Pamela Coyle Brecht to present at “A Day on Health Law”

2019/10/30

Pamela Coyle Brecht has been invited to speak on a panel at the Pennsylvania Bar Institute’s “A Day on Health Law” event which is scheduled to take place on Wednesday, October 30, 2019, in Philadelphia. Ms. Brecht will be a part of the program titled “False Claims Act Update.” The number of False Claims Act cases filed and settled continues to rise. The panel will examine the most notable False Claims Act cases from the past year. The panel will also discuss major issues that have arisen – or that loom on the horizon – involving the FCA. “A Day on Health Law” is a one day event which selects the best of the best from the PBI’s Health Law Institute 2019. There are six one-hour topics on a variety of health law issues giving attendees “must know” information in the ever-changing world of health law. To attend the event, please be sure to register here. For more information about Pamela Coyle Brecht, the Chair of Pietragallo’s national False Claims Act Group, please be sure to visit her biography page. Read More

Michael Morse to present at PICPA Healthcare Conference

2019/06/11

Michael A. Morse will present at the Pennsylvania Institute of Certified Public Accountants on June 11, 2019 in Malvern, PA. His presentation, “Do your Ethics Policies address Fraud, Waste and Abuse?” will address CPA’s Ethical Obligations, Elements of an Effective Healthcare FWA Program, Federal/State Health Care Fraud Statutes, and more. For more information and to register for this event, please visit here: https://www.picpa.org/attend-cpe-events/conferences/picpa-health-care-conference Read More

Fraud and Compliance Forum

2017/10/04

Marc Stephen Raspanti will be speaking at the Fraud and Compliance Forum. His topic for presentation is on Medical Necessity and The False Claims Act. His co-presenters include John-David H. Thomas, J. Reginald Hill, and Jessica Sievert. The name of the presentation is titled, “Medical Necessity and the False Claims Act – Lions and Tigers and Experts, Oh My!” Read More

Sexual Harassment Claims at Educational Institutions, Including Medical Residence Programs, Covered by both Title VII and Title IX

March 31, 2017

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

Mobile Health App Makers Investigated For Fraud Into Settlement With The Office Of The Attorney General For The State Of New York

March 28, 2017

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

HCCA’s 21st Annual Compliance Institute

March 28, 2017

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

Telemedicine Alert

March 24, 2017

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

PBI’s 23rd Annual Health Law Institute

March 8, 2017

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

PBI’s 23rd Annual Health Law Institute

March 7, 2017

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

HCCA San Francisco Regional Conference

December 2, 2016

Pamela Coyle Brecht will speak on “Medicare Part C & D Compliance” at the Health Care Compliance Association’s San Francisco Regional Conference at the Walnut Creek Marriott in Walnut Creek, CA. Read More