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Back to the Drawing Board:  HHS Scraps Initial 340B Rebate Pilot Program

By Robert Nauman on Posted in 340B Program, HHS, Pharmaceutical
In a joint motion filed February 5th with the U.S. District Court for the District of Maine, the U.S. Department of Health and Human Services (“HHS”) stated that it would terminate its current 340B Rebate Pilot Program (the “Program”), which we discussed previously on this blog.  The Program’s termination follows the filing of a lawsuit … Continue Reading

Mental Health Parity and Addiction Equity Act Final Rules (“Final Rules”) Are Released: Plans and Issuers Must Prepare for January 1, 2025 Effective Date (US)

By Kristine Woliver, Ima Nsien and Gabrielle Martin on Posted in HHS, Insurance, Labor and Employment, Regulations
The long-awaited Final Rules amending the Mental Health Parity and Addiction Equity Act (“MHPAEA”) were released on September 9, 2024, with the bulk of the requirements going into effect on January 1, 2025. As we previously reported here, in August 2023, the Departments of Labor, Health and Human Services (“HHS”) and Treasury (together, the “Departments”) … Continue Reading

Private Equity’s Involvement in Health Care Under Increasing Scrutiny

By Robert Nauman on Posted in Antitrust, FTC, HHS, Mergers and Acquisitions, Policy
Private equity’s investment in healthcare has increased rapidly over the past decade, and this is now drawing attention from regulators.  Signifying this increased scrutiny is a joint Request for Information (RFI) issued in March by the Department of Justice’s (DOJ) Antitrust Division, Federal Trade Commission (FTC), and Department of Health and Human Services (HHS) seeking … Continue Reading

42 C.F.R. Part 2 Final Rule to Align with the HIPAA Privacy Rules

By John Wyand, Kimberly Donovan and John Bunch on Posted in Department of Health and Human Services, HHS, HIPAA, Privacy
The US Department of Health and Human Services, Office for Civil Rights (OCR)and the Substance Abuse and Mental Health Services Administration issued a Final Rule modifying the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations under 42 C.F.R. Part 2 (Part 2), applicable to certain federally assisted SUD treatment programs (Part 2 Programs), and … Continue Reading

HHS OIG Introduces Managed Care Strategic Plan

By Squire Patton Boggs on Posted in Compliance, Fraud and Abuse, HHS, Insurance, Managed Care, Medicare Advantage, OIG
In August, the Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services (“HHS”) introduced a new “Strategic Plan for Oversight of Managed Care for Medicare and Medicaid” (the “Strategic Plan”).  The introduction of the Strategic Plan is in response to the continued growth of managed care in government sponsored health … Continue Reading

The Departments of Labor, Health and Human Services, and the Treasury Issue Notice of Proposed Rulemaking Related to the Mental Health Parity and Addiction Equity Act

By Ima Nsien and Kristine Woliver on Posted in HHS, Insurance, Labor and Employment, Proposed Rule
On July 25, 2023, the Departments of Labor, Health and Human Services, and the Treasury (the “Departments”) proposed rules designed to strengthen the Mental Health Parity and Addiction Equity Act’s (“MHPAEA”) goal of ensuring people seeking treatment for mental health and substance use disorders (“MH/SUD”) face no greater barriers to accessing care than those seeking … Continue Reading

The 2022 Proposed Rule on Section 1557 of the Affordable Care Act Reflects a History of Competing Views on the Definition of Discrimination On the Basis of Sex in Healthcare Programs

By Ima Nsien on Posted in ACA, HHS, Proposed Rule
On August 4, 2022, the Department of Health and Human Services (“HHS”) issued its proposed rule on Section 1557 of the Affordable Care Act (“ACA”). Section 1557 prohibits discrimination on the basis of race, color, national origin, sex, age or disability in certain health programs or activities, if any part of the program or activity … Continue Reading

U.S. Supreme Court Agrees with HHS Payment Methodology for Disproportionate Share Hospitals

By Keith Bradley on Posted in HHS, Reimbursement, U.S. Supreme Court
The fight about how Medicare compensates disproportionate share hospitals (“DSH”) is one of the longest-running reimbursement disputes of recent years, and it has generated copious work for judges around the country.  In a 5-4 decision, the U.S. Supreme Court settled one piece of the conflict:  the counting of “Medicare-entitled” patients in the Medicare fraction of … Continue Reading

Recent Supreme Court Decision Creates Basis For Challenge To HHS’s Rescission Of Anti-Discrimination Protections

By Squire Patton Boggs on Posted in ACA, HHS, U.S. Supreme Court
Most readers are likely familiar with the landmark decision issued by the U.S. Supreme Court last week, in which the Court held that Title VII prohibits discrimination on the basis of sexual orientation and transgender status. (Read more about this decision here.) That decision not only provided important clarification to the scope of protections for … Continue Reading

Growing Bullseye on Skilled Nursing Facilities

By Squire Patton Boggs on Posted in CARES Act, CMS, COVID-19, Department of Health and Human Services, HHS
Although nursing homes appreciate the recent release of $4.9 billion in financial assistance, the bullseye on them continues growing.  Troubles that preceded the COVID-19 crisis have gotten worse for facilities caring for high risk seniors.  They face scrutiny over death rates from COVID-19, as well as how they will use relief money.… Continue Reading

CMS Pumps the Brakes on Additional Medicare Accelerated and Advanced Payments as it Simultaneously Deploys COVID-19 Emergency Fund Grants

By Squire Patton Boggs on Posted in COVID-19, HHS, Hospitals, Reimbursement
The Centers for Medicare and Medicaid Services (CMS) announced that it is “reevaluating amounts that will be paid under its Accelerated Payment Program and suspending its Advance Payment Program to Part B suppliers effective immediately.”  CMS explained that it is pumping the brakes because it has already made almost $100 billion in accelerated or advanced … Continue Reading

Tenth Circuit Reverses District Court and Upholds ACA’s Statewide Average Premium Risk Adjustment Methodology

By Max Czernin on Posted in 10th Circuit, ACA, HHS, Insurance, Payer/Insurance Reform
In a unanimous decision, the United States Court of Appeals for the Tenth Circuit reversed a district court decision holding that HHS’ use of the statewide premium average to calculate Affordable Care Act (ACA) risk adjustment charges and payments from 2014 to 2018 was arbitrary and capricious.  See N.M. Health Connections v. U.S. Dep’t of … Continue Reading

Recent Court Decisions Create New Questions About Religious Accommodations for Healthcare Workers

By Squire Patton Boggs on Posted in HHS, Labor and Employment
Over the past two years, unique religious accommodation rules have created unexpected compliance obligations for healthcare entities. As we previously discussed , healthcare employees and government agencies have brought several claims recently challenging healthcare entities’ mandatory vaccination policies, and claiming that these entities must provide broader accommodations for employees’ religious beliefs. Last week, two court decisions … Continue Reading
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