Health Care Checkup
May 12, 2023
THE BIG PICTURE
The COVID-19 public health emergency (PHE) expired on May 11, 2023. In light of the PHE ending, the Department of Health and Human Services (HHS) issued fact sheets to explain how current flexibilities enabled by the PHE will be affected by the termination. Most “major” Medicare telehealth flexibilities will not be impacted by the end of the PHE, and will remain in effect until December 2024. Additionally, access to COVID-19 vaccinations and therapies will be largely unaffected. The Food and Drug Administration’s (FDA’s) Emergency Use Authorizations (EUAs) for COVID-19 treatments will not be impacted either. However, certain Medicare and Medicaid waivers, such as those that allowed for facilities to expand their capacity during the pandemic, will end. The fact sheets can be found here, and here.

Ahead of the expiration of the PHE, the Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a temporary rule to continue waiving the in-person requirement for the prescription of controlled substances through telemedicine for an additional six months, until November 11, 2023. For providers and patients with established telehealth relationships before November 2023, prescribing flexibilities will be extended until November 11, 2024.

The United States Preventive Services Task Force (USPSTF), which is an independent panel of national experts in disease prevention, issued a draft recommendation on breast cancer screening. The new proposal would update guidance issued in 2016, which recommended that women begin receiving mammograms at age 50. The draft shaves ten years off of the 2016 age recommendation, updating the age to 40. The draft recommendation is not final and will be open to public comment through June 5. Additional information can be found here.

The Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing with CEOs of major insulin manufacturers and executives from major pharmacy benefit managers (PBMs) to address the high costs of insulin and other prescription drugs. Committee Chair Bernie Sanders (I-VT) said that Congress must do everything possible to ensure that Americans can access and afford their prescription drugs. Ranking Member Bill Cassidy (R-LA) said that in recent years, the net price of insulin has decreased, while the list price has increased. He recommended realigning incentives to find a way that patients will benefit at the pharmacy counter. MC’s summary of the hearing can be found here.

The Senate HELP Committee also held a markup this week on legislation relating to access to generic drugs, drugs designated for rare diseases, and PBM reform. The results of the markup can be found in the “deep dive” section below.

The Energy and Commerce Health Subcommittee held a hearing to get to the root causes of drug shortages in the U.S. Members discussed how drug shortages have resulted in delayed care, ineffective treatment, and increased hospitalization. They advocated for increased access to generic drugs and increased domestic manufacturing. MC’s summary of the hearing can be found here.

The House Ways and Means Health Subcommittee held a hearing to examine what Congress can do to help promote patient access to innovative care. Subcommittee Chair Vern Buchanan (R-FL) criticized CMS’s restrictive coverage mandate for new Alzheimer’s treatments, as well as the government negotiation of drug prices implemented by the Inflation Reduction Act. The hearing can be found here
What to Expect Next Week: The House and Senate will both be in session. On Tuesday, the House Ways and Means Committee will hold a hearing titled, “Health Care Price Transparency: A Patient's Right to Know.” On Wednesday, the Ways and Means Subcommittee on Health will hold a hearing titled, “Why Health Care is Unaffordable: Anticompetitive and Consolidated Markets.” Additionally, the Senate Homeland Security and Governmental Affairs Permanent Subcommittee on Investigations will hold a hearing titled, “Examining Health Care Denials and Delays in Medicare Advantage.” We also expect that there will be a House Energy and Commerce Health Subcommittee markup on a series of bills related to provider transparency, the 340B program, and possibly site neutral payments next Wednesday. However, there has not yet been an official notice for this markup. 
DEEP DIVE
HHS Releases Fact Sheets on End of COVID-19 Public Health Emergency
The COVID-19 public health emergency (PHE) expired on May 11, 2023. In light of the PHE ending, the Department of Health and Human Services (HHS) issued fact sheets to explain how current flexibilities enabled by the PHE will be affected by the termination. Most “major” Medicare telehealth flexibilities will not be impacted by the end of the PHE, and will remain in effect until December 2024. Additionally, access to COVID-19 vaccinations and therapies will be largely unaffected. The Food and Drug Administration’s (FDA’s) Emergency Use Authorizations (EUAs) for COVID-19 treatments will not be impacted either. However, certain Medicare and Medicaid waivers, such as those that allowed for facilities to expand their capacity during the pandemic, will end. Further, the requirement for private insurers to cover COVID-19 tests without cost sharing will end once the PHE expires. The fact sheets can be found here, and here.
 
DEA, SAMHSA Extend COVID-19 Telehealth Flexibilities for Prescribing Controlled Medications
Ahead of the expiration of the PHE, the Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a temporary rule to continue waiving the in-person requirement for the prescription of controlled substances through telemedicine for an additional six months, until November 11, 2023. For providers and patients with established telehealth relationships before November 2023, prescribing flexibilities will be extended until November 11, 2024. The agencies will review public comments on the matter during this extension. More can be found here.
 
USPSTF Issues Draft Recommendation on Breast Cancer Screening, Proposes to Change the Age Women Should Begin Getting Screened from 50 to 40
The United States Preventive Services Task Force (USPSTF), which is an independent panel of national experts in disease prevention, issued a draft recommendation on breast cancer screening. The new proposal would update guidance issued in 2016, which recommended that women begin receiving mammograms at age 50. The draft shaves ten years off of the 2016 age recommendation, updating the age to 40. Due to the Affordable Care Act’s preventive service coverage requirements, most private insurers must cover USPSTF’s screening recommendations with an “A” or “B” rating. The task force’s new proposal that recommends biennial screening mammography for women ages 40 to 74 years has a “B” grade. The draft recommendation is not final and will be open to public comment through June 5. Additional information can be found here.
 
Senate HELP Committee Holds Hearing with Drug Manufacturers and PBMs on the Cost of Insulin
The Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing with CEOs of major insulin manufacturers and executives from major pharmacy benefit managers (PBMs) to address the high costs of insulin and other prescription drugs. Committee Chair Bernie Sanders (I-VT) said that Congress must do everything possible to ensure that Americans can access and afford their prescription drugs. Ranking Member Bill Cassidy (R-LA) said that in recent years, the net price of insulin has decreased, while the list price has increased. He recommended realigning incentives to find a way that patients will benefit at the pharmacy counter. The drug manufacturer CEOs all claimed that their companies pay substantial rebates to help make drugs more affordable, but that PBMs and insurers keep the prices patients pay high. Meanwhile, the PBM executives stated that drug manufacturers are the ones who keep prices high and abuse patent protections to limit competition in the market. MC’s summary of the hearing can be found here.

Senate HELP Committee Holds Markup on Generic Drug, PBM, and Rare Disease Legislation
On Thursday, the Senate HELP Committee held a markup on four bills relating to access to generic drugs, drugs designated for rare diseases, and PBM reform. The results of the markup are below:


 
 

House Ways and Means Subcommittee on Health Convenes to Examine Policies that Inhibit Innovation and Patient Access 
The House Ways and Means Health Subcommittee held a hearing to examine what Congress can do to help promote patient access to innovative care. Subcommittee Chair Vern Buchanan (R-FL) criticized CMS’s restrictive coverage mandate for new Alzheimer’s treatments, as well as the government negotiation of drug prices implemented by the Inflation Reduction Act. Ranking Member Lloyd Doggett (D-TX) stated that while Big Pharma may claim that their profits are devoted to research and development for new cures, the profits are actually spent on marketing and propaganda. Doggett advocated for advancing solutions that promote competition and lower prices in the drug market. The hearing can be found here.

House Energy and Commerce Health Subcommittee Meets to Discuss the Root Causes of Drug Shortages
The Energy and Commerce Health Subcommittee held a hearing to get to the root causes of drug shortages in the U.S. Members discussed how drug shortages have resulted in delayed care, ineffective treatment, and increased hospitalization. They advocated for increased access to generic drugs and increased domestic manufacturing. MC’s summary of the hearing can be found here.
CONGRESSIONAL HEARINGS
House Committee on Ways and Means - Hearing
House Committee on Ways and Means Hearing: Health Care Price Transparency: A Patient's Right to Know
Tuesday, May 16 at 10:00 AM ET

House Committee on Veterans' Affairs - Hearing
Subcommittee on Disability Assistance and Memorial Affairs (Committee on Veterans' Affairs) Hearing: Reviewing VA's Implementation of the PACT Act
Tuesday, May 16 at 10:30 AM ET

House Select Subcommittee on the Coronavirus Pandemic - Hearing
Select Subcommittee on the Coronavirus Pandemic Hearing: "Like Fire Through Dry Grass: Nursing Home Mortality & COVID-19 Policies"
Wednesday, May 17 at 10:00 AM ET

House Committee on Ways and Means - Hearing
Subcommittee on Health (Committee on Ways and Means) Hearing: Why Health Care is Unaffordable: Anticompetitive and Consolidated Markets
Wednesday, May 17 at 2:00 PM ET

Senate Homeland Security and Governmental Affairs Committee - Hearing
Permanent Subcommittee on Investigations: "Examining Health Care Denials and Delays in Medicare Advantage."
Wednesday, May 17 at 2:00 PM ET

Senate Finance Committee - Hearing
Subcommittee on Health Care Hearing: "Improving Health Care Access in Rural Communities: Obstacles and Opportunities."
Wednesday, May 17 at 2:30 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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