As mentioned in our November 25, 2000 Healthcare Law Blog article, “Big Changes for Health Care Fraud and Abuse: HHS Gifts Providers Updates to the Stark Law and the AKS, Just in Time for the Holidays,” the Centers for Medicare & Medicaid Services (CMS) published a final rule (“Final Rule”) on December 2, 2020 making significant changes to the regulatory framework implementing the federal physician self-referral prohibition (the “Stark Law”), 42 C.F.R. 411.351 et seq.
Continue Reading Critical Analysis and Practical Implications of CMS’ Changes to the Stark Law’s Implementing Regulations

On November 30, 2020, the United States Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a final rule (“Final Rule”) that makes significant changes to the federal Antikickback Statute (“AKS”) safe harbor regulations as such regulations relate to the cost of prescription drugs as covered by the Medicare and Medicaid programs.  More specifically, the Final Rule amends the AKS discount safe harbor (“Discount Safe Harbor”) at 42 C.F.R. §1001.952(h) to eliminate safe harbor protection for drug discounts and rebates offered by pharmaceutical manufacturers to pharmacy benefit managers (“PBMs”) and  Medicare Part D prescription drug plan (“Medicare Part D”) sponsors.  In addition to making significant changes to the Discount Safe Harbor, the Final Rule creates two new pharmaceutical-related safe harbors: (i) a safe harbor applicable to certain prescription drug point-of-sale discounts as offered to Medicare and Medicaid beneficiaries to reduce their direct out-of-pocket prescription drug costs (the “Point-of-Sale Safe Harbor”) and (ii) a safe harbor applicable to flat fee arrangements paid by drug companies directly to PBMs for PBM services (the “PBM Service Fees Safe Harbor”).

Continue Reading Eleventh Hour Rulemaking: HHS Eliminates Safe Harbor Protections for PBM Drug Rebates and Creates Two New Safe Harbors for Point-of-Service Discounts and PBM Fixed-Fee Arrangements

On September 5, 2019, the Centers for Medicare and Medicaid Services (“CMS”) released a final rule with comment period entitled, “Program Integrity Enhancements to the Provider Enrollment Process” (the “Final Rule”). The Final Rule, aiming to “address various program integrity issues and vulnerabilities by enabling CMS to take action against unqualified and potentially fraudulent entities and individuals,” significantly expands CMS’ ability to deny or revoke the Medicare enrollment of providers (e.g., hospitals, skilled nursing facilities, home health agencies, hospices, etc.) and suppliers (e.g., physicians, therapists, ambulance services, durable medical equipment suppliers, etc.) in ways that may create concerns even for providers and suppliers who are fully qualified and have not engaged in any fraudulent conduct.
Continue Reading CMS Finalizes Rule Expanding its Authority to Deny and Revoke Medicare Program Enrollment, Among Other Changes

On January 12, 2017, just a week prior to President Trump’s Inauguration, the Department of Health and Human Service (HHS) Office of Inspector General (OIG) published a final Rule (Rule) regarding one of its most important enforcement mechanisms: its exclusion authority. The Rule, published nearly three years after it was initially proposed by the OIG back in May 2014, expands the OIG’s authority to exclude individuals and entities participation in federal healthcare programs and codifies certain provisions of the Affordable Care Act (ACA). The Rule’s original effective date was February 13, 2017, but due to the Trump Administration’s administrative freeze on the effective date of regulations that had not yet gone as of January 20, 2017, the Rule’s effective date is now set for March 21, 2017.
Continue Reading New OIG Exclusion Authority Rule Set To Go Into Effect on March 21, 2017

On Friday, October 14, 2016, CMS released the much-anticipated final rule (the “Final Rule”) implementing the Quality Payment Program (QPP), mandated by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).  Pursuant to MACRA and the Final Rule, most clinicians will be required to participate in either a new Merit-based Incentive Payment System (MIPS) or an Advanced Alternative Payment Model (Advanced APM).  The Final Rule’s provisions are set to go into effect on January 1, 2017.  CMS will consider comments on the Final Rule submitted within 60 days of its publication (December 13, 2016).
Continue Reading The MACRA Final Rule: The Art of the Transition