Apr 18, 2022
Washington Healthcare Update
This Week in Washington: COVID-19 Public Health Emergency Extended for 90 More Days
The House and Senate are in a district work period this week.
Bipartisan Group Calls on Naloxone Manufacturers to Apply for Over-the-Counter Status
On April 12, Sens. Tammy Baldwin (D-WI), Maggie Hassan (D-NH) and Angus King (I-ME) along with Reps. Carolyn Maloney (D-NY) and Brian Fitzpatrick wrote to seven manufacturers of naloxone, encouraging them to apply for over-the-counter status. Naloxone is an opioid reversal medication that is currently unavailable over the counter. The members stressed that making naloxone more easily accessible would save lives.
Sen. Murray Writes to FDA Calling for Action on Food Safety
On April 11, Sen. Patty Murray (D-WA) wrote to Food and Drug Administration (FDA) Commissioner Robert Califf asking for additional information regarding delays at the FDA’s food safety and nutrition center. Sen. Murray cited her concern regarding FDA’s delayed action on contaminated infant formula, as well as delayed inspections and recalls.
Reforms to Address Medical Debt Announced
On April 11, Vice President Harris announced reforms intended to reduce the burden of medical debt. The reforms aim to hold providers and debt collectors accountable for harmful practices, reduce the role of medical debt in credit scores, forgive veterans’ medical debt and inform consumers of their rights. As part of these reforms, Department of Health and Human Services (HHS) Secretary Xavier Becerra requested data from providers on medical bill collection practices, which will be analyzed and used to make policy recommendations. In addition, the Consumer Financial Protection Bureau (CFPB) will investigate credit reporting companies and debt collectors that violate patient rights.
COVID-19 Public Health Emergency Extended
On April 13, Health and Human Services (HHS) Secretary Xavier Becerra extended the COVID-19 public health emergency for an additional 90 days. The public health emergency was previously set to expire on April 16. HHS has committed to provide a 60-day notice before ending the PHE.
HHS Announces Distribution of $1.75 Billion in Provider Relief Funds
On April 13, the Department of Health and Human Services (HHS) announced that it was distributing $1.75 billion in Phase 4 Provider Relief Fund (PRF) payments to more than 3,600 providers. This makes $21 billion in total PRF payments distributed thus far. Currently, 92 percent of Phase 4 PRF applications have been processed.
FDA Authorizes First COVID-19 Test That Uses Breath Samples
On April 14, the Food and Drug Administration (FDA) authorized the first COVID-19 test that uses breath samples to detect COVID-19 infection. The test detects infection in less than three minutes and is currently only authorized for use under the supervision of a healthcare provider. The manufacturer, InspectIR Systems, plans to produce approximately 100 testing devices per week.
FDA Releases Draft Industry Guidance on Plans to Improve Diversity in Clinical Trials
On April 13, the Food and Drug Administration (FDA) issued a draft guidance titled “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.” The draft guidance recommends that medical product sponsors develop and submit a Race and Diversity Plan to the FDA in the early stages of clinical development. Manufacturers’ Race and Diversity Plan should be based on the framework detailed in the draft guidance.
CDC Extends Mask Requirements for Airplanes and Public Transit
On April 13, the Centers for Disease Control and Prevention (CDC) announced that the CDC Mask Order, which requires masks on airplanes and public transit, would remain in effect for an additional 15 days, until May 3. This extension comes as the number of COVID-19 cases has increased in recent weeks, and the BA.2 subvariant accounts for 85 percent of current cases. In addition, the CDC updated its Travel Health Notice system, which will now reserve Level 4 international travel health notices for special cases, such as rapidly escalating or extreme COVID-19 case numbers, a new variant or healthcare infrastructure collapse.
HRSA Allocates $226.5 Million to Launch the Community Health Worker Training Program
On April 15, the Health Resources and Services Administration (HRSA) announced that $226.5 million in American Rescue Plan funding would be allocated to the launch of the Community Health Worker Training Program. The Community Health Worker Training Program aims to increase the number of community health workers providing COVID-19 care, mental health and substance use disorder prevention and treatment, and other services. The program will be a multi-year program that provides education and training to public health workers.
HRSA Allocates Funds to Improve Maternal Health
On April 13, the Health Resources and Services Administration (HRSA) announced that it would allocate $16 million in grant funding though the Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program. The grants will promote data and technology innovations in maternal and child health. In addition, HRSA also announced that $9 million in funds would be used to expand the State Maternal Health Innovation and Implementation Program.
MACPAC Releases Reference Guide to Federal Medicaid Statute and Regulations
On April 14, the Medicaid and CHIP Payment and Access Commission (MACPAC) released a reference guide, titled “Reference Guide to Federal Medicaid Statute and Regulations.” The reference guide is meant to help users locate provisions in statute, regulation and state plans.
FTC Extends Public Comment Period on PBM Request for Information
On April 13, the Federal Trade Commission (FTC) extended the public comment period on the request for information (RFI) related to the Pharmacy Benefit Manager (PBM) market until May 25, 2022. The FTC is seeking information on PBM practices, including rebates, contract terms and consolidation and their impact on providers, patients and cost.
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.
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.
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.
CBO Publishes Presentation on Variation in Prices for Hospitals’ Services
On April 14, the Congressional Budget Office (CBO) published a presentation by Michael Cohen of CBO’s Health Analysis Division at the American Academy of Actuaries. The presentation, titled “Variation in Prices for Hospitals’ Services,” shows data on how hospitals’ prices for inpatient services vary by state and within metropolitan areas. The presentation also explores the relationship between hospital wages and insurers’ prices for inpatient services.