The Department of Health and Human Services Office of Inspector General (OIG) recently implemented a new safe harbor to the federal Anti-Kickback Statute and beneficiary inducement statute, which went into effect on January 6, 2017.1 The new safe harbor, which was published by the OIG in a final rule dated December 7, 2016,2 protects the provision of free or discounted local transportation by eligible entities to Medicare or Medicaid beneficiaries, provided that certain conditions are met. While non-compliance with the safe harbor does not necessarily mean that a transportation arrangement will violate the Anti-Kickback Statute, children’s hospitals should take note of the safe harbor requirements and assess whether any of their existing transportation arrangements should be restructured. Continue Reading New Local Transportation Safe Harbor to the Anti-Kickback Statute and Beneficiary Inducement Statute
On January 6, 2017, several new regulatory exceptions to the beneficiary inducement statute went into effect. These regulations, published by the Department of Health and Human Services Office of Inspector General (OIG) in a final rule dated December 7, 2016,1 bring long awaited closure to many of the outstanding issues raised in the statutory versions of the exceptions implemented by the Affordable Care Act (ACA) and in the proposed regulations issued by the OIG on October 3, 2014.2 Several exceptions that may be of particular interest to children’s hospitals are highlighted below. Continue Reading New Regulatory Exceptions to the Beneficiary Inducement Statute
On May 9, 2016, the Middle District of Pennsylvania in FTC et al. v. Hershey Medical Center et al. (“Hershey”) denied a preliminary injunction request by the FTC to block a merger between Penn State Hershey Medical Center and PinnacleHealth System. The District Court rejected the FTC’s request based on its finding that the FTC’s geographic market definition was “unrealistically narrow and does not assume the commercial realities faced by consumers in the region.” The proper geographic market is one from which the defendant hospitals draw the bulk of their patients, with few patients entering in from outside that area to seek medical care and few patients within that area leaving to seek care from other hospitals. The District Court found the FTC’s proposed geographic market to be “starkly narrow,” particularly “given the realities of living in Central Pennsylvania, which is largely rural and requires driving distances for specific goods and services.” By failing to set forth a relevant geographic market, the District Court held that the FTC could not demonstrate a likelihood of success on the merits of its Clayton Act case against the merger and denied the preliminary injunction. Continue Reading Court Tells FTC in Hershey to Kiss Off
In a recent webinar, Husch Blackwell healthcare attorney Curt Chase presented strategies for integration in the pediatric marketplace. The webinar focused on the Group Practice Subsidiary Model that balances the respective goals and desires of hospitals and community physicians. Continue Reading Group practice model offers new strategy for pediatric providers
Gov. John Bel Edwards signed an executive order Jan. 19, 2016, to make Louisiana the 32nd state to adopt Medicaid expansion under the Affordable Care Act. Montana’s Medicaid expansion became effective Jan. 1, and South Dakota, Virginia and Wyoming are including Medicaid expansion in upcoming state budget proposals.
This is reflective of a growing trend of so-called “red” states that are nevertheless adopting provisions of the Affordable Care Act that subsidize healthcare costs for new groups of citizens who cannot afford commercial or exchange insurance products and do not qualify for Medicare. To sweeten the pot, the Obama administration announced its 2017 budget proposal will include a legislative proposal to provide any state that expands Medicaid coverage under the Affordable Care Act with the same three years of full federal funding that states that expanded their Medicaid programs in 2014 enjoyed. Continue Reading Red states see green: Opportunities for children’s hospitals
In the 2016 Physician Fee Schedule Final Rule published on Nov. 16, 2014, the Centers for Medicare & Medicaid Services (CMS) finalized the proposed exception for timeshare arrangements that we discussed in our earlier blog post [80 Fed. Reg. 70,886, 71,300 (Nov. 16, 2015)]. As we stated in our earlier post, a timeshare or part-time “space use” arrangement typically provides a physician with the use of office space during scheduled time periods. The space usually includes furnishings with basic medical office equipment, supplies and support personnel so that the physician is able to use the space, on a turn-key basis, to see patients during scheduled times. Prior to the implementation of the new timeshare exception, these types of arrangements needed to be structured to comply with the Rental of Office Space Exception, which includes “exclusive use” requirements that many hospitals and physicians found burdensome [42 C.F.R. § 411.357(a)]. Continue Reading CMS finalizes new timeshare exception to the Stark law
Attorneys, compliance officers, accountants, and other professionals who advise clients in the healthcare industry may want to consider attending a coming event next month in Chicago. Featuring Husch Blackwell attorneys Cori Turner and Bill Hopkins, the Fundamentals of Health Law will be held Nov. 15-17.
The American Health Lawyers Association’s event will offer continuing education credits. Continue Reading November in Chicago: Fundamentals of Health Law conference
On August 31, 2015, the Environmental Protection Agency (“EPA”) issued its long-awaited Management Standards for Hazardous Waste Pharmaceuticals Proposed Rule, which is designed to prevent facilities from disposing of hazardous waste pharmaceuticals by flushing them down the toilet or drain. The proposal creates a new subpart under the Resource Conservation and Recovery Act’s (“RCRA”) hazardous waste regulations for the regulation of hazardous waste pharmaceuticals generated by “healthcare facilities” and “pharmaceutical reverse distributors.” Continue Reading EPA proposes new rule for hazardous waste pharmaceuticals
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. Continue Reading New timeshare exception on the horizon
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.” Continue Reading Per-click leases back in business – but for how long?