’s full complaint can be found here.
 
On Friday, the Chairwoman of the Committee on Oversight and Reform Representative Carolyn Maloney, released the final staff report of  the Committee’s nearly three-year drug pricing investigation. The Committee found that drug companies “aggressively” raise prices to meet revenue goals, target the Medicare program to increase revenues, abuse the patent system, and try to “suppress competition and maintain monopoly pricing.” The press release from the Chairwoman can be found here.

Also this week, Vice President Kamala Harris announced a new initiative in the fight against maternal mortality and morbidity. The new “call to action” includes $3 billion in investments from the Build Back Better Act, which has yet to pass. These investments include funding to address social determinants of maternal health for pregnant and postpartum individuals and to eliminate racial and ethnic disparities in maternal health outcomes. Harris’s initiative also includes new guidance from the Centers for Medicare and Medicaid Services (CMS) to help states provide 12 months of continuous postpartum coverage through their Medicaid programs.
What to Expect Next Week: Next week, the Senate is expected to review and amend the Build Back Better Act with the Senate Parliamentarian. The Senate HELP Committee will hold a hearing on the nomination of Dr. Robert Califf to be Commissioner of the U.S. Food and Drug Administration. Additionally, the House Select Subcommittee on the Coronavirus Crisis will hold a hearing titled, "A Global Crisis Needs a Global Solution: The Urgent Need to Accelerate Vaccinations Around the World."
DEEP DIVE
Congress Votes to Postpone Medicare Payment Cuts and Create Path to Increase Debt Limit
 
In a vote of 222 to 212, the House voted on Tuesday to postpone approximately 6% in Medicare payment cuts, which were slated to go into effect on January 1. The bill, the Protecting Medicare and American Farmers from Sequester Cuts Act, was then sent to the Senate, where it passed on Thursday in a vote of 59-35. 14 Republican Senators (John Thune, Mitch McConnell, John Barrasso, Roger Wicker, Shelley Moore Capito, Susan Collins, Roy Blunt, Thom Tillis, Lisa Murkowski, Richard Burr, Joni Ernst, John Cornyn, Mitt Romney, and Rob Portman) crossed the aisle to advance the legislation.
 
The bill also created a one-time fast-track for a joint resolution to increase the debt limit. As a reminder, the deadline to raise the debt limit is Wednesday, December 15. It is expected that Congress will vote early next week to raise the limit ahead of the deadline.
 
Regarding the Medicare program, the legislation made several changes to postpone payment cuts. Now, the 2% cuts from Medicare sequestration will be delayed until March 31, 2022. Beginning in April, the sequester cuts will be reduced to 1% until June 2022. PAYGO cuts will be postponed until 2023. Additionally, the 3.75% cut to physician payments under the Medicare PFS will be reduced to 0.75%. The bill also delays cuts to the clinical lab fee schedule and Medicare radiation oncology demonstration for one year.
 
Hospitals and Physician Groups File Lawsuit Over No Surprises Act Final Rule
 
On Thursday, the American Hospital Association (AHA) and American Medical Association (AMA) filed a suit against the federal government over its implementation of the No Surprises Act. The lawsuit challenges the Department of Health and Human Services September 30 final rule. Under the rule that HHS issued in September, providers and insurers who have a dispute over the payment rate of certain procedures must participate in a 30-day “open negotiation period” to try to come to an agreement. If the negotiations fail, then either party can begin the “federal independent dispute resolution process” to rectify the payment rate disagreement. In that process, both parties submit their offers to a third-party “certified independent dispute resolution entity,” who then decides the final payment rate. The groups wrote that while they support “a patient-first solution to surprise billing,” HHS’s implementation of the Act “deviates from Congress’s balanced design in a critical respect: the Rule places a heavy thumb on the scale during the independent arbitration process in a way that directly conflicts with the statutory text.” The AHA and AMA’s full complaint can be found here.

House Committee on Oversight and Reform Releases Final Drug Pricing Investigation
 
On Friday, the Chairwoman of the Committee on Oversight and Reform Representative Carolyn Maloney, released the final staff report of  the Committee’s nearly three-year drug pricing investigation. The Committee found that drug companies “aggressively” raise prices to meet revenue goals, target the Medicare program to increase revenues, abuse the patent system, and try to “suppress competition and maintain monopoly pricing.” The press release from the Chairwoman can be found here.
 
CMS Issues Letter to State Medicaid Directors to Help Clarify New Requirements Under the 2021 Consolidated Appropriations Act
 
On Friday, the Centers for Medicare & Medicaid Services (CMS) issued a State Medicaid Director Letter (SMDL) to help guide states through new requirements established under the 2021 Consolidated Appropriations Act. These updates  include new reporting requirements for non-Disproportionate Share Hospital (DSH) supplemental payments, and a change in how the DSH limit is calculated. The letter can be found here.
 
Vice President Kamala Harris Announces New Plan to Help Combat Maternal Mortality
 
This week, Vice President Kamala Harris announced a new initiative in the fight against maternal mortality and morbidity. The new “call to action” includes $3 billion in investments from the Build Back Better Act, which has yet to pass. These investments include funding to address social determinants of maternal health for pregnant and postpartum individuals and to eliminate racial and ethnic disparities in maternal health outcomes. Harris’s initiative also includes new guidance from the Centers for Medicare and Medicaid Services (CMS) to help states provide 12 months of continuous postpartum coverage through their Medicaid programs. Currently, states must only provide Medicaid coverage to postpartum individuals for 60 days. The new plan also creates a “Birthing-Friendly” hospital designation for hospitals that participate in a program aimed at improving patient safety practices. The designation would be added to the hospital’s profile on the CMS “care compare” website, which allows for consumers to choose hospitals based on best practices. More information on the Vice President’s new initiative can be found here, and the press release from CMS can be found here.
 
CDC Expands COVID-19 Booster Eligibility to Include 16-and-17-year-olds
 
On Thursday, the Centers for Disease Control and Prevention (CDC) expanded COVID-19 booster eligibility to teens ages 16 and 17. Currently, the only COVID-19 vaccine authorized for use in adolescents is the Pfizer vaccine. More information can be found here.
 
Senate HELP Committee to Hold Hearing on FDA Commissioner Nominee Dr. Robert Califf
 
On Tuesday, the Senate Health, Education, Labor and Pensions (HELP) Committee announced that it will hold a hearing on Tuesday, December 14 to consider the nomination of Dr. Robert Califf to be Commissioner of the U.S. Food and Drug Administration (FDA). Califf, a cardiologist, previously served as the FDA Commissioner during former President Obama's second administration. Califf is currently a Professor of Cardiology at the Duke University’s School of Medicine. Califf said that if confirmed, he would ask acting FDA Commissioner Janet Woodcock to stay at the FDA in a top role. The HELP Committee’s hearing will be available for viewing here.
 
House Passes 15 Health Bills
 
On Wednesday, the House passed 15 health bills, many of which are aimed at improving health care. The details of the bills can be found below:
 
H.R. 3537, the “Accelerating Access to Critical Therapies for ALS Act,” was introduced by Rep. Mike Quigley (D-IL) and 99 original cosponsors. The bill, among other things, establishes grant programs to address neurodegenerative diseases, such as amyotrophic lateral sclerosis (also known as ALS or Lou Gehrig's disease).The bill passed on the House Floor by a vote of 423-3.

H.R. 5487, the “Stillbirth Health Improvement and Education for Autumn Act of 2021” or the “SHINE for Autumn Act of 2021,” was introduced by Reps. Jaime Herrera Beutler (R-WA), Lucille Roybal-Allard (D-CA), Kathy Castor (D-FL), and Markwayne Mullin (R-OK). The bill authorizes grants and establishes other programs to improve data collection on stillbirths. The bill passed on the House Floor by a vote of 408-18.  

H.R. 5561, the “Early Hearing Detection and Intervention Act of 2021,” was introduced by Reps. Brett Guthrie (R-KY) and Doris Matsui (D-CA). The bill reauthorizes through FY2026 various activities carried out by the Health Resources and Services Administration, the Centers for Disease Control and Prevention, and the National Institute on Deafness and Other Communication Disorders that support screening and early intervention services for newborns, infants, and young children who are deaf or hard of hearing. The bill passed on the House Floor by a vote of 410-17.
 
H.R. 5551, the “Improving the Health of Children Act,” was introduced by Reps. Buddy Carter (R-GA), Henry Cuellar (D-TX), Lori Trahan (D-MA), G.K. Butterfield (D-NC), and Richard Hudson (R-NC). The bill reauthorizes through FY2026 programs and activities of the Centers for Disease Control and Prevention (CDC) for researching and preventing birth defects, developmental disabilities, and other conditions. The bill passed on the House Floor by a vote of 405-20.
 
H.R. 1193, the “Cardiovascular Advances in Research and Opportunities Legacy Act” or the “CAROL Act,” was introduced by Rep. Andy Barr (R-KY). The bill expands research on valvular heart disease and its treatment. This disease is caused by damage to or disease affecting any valve that controls blood flow in the heart. The bill passed on the House Floor by a voice vote.  
 
H.R. 1667, the “Dr. Lorna Breen Health Care Provider Protection Act,” was introduced by Rep. Susan Wild (D-PA) and 14 original cosponsors. The bill establishes grants and requires other activities to improve mental and behavioral health and prevent burnout among health care providers. The bill passed on the House Floor by a vote of 392-36.

H.R. 4555, the “Oral Health Literacy and Awareness Act of 2021,” was introduced by Reps. Tony Cárdenas (D-CA) and Gus Bilirakis (R-FL). The bill authorizes a public education campaign across all relevant programs of the Health Resources and Services Administration to increase oral health literacy and awareness. The bill passed on the House Floor by a vote of 369-58.

H.R. 2355, the “Opioid Prescription Verification Act of 2021,” was introduced by Reps. Rodney Davis (R-IL), Bilirakis, and Ann Wagner (R-MO). The bill modifies overdose prevention activities carried out by the Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC). The bill passed on the House Floor by a vote of 410-15.  

H.R. 2364, the “Synthetic Opioid Danger Awareness Act,” was introduced by Reps. Andy Kim (D-NJ) and Chris Pappas (D-NH). The bill requires the Department of Health and Human Services (HHS) to provide education and training related to synthetic opioids, including fentanyl and its analogues. The bill passed on the House Floor by a vote of 411-14.

H.R. 3743, the “Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act,” was introduced by Reps. Hudson and Eshoo. The bill increases the amount of funds each fiscal year that the Food and Drug Administration (FDA) must transfer to the Reagan-Udall Foundation for the FDA and that the National Institutes of Health (NIH) must transfer to the Foundation for the NIH. The bill passed on the House Floor by a vote of 374-52.

H.R. 3894, the “Collecting and Analyzing Resources Integral and Necessary for Guidance for Social Determinants Act of 2021" or the “CARING for Social Determinants Act of 2021,” was introduced by Reps. Lisa Blunt Rochester (D-DE) and Bilirakis. The bill requires the Centers for Medicare & Medicaid Services to periodically update specified guidance to help states address social determinants of health. The bill passed on the House Floor by a vote of 378-48.  

H.R. 4026, the “Social Determinants of Health Data Analysis Act of 2021,” was introduced by Reps. Michael C. Burgess, M.D. (R-TX) and Blunt Rochester. The bill requires the Government Accountability Office to report on actions taken by the Department of Health and Human Services to address social determinants of health, including how data collection about social determinants of health complies with relevant privacy laws. The bill passed on the House Floor by a vote of 399-28.  

H.R. 550, the “Immunization Infrastructure Modernization Act,” was introduced by Reps. Annie Kuster (D-NH) and Larry Bucshon, M.D. (R-IN). The bill directs the Department of Health and Human Services (HHS) to take actions to improve data sharing and other aspects of immunization information systems. The bill passed on the House Floor by a vote of 294-130.  

H.R. 951, the “Maternal Vaccination Act,” was introduced by Rep. Terri Sewell (D-AL) and 44 original cosponsors. The bill establishes a national campaign to raise awareness and increase rates of maternal vaccinations. The Centers for Disease Control and Prevention (CDC) must consult with various stakeholders to carry out this campaign. The bill passed on the House Floor by a voice vote.  

H.R. 1550, the “Promoting Resources to Expand Vaccination, Education and New Treatments for HPV Cancers Act of 2021” or the “PREVENT HPV Cancers Act of 2021,” was introduced by Reps. Castor and Kim Schrier, M.D. (D-WA). The bill supports efforts to increase human papillomavirus (HPV) vaccination rates and otherwise prevent and treat cervical cancer and other cancers associated with that virus. The bill passed on the House Floor by a voice vote.
SENATE HEARINGS AND EXECUTIVE SESSIONS
Senate Health, Education, Labor and Pensions Committee - Hearing
Full Committee Hearing: Nomination of Dr. Robert Califf to be Commissioner of Food and Drugs, Food and Drug Administration, Department of Health and Human Services
Tuesday, December 14 at 10:00 AM ET
HOUSE HEARINGS AND EXECUTIVE SESSIONS
House Select Subcommittee on the Coronavirus Crisis - Hearing
Select Subcommittee on the Coronavirus Crisis Hearing: "A Global Crisis Needs a Global Solution: The Urgent Need to Accelerate Vaccinations Around the World"
Tuesday, December 14 at 2:00 PM ET
ADMINISTRATION ANNOUNCEMENTS
Centers for Medicare & Medicaid Services
 
Food and Drug Administration
 
Guidance Documents from the Centers for Disease Control and Prevention

National Institutes of Health
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