This Week in Washington: President Biden and Speaker Pelosi Open to Moving Pieces of the Build Back Better Act
Congress
House
- Rep. Brady Announces Updated Ways and Means Subcommittee Assignments
Senate
- Republican Finance Committee Members Voice Their Opposition to Build Back Better Act’s Drug Pricing Measures
- Republican Senators Call for Interim Final Rule Requiring COVID-19 Vaccinations to be Withdrawn
Administration
- White House Announces 400 Million N95 Masks to be Distributed for Free
- President Biden and Speaker Pelosi Open to Moving Pieces of the Build Back Better Act
- HHS Announces Intra-Agency Task Force on Reproductive Healthcare Access
- HHS Announces $6.6 Million in Funding for Title X Family Planning Program
- HRSA Announces $103 Million in Funding to Promote Healthcare Workers’ Mental Health
- HRSA Announces $13 Million Available for Rural Behavioral Health
- CMS Issues Guidance with New Vaccine Requirements for Texas Healthcare Workers
- CMS Releases Updated State Guide for Medicaid Managed Care Contract Review and Approval
- CDC Finds That Americans with a Previous COVID-19 Infection Were Most Protected During Delta Wave
- FDA Publishes Case Studies to Inform Complex Innovative Trial Design Pilot Program
Other Activity
Proposed Rules
- 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- FDA Releases Draft Guidance on the Process Device Makers Should Use to Notify Agency of Critical Device Supply Shortages
- CMS Publishes Proposed Rule on Benefit and Payment Parameters for 2023
- FDA Issues Two Draft Guidances on Medical Devices Authorized During the COVID-19 Pandemic
- CMS Publishes Draft Guidance for Antisense Oligonucleotide Drug Products for Severe Diseases
- FDA Issues Draft Guidance on Premarket Submissions for Device Software Functions
Final Rules
- CMS Issues Final Rule to Revise Procedures for Announcing Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications
- FDA Issues Final Rule to Revoke Regulations for Human Tissue Intended for Transplantation Recovered Prior to 2005
- CMS Issues Durable Medical Equipment Final Rule
- FDA Issues Final Rule to Amend Laboratory Food Testing Requirements
Courts
- Texas 5th Circuit Court Sends Abortion Challenge to State Supreme Court
Reports
- GAO Report on Federal Prisons Implementing COVID-19 Recommendations
- GAO Report on HHS Vaccine Responsibilities
- ASPE Report on Prescription Drug Affordability for Medicare Patients
The House has a district work period this week.
Congress
House
Rep. Brady Announces Updated Ways and Means Subcommittee Assignments
On Jan. 19, the Ranking Member of the House Ways and Means Committee Kevin Brady (R-TX) released updated subcommittee assignments for the 117th Congress. Rep. Vern Buchanan (R-FL) is the new ranking member of the Health Subcommittee and Rep. Greg Murphy (R-NC) will be joining the Ways and Means Committee and will sit on the Health Subcommittee.
The announcement with the full list of subcommittee assignments can be found here.
Senate
Republican Finance Committee Members Voice Their Opposition to Build Back Better Act’s Drug Pricing Measures
On Jan. 20, a group of 14 Republican members of the Senate Finance Committee led by Ranking Member Mike Crapo (R-ID) wrote a letter to their Senate colleagues voicing their opposition to the drug pricing measures in the House-passed Build Back Better Act. In the letter, the senators state that the drug pricing measures in the bill would undermine innovation and cause workforce disruptions.
The letter can be found here.
Republican Senators Call for Interim Final Rule Requiring COVID-19 Vaccinations to be Withdrawn
On Jan. 20, a group of 17 Republican senators wrote to Health and Human Services (HHS) Secretary Xavier Becerra expressing their concern with the Nov. 30 interim final rule that established vaccine and mask mandates in Head Starts and Early Head Start programs. The letter states that other COVID-19 precautions are being taken in these facilities, some district courts have granted injunctions against the final rule and the rule was made without any feedback from Head Start programs. Given these concerns, the senators request that the interim final rule be withdrawn.
The letter can be found here.
Administration
White House Announces 400 Million N95 Masks to be Distributed for Free
On Jan. 19, the White House announced that 400 million N95 masks from the Strategic National Stockpile would be made available to Americans over the next month. The masks will be free and will be shipped to pharmacies and community health centers starting at the end of the week. The White House said the program will be fully running by the end of February.
President Biden and Speaker Pelosi Open to Moving Pieces of the Build Back Better Act
On Jan. 19, President Joe Biden held a news conference during which he stated that he expects the Build Back Better Act to be broken up into pieces that will be supported by the full Democratic Caucus. The Build Back Better Act, which includes measures that would establish Medicare drug price negotiation and extend Affordable Care Act subsidies, has been stalled since December when Sen. Joe Manchin (D-WV) said he would not support the bill. On Jan. 20, House Speaker Nancy Pelosi (D-CA) said she expects Democrats to pursue a single version of a scaled-down Build Back Better Act.
HHS Announces Intra-Agency Task Force on Reproductive Healthcare Access
On Jan. 21, the Secretary of Health and Human Services (HHS) Xavier Becerra announced the creation of the HHS Intra-Agency Task Force on Reproductive Healthcare Access. The task force includes subject-matter experts who will work to facilitate collaborative approaches to sexual and reproductive health.
HHS Announces $6.6 Million in Funding for Title X Family Planning Program
On Jan. 21, the Department of Health and Human Services (HHS) announced it would award $6.6 million through the Title X family planning program. The funding will provide for family planning services in areas that have restricted access to reproductive health.
Information on the Title X grantees can be found here.
HRSA Announces $103 Million in Funding to Promote Healthcare Workers’ Mental Health
On Jan. 20, the Health Resources and Services Administration (HRSA) announced that $103 million in American Rescue Plan funding would be allocated toward addressing mental health and burnout for healthcare professionals providing COVID-19 care. Funds will be given to 45 grantees with the goal of funding evidence-informed programs and training.
More information on the grants can be found here.
HRSA Announces $13 Million Available for Rural Behavioral Health
On Jan. 18, the Health Resources and Services Administration (HRSA) announced that $13 million in funding would be allocated to increase access to behavioral health care in rural areas through Rural Communities Opioid Response Program (RCORP) grants. Eligible applicants include rural health clinics, federal recognized tribes and community- and faith-based organizations. Applications are due by April 19, 2022.
More information on the application process can be found here.
CMS Issues Guidance with New Vaccine Requirements for Texas Healthcare Workers
On Jan. 20, the Centers for Medicare and Medicaid Services (CMS) released a guidance regarding its interim final rule that requires COVID-19 vaccinations for healthcare workers in Medicare- or Medicaid-funded facilities. The guidance requires healthcare workers in Texas to receive their first dose of the COVID-19 vaccine by Feb. 22 and be fully vaccinated by March 21. This guidance comes after a district court dismissed Texas’ lawsuit against the vaccine mandate. The new guidance does not make any changes to vaccination timelines for other states. Healthcare workers in states that were not involved in recent lawsuits on the interim final rule must be fully vaccinated by Feb. 28. Healthcare workers in states that were involved in the lawsuits and were affected by the Supreme Court’s recent decision must be fully vaccinated by March 15.
The guidance can be found here.
CMS Releases Updated State Guide for Medicaid Managed Care Contract Review and Approval
On Jan. 18, the Centers for Medicare and Medicaid Services (CMS) released an updated State Guide to CMS Criteria for Medicaid Managed Care Contract Review and Approval. The state guide lays out the standards used by CMS and the Division of Managed Care Operations (DMCO) to review state contracts with managed care organizations (MCOs), prepaid inpatient health plans, prepaid ambulatory health plans, non-emergency medical transportation prepaid ambulatory health plans, primary care case management entities and health insuring organizations. The new guide incorporates changes to pass-through payments, state-directed payments, appeals and grievances, among other things.
The guide can be found here.
CDC Finds That Americans with a Previous COVID-19 Infection Were Most Protected During Delta Wave
On Jan. 19, the Centers for Disease Control and Prevention (CDC) released a Morbidity and Mortality Weekly Report (MMWR) study on COVID-19 case number and severity based on vaccination status and previous COVID-19 diagnosis. The study, which reviewed data from New York and California, found that during the Delta wave, both COVID-19 vaccination and surviving a prior infection provided protection against infection and hospitalization. People without a prior COVID-19 infection or who were unvaccinated had the highest risk of infection and hospitalization. People with a previous COVID-19 infection were most protected from infection and hospitalization.
Additional information on the study can be found here.
FDA Publishes Case Studies to Inform Complex Innovative Trial Design Pilot Program
On Jan. 18, the Food and Drug Administration (FDA) published several case study examples to inform stakeholders about Complex Innovative Design (CID) Trials. The CID Pilot Meeting Program was launched in 2018 and seeks to advance the use of novel clinical trial designs.
The pilot program page with the updated case studies can be found here.
Other Activity
21 Attorneys General Request Formal Withdrawal of the “Public Charge” Interim Final Rule
On Jan. 18, a group of 21 attorneys general wrote a comment letter to State Department Secretary Antony Blinken requesting the withdrawal of the Trump-era “public charge” interim final rule (IFR). The 2019 public charge IFR stated that someone who is “likely” to become a public charge would not be granted a visa or green card to the U.S. The IRF was blocked from enforcement in March 2021.The attorneys general state that the IRF causes fear and confusion about what public benefits immigrant communities can access, and it should be formally withdrawn.
The letter can be found here.
Proposed Rules
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.
CMS Publishes Proposed Rule on Benefit and Payment Parameters for 2023
On Jan. 5, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule titled “Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2023.” The proposed rule aims to provide a more stable regulatory framework and includes proposed payment parameters related to the risk adjustment data validation programs. In addition, the proposed rule includes 2023 user fee rates for issuers providing qualified health plans through the federal or state-based exchanges, among other things.
Comments will be accepted until Jan. 27, 2022.
The proposed rule 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.
CMS Publishes Draft Guidance for Antisense Oligonucleotide Drug Products for Severe Diseases
On Dec. 8, the Food and Drug Administration (FDA) published a draft guidance document for industry titled “Investigational New Drug (IND) Submissions for Individualized Antisense Oligonucleotide (ASO) Drug Products for Severely Debilitating or Life-Threatening (SDLT) Diseases: Clinical Recommendations.” The guidance is intended to help sponsor-investigators interested in developing ASO products for rapidly progressive SDLT genetic diseases with clinical recommendations for IND applications.
Comments will be accepted until Feb. 4, 2022.
The guidance can be found here.
FDA Issues Draft Guidance on Premarket Submissions for Device Software Functions
On Nov. 3, the Food and Drug Administration (FDA) published new draft guidance titled “Content of Premarket Submissions for Device Software Functions.” The guidance provides information on documentation sponsors need to submit for FDA’s evaluation of the safety and effectiveness of device software functions. When final, the guidance will replace prior guidance issued in 2005.
Public comments will be accepted until Feb. 2, 2022.
The draft guidance can be found here.
Final Rules
CMS Issues Final Rule to Revise Procedures for Announcing Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications
On Jan. 13, the Food and Drug Administration (FDA) published a final rule titled “Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications.” The final rule amends medical device regulations regarding the procedures for announcing approvals and denials of premarket approval applications (PMAs) and humanitarian device exemption applications (HDEs).
The rule will be effective on Feb. 14, 2022.
The final rule can be found here.
FDA Issues Final Rule to Revoke Regulations for Human Tissue Intended for Transplantation Recovered Prior to 2005
On Jan. 13, the Food and Drug Administration (FDA) published a final rule titled “Revocation of the Regulations for Human Transplantation and Human Dura Mater.” The final rule revokes regulations for human tissue products intended for transplantation that were recovered before May 25, 2005, saying these regulations are outdated as no human tissue products remain in inventory from that time.
The final rule goes into effect on Feb. 14, 2022.
The rule can be found here.
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.
FDA Issues Final Rule to Amend Laboratory Food Testing Requirements
On Dec. 1, the Food and Drug Administration (FDA) issued a final rule titled “Laboratory Accreditation for Analyses of Foods.” The rule amends FDA regulations to establish a program for accredited laboratories to test food under certain circumstances.
The final rule will go into effect on Feb. 1, 2022.
The final rule can be found here.
Courts
Texas 5th Circuit Court Sends Abortion Challenge to State Supreme Court
On Jan. 17, the 5th Circuit Court of Appeals ruled against hearing a challenge to Texas’s anti-abortion law and directed the case to the Texas Supreme Court. The U.S. Supreme Court did not intervene or accelerate the challenge, leaving the law in place as the challenge proceeds.
Reports
GAO Report on Federal Prisons Implementing COVID-19 Recommendations
On Jan. 21, the Government Accountability Office (GAO) published a study titled “Federal Prisons: Monitoring Efforts to Implement COVID-19 Recommendations and Examining First Step Act Implementation.” The report found that while the Bureau of Prison’s (BOP) response to the COVID-19 pandemic included updated guidance, BOP staff reported confusion on how to implement the new guidance. The GAO recommended that BOP evaluate communication of COVID-19 guidance and develop a plan to share best practices.
The full report can be found here.
GAO Report on HHS Vaccine Responsibilities
On Jan. 19, the Government Accountability Office (GAO) released a report titled “COVID-19: HHS and DOD Transitioned Vaccine Responsibilities to HHS, but Need to Address Outstanding Issues.” The report notes that federal efforts to accelerate the development, manufacturing and distribution of the COVID-19 vaccine have been led by the Department of Health and Human Services (HHS) in partnership with the Department of Defense (DOD). The partnership between the two agencies was named HHS-DOD COVID-19 Countermeasures Acceleration Group (CAG). Following a memo of understanding, DOD-led vaccine activities were transferred from CAG to HHS by Dec. 31, 2021. The report notes that HHS lacks strategies to address workforce needs now that CAG has dissolved, and GAO makes five recommendations to better address this issue.
The full report can be found here.
ASPE Report on Prescription Drug Affordability for Medicare Patients
On Jan. 19, the Assistant Secretary for Planning and Evaluation’s (ASPE) Office of Health Policy published a report titled “Prescription Drug Affordability Among Medicare Beneficiaries.” The report found that 3.5 million adults aged 65 and older and 1.8 Medicare beneficiaries under age 65 had difficulty affording their medications in 2019, with Black and Latino adults 1.5 to 2 times as likely to experience difficulty in affording their medications. In addition, Medicare beneficiaries below age 65 had much higher rates of affordability problems than people over 65.
The full report can be found here.
