The Office of Inspector General of the Department of Health and Human Services (“OIG”) released a proposed rule to eliminate safe harbor protection under the anti-kickback statute for drug price reductions that pharmaceutical...more
2/6/2019
/ Anti-Kickback Statute ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Manufacturers ,
MCOs ,
Medicaid ,
Medicare ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Rules ,
Rebates ,
Safe Harbors
Many regulatory and legislative calls for modernizing the federal physician self-referral law (or “Stark Law”) in light of the move to value-based payment under Medicare have been made in recent months. Most recently, a...more
On February 9, President Trump signed the Bipartisan Budget Act of 2018 (“BBA”) into law. The BBA funds the federal government through March 23 and included a bipartisan agreement to increase annual spending authority for a...more
2/22/2018
/ ACOs ,
Bipartisan Budget Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Fraud and Abuse ,
Health Care Providers ,
Medicaid ,
Medicare ,
Penalties ,
Physician Fee Schedule ,
Stark Law ,
Telehealth
The Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma recently identified federal physician self-referral law (or “Stark Law”) reform as a top policy priority and reported that an inter-agency group is...more
In a prior blog post from September 8, 2017, we wrote about the many ways in which states are addressing the opioid crisis through legislation. One of the states we discussed was New Jersey who at the time had proposed a new...more
On October 2, the Veterans Administration (VA) proposed a new rule that would expand access to quality care and availability of mental health, specialty, and general clinical care for VA beneficiaries through the use of...more
The Cybersecurity Act of 2015 established the Health Care Industry Cybersecurity Task Force to respond to severe cyber-attacks within the rapidly-expanding information technology (“IT”) aspect of health care. Section 405(c)...more
The FDA has called on the drugmaker Endo Pharmaceuticals to stop selling the opioid Opana ER. The press release on June 8th reflecting this announcement marks a novel approach from the FDA, as the agency for the first time...more
Not relying on Congress to take action on the Affordable Care Act, the Centers for Medicare and Medicaid Services (“CMS”) has proposed new regulations intended to attract health insurance issuers back into ACA health...more
One of President Trump’s first actions in office was to sign an Executive Order stating that his Administration will seek to repeal the Affordable Care Act (the “Act”). In the meantime, President Trump directed the executive...more
The 21St Century Cures Act, Pub. L. No. 114-255, 130 Stat. 1033, was signed into law on December 13, 2016. This expansive statute addresses topics ranging from investigational drug clinical trial design, mental health...more
On November 2, the Centers for Medicare & Medicaid Services (CMS) finalized the 2017 Medicare Physician Fee Schedule (PFS) rule. This rule, which takes effect on January 1, 2017, updates payment policies and rates for...more
In its CY 2016 physician fee schedule proposed rule, the Centers for Medicare and Medicaid Services (“CMS”) proposes significant amendments and clarifications to the federal physician self-referral regulations, commonly known...more