Washington Healthcare Update - February 2023

McGuireWoods Consulting
Contact

This Week in Washington: President Biden announces ending date of COVID-19 PHE, House begins investigations into COVID-19 origins; State of the Union scheduled for Feb. 7

Upcoming Hearings

Congress

House

  • House Energy and Commerce Committee Begins Investigation into COVID-19 Origin
  • House Democrats Introduce the Protect Social Security and Medicare Act
  • House Passes Pandemic is Over Act
  • Reps. Pallone, Eshoo and Castor Send Letter Urging Action on Short-Term, Limited-Duration Insurance Plans
  • House Republicans Introduce Protecting Health Care for All Patients Act
  • House and Senate Members Urge Investment in KidneyX Program

Senate

  • The Ensuring Kids Have Access to Medically Necessary Dental Care Act is Introduced
  • Senators Send Letter to CMS in Support of Medicare Advantage Program
  • American Values Act Reintroduced

Administration

  • President Biden Announces End Date for COVID-19 National and Public Health Emergencies
  • CMS Releases 2024 Medicare Advantage and Part D Prescription Drug Program Advance Notice
  • FDA Approves Jesduvroq Anemia Treatment Tablets
  • FDA Revises Letters of Emergency Use Authorization for Paxlovid and Lagevrio
  • FDA Announces Joint Public Meeting with Reagan-Udall Foundation
  • FDA Releases Industry Guidance Regarding Design and Conduct of Drug and Biological Product Externally Controlled Trials
  • FDA Advisory Committee to Meet and Discuss Pfizer and GSK Proposed RSV Vaccines
  • FDA Announces Return of In-Person, Face-to-Face Formal Meetings
  • FDA Grants Moderna RSV Vaccine Breakthrough Therapy Designation
  • FDA Publishes FY2022 Generic Drug User Fee Amendments Science and Research Report
  • FDA Device Center Releases 2022 Annual Report
  • CDC Releases Updated COVID-19 Prevention Guidelines for Immunocompromised Individuals

Proposed Rules

  • 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
  • SAMHSA Seeking Public Comments Regarding Opioid Use Disorder Treatment Medication Requirement Reforms
  • CMS Releases Proposed Changes to Contract Year 2024 Medicare Program Plans
  • CMS Proposes MA Plan Marketing, Part D Low-income Access, Prior Authorization and Behavioral Health Reforms
  • 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

Courts

  • Texas Medical Association Files Second Lawsuit Over No Surprises Act IDR Fee Increase
  • FDA Announces Federal Court Consent Decree Ruling Against Florida Pharmaceutical Company

Reports

  • GAO Report Urges CMS to Make Nursing Home Ownership Information More Transparent
  • GAO Report Urges HHS to Develop Stronger Plans for Medical Countermeasure Developments and Manufacturing Risks
  • GAO Report Analyzes Impact of RACE Act on Pediatric Cancer Research
  • GAO Report Analyzes Utilization of Medicare Advantage Supplemental Benefits
  • MACPAC and MEDPAC Release 2023 Dually Eligible Data Book

Upcoming Hearings

Feb. 8

House Energy and Commerce Subcommittee on Oversight and Investigation and Subcommittee on Health Joint Hearing: “The Federal Response to COVID-19”

10:00 a.m., Rayburn House Office Building 2123

Announced witnesses are:

  • Lawrence A. Tabak, Acting Director of the National Institutes of Health
  • The Honorable Robert Califf, Commissioner of the U.S. Food and Drug Administration
  • Rochelle Walensky, Director of the U.S. Centers for Disease Control and Prevention
  • The Honorable Dawn O’Connell, Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services

Congress

House

House Energy and Commerce Committee Begins Investigation into COVID-19 Origin

On Feb. 2, Reps. Rodgers (R-WA), Griffith (R-VA) and Guthrie (R-KY) began the House Energy and Commerce Committee’s investigation into the origin of COVID-19. The members sent letters to the National Institutes of Health (NIH) and EcoHealth Alliance requesting the preservation of any document detailing research done at the Wuhan Institute of Virology (WIV).

For more information, click here.

House Democrats Introduce the Protect Social Security and Medicare Act

On Feb. 2, Reps. Pocan (D-WI), Doggett (D-TX) and Frost (D-FL) introduced the Protect Social Security and Medicare Act. The bill would raise to two-thirds the vote threshold needed to introduce any legislation in the House that would reduce benefits under either program.

House Passes Pandemic is Over Act

On Jan. 31, the U.S. House of Representatives passed the Pandemic is Over Act with a vote of 220-210. If enacted, the bill would immediately terminate the COVID-19 Public Health Emergency. The bill is not expected to pass in the Senate.

For more information, click here.

Reps. Pallone, Eshoo and Castor Send Letter Urging Action on Short-Term, Limited-Duration Insurance Plans

On Jan. 31, Reps. Pallone (D-NJ), Eshoo (D-CA) and Castor (D-FL) sent a letter to the Department of Health and Human Services (HHS), the Department of Labor and the Department of the Treasury, urging the departments to roll back short-term limited-duration health insurance plans before Medicaid and Children’s Health Insurance Program (CHIP) redeterminations begin on March 31, 2023.

For more information, click here.

House Republicans Introduce Protecting Health Care for All Patients Act

On Jan. 31, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), House Ways and Means Committee Chair Jason Smith (R-MO) and GOP Doctors Caucus Co-Chairs Rep. Brad Wenstrup, D.P.M. (R-OH), and Rep. Michael Burgess, M.D. (R-TX), introduced H.R. 485, the Protecting Health Care for All Patients Act, which would expand access to cures and prevent discrimination against Americans with disabilities. On Feb. 1, the House Energy and Commerce Committee Subcommittee on Health held a hearing titled “Lives Worth Living: Addressing the Fentanyl Crisis, Protecting Critical Lifelines, and Combatting Discrimination Against Those with Disabilities.” The legislation was discussed at the hearing.

H.R. 485 would prohibit the use of quality-adjusted life years (QALYs) in all federal programs—an expansion from the current prohibition that only applies in a limited fashion to the Medicare program.

The bill would also prohibit the importation of price controls from countries that use QALYs.

House and Senate Members Urge Investment in KidneyX Program

On Jan. 30, Reps. DelBene (D-WA) and Bucshon (R-IN), along with Sens. Cardin (D-MD) and Young (R-IN), sent a letter to the Office of Management and Budget (OMB), urging President Biden and OMB Director Shalanda Young to add a $25 million investment to the president’s fiscal year (FY) 2024 budget for KidneyX. KidneyX is a public-private partnership between the U.S Department of Health and Human Services (HHS) and the American Society of Nephrology (ASN) devoted to the development of the world’s first artificial kidney. The members stressed the high cost of kidney disease treatment and the urgent need for artificial kidneys in their letter.

For more information, click here.

Senate

The Ensuring Kids Have Access to Medically Necessary Dental Care Act is Introduced

On Feb. 2, Sens. Cardin (D-MD), Stabenow (D-MI) and Rep. Barragán (D-CA) reintroduced the Ensuring Kids Have Access to Medically Necessary Dental Care Act. The bill would eliminate lifetime and annual limits for children receiving dental care through the Children’s Health Insurance Program (CHIP). The bill would also require CHIP to cover dental services for eligible children who are not currently enrolled in the program.

Senators Send Letter to CMS in Support of Medicare Advantage Program

On Feb. 1, Sens. Cassidy (R-LA), Cortez Masto (D-NV), Scott (R-SC), Peters (D-MI) and Capito (R-WV), along with 57 other senators, issued a letter to Centers of Medicare and Medicaid Services (CMS) Administrator Brooks-LaSure expressing their support of the Medicare Advantage (MA) Program. The senators urged Administrator Brooks-LaSure and CMS to take steps toward sustaining and strengthening the MA Program.

For more information, click here.

American Values Act Reintroduced

On Jan. 31, Sens. Risch (R-ID), Cruz (R-TX), Rubio (R-FL), Young (R-IN), Hagerty (R-TN), Johnson (R-WI) and Barrasso (R-WY) reintroduced the American Values Act. The bill would permanently prohibit the use of U.S. foreign assistance funds to pay for abortion services overseas.

Administration

President Biden Announces End Date for COVID-19 National and Public Health Emergencies

On Jan. 30, President Biden announced that he will end the COVID-19 National and Public Health Emergency (PHE) on May 11, 2023. The emergencies were originally set to expire on March 1 and April 11, respectively. The termination of both emergencies will impact a number of policies enacted during the COVID-19 pandemic, including emergency supplemental funding for Medicaid and the Title 42 immigration policy.

For more information, click here

CMS Releases 2024 Medicare Advantage and Part D Prescription Drug Program Advance Notice

On Feb. 1, the Centers for Medicare and Medicaid Services (CMS) released the 2024 Advance Notice for the Medicare Advantage (MA) and Medicare Part D Prescription Drug Programs. The Advance Notice outlines planned changes CMS will make to the capitation rate and risk adjustment payment methodologies for both programs. The Advance Notice also explains the impact Inflation Reduction Act (IRA) Medicare provisions will have on the Medicare Part D program once they go into effect on Jan. 1, 2024. CMS will accept public comments on the Advance Notice until March 3, 2023 and will publish the finalized calendar year (CY) 2024 Rate Announcement by April 3, 2023.

For more information, click here.

FDA Approves Jesduvroq Anemia Treatment Tablets

On Feb. 1, the Food and Drug Administration (FDA) granted approval of GlaxoSmithKline’s anemia treatment drug Jesduvroq. The FDA approval comes after the agency reviewed drug trial data that showed the hemoglobin levels of dialysis patients rising and stabilizing after taking the drug. Jesduvroq will be available to adults who have been receiving dialysis for at least four months.

For more information, click here.

FDA Revises Letters of Emergency Use Authorization for Paxlovid and Lagevrio

On Feb. 1, the Food and Drug Administration (FDA) announced that it was revising the emergency use authorization (EUA) letters for COVID-19 drugs Paxlovid and Lagevrio. The FDA is removing the requirement that individuals test COVID-19 positive to become eligible to be prescribed both products.

FDA Announces Joint Public Meeting with Reagan-Udall Foundation

On Feb. 1, the Food and Drug Administration (FDA) announced that it would hold a joint virtual public meeting with the Reagan-Udall Foundation on March 8-9, 2023. The meeting, titled “Understanding the Fatal Overdoses to Inform Product Development and Public Health Interventions to Manage Overdose”, will focus on how to treat overdoses and will explore epidemiological trends surrounding public health interventions and drug development opportunities.

FDA Releases Industry Guidance Regarding Design and Conduct of Drug and Biological Product Externally Controlled Trials

On Jan. 31, the Food and Drug Administration (FDA) released an industry guidance regarding the design and conduct of externally controlled trials for drug and biological products. The guidance offers sponsors suggestions on how to reduce the potential for bias in externally controlled trials, how to assess and interpret data from other clinical trials and how to support the FDA regulatory review process.

For more information, click here.

FDA Advisory Committee to Meet and Discuss Pfizer and GSK Proposed RSV Vaccines

On Jan. 31, the Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) announced that it would hold a public meeting on Feb. 28 and March 1 to discuss the proposed RSV vaccines developed by Pfizer and GlaxoSmithKline (GSK). The meeting will be held virtually.

For more information, click here.

FDA Announces Return of In-Person, Face-to-Face Formal Meetings

On Jan. 30, the Food and Drug Administration (FDA) announced that as of Feb. 13, 2023, it would begin offering in-person, face-to-face meetings for FDA Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) industry meetings. In-person, face-to-face meetings will only apply to Type A, BPD Type 1 and Type X meeting requests initially, due to FDA conference room limitations. All meetings will still have a remote option available to attendees.

FDA Grants Moderna RSV Vaccine Breakthrough Therapy Designation

On Jan. 30, the Food and Drug Administration (FDA) granted Moderna’s respiratory syncytial virus (RSV) vaccine breakthrough therapy designation. The designation comes after the FDA received data of the vaccine’s Phase 3 Trial, which demonstrated the vaccine having an efficacy rate of 83.7 percent against RSV lower respiratory tract disease. Moderna plans to submit a license application for regulatory approval of the vaccine in the first half of this year.

FDA Publishes FY2022 Generic Drug User Fee Amendments Science and Research Report

On Jan. 31, the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) published its fiscal year (FY) 2022 Generic Drug User Fee Amendments (GDUFA) science and research report. The report provides information on active CDER research projects, and highlights completed grants and contracts that impacted the 13 CDER scientific areas.

For more information, click here.

FDA Device Center Releases 2022 Annual Report

On Jan. 26, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) released its 2022 annual report. The report highlights the Center’s 2022 accomplishments, and includes topics related to COVID-19 response, the Medical Device User Fee Amendments (MDUFA) V, device innovation, the over-the-counter (OTC) hearing aid final rule and device safety.

For more information, click here.

CDC Releases Updated COVID-19 Prevention Guidelines for Immunocompromised Individuals

On Jan. 27, the Centers for Disease Control and Prevention (CDC) released updated COVID-19 prevention guidelines for immunocompromised individuals. The CDC recommends all immunocompromised individuals stay up to date with their COVID-19 vaccinations, maintain physical distance from others, wear a mask when out in crowded spaces and develop a COVID-19 action plan with family, friends and healthcare providers.

For more information, click here.

Proposed Rules

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.

SAMHSA Seeking Public Comments Regarding Opioid Use Disorder Treatment Medication Requirement Reforms

On Dec. 16, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a notice of proposed rulemaking, requesting public comments on its proposal to modify regulations for opioid use disorder treatment medications. The proposed rule seeks to make treatment in Opioid Treatment Programs (OTP) more accessible to patients, and easier to deliver to providers. The proposed rule also seeks to increase the uptake of evidence-based treatments for substance use disorders and is in line with the Department of Health and Human Services’ (HHS) Overdose Prevention Strategy.

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

CMS Releases Proposed Changes to Contract Year 2024 Medicare Program Plans

On Dec. 27, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would revise regulations for Medicare Advantage, Prescription Drug Benefit, Cost Plan and Programs of All-Inclusive Care for the Elderly (PACE) plans. The proposed rule would implement changes related to:

  • Star Ratings
  • Medication therapy management
  • Marketing and communications
  • Health equity
  • Provider directories
  • Coverage criteria
  • Prior authorization
  • Passive enrollment
  • Network adequacy
  • Identification of overpayments
  • Formulary changes

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

CMS Proposes MA Plan Marketing, Part D Low-income Access, Prior Authorization and Behavioral Health Reforms

On Dec. 14, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that seeks to overhaul marketing practices for Medicare Advantage (MA) plans. The proposed rule comes after CMS told MA plan issuers that it was concerned with the manner in which MA plans were marketed, particularly on television and by third-party marketing organization ads.

Some of the proposed rule changes include:

  • Prohibiting television advertisements that don’t specify a plan name.
  • Prohibiting advertisements that use words and imagery that may mislead or confuse MA plan beneficiaries.
  • Prohibiting the use of Medicare language or logos in advertisements.
  • Prohibiting MA plan marketers from using the words “best” and “most” to describe their plans, unless they have documentation to support such statements.
  • Banning sales presentations that immediately follow an educational event.
  • Banning agent distribution and collection of Scope of Appointment and Business Reply Cards at educational events.
  • Banning agents from conducting sales or enrollment meetings with beneficiaries within 48 hours after obtaining their consent.

Additionally, the proposed rule seeks to expand access to low-income Part D subsidies and biosimilars. CMS would like to grant Part D low-income subsidies to individuals who currently qualify for partial low-income subsidies. The agency wants to ensure that individuals who qualify for full low-income subsidies do not have to face deductibles, premiums or fixed copay requirements for certain drugs. CMS is also proposing that Part D plan sponsors be able to substitute brand drugs with lower-cost options.

The proposed rule also contains language regarding the prior authorization process and behavioral health reforms. CMS is incorporating several recommendations from a report on prior authorization request denials, issued by the Office of the Inspector General (OIG). The proposed rule also includes provisions that seek to grant MA enrollees access to behavioral health service providers. The proposed rule would require MA organizations to include behavioral health services in care coordination programs.

Public comments will be accepted until Feb. 13, 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.

Courts

Texas Medical Association Files Second Lawsuit Over No Surprises Act IDR Fee Increase

On Feb. 1, the Texas Medical Association (TMA) announced that it is suing the Centers for Medicare and Medicaid Services (CMS) over the No Surprises Act independent dispute resolution (IDR) process fee increase. CMS announced that it was increasing the IDR fee from $50 to $350 in December 2022, following a previous announcement that suggested the fee would remain at $50 in 2023. TMA stated that the fee increase is cost-prohibitive to many providers. This is TMA’s fourth challenge to the implementation of the No Surprises Act.

FDA Announces Federal Court Consent Decree Ruling Against Florida Pharmaceutical Company

On Jan. 30, the Food and Drug Administration (FDA) announced that the case that had been submitted on its behalf by the U.S Department of Justice Consumer Protection Branch against LGM Pharma LLC had entered a consent decree. The FDA issued a lawsuit against LGM Pharma LLC after the company failed to comply with Food, Drug and Cosmetic (FD&C) Act current good manufacturing practice (CGMP) requirements. The company had failed to investigate quality-related customer complaints involving out-of-specification (OOS) active pharmaceutical ingredients (API) and had improperly labeled APIs, among other violations. The consent decree will allow the FDA to monitor LGM Pharma LLC and will give the company a set timeline to correct CGMP violations.

Reports

GAO Report Urges CMS to Make Nursing Home Ownership Information More Transparent

On Feb. 2, the U.S. Government Accountability Office (GAO) released a report on the collection and dissemination of nursing home ownership information by the Centers of Medicare and Medicaid Services (CMS). CMS publishes this information on a web-based tool called Care Compare, which allows Medicare beneficiaries to compare the quality of different nursing home care providers. GAO found that the information displayed on the Care Compare website lacks transparency and makes it difficult for beneficiaries to grasp data easily. GAO is recommending that CMS use plain language in the nursing home ownership information section of Care Compare, and that CMS consolidate all relevant nursing home ownership information and display it in a list format.

For more information, click here.

GAO Report Urges HHS to Develop Stronger Plans for Medical Countermeasure Developments and Manufacturing Risks

On Feb. 2, the U.S. Government Accountability Office (GAO) released a report on the Department of Health and Human Services’ (HHS) ability to produce drugs and vaccines during public health emergencies (PHEs). GAO discovered that HHS’ ability to produce drugs and vaccines on a large scale via the Center for Innovation in Advanced Development and Manufacturing (CIADM) program was hampered by challenges such as a lack of quality control and regular manufacturing work. GAO conducted the study because a provision in the Coronavirus Aid, Relief, and Economic Security (CARES) Act asked GAO to monitor the effectiveness and efficiency of the CIADM program in response to the COVID-19 pandemic. GAO is recommending that HHS incorporate a better approach to assess, identify and respond to challenges and risks encountered in the development and manufacturing of medical countermeasures.

For more information, click here.

GAO Report Analyzes Impact of RACE Act on Pediatric Cancer Research

On Jan. 31, the U.S. Government Accountability Office (GAO) released a report analyzing the impact of the Research to Accelerate Cures and Equity (RACE) for Children Act on pediatric cancer research. GAO was required to conduct the study due to a provision in the Food and Drug Administration (FDA) Reauthorization Act of 2017, which called on GAO to analyze the effectiveness of pediatric study requirements included in the RACE Act. GAO determined that the study requirements have increased the amount of research conducted on pediatric cancer, but it is still unclear whether the research will lead to the development of new pediatric cancer drugs.

For more information, click here.

GAO Report Analyzes Utilization of Medicare Advantage Supplemental Benefits

On Jan. 31, the U.S. Government Accountability Office (GAO) released a report analyzing the utilization of supplemental benefits by Medicare Advantage (MA) beneficiaries. Although MA plans are not required to provide beneficiaries with supplemental benefits, many choose to do so. The most common supplemental benefits include vision and hearing. GAO analyzed approximately 4,000 MA plans, to gain insight into which supplemental benefits were offered by each. GAO conducted the study because a provision in the 2018 Bipartisan Budget Act called on GAO to review MA plan supplemental benefits utilization. GAO determined that the Centers for Medicare and Medicaid Services (CMS) is not receiving clear data on supplemental benefits utilization. GAO is recommending that CMS clarify the extent to which MA plan providers should collect and submit this information.

For more information, click here.

MACPAC and MEDPAC Release 2023 Dually Eligible Data Book

On Feb. 2, the Medicaid and CHIP Payment and Access Commission (MacPAC) and the Medicare Payment Advisory Commission (MEDPAC) released the 2023 Data Book for Dually Eligible Beneficiaries. The data book is intended to help individuals understand the demographics, personal characteristics, expenditures and healthcare utilization of dual-eligible beneficiaries.

For more information, click here.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© McGuireWoods Consulting | Attorney Advertising

Written by:

McGuireWoods Consulting
Contact
more
less

McGuireWoods Consulting on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide