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White Paper: CMS Finalizes Updates to the Stark Law to Reduce Regulatory Burdens and Provide Flexibility to Providers

On 2 December 2020, the Centers for Medicare & Medicaid Services (CMS) published a Notice of Final Rulemaking in the Federal Register (Final Rule), modifying the regulations implementing the federal physician self-referral...more

Triage: Updates to Mental Health Parity in California and Nationwide

In this week’s episode, Carla DewBerry and Kelsey Jernigan discuss issues in mental health parity in the context of recent California legislation. In particular, the presenters discuss how a new California bill has sparked a...more

A Starkly Different Landscape – A Deep Dive Into CMS’ Recently Proposed Amendments to the Stark Law

On October 17, 2019, the Centers for Medicare & Medicaid Services (“CMS”) published a Notice of Proposed Rulemaking in the Federal Register (“Proposed Rule”), modifying the regulations implementing the federal physician...more

CMS Proposes Rules to Implement SUPPORT Act Coverage and Reimbursement of Opioid Treatment

Recently, the Centers for Medicare & Medicaid Services (“CMS”) published its annual proposed rule outlining potential changes to the Medicare Physician Fee Schedule (“PFS”) for upcoming Calendar Year (“CY”) 2020 (“Proposed...more

CMS Issues Final Medicare PFS Rule for CY 2019

On November 1, 2018, the Centers for Medicare and Medicaid Services (CMS) released in pre-publication form the Medicare Physician Fee Schedule (PFS) Final Rule for Calendar Year (CY) 2019 (PFS Final Rule)....more

OCR Clarifies Confusion Related to Authorizations for Ongoing and Future Research Purposes

As mandated by the 21st Century Cures Act of 2016 (the “Cures Act”), in June 2018 the Office for Civil Rights (“OCR”) issued guidance clarifying how individual authorizations under the Privacy Rule of the Health Insurance...more

CMS Issues Proposed OPPS Rule for CY 2019

On July 31, 2018, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule for the Medicare Hospital Outpatient Prospective Payment System (“OPPS”) and the Medicare Ambulatory Surgical Center payment...more

Increased Scrutiny of Patient Assistance Programs: Enforcement Overview and Considerations

In the midst of ongoing national debates regarding drug pricing [1] and access to innovative therapies, patient assistance programs (“PAPs”) are facing an evolving legal landscape, as well as increased enforcement scrutiny...more

CMS Finalizes Two New Exceptions and Other Modifications to the Stark Law

On October 30, 2015, the Centers for Medicare and Medicaid Services (“CMS”) posted a final rule, which was published in the Federal Register on November 16, 2015 (“Final Rule”), modifying the regulations implementing the...more

The “Cross-Your-Fingers-And-Hope-It-Goes-Away” School of Statutory Interpretation”: Recent D.C. Circuit Opinion Orders HHS To...

On June 12, 2015, the U.S. Court of Appeals for the District of Columbia (the “Court”) issued an opinion questioning the Department of Health & Human Services’ (“HHS”) interpretation of congressional intent when it...more

Potential Stark Changes Ahead

On July 15, 2015, the Centers for Medicare and Medicaid Services (“CMS”) published proposed regulations governing policies and payments made under the Physician Fee Schedule for calendar year 2016 (the “Proposed Rule”). In...more

Final Rule Sets Out Detailed Requirements for Charitable Hospitals

On December 31, 2014, the Treasury Department and the Internal Revenue Service (“IRS”) published a final rule (the “Final Rule”) implementing the requirements in Internal Revenue Code Section 501(r) for tax-exempt hospitals...more

A Possible Green Light for Patient Transportation Services: OIG Proposes Revised Safe Harbors to the Anti-Kickback Statute for...

On October 3, 2014, the Office of Inspector General of the Department of Health and Human Services (“OIG”) published a proposed rule and request for comments (“Proposed Rule”), which would amend the Anti-Kickback Statute...more

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