This Week in Washington: CBO 2023 Budget Report is released

Upcoming Hearings

Congress

House

• CBO Releases Presentation of its 2023 Budget and Economic Outlook Report
• House Members Urge More Oversight into Hospice Care Fraud and Abuse
• Outpatient Surgery Quality and Access Act Introduced

Senate

• Senate HELP Committee Announces Hearing on Moderna COVID-19 Vaccine
• Twenty Senators Send Letter Concerning Alzheimer’s Treatment Access
• Mental Health Professionals Workforce Shortage Loan Repayment Act Introduced
• Sen. Grassley Urges Oversight of Nursing Home Psychotropic Medicines
• Promoting Public Health Information Act Introduced
• Senate Finance Committee Chairman Urges CMS to Finalize Medicare Advantage Consumer Protections

Administration

• HHS OIG Releases February Work Plan
• HHS OIG Finds Michigan HHS Broke Foster Care Prescription Requirements
• HHS Announces Changes to Institutional Review Board Exception
• NIH Data Identifies Long-COVID Disparities
• CMS Proposes Expanding Benefits for Mobility Devices
• CMS Innovation Center Releases New Models on Prescription Drug Prices
• CMS Releases Medicaid Drug Rebate Program Notice
• FDA Releases Guidance for Abbreviated New Drug Application Applicants
• FDA Announces Biosimilar Products Funding Opportunity
• FDA Releases External Report of Agency’s Actions on Opioid Analgesics Abuse
• FDA Advisory Committee to Review Opioid Analgesics Efficacy and Risk
• NARCAN Over-the-Counter Approval Recommended
• FDA and EPA Seeking Public Input on Oversight Approaches
• FDA Updates Compounding Ibuprofen Oral Suspension Products Guidance

Proposed Rules

• ACF Proposes Rule to Revise Foster Family Home Definition
• CMS Proposes Rule to Increase Nursing Home Transparency
• SAMSHA Issues Proposed Rule to Eliminate X-Waiver Requirement
• HHS Proposes Rule to Expand Access to ACA Birth Control Coverage
• HHS Proposes Rule to Clarify Beneficiary Religious Protections
• HHS Office for Civil Rights Releases Proposed Rule Seeking to Clarify Healthcare Provider Conscience Protection Rights
• CMS Proposes Healthcare Plan Exchange Rule for 2024
• HHS Proposes Adopting Healthcare Attachments Standards
• FDA Proposed Rule Would Replace Investigational New Drug Annual Report
• FDA Proposes Exempting Certain Conventional Food, Dietary Supplements and Cosmetics From Investigational New Drug Requirements

Final Rules

• CMS Issues Final Rule Regarding Medicare Advantage Risk Adjustment Data Validation Program
• CMS Final Rule Adds Items to DMEPOS Order List and Updates Healthcare Common Procedure Coding System (HCPCS)
• FDA Delays Tobacco Product Required Warning Final Rule Effective Date
• CMS Issues Correction on Clinical Laboratory Improvement Amendments (CLIA) Final Rule

Reports

• GAO Releases Report on Federal Oversight of Institutional Review Boards
• CRS Releases Report on Telehealth

Upcoming Hearings

March 22

Senate Committee on Health, Education, Labor and Pensions Hearing: “Taxpayers Paid Billions For It: So Why Would Moderna Consider Quadrupling the Price of the COVID Vaccine?”
10:00 a.m., Dirksen Senate Building 430

Congress

House

House Not in Session

CBO Releases Presentation of its 2023 Budget and Economic Outlook Report

On Feb. 16, the Congressional Budget Office (CBO) released a presentation showcasing the results it published in its 2023 Budget and Economic Outlook report. The report highlights CBO’s projections of the federal deficit over the next 10 years. It also showcases the amount of federal debt held by the public, and projected outlay, revenue, interest, inflation, unemployment and real GDP rates.

For more information, click here.

House Members Urge More Oversight into Hospice Care Fraud and Abuse

On Feb. 14, Reps. Blumenauer (D-OR), Van Duyne (R-TX), Panetta (D-CA) and Wenstrup (R-OH) sent a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure, expressing their concerns over hospice care fraud and abuse. The representatives are asking CMS to identify additional oversight measures that Congress could take, to combat hospice care fraud and abuse.

For more information, click here.

Outpatient Surgery Quality and Access Act Introduced

On Feb. 10, Reps. Wenstrup (R-OH) and Larson (D-CT) introduced the Outpatient Surgery Quality and Access Act. Sens. Cassidy (R-LA) and Blumenthal (D-CT) introduced a companion bill in the Senate. The legislation seeks to make outpatient surgical care more affordable for Medicare beneficiaries. The bill would:

• Make permanent the alignment of Medicare reimbursement update factors for the Ambulatory Surgical Center (ASC) and Hospital Outpatient Department (HOPD) payment systems under Medicare to ensure the disparity between HOPD and ASC payments is reduced
• Eliminate copay penalties for Medicare beneficiaries
• Reduce other barriers Medicare beneficiaries may encounter when searching for affordable, quality care

For more information, click here.

Senate

Senate HELP Committee Announces Hearing on Moderna COVID-19 Vaccine

On Feb. 15, Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) announced that the Senate HELP committee will hold a hearing on March 22, where it will question Moderna’s CEO Stéphane Bancel over the company’s plan of quadrupling the price of its COVID-19 vaccine. On Feb. 16, Moderna announced that it will keep its vaccine available to everyone at no cost. Insured individuals will have access to the vaccine through their doctors’ offices and pharmacies, and the Moderna Patient Assistance Program will help underinsured and uninsured individuals receive the vaccine at no cost.

Announced hearing panelists include:

• Stéphane Bancel, CEO and Director of Moderna, Inc.
• Christopher J. Morten, Ph.D., J.D., Associate Clinical Professor of Law at Columbia Law School
• Ameet Sarpatwari, Ph.D., J.D., Assistant Professor of Medicine at Harvard Medical School
• Craig Garthwaite, Ph.D., M.P.P., Herman R. Smith Research Professor in Hospital and Health Services Management at the Northwestern University Kellogg School of Management

Twenty Senators Send Letter Concerning Alzheimer’s Treatment Access

On Feb. 17, Sens. Collins (R-ME) and Capito (R-WV) led a bipartisan group of 20 senators in sending a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra and Centers of Medicare and Medicaid (CMS) Administrator Chiquita Brooks-LaSure. The letter asks CMS to reconsider the Coverage with Evidence Development (CED) requirements for Alzheimer’s monoclonal antibody treatments recently approved by the Food and Drug Administration (FDA).

The other senators who signed the letter include Sens. Barrasso (R-WY), Lankford (R-OK), Moran (R-KS), Cramer (R-ND), Budd (R-NC), Mullin (R-OK), Rubio (R-FL), Lummis (R-WY), Murkowski (R-AK), Peters (D-MI), Wicker (R-MS), Fischer (R-NE), Hyde-Smith (R-MS), Tillis (R-NC), Klobuchar (D-MN), Hoeven (R-ND), Rounds (R-SD) and Boozman (R-AR).

For more information, click here.

Mental Health Professionals Workforce Shortage Loan Repayment Act Introduced

On Feb. 17, Sens. Smith (D-MN), Murkowski (R-AK) and Hassan (D-NH) reintroduced the Mental Health Professional Workforce Shortage Loan Repayment Act of 2023. The bill would establish a loan repayment program that would provide loan repayment services to full-time employees who worked a minimum of 6 years as a behavioral or mental health professional, or a substance use disorder treatment professional.

Sen. Grassley Urges Oversight of Nursing Home Psychotropic Medicines

On Feb. 16, Sen. Chuck Grassley (R-IA) sent a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra and Centers of Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure, asking for improvements to be made to CMS’ oversight and enforcement of psychotropic drug deficiencies in nursing home facilities. Sen. Grassley stressed his concern over reports of nursing homes misdiagnosing seniors with schizophrenia and prescribing them antipsychotic drugs, which can pose significant risks.

For more information, click here.

Promoting Public Health Information Act Introduced

On Feb. 15, Sens. Murphy (D-CT) and Ray Luján (D-NM) reintroduced the Promoting Public Health Information Act. The legislation aims to assist the Department of Health and Human Services (HHS) with addressing health disinformation during public health emergencies. Reps. DeGette (D-CO) and Castor (D-FL) introduced a companion bill in the House.

The Promoting Public Health Information Act would grant the HHS Secretary authority to:

• Establish a Public Health Information and Communications Advisory Committee within HHS composed of federal officials with backgrounds in public health, medicine, communications and national security. The committee would be tasked with issuing recommendations on how to communicate scientific and medical information during a public health emergency, and how to curb the spread of disinformation.
• Issue awards to encourage evidence- and fact-based initiatives that educate people on public health and medical science.
• Spend $45 million for educational initiatives and committee tasks.

For more information, click here.

Senate Finance Committee Chairman Urges CMS to Finalize Medicare Advantage Consumer Protections

On Feb. 14, Senate Finance Committee Chairman Ron Wyden (D-OR) wrote to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure, asking CMS to finalize a proposed rule that would implement new restrictions on private insurance agent and broker deceptive consumer marketing practices. Sen. Wyden led an investigation into deceptive marketing practices last year, which revealed that private agents and brokers were using misleading language, cold calls and the Medicare name and logo in marketing, to mislead seniors into signing up for fraudulent Medicare Advantage (MA) plans.

For more information, click here.

Administration

HHS OIG Releases February Work Plan

On Feb. 15, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its February 2023 work plan. The OIG work plan identifies audits and evaluations that the OIG Office of Audit Services and Office of Evaluation and Inspections have planned for the month. The OIG plans to conduct in-depth reviews and audits on the following subjects:

• Medicare Enrollment Race and Ethnicity Data
• Nursing Home Citations Related to the Use of Antipsychotic Drugs
• Medicare and Medicaid Payments Made to Providers
• Substance Abuse and Mental Health Services Administration’s (SAMSHA) Behavioral Health Treatment Services Locator

For more information, click here.

HHS OIG Finds Michigan HHS Broke Foster Care Prescription Requirements

On Feb. 13, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a report highlighting the findings of an audit it conducted into whether the Michigan Department of Health and Human Services complied with requirements regarding psychotropic and opioid medication prescriptions for foster care children. Title IV-E of the Social Security Act, which established the Federal Foster Care Program, requires states to submit detailed plans regarding the oversight and coordination of healthcare services for foster care children. These plans must address how states will oversee drugs prescribed to foster care children, including psychotropic and opioid medicines. The HHS OIG discovered that Michigan’s Department of Health and Human Services had failed to correctly report and maintain records of psychotropic and opioid medications prescriptions and consent forms for several foster care children.

For more information, click here.

HHS Announces Changes to Institutional Review Board Exception

On Feb. 10, the Department of Health and Human Services (HHS) announced that it would not extend an exception that the HHS Office for Human Research Protections (OHRP) issued on Oct. 8, 2020, which exempted institutions engaged in certain cooperative research supported or conducted by HHS from complying with the single Institutional Review Board (IRB) mandate. The IRB mandate requires institutions in the United States to receive approval from an IRB before engaging in cooperative research (research involving more than one institution). HHS decided to exempt institutions engaged in cooperative research from the IRB mandate if the following conditions were met:

• If the institution’s cooperative research was ongoing or initially reviewed by an IRB during the COVID-19 PHE;
• Where reliance on a single IRB was not practical; and
• When the HHS division supporting or conducting the research approved the use of the exception.

For more information, click here.

NIH Data Identifies Long-COVID Disparities

On Feb. 16, the National Institutes of Health (NIH) released data from its Researching COVID to Enhance Recovery (RECOVER) initiative, showing that Black and Hispanic Americans experience more Long-COVID health problems and symptoms than other racial and ethnic groups. The NIH looked at approximately 13,100 Long-COVID patients who were hospitalized and determined that 1 in 4 patients were either Black or Hispanic American. These patients were also more likely to be diagnosed with diabetes, anemia, chest pains and joint pain.

For more information, click here.

CMS Proposes Expanding Benefits for Mobility Devices

On Feb. 15, the Centers for Medicare and Medicaid Services (CMS) released a proposed National Coverage Determination (NCD) decision that would allow Medicare to cover the costs of power seat elevation equipment for individuals using Group 3 power wheelchairs. CMS is requesting interested parties to leave feedback and comments on the proposed NCD. Public comments will be accepted until March 17, 2023.

For more information, click here.

CMS Innovation Center Releases New Models on Prescription Drug Prices

On Feb. 14, the Centers for Medicare and Medicaid Services (CMS) announced that the Secretary of the Department of Health and Human Services (HHS) had selected three new CMS Innovation Center models, which will look at how Medicare and Medicaid plans could work toward lowering prescription drug costs. The Innovation Center was asked to create models focused on prescription drug costs in Executive Order 14087 titled “Lowering Prescription Drug Costs for Americans,” which President Biden signed in October 2022.

The three models are listed below:

• Medicare $2 Drug List Model: This model encourages Medicare Plan D providers to offer low, fixed co-payments for all cost-sharing phases of the Part D drug benefit for generic drugs that treat chronic conditions. This model would cap out-of-pocket costs for applicable generic drugs at $2 per month.

• Cell and Gene Therapy Access Model: This model would require state Medicaid agencies to grant CMS oversight over the coordination and administering of agreements with applicable cell and gene therapy manufacturers. This would expand Medicaid beneficiary access to specialty drugs released on the market.

• Accelerating Clinical Evidence Model: This model would allow CMS to develop payment methods for drugs that are granted accelerated approval by the Food and Drug Administration (FDA). This would reduce Medicare spending on drugs that may not have a confirmed clinical benefit.

For more information, click here.

CMS Releases Medicaid Drug Rebate Program Notice

On Feb. 10, the Centers for Medicare and Medicaid Services (CMS) issued a notice for states regarding the Medicaid drug rebate program. The notice reminds states that they must submit state data on CMS-authorized supplemental rebate agreements with value-based purchasing arrangements no later than March 1, 2023. States must also certify their state drug utilization data (SDUD).

For more information, click here.

FDA Releases Guidance for Abbreviated New Drug Application Applicants

On Feb. 17, the Food and Drug Administration (FDA) released guidance for prospective abbreviated new drug application (ANDA) applicants. The guidance provides applicants with information on how they can request and conduct product-specific guidance (PSG) meetings with the FDA. The guidance also informs applicants on how they can properly schedule and manage PSG meetings.

For more information, click here.

FDA Announces Biosimilar Products Funding Opportunity

On Feb 16, the Food and Drug Administration (FDA) announced that it is opening a regulatory science program funding opportunity to support research projects related to the development of biosimilar and interchangeable biological products. The FDA is required to pilot a regulatory science program to facilitate biosimilar and interchangeable biological product development for fiscal years (FYs) 2023-2027, as outlined in the Biosimilar User Fee Act (BsUFA). The program aims to increase the accuracy and capability of biosimilar product manufacturing and controls and develop alternatives to current biosimilar product human trials. Submissions for the funding opportunity will be accepted until April 26.

For more information, click here.

FDA Releases External Report of Agency’s Actions on Opioid Analgesics Abuse

On Feb. 16, the Food and Drug Administration (FDA) released a report conducted by an external team of experts at the Ohio State University, which analyzed the effectiveness of FDA regulation that aims to reduce and prevent opioid drug overdoses and deaths. The report looks specifically at how well the FDA has implemented drug prevention recommendations set forth in 2017 by the National Academies of Sciences, Engineering, and Medicine’s (NASEM). The report urges the FDA to continue implementing NASEM recommendations and to increase transparency of its decision-making over opioid analgesics. The report also asks the FDA to consider asking Congress for help in strengthening oversight of prescription opioid analgesics.

For more information, click here.

FDA Advisory Committee to Review Opioid Analgesics Efficacy and Risk

On Feb. 16, the Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee announced that it would meet to discuss the long-term efficacy of opioid analgesics and the risk of opioid-induced hyperalgesia. The advisory committee will also discuss post-marketing requirement (PMR) 3033-11, issued to new drug application holders for extended-release and long-acting opioid analgesics. The meeting will be held virtually on April 19 and public comments will be accepted until April 18.

For more information, click here.

NARCAN Over-the-Counter Approval Recommended

On Feb. 15, the Food and Drug Administration’s (FDA) advisory committee on nonprescription drugs and pain medications voted 19 to 0 to recommend FDA approve an over-the-counter naloxone nasal spray. The FDA has until March 29 to make a decision. It would be the first time the FDA has made naloxone available without a prescription.

FDA and EPA Seeking Public Input on Oversight Approaches

On Feb. 15, the Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) and the Environmental Protection Agency (EPA) Office of Chemical Safety and Pollution Prevention (OSCPP) announced that they are seeking public comment on their respective approaches to oversee products regulated as new animal drugs and pesticides. The FDA and EPA will host a joint meeting on March 22, and members of the public will be able to submit comments at the meeting.

For more information, click here.

FDA Updates Compounding Ibuprofen Oral Suspension Products Guidance

On Feb. 13, the Food and Drug Administration (FDA) again updated its guidance on the compounding of ibuprofen oral suspension products. The latest guidance replaces the previous revision the FDA issued on Jan. 20, 2023. The FDA continues to receive reports of hospitals, health systems and state-licensed pharmacies having difficulty obtaining ibuprofen oral suspension products to treat pediatric and adult patients who require them. The latest guidance spells out the FDA’s latest recommendations on the matter.

For more information, click here.

Proposed Rules

ACF Proposes Rule to Revise Foster Family Home Definition

On Feb. 14, the Department of Health and Human Services (HHS) Administration for Children and Families (ACF) released a proposed rule that would revise the current definition of “foster family home” and allow Title IV-E agencies to adopt foster family home licensing and approval standards for foster family homes of individuals related to children by “kin” (blood, marriage or adoption). Title IV-E agencies would also be allowed to adopt licensing and approval standards for individuals related by emotionally significant relationships. The proposed rule would also allow Title IV-E agencies to claim federal financial participation (FFM) for the costs of foster care maintenance payments (FCMP) and would make changes to the requirement that Title IV-E agencies review FCMP amounts to ensure that children placed in “kin” foster homes receive the same FCMP as those in non-kin foster family homes.

For more information, click here.

CMS Proposes Rule to Increase Nursing Home Transparency

On Feb. 15, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that seeks to increase the transparency of nursing home facility information. The proposed rule would require Medicare skilled nursing facilities (SNFs) and Medicaid nursing facilities to disclose the following information:

• Names, titles and period of service for every member of the nursing home facility’s governing body
• Names, titles and period of service for the nursing home facility’s officer, director, member, partner, trustee and managing employee
• Names, titles and period of service for any additional disclosable parties of the nursing home facility
• A description of the relationship the additional disclosable parties have with the nursing home facility and other disclosable parties

For more information, click here.

SAMSHA Issues Proposed Rule to Eliminate X-Waiver Requirement

On Feb. 10, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a notice of proposed rulemaking to solicit public comment on its proposal to remove certain provisions under the Controlled Substances Act (CSA). The removal of these provisions is a result of the Consolidated Appropriations Act (CAA) of 2023. The CAA amended the CSA by eliminating the requirement that practitioners obtain a waiver to prescribe certain Schedule III-V drugs to treat opioid use disorder (OUD).

Public comments will be accepted until March 14, 2023. For more information, click here.

HHS Proposes Rule to Expand Access to ACA Birth Control Coverage

On Jan. 30, the Department of Health and Human Services (HHS) released a proposed rule that seeks to strengthen and expand health insurance birth control coverage for women. The proposed rule would prevent private health plans and insurers from excluding coverage of contraceptive services based on moral exemptions. It would also establish an independent birth control pathway for women covered under an objecting entity, which would allow them to access contraceptive services from a willing provider without any cost. Private health plans and insurers would still be allowed to deny birth control coverage based on religious exemptions and objecting private employers and universities would still have the right to choose whether to allow plan participants access to optional contraceptive services.

Public comments will be accepted until April 3, 2023. For more information, click here.

HHS Proposes Rule to Clarify Beneficiary Religious Protections

On Jan. 13, nine federal agencies, including the Department of Health and Human Services (HHS), released a proposed rule that seeks to clarify and restore religious liberty protections for individuals who receive federally funded social services. The proposed rule would require federal grantees who administer social service programs to notify individuals that they may not be discriminated against based on their religion. The rule would also advise federal agencies on how they can assist individuals with finding providers that are more reflective of their beliefs.

In addition to HHS, the Departments of Agriculture, Education, Homeland Security, Housing and Urban Development, Justice, Labor and Veterans Affairs and the U.S. Agency for International Development are proposing the rule.

Public comments will be accepted until March 14, 2023. For more information, click here.

HHS Office for Civil Rights Releases Proposed Rule Seeking to Clarify Healthcare Provider Conscience Protection Rights

On Jan. 5, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released a proposed rule that seeks to partially rescind a 2019 final rule titled “Protecting Statutory Conscience Rights in Health Care; Delegations of Authority.” The proposed rule would keep a framework in place created by a 2011 final rule titled “Regulation for the Enforcement of Federal Health Care Provider Conscience Protection Laws.” Certain provisions of the 2019 final rule related to federal conscience protections would be retained, but those that are redundant and confusing would be eliminated.

Public comments will be accepted until March 6, 2023. For more information, click here.

CMS Proposes Healthcare Plan Exchange Rule for 2024

On Dec. 12, the Centers for Medicare and Medicaid Services (CMS) released the 2024 proposed rule for plans in the exchange. The proposed rule includes key changes to network adequacy standards and will slightly lower user fees for 2024. In addition, the rule:

• Proposes to limit to two the nonstandardized plan options for each product network type and metal tier level, with an exception for catastrophic plans. This requirement only applies to HealthCare.gov, which residents in 38 states use to buy ACA plans. It does not apply to state-run marketplaces.
• Seeks to add to the standardized plan option requirements including a proposal to no longer include a standard option for the nonexpanded bronze plan tier.

Public comments will be accepted until March 13, 2023. For more information, click here.

HHS Proposes Adopting Healthcare Attachments Standards

On Dec. 15, the Office of the Secretary of the Department of Health and Human Services (HHS) released a proposed rule that would implement standards for “health care attachments” transactions, to support healthcare claims and prior authorization transactions. The proposed rules would also implement a standard for electronic signatures and modify the standard for referral certification and authorization transactions.

Public comments will be accepted until March 21, 2023. For more information, click here.

FDA Proposed Rule Would Replace Investigational New Drug Annual Report

On Dec. 9, the Food and Drug Administration (FDA) released a proposed rule that would change the investigational new drug (IND) annual reporting requirement. The proposed rule would replace the IND annual report with a new report titled the Food and Drug Administration Development Safety Update Report (FDA DSUR). The FDA intends to make the new report consistent with the format and content of the development safety update report that is supported by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Public comments will be accepted until March 9, 2023. For more information, click here.

FDA Proposes Exempting Certain Conventional Food, Dietary Supplements and Cosmetics From Investigational New Drug Requirements

On Dec. 9, the Food and Drug Administration (FDA) released a proposed rule that seeks to exempt certain clinical investigations of lawfully marketed conventional foods, dietary supplements and cosmetics from the investigational new drug application (IND) requirement, when the clinical investigations are conducted for the purposes of studying the products’ potential use as a drug. Although these products would be exempt from IND requirements, they would still be subject to other investigations to ensure the rights and safety of individuals. The FDA believes the proposed rule will reduce regulatory burden on the agency.

Public comments will be accepted until March 9, 2023. For more information, click here.

Final Rules

CMS Issues Final Rule Regarding Medicare Advantage Risk Adjustment Data Validation Program

On Jan. 30, the Centers for Medicare and Medicaid Services (CMS) released a final rule that alters the audit methodology for the Medicare Advantage Risk Adjustment Data Validation (RADV) program and implements new requirements on Medicare Advantage Organizations (MAOs). The final rule establishes that CMS will begin extrapolating RADV audit findings with payment year (PY) 2018 and will not extrapolate audit findings for PYs 2011 through 2017. It also codifies CMS’ intention of not applying a fee-for-service adjustment factor to RADV program audits. The final rule will also require Medicare Advantage Organizations (MAOs) to remit improper payments identified by CMS during RADV audits.

The rule is set to go into effect on April 3, 2023. For more information, click here.

CMS Final Rule Adds Items to DMEPOS Order List and Updates Healthcare Common Procedure Coding System (HCPCS)

On Jan. 17, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will update the Healthcare Common Procedure Coding System (HCPCS) codes for required Face-to-Face Encounter and Written Order Prior to Delivery (F2F/WOPD) requirements applicable to Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) orders. The update follows CMS’ decision to add new non-statutorily required DMEPOS items to the F2F/WOPD list. CMS believes the addition of these items will protect Medicare enrollees and further reduce Medicare fraud, waste and abuse.

The rule is set to go into effect on April 17, 2023. For more information, click here.

FDA Delays Tobacco Product Required Warning Final Rule Effective Date

On Nov. 25, the Food and Drug Administration (FDA), in compliance with an order issued by the U.S. District Court for the Eastern District of Texas, delayed the effective date of a final rule published on March 18, 2020, titled “Tobacco Products; Required Warnings for Cigarette Packages and Advertisements.” The rule, which was originally supposed to go into effect on June 18, 2021, establishes new cigarette health warnings for cigarette packages and advertisements.

The rule is now set to go into effect on Nov. 6, 2023. For more information, click here.

CMS Issues Correction on Clinical Laboratory Improvement Amendments (CLIA) Final Rule

On Nov. 17, the Centers for Medicare and Medicaid Services (CMS) corrected a technical error that was found in a final rule published in the Federal Register on July 11, 2022. The final rule updates proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), to address analytes and newer technologies.

The rule goes into effect July 11, 2024. For more information, click here.

Reports

GAO Releases Report on Federal Oversight of Institutional Review Boards

On Feb. 16, the U.S. Government Accountability Office (GAO) released a report revealing shortcomings in the federal government’s oversight of institutional review boards (IRBs). IRBs are tasked by the Department of Health and Human Services (HHS) to assess the ethics and safety of drug and medical device research projects involving human subjects. GAO found that most IRBs are located at universities, and that the federal government is not carrying out routine inspections of IRBs to ensure that they are following federal laws. GAO conducted the study because it was asked to examine independent IRBs’ review processes and standards. GAO submitted four recommendations to HHS, urging the Department to increase its oversight over IRB effectiveness and operations.

For more information, click here.

CRS Releases Report on Telehealth

On Feb. 14, the Congressional Research Service (CRS) released a report on telehealth. The report analyzes the use of telehealth by private health insurance providers and the impacts the COVID-19 public health emergency (PHE) had on telehealth coverage. CRS also looked at flexibilities the federal government granted private health insurance providers to add telehealth services to their plans during the COVID-19 PHE. CRS believes that telehealth services will remain easily accessible following the upcoming termination of the COVID-19 PHE.

For more information, click here.