On March 7, 2017 the Third Circuit issued its opinion in Doe v. Mercy Catholic Med. Ctr., 16-1247, — F.3d —-, 2017 WL 894455 (3d Cir. Mar. 7, 2017) addressing two matters of first impression in the Third Circuit: (a) whether a hospital’s residency program was an education program under Title IX of the Education Amendments of 1972; and (b) whether an employee of an educational program covered by Title IX could seek relief for sex discrimination despite the availability of relief under Title VII.
In Doe, plaintiff, a former medical resident of the defendant medical center, a private teaching hospital with a medical program, brought a claim of sex discrimination against Defendant. The District Court dismissed plaintiff’s complaint, finding that Mercy was not an “education program or activity” under Title IX.
The Third Circuit found that Title IX applied to Mercy’s medical residency program. The Court recognized that “education program or activity” was left undefined by statute but that Mercy’s position that the statute only applies to entities (unlike Mercy), principally engaged in providing educational offerings was untenable given the wide breadth of Title IX. The Third Circuit found that a “program or activity” is covered by Title XI “if it has features such that one could reasonably consider its mission to be, at least in part, educational.” Id. at *6 (internal quotation marks and citations omitted). The holding is in accord with case law from the First, Second, Eight, and Ninth Circuits as well as the interpretations of twenty-one federal agencies. Id. at *6.
In analyzing the framework for the “educational program or activity” inquiry, the Court considered whether:
(A) a program is incrementally structured through a particular course of study or training, whether full- or part-time; (B) a program allows participants to earn a degree or diploma, qualify for a certification or certification examination, or pursue a specific occupation or trade beyond mere on-the-job training; (C) a program provides instructors, examinations, an evaluation process or grades, or accepts tuition; or (D) the entities offering, accrediting, or otherwise regulating a program hold it out as educational in nature. Read More
New York State Attorney General, A.G. Schneiderman, has put mobile health application developers on notice – “We won’t tolerate non-evidence-based apps that threaten the wellbeing of New Yorkers”.
On March 23, 2017, AG Schneiderman announced settlements with three mobile health application developers after a year-long investigation into the marketing of mobile health applications distributed through Apple’s App Store and Google Play. Three of the companies targeted in the investigation Cardiio, Runtastic, and Matis each entered into settlement agreements that require the companies to: (1) provide additional information about the testing of their apps; (2) change their ads to make them non-misleading; (3) post clear and prominent disclaimers informing consumers that the apps are not medical devices and are not approved by the FDA; and, (4) to pay $30,000 in combined penalties to the Office of the Attorney General.
The settlements also require the developers to make certain fundamental changes to their apps to protect consumers’ privacy. The developers are now required to (1) secure affirmative consent to their privacy policies for these apps; and (2) disclose what information they collect and share that may be personally identifying, including a users’ GPS location, unique device identifier, and “deidentified” data that third parties may be able to use to re-identify specific users.
Cardiio is an app “downloaded hundreds of thousands of times that claims to measure heart rates” during rigorous exercise, yet the accuracy of the app had not been tested for that purpose. The Runtastic app “purports to measure heart rate and cardiovascular performance under stress” and again, as noted by the N.Y. AG’s office, the developer had failed to test the apps accuracy with users who had engaged in vigorous exercise. Matis, an app downloaded hundreds of thousands of times, had previously claimed that its app could turn any smartphone into a fetal heart monitor, despite the fact that: (1) it had never been approved by the FDA; and, (2) it never conducted a comparison to an FDA approved fetal heart monitor or any other device that had been scientifically proven to amplify the sound of a fetal heartbeat. Read More
Pamela Coyle Brecht will speak on, “Managed Care Fraud: Enforcement and Compliance,” at the HCCA’s 21st Annual Compliance Institute in National Harbor, MD. Read More
When Congress discovered that Great Depression-era employers were scheming to circumvent wage provisions in federal contracts, it enacted the first anti-kickback law, the Copeland Act, in 1931. The statute, which is still good law, prohibits federal building contractors and subcontractors from inducing their workers to “kick back” or return any part of the compensation to which they are entitled under their employment agreements.
Over the last 45 years, however, federal kickback enforce-ment has changed dramatically. Beginning in the 1970s, it became focused on the health care industry—and the billions of dollars flowing from massive government programs like Medicare and Medicaid. This article traces the development of the federal Anti-Kickback Statute (AKS), one of the government’s most potent weapons to fight fraud, waste, and abuse in the health care industry. It then reviews some of the major anti-kickback cases that have unfolded over the past few years to highlight the particular relationships and schemes on which the government and private attorney generals known as qui tam relators are focusing their enforcement efforts.
Enactment and Expansion of the Federal Anti-Kickback Statute
Created in 1965, the Medicare and Medicaid programs afforded access to health care insurance for millions of Americans. The programs’ deep pockets and flawed mechanisms for reimbursement quickly gave rise to fraud, waste, and abuse. More patients meant more claims which meant more revenue for health care providers. In an effort to ensure that only necessary items and services were being provided to Medicare and Medicaid beneficiaries, Congress passed the AKS in 1972, as an amendment to the Social Security Act. As originally written, the statue made it a misdemeanor to:
“furnish[] items or services to an individual for which payment is or may be made [through Medicare or Medic-aid]” where the provider “solicits, offers, or receives any (1) kickback or bribe in connection with furnishing of such items or services or making receipt of such payment, or (2) rebate of any fee or charge for referring any such individual to another person for furnishing of such items or services.” Read More
The State Medical Board of Ohio (SMBO) has released Rules 4731-11-01 and 4731-11-09 which take effect March 23, 2017. As previously reported in , the SMBO has chosen to take an approach consistent with several other states’ more recent statutory/regulatory amendments to their telemedicine rules. That is, rather than delineating a set of specific requirements as to how a physical exam should be conducted remotely, the SMBO has taken a more balanced approach focusing instead on documentation of the visit, informed consent, follow-up care, etc. With regard to the issue of how to properly conduct a remote physical exam, the rule leaves the discretion of whether or not telemedicine is the appropriate forum for the patient visit where it belongs, with the provider.
As an initial matter, Rule 4731-11-09 defines “informed consent” as:
[a] process of communication between a patient and physician discussing the risks and benefits of, and alternatives to, treatment through a remote evaluation that results in the patient’s agreement or signed authorization to be treated through an evaluation conducted through appropriate technology when the physician is in a location remote from the patient.
Further, a “patient” is defined as:
[a] person for whom the physician provides healthcare services or the person’s representative.
Additional definitions and references of importance are contained within Rule 4731-11-01.
With regard to the central purpose of 4731-11-09, Prescribing to persons not seen by the physician, the rule now authorizes a provider to prescribe non-controlled substances to a patient whom the provider has never physically examined and who is in a remote location from the provider, when the provider:
Establishes the patient’s identity and physical location;
Obtains the patient’s informed consent for treatment through remote examination;
Obtains the patient’s consent to forward the medical record to the patient’s PCP or other healthcare provider;
Completes a medical evaluation through interaction with the patient that meets the minimal standards of care appropriate to the condition for which the patient presents;
Establishes a diagnosis and treatment plan, including documentation of necessity for the utilization of a prescription (non-narcotic) drug; including contraindications to the recommended treatment;
Documents the consent to remote care, pertinent history, contraindications and referrals made to other providers;
Provides appropriate follow-up care or recommended follow-up care;
Makes the medical record of the visit available to the patient; and
Uses appropriate technology that is sufficient for the physician to conduct all of the above steps and as if the medical evaluation occurred in-person. Read More
A recent decision in the case of Wilson v. TA Operating, LLC, No. 4:14-cv-00771, 2017 WL 569195 (M.D. Pa. Feb. 13, 2017) (Brann, J.), should be an eye-opener for any defendant facing a claim of punitive damages.
The facts in Wilson were both tragic and unusual. The decedent-driver experienced a fire in the front brakes of his tractor trailer as he was traveling on Interstate 80. After extinguishing the flames, he brought the rig to the nearest service station for repairs. Having been assured that the brakes were fixed, the decedent was sent on his way. But after just 15 miles on the road, the brakes again caught fire. While trying to put out the blaze, he suddenly collapsed and died along a remote stretch of highway. Although the opinion does not say so explicitly, it appears that the cause of death was a heart attack.
The defendants—the service station where the repairs were made and the technician who made them—moved for summary judgment on the plaintiff’s claim for punitive damages. The court, however, denied the motion, finding genuine issues of material fact concerning the defendants’ training, supervision, and expertise. Thus, construing Pennsylvania law, District Judge Brann held that the mechanic’s failure to properly repair the brakes could, under the circumstances presented, rise to the requisite level of recklessness to support a claim for punitive damages. Ultimately, the question was left to the jury as one of fact.
Of course, the potential for an award of punitive damages in a negligence action is not remarkable, in and of itself. Indeed, it’s long been the rule in Pennsylvania that willfulness, wantonness, or recklessness can justify the imposition of exemplary damages.
But what makes Wilson noteworthy is the fact that the alleged recklessness (i.e., failure to repair the brakes) did not lead directly to decedent’s death. Read More
Articles in This Issue:
Superior Court of PA Again Calls on Legislature to Amend Workers’ Compensation Law to Permit an Injured Employee of a Subcontractor to Recover Damages Against a General Contractor
Preserving & Collecting Electronically Stored Information for Construction Litigation
Is Liquid Concrete Potentially an “Unreasonable Dangerous” Product for Purposes of a Personal Injury Claim?
A Tale of an Architect’s Office: Design for the 21st Century Office
The Misuse of Estimates in Forensic Delay Analysis: Forensic Schedule Analyses & As-Built Critical Path Analysis
Related Information:
construction_legal_edge,_spring_2017_edition.pdf Read More
Marc Stephen Raspanti and Pamela Coyle Brecht will discuss, “Dealing with States in Complex Health Care Fraud Investigations,” at PBI’s 23rd Annual Health Law Institute. The event takes place at the Pennsylvania Convention Center in Philadelphia, PA. Read More
Martin T. Durkin will discuss, “Telemedicine and the Legal Challenges that Keep us from Building a Virtual Mayo Clinic,” at PBI’s 23rd Annual Health Law Institute. The event takes place at the Pennsylvania Convention Center in Philadelphia, PA. Read More
