This Week in Washington: Robert Califf Confirmed as FDA Commissioner
Congress
Senate
- Short-Term Continuing Resolution Passes Senate and is Signed by the President
- Sens. Casey and Young Introduce the BENES 2.0 Act
- Sen. Kaine Leads Letter Calling for Development of Next-Generation COVID-19 Vaccines
- Sen. Hassan Calls for Enforcement of ACA Birth Control Coverage Requirement
- Senate Confirms Robert Califf as FDA Commissioner
- Sens. Baldwin, Murphy and Shaheen Request Limits for Short-Term Insurance Plans
Administration
- FDA Announces Good Manufacturing Practice Advisory Committee Public Meeting
- FDA Announces Peripheral and Central Nervous System Drugs Advisory Committee Public Meeting
- FDA to Hold Public Meeting Assessing the Enhanced Review Transparency and Communication Program in the Biosimilar User Fee Act
- FDA Awards Priority Review Vouchers to Moderna and BioNTech’s COVID-19 Vaccines
- CMS Issues Request for Information on Access to Care and Coverage for Medicaid and CHIP Beneficiaries
- CMS to Hold Open Door Forum to Discuss Surprise Billing
- CMS Says Monthly Special Enrollment Period Will Begin Late March
- HRSA Announces $55 Million to be Allocated to Improve Virtual Healthcare at Community Health Centers
- President Biden Announces Changes to OSTP Leadership
- FTC Declines to Investigate PBM Practices
Proposed Rules
- FDA Issues Draft Guidance on Developing Non-Addictive Opioid Alternatives
- FDA Issues Proposed Rule with Potential Standards for Wholesale Drug Distributors and Third-Party Logistics Providers
- FDA Issues Proposed Rule to Amend Certain Prescription Drug Marketing Regulations
- FDA Releases Draft Guidance on Formal Meetings Between the FDA and Sponsors or Requesters for OTC Monograph Drugs
- CMS Issues CY 2023 Medicare Advantage and Part D Proposed Rule
- FDA Releases Draft Guidance on the Process Device Makers Should Use to Notify Agency of Critical Device Supply Shortages
- FDA Issues Two Draft Guidances on Medical Devices Authorized During the COVID-19 Pandemic
Final Rules
- CMS Issues Durable Medical Equipment Final Rule
Courts
- Delaware District Court Rules Against HHS in 340B Lawsuit
Reports
- GAO Report on Challenges to National Biodefense Efforts
- CDER’s Office of Generic Drugs Releases Annual Report
Congress
The House is in a district work period this week.
The Senate is in a state work period this week.
Senate
Short-Term Continuing Resolution Passes Senate and is Signed by the President
On Feb. 18, President Biden signed a short-term continuing resolution (CR), averting a government shutdown and funding the government through March 11. The House had passed the measure several weeks ago, but it had been held up in the Senate. While the House and Senate are in recess this week, talks on an omnibus funding bill will continue, with all appropriation leaders saying they do not want to do another CR and instead hope to find an agreement that would fund the government through the rest of the fiscal year.
Sens. Casey and Young Introduce the BENES 2.0 Act
On Feb. 18, Sens. Bob Casey (D-PA) and Todd Young (R-IN) introduced the Beneficiary Enrollment Notification and Eligibility Simplification (BENES) 2.0 Act. The bill aims to simplify Medicare enrollment for seniors and people with disabilities by providing advance notice to people approaching Medicare eligibility. The BENES 2.0 Act is a follow-up to the 2020 BENES Act, which updated Medicare enrollment rules.
The bill text can be found here.
Sen. Kaine Leads Letter Calling for Development of Next-Generation COVID-19 Vaccines
On Feb. 17, Sen. Tim Kaine (D-VA) led a group of six senators in a letter to the Assistant Secretary for Preparedness and Response at the Department for Health and Human Services (HHS) Dawn O’Connell. In the letter, the senators encourage Assistant Secretary O’Connell to outline the department’s plan to develop next-generation COVID-19 vaccines. The letter was also signed by Sens. Roger Marshall (R-KS), Bob Casey (D-PA), Mitt Romney (R-UT), Chris Murphy (D-CT), Tammy Baldwin (D-WI) and Tina Smith (D-MN).
The full letter can be found here.
Sen. Hassan Calls for Enforcement of ACA Birth Control Coverage Requirement
On Feb. 16, Sen. Maggie Hassan (D-NH) led a group of 33 senators in a letter to the Secretary of Health and Human Services (HHS) Xavier Becerra, Secretary of Labor Marty Walsh and Secretary of the Treasury Janet Yellen requesting that the federal law guaranteeing complete coverage of birth control for women insured under the Affordable Care Act (ACA) be better enforced. The letter states that certain insurers have not complied with the ACA’s requirement and have denied coverage for birth control. In the letter, the senators called on the Departments of Labor, HHS and Labor to issue specific updated guidance and to take enforcement measures to improve compliance.
The letter can be found here.
Senate Confirms Robert Califf as FDA Commissioner
On Feb. 15, the Senate voted to confirm Robert Califf as Commissioner of the Food and Drug Administration (FDA) by a narrow vote of 50-46. Califf served as FDA Commissioner from 2016-2017 during the Obama administration. He was sworn in on Feb. 17. Janet Woodcock, who has been serving as Acting FDA Commissioner, will stay on in the role of Principal Deputy Commissioner.
Sens. Baldwin, Murphy and Shaheen Request Limits for Short-Term Insurance Plans
On Feb. 14, Sens. Tammy Baldwin (D-WI), Chris Murphy (D-CT) and Jeanne Shaheen (D-NH) led a group of 37 senators in a letter to the Department of Health and Human Services (HHS) Secretary Xavier Becerra requesting that HHS limit the sale and availability of short-term limited-duration insurance (STLDI) plans. In the letter, the senators state that STLDI plans fail to provide adequate health insurance coverage. The senators expressed concern that STLDI plans are not required to follow certain standards such as annual out-of-pocket maximums and prohibiting discrimination against people with pre-existing conditions.
The letter can be found here.
Administration
FDA Announces Good Manufacturing Practice Advisory Committee Public Meeting
On Feb. 17, the Food and Drug Administration (FDA) announced that the Device Good Manufacturing Practice Advisory Committee would be holding a public meeting on March 2, 2022, from 9:00 a.m. to 6:00 p.m. The committee will discuss and make recommendations concerning the current good manufacturing practice requirements for medical devices to better align the requirements with an international consensus.
More information on the meeting can be found here.
FDA Announces Peripheral and Central Nervous System Drugs Advisory Committee Public Meeting
On Feb. 17, the Food and Drug Administration (FDA) announced that the Peripheral and Central Nervous System Drugs Advisory Committee would be holding a public meeting on March 30, 2022, from 10:00 a.m. to 4:30 p.m. The objective of the meeting is for the public to make recommendations to the FDA on regulatory issues.
More information on the meeting can be found here.
FDA to Hold Public Meeting Assessing the Enhanced Review Transparency and Communication Program in the Biosimilar User Fee Act
On Feb. 17, the Food and Drug Administration (FDA) announced that it would be holding a virtual public meeting titled “Final Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act” on March 22, 2022, from 9:30 a.m. to 12:30 p.m. The meeting will include third-party contractor feedback on the Program for Enhanced Review Transparency and Communication.
More information on the meeting can be found here.
FDA Awards Priority Review Vouchers to Moderna and BioNTech’s COVID-19 Vaccines
On Feb. 16, the Food and Drug Administration (FDA) announced that it had awarded priority review vouchers under the agency’s medical countermeasure priority review voucher program to Moderna and BioNTech for their COVID-19 vaccines. Both vaccines have received FDA approval. The vouchers can be used to receive priority review for future product applications.
CMS Issues Request for Information on Access to Care and Coverage for Medicaid and CHIP Beneficiaries
On Feb. 17, the Centers for Medicare and Medicaid Services (CMS) published a Request for Information (RFI) seeking feedback on healthcare access. Specifically, CMS is seeking feedback on potential ways to improve access to care and coverage for individuals enrolled in Medicaid and the Children’s Health Insurance Program (CHIP).
The RFI can be found here.
CMS to Hold Open Door Forum to Discuss Surprise Billing
On Feb. 17, the Centers for Medicare and Medicaid Services (CMS) announced that it would be holding a Special Open Door Forum on Feb. 23, 2022, from 2:00 p.m. to 3:00 p.m. to discuss surprise billing protections. Specifically, the session will provide information on the No Surprises rules.
CMS Says Monthly Special Enrollment Period Will Begin Late March
On Feb. 16, the Centers for Medicare and Medicaid Services (CMS) stated that low-income individuals would be able to access the new monthly special enrollment period (SEP) through healthcare.gov beginning in late March.
HRSA Announces $55 Million to be Allocated to Improve Virtual Healthcare at Community Health Centers
On Feb. 14, the Health Resources and Services Administration (HRSA) announced that $55 million would be awarded to HRSA-funded health centers to increase access to virtual healthcare technology. HRSA-funded health centers are community-based organizations that provide care to 29 million Americans. The grants will provide improved virtual care such as telehealth, remote patient monitoring, digital patient tools and health information technology platforms for underserved communities.
President Biden Announces Changes to OSTP Leadership
On Feb. 16, President Biden announced that Alondra Nelson will take on the role of Director of the White House Office of Science and Technology Policy (OSTP). This comes after previous OSTP Director Eric Lander resigned on Feb. 7. In addition, Francis Collins will perform the duties of Science Adviser to the President and Co-Chair of the President’s Council of Advisors on Science and Technology until the position is permanently filled.
FTC Declines to Investigate PBM Practices
The Federal Trade Commission (FTC) will not begin a study into the pricing and contractual practices of pharmacy benefit managers (PBMs) after a 2-2 vote at a meeting on Feb. 17. A majority vote was needed to move ahead and require PBMs to turn over information. Two commissioners appointed by President Trump voted against the study because of concerns about its design and whether the current draft asked the proper questions for the answers the FTC is seeking. One commissioner complained they had received a “substantially revised” draft just hours before the meeting.
Independent pharmacists had asked the agency to investigate what they view as noncompetitive practices that threaten independent pharmacists’ ability to compete.
Proposed Rules
FDA Issues Draft Guidance on Developing Non-Addictive Opioid Alternatives
On Feb. 9, the Food and Drug Administration (FDA) published a draft guidance titled “Development of Non-Opioid Analgesics for Acute Pain.” The guidance provides recommendations to companies for developing non-opioid analgesics for acute pain lasting up to 30 days. The guidance includes information about what type of data would be necessary to demonstrate acute pain management. The guidance stresses the FDA’s commitment to providing non-addictive alternatives to opioids and decreasing exposure to opioids.
The FDA will accept public comments on the draft guidance until April 11, 2022.
The draft guidance can be found here.
FDA Issues Proposed Rule with Potential Standards for Wholesale Drug Distributors and Third-Party Logistics Providers
On Feb. 4, the Food and Drug Administration (FDA) issued a proposed rule titled “National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics.” The proposed rule includes proposed national standards for the licensing of prescription drug wholesale distributors and third-party logistics providers.
Public comments are accepted until June 6, 2022.
The proposed rule can be found here.
FDA Issues Proposed Rule to Amend Certain Prescription Drug Marketing Regulations
On Feb. 4, the Food and Drug Administration (FDA) issued a proposed rule titled “Certain Requirements Regarding Prescription Drug Marketing.” The proposed rule would amend certain drug marketing regulations of the Federal Food, Drug, and Cosmetic Act to reflect changes resulting from the Drug Supply Chain Security Act.
Public comments are accepted until April 5, 2022.
The proposed rule can be found here.
FDA Releases Draft Guidance on Formal Meetings Between the FDA and Sponsors or Requesters for OTC Monograph Drugs
On Feb. 4, the Food and Drug Administration (FDA) released a notice to announce the availability of draft guidance for industry titled “Formal Meetings Between the FDA and Sponsors or Requestors of Over-the-Counter (OTC) Monograph Drugs.” The draft guidance makes non-binding recommendations to industry on the procedures and principles for formal meetings between the FDA and sponsors or requestors for OTC monograph drugs.
Comments will be accepted until April 8, 2022.
The draft guidance can be found here.
CMS Issues CY 2023 Medicare Advantage and Part D Proposed Rule
On Jan. 12, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule titled “Medicare Program: Contract Year (CY) 2023 Policy and Technical Changes to the Medicare Advantage (MA) and Medicare Prescription Drug Benefit Programs.” The proposed rule makes a number of revisions to the following topics: MA and Part D regulations on marketing and communications, new or expanded MA and Part D plan criteria, MA and Part D plan quality ratings, provider network adequacy requirements, disaster or public emergency special requirements, medical loss ratio reporting, D-SNPs regulations and pharmacy price concessions. The proposed rule aims to lower out-of-pocket Medicare Part D prescription drug costs and improve health equity in MA and Part D.
Public comments are accepted until March 7, 2022.
The proposed rule can be found here.
FDA Releases Draft Guidance on the Process Device Makers Should Use to Notify Agency of Critical Device Supply Shortages
On Jan. 11, the Food and Drug Administration (FDA) issued a draft guidance to explain how device makers should notify the agency of potential shortages during or before public health emergencies. The guidance requests that manufacturers inform the FDA of meaningful supply disruptions at least six months in advance, and if this is not possible, to notify the FDA as soon as is “practicable,” and no later than seven days after a disruption happens. The guidance is almost identical to a May 2020 guidance, and its recommendations are nonbinding.
Public comments will be accepted until March 12, 2022.
The draft guidance can be found here.
FDA Issues Two Draft Guidances on Medical Devices Authorized During the COVID-19 Pandemic
On Dec. 23, the Food and Drug Administration (FDA) issued two draft guidance documents related to medical devices that received Emergency Use Authorization (EUA) during the COVID-19 pandemic. The guidance documents, titled “Transition Plan for Medical Devices Issued EUAs During the COVID-19 Public Health Emergency (PHE)” and “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the COVID-19 PHE,” are intended to help manufacturers and stakeholders adapt to the eventual resumption of normal operations upon the end of the PHE.
Public comments will be accepted until March 23, 2022.
The guidance document titled “Transition Plan for Medical Devices Issued EUAs During the COVID-19 Public Health Emergency” can be found here.
The guidance document titled “Transition Plan for Medical Devices that Fall Within Enforcement Policies Issued During the COVID-19 Public Health Emergency” can be found here.
Final Rules
CMS Issues Durable Medical Equipment Final Rule
On Dec. 28, the Centers for Medicare and Medicaid Services (CMS) published a final rule titled “Medicare Program; Durable Medical Equipment (DME), Prosthetics, Orthotics, and Supplies (DMEPOS) Policy Issues, and Level II of the Healthcare Common Procedure Coding System (HCPCS); DME Interim Pricing in the CARES Act; Durable Medical Equipment Fee Schedule Adjustments To Resume the Transitional 50/50 Blended Rates To Provide Relief in Rural Areas and Non-Contiguous Areas.” The final rule aims to increase access to certain DME by establishing methodologies to adjust the Medicare DMEPOS fee schedule amounts. In addition, the final rule sets procedures for creating benefit categories and payment determinations for new DMEPOS.
The final rule will go into effect on Feb. 28, 2022.
The final rule can be found here.
Courts
Delaware District Court Rules Against HHS in 340B Lawsuit
On Feb. 16, the U.S. District Court of Delaware ruled in favor of pharmaceutical company AstraZeneca in a lawsuit regarding 340B drug discounts. The Department of Health and Human Services (HHS) has been attempting to require pharmaceutical companies to offer 340B drug discounts to hospitals, regardless of the number of contract pharmacies employed to dispense the drugs. Pharmaceutical companies took issue with this, and several different lawsuits were filed on the matter.
With the Feb. 16 decision, the district court vacated a May 2021 letter from the Health Resources and Services Administration (HRSA) in which the agency threatened to fine AstraZeneca and five other pharmaceutical companies if they continued to restrict 340B drug discounts.
Reports
GAO Report on Challenges to National Biodefense Efforts
On Feb. 17, the Government Accountability Office (GAO) released a report titled “Biodefense: Opportunities to Address National Strategy and Programmatic Challenges.” The report notes that the GAO has evaluated federal biodefense efforts for over a decade. In 2020, the GAO found barriers to the implementation of the 2018 National Biodefense Strategy. The GAO notes that it has made 29 recommendations to improve biodefense preparedness, and 25 of these recommendations remain open.
The full report can be found here.
CDER’s Office of Generic Drugs Releases Annual Report
On Feb. 14, the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) released an annual report from the Office of Generic Drugs (OGD). The report highlights the successes of the generic drug program in 2021.
The full report can be found here.
