Children's Hospitals and Pediatric Providers

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Traffic lights over blue skyGov. 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

corporative buildingIn 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

Closeup of a lecturer speaking to a group of business people

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

Pills bottle-92816346On 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

horizon_lights178441822Proposed 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.
Continue Reading New timeshare exception on the horizon

clipboard with white blank paper masks stethoscope blood pressurThe 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?

patient493915589The 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.
Continue Reading FDA guidance may improve pediatric orphan drug success

Gavel_iStock_000003118029Small_BWThe District of Columbia reached a settlement agreement with Children’s Hospital, Children’s National Medical Center Inc. and its affiliates (collectively, “CNMC”) on June 15, 2015, to resolve allegations that CNMC violated the False Claims Act by submitting false cost reports and other applications to the U.S. Department of Health & Human Services (“HHS”) as well as to the Virginia and District of Columbia Medicaid programs. Further details can be found in the Department of Justice’s press release announcing the settlement.
Continue Reading Children’s hospital to pay $12.9 million to settle alleged False Claims Act violations

medical-filesiStock_000020182957_LargeThe 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.
Continue Reading Grady Health System to pay over $2.9 million to settle claims of alleged inflated Medicaid NICU billing

cannabisHusch Blackwell Partner Winn Halverhout authored a briefing on the emerging use of medical marijuana in pediatric healthcare for the American Health Lawyers Association. The briefing, titled “Legal Aspects of Marijuana Applications in Pediatric Health Care,” addresses the development of state laws and cultural acceptance of marijuana.
Continue Reading Briefing explores legal aspects of marijuana applications in pediatric healthcare