April 2016

On April 27, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would implement changes to reimbursement under the Medicare Physician Fee Schedule (PFS) as required by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).  The proposed rule contains the following key elements: (i) a framework for the new Merit-based Incentive Payment System (MIPS), (ii) a methodology for making incentive payments for participation in alternative payment models (APMs), and (iii) proposed criteria for use by the Physician-Focused Payment Model Technical Advisory Committee (PTAC) in making recommendations on physician-focused payment models (PFPMs).

On Tuesday, the U.S. Supreme Court appeared reluctant to embrace the government’s expansive view of liability under the False Claims Act (“FCA”), as it heard oral arguments in what may prove to be one of the most significant FCA cases in decades. While it is always hazardous to draw conclusions from questions at oral argument, some of the questioning indicated that the Court may offer qualified support for some kind of “implied certification” theory of legal falsity that falls short of the government’s broad position.  The case is Universal Health Services v. U.S. ex rel. Escobar.  For healthcare providers and government contractors, the decision could radically alter the landscape of potential liability for false claims.

The use of cannabis for restricted medical purposes is set to be legalised in Victoria following the passing of the Access to Medicinal Cannabis Bill 2015.  The Bill creates a new legal regime that regulates the cultivation, manufacture and supply of cannabis in Victoria, and allows for specified categories of patients to have access to cannabis for medicinal purposes.

On April 18, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to implement Medicare payment policy changes and rates for hospitals under the acute care hospital Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital Prospective Payment System (LTCH PPS). CMS’s proposed rule continues to shift Medicare payments from volume to value-based and is projected to increase Medicare spending on inpatient hospitals to about $539 million for fiscal year (FY) 2017.

Increasing concerns about data integrity in the pharmaceutical industry have prompted the U.S. Food and Drug Administration (“FDA”) to release Draft Guidance addressing the issue as it relates to current good manufacturing practices (cGMP) for pharmaceutical companies. The Draft Guidance – titled Data Integrity and Compliance with CGMP, Guidance for Industry – is framed a series of 18 questions and answers, starting with the most basic: “what is data integrity?”

On April 15, 2016, the U.S. Food and Drug Administration (FDA) released three draft guidance documents addressing human drug compounding under the Federal Food Drug, and Cosmetic Act (FDCA). FDA issued new policies concerning the prescription requirement under section 503A of the FDCA, human drug compounding in hospitals and health systems, and the facility definition in section 503B of the FDCA. The FDA intends that its clarifying policies will ensure greater protections for patients whose needs cannot be met by an FDA-approved drug product.

The OIG has issued updated guidance on the agency’s exclusion authority, as announced by Inspector General Daniel Levinson at the HCCA’s 2016 Compliance Institute.

According to the new guidance, good-faith self-disclosures will place providers at the lower-risk end of the…