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A New Era in Healthcare Regulation & Compliance

By Kayla Mendez on Posted in Regulations, U.S. Supreme Court
Loper Bright Shifts Statutory Interpretation Powers Back to the Courts. On June 28, 2024, the Supreme Court overturned the Chevron doctrine with its decision in Loper Bright Enterprises v. Raimondo.  Under Chevron, courts have historically deferred to a federal agency’s interpretation of ambiguity in statutes that the agency administers.  Courts premised Chevron deference on the notion that … Continue Reading

The End of “Chevron” or Its Rebirth?

By Squire Patton Boggs on Posted in Regulations, U.S. Supreme Court
Fishermen in the small town of Cape May, New Jersey, are at the epicenter of a legal challenge that could reshape the landscape of agency authority. The fishermen are challenging the entrenched “Chevron” doctrine, which for years has afforded deference to government agencies with respect to reasonable interpretation of ambiguous statutes. Once again, the US … Continue Reading

Revamping of Cosmetics Regulation and Safety

By Squire Patton Boggs on Posted in FDA, Regulations
President Biden signed into law the “Consolidated Appropriations Act, 2023” on December 29, 2022 (the enactment date). The Act includes the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”) which increases the authority of the United States Food and Drug Administration (“FDA”) to regulate cosmetics and provide enhanced protections for consumers. The new law includes … Continue Reading

Biden Administration 60-day Regulatory Freeze

By John Wyand and Kara-Marie Urban on Posted in Regulations
On Wednesday, January 20, 2021, President Biden’s chief of staff, Ronald A. Klain, circulated a memorandum (memo) to the heads of federal executive departments and agencies outlining an Executive Action implementing a 60-day freeze on any new or pending regulations. This is a customary practice for new administrations. The freeze allows the administration to conduct … Continue Reading

CMS Publishes Stark Law Final Rules-Updated

By Robert Nauman on Posted in CMS, Regulations, Stark Law
In follow up to our post last month, on Wednesday, December 2, The Centers for Medicare and Medicaid Services (CMS) published final rules implementing many of the Stark Law changes first proposed in October 2019 (the Final Rules). These changes have been adopted to address the shift to a value-based and coordinated healthcare environment. The … Continue Reading

CMS Releases Final Rules Implementing Stark Law Changes to Reflect Value-Based Healthcare Delivery and Payment Environment

By Robert Nauman on Posted in CMS, Regulations, Stark Law
On Friday, November 20, CMS released final rules implementing many Stark Law changes first proposed in October 2019 (the “Final Rules”). This release comes despite earlier suggestions that these Final Rules may be delayed until sometime in 2021. Developed as part of the Regulatory Sprint to Coordinated Care program, the Final Rules represent CMS’s recognition … Continue Reading

Financial Lifelines, Waivers and Other Support for Hospitals and Healthcare Systems Responding to the Coronavirus Pandemic

By Robert Nauman, Laura Lawless and Beth Goldstein on Posted in CARES Act, COVID-19, Hospitals, Regulations
In just the past week, the federal government has issued a flurry of legislative and regulatory aid packages, programs and rule changes for hospitals and health systems responding to the COVID-19 pandemic. These measures are designed to give emergency financial support and to cut through regulatory roadblocks to delivering care during the crisis. The federal … Continue Reading

Saved by the Gel?

By Dickie Chan on Posted in COVID-19, Policy, Regulations
UPDATE: Saved by the Gel…again? Since our original post, the UK’s Competition and Markets Authority (CMA) issued a statement March 5 that it will be monitoring reports of changes to sales and pricing practices for coronavirus-related products. The CMA will consider direct enforcement action in appropriate cases if it has evidence that businesses have broken … Continue Reading

USDA’s Hemp Production Program Advances

By John Wyand and Austin M. Harrison on Posted in Cannabis/Hemp, Regulations, USDA
On January 29, 2020, the comment period closed for the United States Department of Agriculture (USDA) interim final rule, published on October 31, 2019, to establish the Domestic Hemp Production Program. The comment period, which the USDA extended by 30 days, received over 4,000 comments from interested parties, including states, tribal governments, and hemp industry … Continue Reading

Proposed Changes to the Anti-Kickback Statute, Stark Law and Civil Monetary Penalties Law Address Value-Based Healthcare Environment

By Robert Nauman on Posted in Anti-kickback Statute, Civil Monetary Penalties Law, CMS, Department of Health and Human Services, Fraud and Abuse, OIG, Proposed Rule, Regulations, Stark Law, Uncategorized
On October 9, the Department of Health and Human Services (HHS) released proposed rules (the Proposed Rules) aiming to update the Anti-Kickback Statute (the AKS), Stark Law and Civil Monetary Penalties Law (CMPL) to address today’s value-based and coordinated healthcare environment. The proposals reflect a recognition on HHS’s part that the healthcare landscape of today … Continue Reading

Cracks in the Façade—Supreme Court to Reconsider “Auer Deference” Rule and Possibly Shrink Agency Leeway In Interpreting Regulations

By Keith Bradley on Posted in Regulations, U.S. Supreme Court
The playing field in a lawsuit challenging agency action is tilted toward the agency, largely by means of various deference doctrines. One of the most important has been deference to an agency’s interpretation of its own regulations. Courts have been deferring to those interpretations for decades, following a 1940s Supreme Court case, Bowles v. Seminole … Continue Reading

DOL Issues Final Rule Expanding Access to Association Health Plans

By John Wyand and Doug Anderson on Posted in ERISA, Insurance, Labor and Employment, Payer/Insurance Reform, Regulations
On June 21, 2018, the US Department of Labor (DOL or the Department) published its final rule, amending the definition of “employer” under section 3(5) of the Employee Retirement Income Security Act (ERISA) to allow for the establishment of group or association health plans (AHPs) (Final Rule). Similar to a corresponding proposed rule issued earlier … Continue Reading

How To Avoid Paying $2,000 A Day To Encrypt ePHI

By Squire Patton Boggs on Posted in Compliance, Cybersecurity, Data Protection, Department of Health and Human Services, HIPAA, Regulations, Technology, Telehealth
Let’s hope you don’t pay that much to encrypt electronic Protected Health Information (ePHI). How about a total of $4.3 million over two years? Well, that’s the total penalty for encryption violations assessed by Health and Human Services (HHS). An Administrative Law Judge found the penalty could have been much worse. The facts are sobering. … Continue Reading

HHS Final Rule Scales Back Affordable Care Act Regulations

By John Wyand and Doug Anderson on Posted in ACA, Payer/Insurance Reform, Regulations
Earlier this month, the US Department of Health and Human Services (HHS) published a Final Rule in the Federal Register that will scale back regulations applicable to health insurance subject to the Patient Protection and Affordable Care Act (ACA). In issuing the Final Notice of Benefit and Payment Parameters for 2019 Rule (Final Rule), HHS … Continue Reading

CMS Republishes the 2018 OPPS Final Rule

By John Wyand on Posted in CMS, Regulations, Reimbursement
On December 14, 2017, the Centers for Medicare & Medicaid republished the final rule with comment period for the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 (“Final Rule”). The republication included an editorial note stating that the Final Rule was originally published in … Continue Reading
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