This Week in Washington: Senate Confirms Ketanji Brown Jackson to Supreme Court
Congress
House
- House Passes the Medical Marijuana Research Act
- House Passes the Ensuring Lasting Smiles Act
- Reps. Pressley, Beyer and Blunt Rochester Introduce Bill to Expand Access to Long COVID Care
- Reps. Wenstrup and Ferguson Introduce Bill to Improve U.S. Medical Supply Chain
Senate
- COVID-19 Bill Stalled in Senate
Administration
- President Biden Signs Executive Order That Aims to Strengthen Medicaid and the ACA
- HHS Announces Medicare Part B Beneficiaries Can Access Free Over-the-Counter COVID-19 Tests
- CMS Releases National Coverage Determination for Aduhelm
- CMS Announces Rollback of Some Temporary COVID-19 Policies in Long-Term Care Facilities
- CMS Releases Announcement of CY 2023 MA Capitation Rates and Parts C and D Payment Policies
- HRSA Seeking Funding for the Pediatric Mental Health Care Access Program
- FDA Updates Emergency Use Authorization for COVID-19 Monoclonal Antibody Treatment Sotrovimab
Proposed Rules
- CMS Issues Proposed Rule to Delay Start of Radiation Oncology Model
- IRS Publishes Proposed Rule to Address Affordable Care Act “Family Glitch”
- HHS’ Office for Civil Rights Announces RFI on Security Practices and Monetary Settlements Included in the HITECH Act
- CMS Releases Proposed Rule with Updates for the Inpatient Psychiatric Facilities Prospective Payment System
- CMS Releases Proposed Rule to Update the Hospice Wage Index, Payment Rate and Hospice Quality Reporting Requirements
- CMS Releases Proposed Rule to Update Medicare
- FDA Announces Request for Public Comments for Adding Maximum Daily Exposure Information to Inactive Ingredient Database
- FDA Releases Draft Guidance on Verification System Requirements for Certain Prescription Drugs
- HHS Issues RFI on the Impact of COVID-19 Misinformation
- DHS Issues Notice of Proposed Rulemaking to Edit Public Charge Definition
- FDA Issues Proposed Rule to Amend Medical Device Manufacturing Practice Requirements
- FDA Issues Proposed Rule with Potential Standards for Wholesale Drug Distributors and Third-Party Logistics Providers
Final Rules
- Final Rule to Change Qualifications for Products to be Considered “Made in America” Released
- HHS Delays SUNSET Final Rule Implementation
Reports
- NASEM Report Calls for Changes to Nursing Homes
- GAO Report on DOD Actions Needed to Address Military Suicide
- GAO Report on Defined Contribution Plans
Congress
The Senate and House are in a district work period this week.
House
House Passes the Medical Marijuana Research Act
On April 4, the Medical Marijuana Research Act (H.R. 5657) passed the House with a vote of 343-75. The bill was introduced by Reps. Earl Blumenauer (D-OR), Andy Harris (R-MD) and Morgan Griffith (R-VA). The bill would amend the Controlled Substances Act, establishing a separate registration process for biomedical research on marijuana.
House Passes the Ensuring Lasting Smiles Act
On April 4, the House passed the Ensuring Lasting Smiles Act with a vote of 310-110. The bill would require all individual and group market health plans to cover medically necessary treatment resulting from congenital anomalies or birth defects. The Congressional Budget Office (CBO) cost estimate of the pay-as-you-go measures in the bill can be found here.
Reps. Pressley, Beyer and Blunt Rochester Introduce Bill to Expand Access to Long COVID Care
On April 7, Reps. Ayanna Pressley (D-MA), Don Beyer (D-VA) and Lisa Blunt Rochester (D-DE) introduced the Targeting Resources for Equitable Access to Treatment (TREAT) for Long COVID Act. The bill was also introduced in the Senate by Tammy Duckworth (D-IL), Tim Kaine (D-VA) and Ed Markey (D-MA). The bill would provide grant funding to community health centers treating long COVID and fund the creation of Long COVID clinics.
Reps. Wenstrup and Ferguson Introduce Bill to Improve U.S. Medical Supply Chain
On April 5, Reps. Brad Wenstrup (R-OH) and Drew Ferguson (R-GA) introduced the American Made Medicine Act, which aims to improve medical supply chains in the U.S. The legislation would lower the tax rate on the income gained from domestic pharmaceutical manufacturing and also offer a tax credit for investments in manufacturing equipment to produce drugs, biologics or medical devices.
Senate
COVID-19 Bill Stalled in Senate
On April 6, the Senate bill that would have provided an additional $10 billion in funding for COVID-19 programs stalled in the Senate. Senate Republicans said they could not support the bill as it did not include a reinstatement of Title 42, which permits the expulsion of migrants at the border during the pandemic.
Administration
President Biden Signs Executive Order That Aims to Strengthen Medicaid and the ACA
On April 5, President Biden signed an executive order titled “Strengthening Medicaid and the Affordable Care Act.” The executive order directs agencies with responsibilities related to the Affordable Care Act (ACA) and Medicaid to review their regulations and policies to ensure that their objectives will help strengthen the programs and ensure they are affordable and accessible.
HHS Announces Medicare Part B Beneficiaries Can Access Free Over-the-Counter COVID-19 Tests
On April 4, the Department of Health and Human Services (HHS) announced that beneficiaries enrolled in Medicare Part B and Medicare Advantage are now eligible for Food and Drug Administration- (FDA) approved over-the-counter COVID-19 tests at no cost.
CMS Releases National Coverage Determination for Aduhelm
On April 7, the Centers for Medicare and Medicaid Services (CMS) released the National Coverage Determination (NCD) for Aduhelm and any other future antibody treatments directed against amyloid to treat Alzheimer’s disease. Under the NCD, Aduhelm will only be covered by Medicare for patients participating in clinical trials administered by the Food and Drug Administration (FDA) or the National Institutes of Health (NIH), and the trials do not need to be approved by CMS. This is a slightly more flexible requirement than the proposed NCD released in January. In addition, CMS stated that future Alzheimer’s drugs that target amyloid that go through the traditional approval process will not need to carry out randomized controlled trials. Instead, a patient registry, which tracks how patients fare after receiving the drug, can be used.
CMS Announces Rollback of Some Temporary COVID-19 Policies in Long-Term Care Facilities
On April 7, the Centers for Medicare and Medicaid Services (CMS) issued a memo to announce the rollback of some COVID-19 waivers for long-term care facilities. The temporary waivers were intended to provide facilities with flexibilities to respond to COVID-19, and some waivers suspended requirements. CMS stated that some flexibilities would be phased out to reestablish certain minimum standards now that facilities have increased vaccination rates and are better able to respond to COVID-19 outbreaks.
CMS Releases Announcement of CY 2023 MA Capitation Rates and Parts C and D Payment Policies
On April 4, the Centers for Medicare and Medicaid Services (CMS) released the Announcement of Calendar Year 2023 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies. A CMS fact sheet that summarizes the changes can be found here.
HRSA Seeking Funding for the Pediatric Mental Health Care Access Program
The Health Resources and Services Administration (HRSA) is seeking funding for fiscal year (FY) 2023 to support increasing access to pediatric telemental health services through its Pediatric Mental Health Care Access (PMHCA) program. The PMHCA program works to connect primary care providers with mental health care specialists in rural and underserved areas. In President Biden’s budget request, he allocated $10 million to continue the PMHCA program in 2023.
FDA Updates Emergency Use Authorization for COVID-19 Monoclonal Antibody Treatment Sotrovimab
On April 5, the Food and Drug Administration (FDA) announced an update to the emergency use authorization for sotrovimab, a monoclonal antibody used to treat COVID-19. Sotrovimab is no longer authorized to treat COVID-19 in any U.S. region. Sotrovimab is unlikely to be effective in treating COVID-19’s Omicron BA.2 variant, which is the strain currently causing over 50 percent of COVID-19 cases in the U.S.
Proposed Rules
CMS Issues Proposed Rule to Delay Start of Radiation Oncology Model
On April 8, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule titled “Radiation Oncology (RO) Model.” The proposed rule delays the start of the RO to an undetermined future date that will be determined by future rulemaking.
Comments will be accepted until June 7, 2022.
IRS Publishes Proposed Rule to Address Affordable Care Act “Family Glitch”
On April 7, the Internal Revenue Service (IRS) published a proposed rule titled “Affordability of Employer Coverage for Family Members of Employees.” The proposed rule would make changes to the eligibility for the premium tax credit to ensure that the affordability of employer-sponsored minimum essential coverage for family members of an employee is determined on the employee’s share of the cost of covering themselves and their family members. Currently, regulations define “affordable” employer-based coverage as coverage that is affordable for the employee, not considering whether it is affordable for the employee’s family members. This can lead family members to be ineligible for a premium tax credit, and this situation is referred to as the “family glitch.”
Public comment will be accepted until June 6, 2022.
HHS’ Office for Civil Rights Announces RFI on Security Practices and Monetary Settlements Included in the HITECH Act
On April 6, the Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) announced it was seeking public input on two provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009, which was amended in 2021. The Request for Information (RFI) will inform the OCR’s policies to support the healthcare industry’s security practices going forward. In addition, the RFI will inform how the OCR will share funds collected from HIPAA rule violation enforcement.
Comments will be accepted until June 6, 2022.
CMS Releases Proposed Rule with Updates for the Inpatient Psychiatric Facilities Prospective Payment System
On March 31, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule titled “Medicare Program: Fiscal Year 2023 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update and Quality Reporting.” The proposed rule would make updates to prospective payment rates, the outlier threshold and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF). The proposed rule would also establish a mitigation policy to facilitate the yearly changes in IPF payments. The changes are summarized in this CMS fact sheet. The proposed changes would be in effect from Oct. 1, 2022, to Sept. 30, 2023.
Public comments will be accepted until May 31, 2022.
CMS Releases Proposed Rule to Update the Hospice Wage Index, Payment Rate and Hospice Quality Reporting Requirements
On March 31, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule titled “Medicare Program: FY 2023 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements.” The proposed rule would establish a mitigation policy to facilitate the yearly changes to the hospice wage index. The proposed rule would also update the hospice wage index, payment rates and aggregate cap amount for Fiscal Year 2023, and make changes to the Hospice Quality Reporting Program (HQRP). The changes are summarized in this CMS fact sheet.
Public comments will be accepted until May 31, 2022.
CMS Releases Proposed Rule to Update Medicare
On March 31, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule titled “Medicare Program: Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2023 and Updates to the Inpatient Rehabilitation Facility Quality Reporting Program.” The proposed rule would update Medicare payment policies and rates under the Inpatient Rehabilitation Facility (IRF) Prospective Payment System (PPS) and the IRF Quality Reporting Program for Fiscal Year 2023. The changes are summarized in this CMS fact sheet.
Public comments will be accepted until May 31, 2022.
FDA Announces Request for Public Comments for Adding Maximum Daily Exposure Information to Inactive Ingredient Database
On March 22, the Food and Drug Administration (FDA) issued a notice titled “Prioritizing the Addition of Maximum Daily Exposure Information and Removing Dosage Form Information From the Inactive Ingredient Database” to establish a public docket and request public comment. The public comments will help the FDA determine how to best prioritize maximum daily exposure (MDE) information for inactive ingredients that are not currently included in the Centers for Drug Evaluation and Research’s Inactive Ingredient Database, as well as if the database should be restructured by removing dosage form information.
Public comments will be accepted until June 21, 2022.
FDA Releases Draft Guidance on Verification System Requirements for Certain Prescription Drugs
On March 9, the Food and Drug Administration released draft guidance titled “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.” The draft guidance details the statutory verification system requirements that products need to comply with under the Federal Food, Drug, and Cosmetic Act as amended by the Drug Supply Chain Security Act. Specifically, the draft guidance provides information on verification system requirements to quarantine and investigate products determined to be illegitimate. The guidance document includes non-binding recommendations.
Comments will be accepted until May 9, 2022.
HHS Issues RFI on the Impact of COVID-19 Misinformation
On March 7, the Department of Health and Human Services’ (HHS) Office of the Surgeon General published a notice titled “Request for Information: Impact of Health Misinformation in the Digital Information Environment in the United States Throughout the COVID-19 Pandemic.” The Office of the Surgeon General is seeking input on COVID-19 misinformation online to better understand the impact of misinformation on healthcare infrastructure and public health.
Public comments will be accepted until May 2, 2022.
DHS Issues Notice of Proposed Rulemaking to Edit Public Charge Definition
On Feb. 24, the Department of Homeland Security (DHS) issued a notice of proposed rulemaking titled “Public Charge Ground of Inadmissibility,” which would make the public charge standard less restrictive, as it would no longer include people receiving Medicaid and Supplemental Nutrition Assistance Program (SNAP) benefits.
Under the current law, a noncitizen seeking admission to the U.S. or seeking a visa or status must prove that they are not “likely to become a public charge” in order to be admitted to the U.S. The new proposed rule states that someone is likely to become a public charge if they are “likely to become primarily dependent on the government for subsistence,” which includes the receipt of public cash assistance for income maintenance or long-term institutionalization at government expense. This represents a change from the 2019 Public Charge Final Rule definition of public charge, which also considered receipt of Medicaid, public housing or SNAP benefits as making someone a “public charge.” The 2019 final rule has not been in effect since 2021.
Public comments will be accepted until April 25, 2022.
FDA Issues Proposed Rule to Amend Medical Device Manufacturing Practice Requirements
On Feb. 23, the Food and Drug Administration (FDA) published a proposed rule titled “Medical Devices; Quality System Regulation Amendments.” The proposed rule would amend the Quality System Regulation’s device current good manufacturing practice (CGMP) requirements to align more closely with international device standards.
Public comments are accepted until May 24, 2022.
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 Providers.” 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.
Final Rules
Final Rule to Change Qualifications for Products to be Considered “Made in America” Released
On March 4, the Department of Defense, the General Services Administration and the Aeronautics and Space Administration announced a final rule that aims to increase manufacturing of critical supplies in the U.S. as part of President Biden’s “Made in America” policy. The final rule would require pharmaceutical companies that want their products to qualify as being “Made in America” for federal procurement purposes to increase the percentage of drug ingredients made in the U.S. from 55 percent to 75 percent in the next seven years. Specifically, the final rule would increase the threshold to 60 percent in 2022, 65 percent in 2024 and 75 percent in 2029. In addition, the rule will allow the government to apply price preferences to select drug products and components that will support the expansion of the domestic supply chain. The final rule will go into effect on Oct. 25, 2022.
The White House Fact Sheet on the final rule can be found here.
HHS Delays SUNSET Final Rule Implementation
On March 4, the Department of Health and Human Services (HHS) released a final rule to postpone the final rule titled “Securing Updated and Necessary Statutory Evaluations Timely (SUNSET Final Rule). The SUNSET final rule was first published on Jan. 19, 2021, and was set to go into effect on March 22, 2022. The final rule would establish a new process to review HHS regulations, with automatic expiration of regulations that meet certain circumstances. The final rule will now be delayed further and will go into effect on Sept. 22, 2022.
Reports
NASEM Report Calls for Changes to Nursing Homes
On April 6, the National Academies of Sciences, Engineering and Medicine (NASEM) released a report titled “The National Imperative to Improve Nursing Home Quality.” The report states that the way nursing home care is delivered and regulated needs to undergo a major shift to be able to provide high-quality care to all nursing home residents. Specifically, NASEM calls for developing quality measures for palliative care and behavioral health as well as collecting and making public resident and family satisfaction information.
GAO Report on DOD Actions Needed to Address Military Suicide
On April 6, the Government Accountability Office (GAO) released a report titled “Military Suicide: Preliminary Observations on Actions Needed to Enhance Prevention and Response Affecting Remote Installations.” The report found that the Department of Defense’s (DOD) suicide prevention and response programs have faced challenges such as assessing suicide risk at remote installations outside the contiguous U.S., implementing key prevention activities, integrating suicide prevention into primary care and providing response guidance to personnel. The GAO recommended that the DOD establish a process to improve guidance and training for commanders, develop a strategy to hire behavioral health personnel and create a procedure to assess suicide risk at remote installations outside the contiguous U.S.
GAO Report on Defined Contribution Plans
On April 4, the Government Accountability Office (GAO) released a report titled “Defined Contribution Plans: 403(b) Investment Options, Fees, and Other Characteristics Varied.” The report states that total assets held by 403(b) plans was $1.1 trillion in 2020, with about half of these assets covered by the Employee Retirement Income Security Act (ERISA) of 1974. The report found that ERISA 403(b) assets grew from 2010 to 2019, a trend likely the result of consolidation of healthcare sector firms.
