This Week in Washington: President Biden Invokes Defense Production Act to Increase Supply of Infant Formula

Upcoming Hearings

Congress

House

• House Passes Bill to Help the FDA Address the Infant Formula Shortage
• House Energy and Commerce Committee Advances User Fee Legislation
• Rep. Robin Kelly Introduces Bill to Increase Diversity of NIH-Funded Clinical Trials
• Rep. Schakowsky Introduces Bill to Reduce Exclusivity Period for Brand-Name Biologics to 5 Years

Senate

• Sens. Baldwin and Capito Introduce Bill to Improve the Palliative and Hospice Care Workforce
• Sen. Bennet Introduces Bill to Reduce Healthcare Costs for Retired Public Safety Officers
• 30 Democratic Senators Call on President Biden to Assign a White House Infant Formula Coordinator

Administration

• President Biden Invokes Defense Production Act to Address Infant Formula Shortage
• HHS Announces $300 Million Will Be Allocated to Combat Antimicrobial-Resistant Infections
• HHS Allocated $1.5 Billion to Help States Address Opioid Response
• HHS Announces $10 Million Competition to Advance Lyme Disease Testing
• HHS Announces Funding Opportunity to Develop Center of Excellence to Improve Behavioral Health in the Asian American, Native Hawaiian and Pacific Islander Communities
• HHS Announces Funding to Improve Behavioral Healthcare in Nursing Homes and Long-Term Care Facilities
• CMS Updates Medicare.gov Website
• CMS to Hold Monthly Stakeholder Calls to Prepare for the Medicaid and CHIP Redetermination Process to Resume
• FDA Principal Deputy Commissioner Woodcock to Take on Greater Role in Food Policy
• FDA Authorizes Pfizer’s COVID-19 Vaccine for Booster Doses for Children Aged 5-11
• FDA Issues Guidance Explaining Flexibilities for Importing Infant Formula
• FDA Authorizes First COVID-19 Test That Does Not Require a Prescription and Also Detects Flu and RSV
• CDC Vaccine Advisory Panel Recommends That Children Aged 5-11 Receive Pfizer COVID-19 Booster Dose

Proposed Rules

• FDA Issues Proposed Rules to Ban the Sale of Menthol Cigarettes and Flavored Cigars
• CMS Releases FY 2023 Inpatient Prospective Payment System and Long-Term Care Hospital Prospective Payment System Rule
• CMS Releases FY 2023 Skilled Nursing Facilities Prospective Payment System Proposed Rule
• 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 Inpatient Rehabilitation Facility Prospective Payment System and Quality Reporting Program
• FDA Announces Request for Public Comments for Adding Maximum Daily Exposure Information to Inactive Ingredient Database
• 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

• CMS Releases Reassignment of Medicaid Provider Claims Final Rule
• CMS Releases Notice of Benefit and Parameters for 2023 Final Rule
• CMS Releases Final Rule for Medicare Out-of-Pocket (MOOP) Limits and Service Category Cost Sharing
• Final Rule to Change Qualifications for Products to be Considered “Made in America” Released
• SUNSET Final Rule Implementation Delayed

Reports

• GAO Report on How VA Vet Centers Could Better Meet the Readjustment and Counseling Needs of Veterans and Servicemembers

Upcoming Hearings

May 24

House Committee on Financial Services Subcommittee on Diversity and Inclusion Hearing: “Diversity Includes Disability: Exploring Inequities in Financial Services for Persons with Disabilities, Including Those Newly Disabled Due to Long-Term COVID”
12:00 p.m.

May 25

House Committee on Energy and Commerce Subcommittee on Oversight and Investigations Hearing: “Formula Safety and Supply: Protecting the Health of America’s Babies”
11:00 a.m.

House Committee on Appropriations Subcommittee on Defense Health and Medical Readiness Hearing: “Defense Health and Medical Readiness”
12:00 p.m.

House Committee on Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies Hearing: “The Infant Formula Crisis”
2:00 p.m.

Senate Committee on Finance Subcommittee on International Trade, Customs, and Global Competitiveness Hearing: “Supply Chain Resiliency: Alleviating Backlogs and Strengthening Long-Term Security”
3:00 p.m.

Congress

House

House Passes Bill to Help the FDA Address the Infant Formula Shortage

On May 18, the House passed a supplemental appropriations bill that would provide $28 million in emergency funding to help the Food and Drug Administration (FDA) address the current infant formula shortage. The funding would help the FDA increase the number of inspection staff and provide additional resources to personnel working on formula issues.

The Congressional Budget Office (CBO) published a cost estimate of the bill the same day.

House Energy and Commerce Committee Advances User Fee Legislation

On May 18, the House Energy and Commerce Committee voted unanimously to pass the comprehensive user fee legislation. The bill, the Food and Drug Amendments of 2022, now goes to the House floor. If approved, the bill would allow the Food and Drug Administration (FDA) to collect funds from industry, which could be used to hire new reviewers.

On May 17, the Senate Health, Education, Labor and Pensions Committee released a bipartisan draft bill to reauthorize the FDA’s user fee programs. The Senate discussion draft has a further reach than the House legislation.

Rep. Robin Kelly Introduces Bill to Increase Diversity of NIH-Funded Clinical Trials

On May 19, Rep. Robin Kelly (D-IL) introduced the NIH Clinical Trial Diversity Act, which would increase the diversity of National Institutes of Health (NIH)-funded trial participants. The bill is cosponsored by Reps. Brian Fitzpatrick (R-PA), Yvette Clarke (D-NY), Tony Cárdenas (D-CA) and G.K. Butterfield (D-NC).

Rep. Schakowsky Introduces Bill to Reduce Exclusivity Period for Brand-Name Biologics to 5 Years

On May 18, Rep. Jan Schakowsky (D-IL) introduced a bill that would amend the Public Health Service Act to shorten the exclusivity period for brand-name biological products from 12 years to 5 years. The bill has seven Democratic cosponsors.

Senate

Sens. Baldwin and Capito Introduce Bill to Improve the Palliative and Hospice Care Workforce

On May 19, Sens. Tammy Baldwin (D-WI) and Shelley Moore Capito (R-WV) reintroduced the Palliative Care and Hospice Education and Training Act. The bill aims to improve the palliative and hospice care workforce.

Sen. Bennet Introduces Bill to Reduce Healthcare Costs for Retired Public Safety Officers

On May 19, Sen. Michael Bennet introduced the Public Safety Officer Health Improvement Act. The bill would reduce the healthcare costs for retired public safety officers who are not yet eligible for Medicare by creating a tax credit of up to $4,800.

30 Democratic Senators Call on President Biden to Assign a White House Infant Formula Coordinator

On May 18, Sens. Patty Murray (D-WA) and Bob Casey (D-PA) led 30 Democratic senators in a letter calling on President Biden to assign a White House coordinator on infant formula to address the current shortage. In addition, the senators call for a national strategy to increase the infant formula supply chain resiliency.

Administration

President Biden Invokes Defense Production Act to Address Infant Formula Shortage

On May 18, President Biden announced that he was invoking the Defense Production Act (DPA) to speed the domestic production of infant formula. He also directed the Department of Health and Human Services (HHS) and the Agriculture Department to use the Defense Department’s commercial aircraft to import infant formula products from abroad.

HHS Announces $300 Million Will Be Allocated to Combat Antimicrobial-Resistant Infections

On May 19, the Department of Health and Human Services (HHS) announced it would commit $300 million over the next 10 years to research and develop therapeutics and diagnostics to combat antimicrobial-resistant infections. The initiative will be spearheaded by the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) at Boston University.

HHS Allocated $1.5 Billion to Help States Address Opioid Response

On May 19, the Department of Health and Human Services (HHS) announced that $1.5 billion in funding would be made available through the Substance Abuse and Mental Health Services Administration’s (SAMHSA) State Opioid Response grant program to help states address substance use disorder and overdoses. Specifically, the funds will help states access medications to treat opioid use disorder.

HHS Announces $10 Million Competition to Advance Lyme Disease Testing

On May 18, the Department of Health and Human Services (HHS) and the Steven and Alexandra Cohen Foundation launched a competition to accelerate the development of Lyme disease diagnostics called the LymeX Diagnostics Prize. The competition offers a $10 million prize. Phase one of the competition calls on scientific and clinical experts to submit new methods for detecting active Lyme disease infections.

HHS Announces Funding Opportunity to Develop Center of Excellence to Improve Behavioral Health in the Asian American, Native Hawaiian and Pacific Islander Communities

On May 17, the Department of Health and Human Services (HHS) announced that the Substance Abuse and Mental Health Services Administration (SAMHSA) would be awarding $3.5 million to establish a Center of Excellence to advance behavioral healthcare for the Asian American, Native Hawaiian and Pacific Islander communities. The Center of Excellence will provide culturally and linguistically appropriate behavioral healthcare, establish a steering committee to identify emerging problems and provide technical assistance to providers and educators.

HHS Announces Funding to Improve Behavioral Healthcare in Nursing Homes and Long-Term Care Facilities

On May 16, the Department of Health and Human Services (HHS) announced that $15 million in grant funding would be made available to establish a Substance Abuse and Mental Health Services Administration (SAMHSA) program that would improve mental health care for residents of nursing homes and long-term care facilities. The SAMHSA program would establish the new Center of Excellence for Building Capacity in Nursing Facilities to Care for Residents with Behavioral Health Conditions.

CMS Updates Medicare.gov Website

On May 18, the Centers for Medicare and Medicaid Services (CMS) announced that it had made several updates to the Medicare.gov website to make it easier to navigate. The changes were made based on consumer feedback.

CMS to Hold Monthly Stakeholder Calls to Prepare for the Medicaid and CHIP Redetermination Process to Resume

The Centers for Medicare and Medicaid Services (CMS) will hold the first of its monthly stakeholder webinars on May 25 to prepare for the Medicaid and CHIP redetermination process, which will restart at the end of the public health emergency. Currently, the public health emergency is scheduled to last through July 15, but since the administration has committed to informing stakeholders 60 days in advance of ending the declaration, it is likely that the emergency will be extended further.

FDA Principal Deputy Commissioner Woodcock to Take on Greater Role in Food Policy

On May 18, the Food and Drug Administration (FDA) Commissioner Robert Califf announced that the FDA’s Principal Deputy Commissioner Janet Woodcock would provide counsel and support to key initiatives within the FDA’s food center. This decision comes as the FDA is attempting to resolve the infant formula shortage caused by a recall. Dr. Woodcock has worked extensively on the drug side of the FDA and does not have experience with the food side.

FDA Authorizes Pfizer’s COVID-19 Vaccine for Booster Doses for Children Aged 5-11

On May 17, the Food and Drug Administration (FDA) updated the emergency use authorization (EUA) for Pfizer’s COVID-19 vaccine. With this change, the FDA authorized a single booster dose for children aged 5-11 at least five months after the primary series of Pfizer’s COVID-19 vaccine.

FDA Issues Guidance Explaining Flexibilities for Importing Infant Formula

On May 16, the Food and Drug Administration (FDA) issued a guidance that explains the increased flexibilities on importing infant formula products. The guidance states that the FDA would not object to the importation of infant formula products that were intended for a foreign market, and also would not oppose the domestic distribution of infant formula products that were intended for export.

FDA Authorizes First COVID-19 Test That Does Not Require a Prescription and Also Detects Flu and RSV

On May 16, the Food and Drug Administration (FDA) authorized the first COVID-19 test available without a prescription that also detects flu and respiratory syncytial virus (RSV). The test, the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test allows an individual to collect a nasal swab at home and then send the sample to Labcorp for testing.

CDC Vaccine Advisory Panel Recommends That Children Aged 5-11 Receive Pfizer COVID-19 Booster Dose

On May 19, the Centers for Disease Control and Prevention’s (CDC) vaccine advisory committee voted 11-1 to recommend Pfizer COVID-19 booster doses for children aged 5-11. The vaccine advisors recommended that children aged 5-11 “should” receive a booster dose of Pfizer’s COVID-19 vaccine, a change from the previous language, which stated that children that age “may” receive a booster dose.

Proposed Rules

FDA Issues Proposed Rules to Ban the Sale of Menthol Cigarettes and Flavored Cigars

On April 28, the Food and Drug Administration (FDA) issued two proposed rules, the “Tobacco Product Standard for Menthol in Cigarettes” and the “Tobacco Product Standard for Characterizing Flavors in Cigars.” Together, the proposed rules would ban the sale of menthol cigarettes and flavored cigars, citing the need to protect public health, combat youth tobacco use and promote health equity. The FDA will hold listening sessions to discuss the proposed rules on June 13 and 15.

Public comment on both rules will be open until June 6, 2022.

CMS Releases FY 2023 Inpatient Prospective Payment System and Long-Term Care Hospital Prospective Payment System Rule

On April 18, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule titled “Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year (FY) 2023 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Costs Incurred for Qualified and Non-qualified Deferred Compensation Plans; and Changes to Hospital and Critical Access Hospital Conditions of Participation.” The proposed rule, which is referred to as the FY 2023 Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) rule, updates the Medicare fee-for-service payment rates for long-term care hospitals (LTCHs). The rule also establishes new requirements for hospitals and critical access hospitals participating in the Medicare Promoting Interoperability Program. In addition, the proposed rule adds three health equity measures to hospital quality programs.

A CMS fact sheet on the proposed rule can found here.

Public comments will be accepted until June 17, 2022.

CMS Releases FY 2023 Skilled Nursing Facilities Prospective Payment System Proposed Rule

On April 15, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule titled “Medicare Program: Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program; Long Term Care Facilities to Establish Mandatory Minimum Staffing Levels.” The proposed rule, which is referred to as the fiscal year (FY) 2023 Skilled Nursing Facilities Prospective Payment System (SNF PPS) proposed rule, adds three new measures to the SNF Value-Based Purchasing (VBP) Program. As part of the proposed rule, CMS is seeking public input on how to best establish minimum staffing requirements at nursing homes. CMS is also seeking public comment on how to address staff turnover in nursing homes.

Public comments will be accepted until June 10, 2022.

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.

Public 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 comments 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.

Public 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 Inpatient Rehabilitation Facility Prospective Payment System and Quality Reporting Program

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 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 will be 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 will be accepted until June 6, 2022.

Final Rules

CMS Releases Reassignment of Medicaid Provider Claims Final Rule

On May 12, the Centers for Medicare and Medicaid Services (CMS) released a final rule titled “Medicaid Program; Reassignment of Medicaid Provider Claims.” The final rule authorizes states to make payments to third parties on behalf of individual Medicaid practitioners for whom Medicaid is their primary source of revenue. The rule allows payments for health insurance, skills training and other benefits typical for employees. The rule will go into effect on June 15, 2022.

CMS Releases Notice of Benefit and Parameters for 2023 Final Rule

On April 28, the Centers for Medicare and Medicaid Services (CMS) announced the 2023 Notice of Benefit and Payment Parameters Final Rule, which aims to strengthen plan coverage offered on the federal Marketplace. The final rule will require healthcare.gov plans to offer a standardized version of each product an issuer sells in each metal tier for plan year 2023. The final rule also finalizes exchange user fees, updates quality improvement standards related to health equity and reduces the number of verification requirements for special enrollment periods.

A CMS fact sheet on the final rule can be found here.

CMS Releases Final Rule for Medicare Out-of-Pocket (MOOP) Limits and Service Category Cost Sharing

On April 14, the Centers for Medicare and Medicaid Services (CMS) released a final rule titled “Medicare Program; Maximum Out-of-Pocket (MOOP) Limits and Service Category Cost Sharing Standards.” The rule finalizes the maximum out-of-pocket (MOOP) limits for Medicare Parts A and B services and cost sharing limits for Medicare Parts A and B services. CMS is also requesting public comment on new ways to update cost sharing limits in the future. The regulations go into effect on June 13, 2022.

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.

SUNSET Final Rule Implementation Delayed

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

GAO Report on How VA Vet Centers Could Better Meet the Readjustment and Counseling Needs of Veterans and Servicemembers

On May 17, the Government Accountability Office (GAO) published a report titled “VA Vet Centers: Opportunities Exist to Help Better Ensure Veterans’ and Servicemembers’ Readjustment Counseling Needs Are Met.” The report states that the Veterans Health Administration (VHA) Readjustment Counseling Service (RCS) could better assess if Vet Centers are meeting the needs of client subpopulations. The GAO recommends that the VHA provide support and guidance to Vet Centers to ensure that they are meeting the needs of clients.