Tagged: HHS

HHS and FDA Take Additional Measures to Aid Post-PHE Transition for Pharmacy Providers

For the last three years, the federal government has taken considerable steps to aid providers in the fight against COVID-19. Although many of the waivers and flexibilities initiated in response to the pandemic have since expired or are in the process of being phased out, other federal agencies, including the Department of Health and Human...

HHS OIG Releases an Updated Health Care Fraud Self-Disclosure Protocol

On November 8, 2021, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) released a revised Provider Self-Disclosure Protocol, renamed Health Care Fraud Self-Disclosure Protocol (“SDP”).  Prior to this update, the SDP had not been updated since 2013.  While many of the revisions were procedural only, some of the revisions were...

CMS Advisory Opinion Approves Parent and Wholly-Owned Subsidiary Qualifying as “Single Legal Entity” under the Stark “Group Practice” Definition

The Centers for Medicare & Medicaid Services (“CMS”) released Advisory Opinion No. CMS-AO-2021-01 in June 2021, which gave the requestor the green light to provide designated health services (“DHS”) through wholly-owned subsidiaries while the parent and subsidiaries could qualify as a “single legal entity” under the “group practice” definition of the federal physician self-referral law...

HHS Announces Additional Allocations of CARES Act Provider Relief Fund

On April 22, 2020, the Department of Health and Human Services (“HHS”) issued a press release outlining the allocation of an additional $70 billion dollars in appropriations allocated by the CARES Act to the Public Health and Social Services Emergency Fund.  The initial $30B tranche of the total $100 billion provided for under the CARES...

New Proposal to Remove Disincentives to Living Organ Donation

On December 20, 2019, the Department of Health and Human Services (“DHHS”) issued a notice of proposed rulemaking (the “Proposal”) that removes financial barriers to organ donation by expanding the scope of reimbursable expenses paid through the Health Resources and Services Administration’s Reimbursement of Travel and Subsistence Expenses Incurred toward Living Organ Donation program (the...

CMS Finalizes Changes to the Stark Advisory Opinion Regulations; 2020 DHS Code List and CPI-U Updates

In the calendar year 2020 Medicare physician fee schedule final rule (“PFS”), which was published in the Federal Register on November 15, 2019 (available here), CMS finalized changes to the advisory opinion process under the federal physician self-referral law (“Stark Law” or “Stark”).  CMS also published its annual update to CPT/HCPCS codes used to identify...

A Massive Number of New Health Law Regulatory Proposals as Part of the “Regulatory Sprint to Coordinated Care”: Proposed Changes to the Stark Law, Anti-Kickback Statute, Beneficiary Inducement CMP, Privacy Laws Governing Substance Use Disorder Records, and the Stark Law Advisory Opinion Process

Today, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) each released their long-anticipated proposed rules to revise the federal self-referral law (or “Stark Law”) regulations, the safe harbors under the federal anti-kickback statute (AKS), and the civil monetary penalty law (CMP)...

CMS “Actively Working” on Stark Law Reforms to be Issued Later this Year; “Regulatory Sprint to Coordinated Care” Continues

The Centers for Medicare & Medicaid Services (CMS) is “actively working” on updates to regulations under the federal physician self-referral law (or “Stark Law”), according to CMS Administrator Seema Verma during a March 4, 2019 speech. Verma stated that the updated regulations will be issued later this year, and “will represent the most significant changes...