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Megan works closely with clients, including large health systems, adult and pediatric hospitals, physician practices and wellness companies, to address complicated situations that arise under the Stark Law, Anti-Kickback Statute, False Claims Act and state laws.

Many colleges and universities offer on-campus healthcare clinic services to their students. These student health clinics are typically staffed by a physician or advanced practice provider such as a nurse practitioner. In addition to providing professional services, these providers may on occasion prescribe medications to students. Some of our clients have asked whether it is also permissible for the providers to actually dispense these medications on-site, even though the clinic is not licensed as a pharmacy.
Continue Reading Dispensing Medications at Student Health Clinics

In January of 2019, the Centers for Medicare and Medicaid Services (“CMS”) implemented a helpful change to the signature exception to the Stark Law. In particular, the exception may now be used more than once during a 3-year period for compensation arrangements with the same referring physician.

History of Signature Exception

The signature exception to the Stark Law has undergone several revisions within the past few years. The original version of the exception was implemented by CMS effective October 1, 2008 in response to concerns regarding the potential for significant Stark Law penalties for mere “technical” violations of the statute. The original language in the signature exception provided for a grace period for noncompliance with the signature requirement of many of the compensation arrangement exceptions to the Stark Law, such as the personal service arrangements exception and fair market value exception. In particular, a 90-day grace period was permitted for late signatures that were inadvertent, and a 30-day grace period was permitted for late signatures that were “not inadvertent.” In addition, the exception could only be used once for the same referring physician during a 3-year period. In other words, after the exception was used once by a DHS entity for a late signature on a compensation agreement with a referring physician, any late signatures on other agreements entered into by the DHS entity and the same referring physician during the following 3-year period would trigger a violation of the Stark Law.
Continue Reading CMS Finalizes Helpful Change to Stark Law Signature Exception

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

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

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?

The Federal Trade Commission (FTC) recently issued a policy paper urging state legislators to carefully evaluate proposals that limit nurse practitioners’ scope of practice. Nurse practitioners (also known as Advanced Practice Registered Nurses, or APRNs) are registered nurses who have been both educated and received specialized training beyond the requirements for a registered nurse. Notably, the FTC paper concluded that expanding the scope of APRN practice would create more competition in the health care sector – helping to control costs, improve quality, promote innovation, and expand access to care.
Continue Reading FTC urges state legislators to reconsider limitations on nurse practitioners’ scope of practice

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 frequency given that the demand for telemedicine services are rising sharply.  According to a Law360 article, Deloitte Touche Tohmatsu Ltd. estimates that 75 million digital doctor visits will occur this year in North America.
Continue Reading Organizations Aim to Standardize Telehealth Practices

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 System.
Continue Reading Recent Stark Law Developments: Is the Medicaid comfort zone coming to an end?