Government Issues

The Office of the Inspector General (OIG) for the U.S. Department of Health & Human Services recently published its Fiscal Year 2016 Work Plan, which summarizes OIG’s priorities over the coming year. Notably, the 2016 Work Plan demonstrates the OIG’s expanded focus on delivery system reform and the effectiveness of alternate payment models, coordinated care programs, and value-based purchasing.

There were also noteworthy areas of new focus for several provider types, including skilled nursing facilities, hospice organizations, ambulatory surgical centers, and physician practices.  Below we have highlighted a few key areas from the FY 2016 Work Plan that will likely impact these providers. Please note this is not intended to be a comprehensive summary of the 2016 Work Plan and is focused only on the new OIG focal areas for these certain providers.

The Office of Inspector General (OIG) for the U.S. Department of Health & Human Services (HHS) issued a fraud alert on June 9, 2015, targeting physician compensation agreements that potentially violate the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b). The Anti-Kickback Statute prohibits remuneration of payment in exchange for referrals of patients receiving aid from federally funded healthcare programs (i.e. Medicare and Medicaid). The OIG alert references 12 recent settlements with individual physicians who entered into “questionable” medical directorship and office staff arrangements. The key concern in those cases centered on individual physicians entering into arrangements where the compensation did not “reflect [the] fair market value for bona fide services the physicians actually provide[d].”

Proposed Stark exception could impact hospital and physicians timeshare/ part-time agreement arrangements

In July 2015, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule pertaining to payment policies under the 2016 Medicare Physician Fee Schedule (“Proposed Rule”) (80 Fed. Reg. 41,685). In addition to changes to the Medicare Physician Fee Schedule and other Medicare Part B payment policies, the Proposed Rule addresses modifications to the Stark Law and provides guidance on CMS’s interpretation of existing Stark Law exceptions.

The U.S. Court of Appeals for the District of Columbia Circuit issued an opinion June 12, 2015, lambasting the Centers for Medicare & Medicaid Services’ (“CMS”) rationale in implementing the ban on “per-click” space and equipment leases under the Stark Law. This ban, which went into effect Oct. 1, 2009, was effectively challenged by the Council for Urological Interests (“Council”), which was also behind the successful challenge against the application of the Stark Law to hospital lithotripsy services in 2002.

Among the more colorful descriptions used by the Court in describing CMS’s position were that it was “incomprehensible,” “tortured”, and “the stuff of caprice.” And on an even more scathing note, the Court described CMS’s reading of the legislative history of the Stark Law as belonging to the “cross-your-fingers-and-hope-it-goes-away school of statutory interpretation.”

The Orphan Drug Act aims to incentivize treatment of rare disorders or conditions affecting fewer than 200,000 persons in the United States through: (1) federal funding of grants and contracts to perform clinical trials of orphan products; (2) a tax credit of 50 percent of clinical testing costs; and (3) an exclusive right to market the orphan drug for approved orphan indications for 7 years from the date of marketing approval. While these financial incentives certainly make the business decision to engage in orphan drug development more palatable, the FDA does not approve orphan drugs on a separate pathway, despite the limited understanding of the diseases in question that presents developers of these drugs with problems stemming from small sample size and lack of well-defined efficacy endpoints.

A New York district court issued the first judicial opinion Monday, Aug. 3 on the Affordable Care Act’s “60-day rule,” which requires that a Medicare or Medicaid overpayment be reported and returned within 60 days of the date on which the overpayment was “identified.” The decision by Judge Edgardo Ramos provided a definition of what it means to “identify” an overpayment and thus begin the 60-day time period in which overpayments must be reported and returned. Given that the 60-day rule maintains that any person who knowingly fails to comply with this obligation within the 60-day timeframe has violated the False Claims Act (“FCA”), the potential implications of Judge Ramos’s decision are significant.

On Thursday, July 16, 2015, the Texas Health and Human Services Commission (HHSC) held a public meeting regarding its request to seek an extension of its Section 1115 Medicaid Transformation Waiver. The current waiver covered a five year period ending September 30, 2016. Under the waiver Texas has expanded Medicaid managed care, created a funding pool to offset uncompensated care and provided incentives for hospitals and other providers to develop delivery system infrastructure in Texas. Over the waiver period, Texas will commit $29 Billion to the uncompensated care and delivery system payment pools (approximately 58% or $16.82 Billion represent federal funds).

The U.S. Department of Health & Human Services Office of Inspector General (OIG) issued a special fraud alert on June 9, 2015, stating that physician compensation arrangements may result in significant liability. Hopefully this is not a surprise to any physician or entity that treats federal health plan beneficiaries. However, given that, historically, OIG regulatory actions largely (although not exclusively) focused on the entity from which a physician received compensation, such as hospitals, laboratories, durable medical equipment suppliers, pharmacies, etc., the June 9, 2015, fraud alert highlights the potential for physician liability in these arrangements.

The state of Georgia reached a civil settlement agreement on April 23, 2015, with Grady Health System based on allegations that Grady incorrectly coded claims for neonatal intensive care unit (NICU) patients, resulting in overpayments by Georgia Medicaid. For more details, read the Georgia Attorney General’s press release announcing the settlement.