Last week, the United States and New York announced a settlement with Mount Sinai Health System for $3 million dollars to resolve allegations that Mount Sinai violated the False Claims Act by retaining overpayments for longer than 60 days after identifying them. The settlement is the first of its kind regarding the Affordable Care Act’s creation of FCA liability for providers that have identified overpayments but have not refunded such payments within 60 days.
Australia: Regulator considers permitting the sale of food derived from low THC hemp seeds
Food Standards Australia New Zealand (FSANZ) is calling for submissions in response to its draft variation of the Food Standards Code that would permit the sale of foods derived from low tetrahydrocannbinol (THC) hemp. The proposal follows a request by the Australia and New Zealand Ministerial Forum on Food Regulation (Forum) for FSANZ to consider how THC could be legally designated as food.
Judge declines to certify order for appeal in Texas Teladoc case
On August 15, 2016, United States District Judge Robert Pitman denied the motion of the Texas Medical Board (“TMB”) to certify order for an immediate appeal of the court’s decision not to dismiss the Teladoc case. The court previously denied the TMB’s attempt to have the case against it dismissed, which was brought by Teladoc challenging the TMB’s adoption of a rule requiring physicians prescribing certain medications to first see patients face to face.
Australia trials “Health Care Homes”, a new model of primary health care
Australia is set to trial a new model of primary health care based on the successful “Health Care Homes” programs in Canada and the United States. Australia’s version of the Health Care Homes scheme was proposed in broad terms in December 2015 by the Primary Health Care Advisory Group, in its Better Outcomes for People with Chronic and Complex Health Conditions report. Key elements of the proposed scheme included:
Administrative dispute resolution process is proposed to resolve 340B drug pricing program disputes
On August 11 the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking (RIN 0906-AA90) that would implement an administrative dispute resolution (ADR) process that would apply to all drug manufacturers and covered entities that participate in
FDA issues draft guidance on Unique Device Identifiers
On July 26, 2016, the FDA issued draft guidance to help clarify the form and content requirements of the Unique Device Identifier (UDI). Industry groups have 60 days to comment on the draft guidance.
Background
The UDI final rule,
Zika outbreak in Miami triggers CDC travel warning
In response to the most recent Zika virus outbreak in the Wynwood neighborhood of Miami, Florida, the Centers for Disease Control and Prevention (“CDC”) issued an immediate travel warning advising all pregnant women against traveling to the Wynwood neighborhood at this time.
Physicians’ compensation structure results in $17M Stark Law fine and CIA for hospital
Lexington Medical Center (“LMC”), a 428-bed hospital in South Carolina, has agreed to pay $17 million to resolve allegations that it violated the federal False Claims Act (“FCA”), 31 U.S.C. §§ 3729 et seq., and Physician Self-Referral Law (“Stark Law”), 42 U.S.C. § 1395nn, by allegedly providing improper financial incentives to 28 physicians for referrals.