Archives: Children’s Hospitals and Pediatric Providers

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New Local Transportation Safe Harbor to the Anti-Kickback Statute and Beneficiary Inducement Statute

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 … Continue Reading

New Regulatory Exceptions to the 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 … Continue Reading

Red states see green: Opportunities for children’s hospitals

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 … Continue Reading

CMS finalizes new timeshare exception to the Stark law

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” … Continue Reading

November in Chicago: Fundamentals of Health Law conference

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 … Continue Reading

EPA proposes new rule for hazardous waste pharmaceuticals

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 … Continue Reading

New timeshare exception on the horizon

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 … Continue Reading

Per-click leases back in business – but for how long?

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 … Continue Reading

FDA guidance may improve pediatric orphan drug success

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 … Continue Reading

Children’s hospital to pay $12.9 million to settle alleged False Claims Act violations

The 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 … Continue Reading

Grady Health System to pay over $2.9 million to settle claims of alleged inflated Medicaid NICU billing

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.… Continue Reading

Briefing explores legal aspects of marijuana applications in pediatric healthcare

Husch 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

Still no word from DOL on changes to FLSA regulations

The DOL’s self-imposed February deadline for announcing new FLSA regulations redefining “white collar” exemptions has come and gone with without any action from the DOL. No new deadline has been announced; however, the DOL’s website suggests that it still hopes to release the new regulations soon. Stayed tuned, and we will report back when the … Continue Reading

Don’t let research on 'little' subjects get you in big trouble

Over the last few decades, the healthcare industry has come to recognize that research on children is necessary to determine the safest and most effective treatments for pediatric patients. Whether your institution is part of a nationally renowned research program or participates in a few pharmaceutical research studies a year, the following two issues are … Continue Reading

UPDATE: FTC victory creates challenge for physician acquisitions

The U.S. Court of Appeals for the 9th Circuit affirmed a lower court’s findings Feb. 10, 2015, that the acquisition by St. Luke’s Health System (“St. Luke’s”) of Saltzer Medical Group (“Saltzer”), a physician group consisting mostly of primary care physicians, violated Section 7 of the Clayton Act. This is the first case in which … Continue Reading

Changes coming to FLSA regulations – Time to get ready

In March 2014, President Obama directed the Secretary of Labor to prepare and propose new FLSA regulations. These new rules were to be announced late last year, but have been repeatedly delayed. Now it appears the new rules will be announced later this month. While the scope of the changes is unknown, it is anticipated … Continue Reading

Husch Blackwell Partner Brian Flood featured in Financier Worldwide forum on 'Managing Fraud and Bribery Risks in the Healthcare Sector'

Brian G. Flood of Husch Blackwell LLP‘s Austin office participated in a recent forum on “Managing Fraud and Bribery Risks in the Healthcare Sector.” The Q&A Forum forms part of a Special Report on Corporate Fraud & Corruption, which appears in the February 2015 issue of Financier Worldwide magazine. For the Q&A Forum, Financier Worldwide … Continue Reading

Healthcare employers: Plan now for filing H-1B petitions for foreign national candidates, OPT employees

It’s time to begin preparing H-1B petitions for an early April filing and Oct. 1, 2015, effective date. Advance planning is crucial. Due to the improving economy and the backlog of demand from April 2014, the H-1B cap will likely be exceeded again this year. Employers that fail to file H-1B petitions on April 1 … Continue Reading

Husch Blackwell attorneys address Ebola challenges

A Dec. 1 Strafford webinar on the legal and regulatory challenges of Ebola will feature five Husch Blackwell attorneys. The 90-minute CLE webinar with interactive Q&A will provide guidance to healthcare counsel and their clients in addressing HIPAA and EMTALA concerns when treating Ebola patients. The panel will discuss state and federal mandatory reporting requirements, … Continue Reading

Pediatric Hospitals and Medicaid Managed Care Networks

Many pediatric hospitals have an opportunity to be a lead provider of patient care and administrative services to patients in states that are outsourcing Medicaid program administration to managed care companies.  Winn Halverhout presented on this topic for an AHLA webinar titled “Innovative Pediatric Hospital/Provider Partnerships.” Thirty-seven states currently outsource all or part of their … Continue Reading

Organizations Aim to Standardize Telehealth Practices

The Federation of State Medical Boards recently endorsed a model policy that addresses the proper use of telemedicine services.  Only a few weeks later, a not-for-profit foundation released  a report highlighting the benefits of telemedicine and making recommendations for telehealth services.  It’s no surprise that telehealth and telemedicine have been in the news with increasing … Continue Reading

Recent Stark Law Developments: Is the Medicaid comfort zone coming to an end?

For many years, healthcare providers – particularly children’s hospitals – took comfort in a belief held widely throughout the healthcare industry that the Stark Law did not apply to Medicaid. That belief has now been challenged by several district court cases involving alleged False Claims Act violations, most recently in U.S. v. All Children’s Health … Continue Reading
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