The Office of Inspector General for the Department of Health and Human Services (“OIG”) recently issued an updated Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs, an update that comes 13 years after publication of its initial Special Advisory Bulletin on Exclusion. Of particular note is the OIG’s recognition that health care providers may employ or contract with excluded individuals and entities, yet it places the burden on providers to show that the excluded party has no involvement with federally funded health care programs or beneficiaries.
A recent Mintz Levin Health Law Advisory, Five Takeaways from OIG’s Special Advisory Bulletin on Exclusion, written by Ellyn Sternfield, answers many of the important questions resulting from the Special Advisory Bulletin, including:
1. Why does exclusion matter?
2. Can a health care provider employ/contract with excluded parties?
3. How and how often should employees and contractors be screened?
4. Do I need to document exclusion screening efforts?
5. How should providers address potential liability for excluded parties?
Yesterday, Mintz Levin hosted a Health Beat Webinar that focused on strategies for minimizing the risk of whistleblower actions. Attorneys from our Health Care Enforcement Defense, Class Action, and Employment, Labor & Benefits practices discussed how to establish an effective qui tam avoidance program. Click here to watch the webinar.
Written by Susan Berson and Roy Albert
Last week, CMS published a final rule implementing the ACA’s medical loss ratio (“MLR”) requirements that will apply to the Medicare Advantage (Part C) and prescription drug (Part D) programs beginning in contract year 2014. CMS already issued a final MLR rule applicable to commercial plans last year, which CMS notes served as a model for the Medicare Advantage and Part D MLR rule. Continue Reading
The HHS Office of Civil Rights (OCR) and the Workgroup for Electronic Data Interchange (WEDI) are co-sponsoring four upcoming webinars to help smaller health care providers feeling overwhelmed by the 138-page HIPAA Omnibus Rule better understand HIPAA compliance and enforcement topics. The webinars will specifically focus on practical strategies for implementing the Omnibus Rule’s new requirements within a small clinical practice. Continue Reading
Graduate medical education programs and residents should be getting used to change by now. Last year, the ACGME introduced the Next Accreditation System, and then eight months later, it announced it was developing a unified accreditation system with the American Osteopathic Association (AOA) and the American Association of Colleges of Osteopathic Medicine (AACOM), and that AOA and AACOM would become part of ACGME. The “merger” and subsequent unified accreditation system for graduate medical education programs could happen as early as July 2015. Continue Reading
Written by: Dianne Bourque and M. Daria Niewenhous
The Massachusetts Department of Public Health Public Health Council approved, by unanimous vote, final regulations for the implementation of the medical marijuana ballot initiative law that will allow qualifying patients with certain medical conditions to obtain and use marijuana for medicinal purposes. Approved on May 8, the final regulations provide an implementation framework for the new law and, among other things:
- define debilitating medical conditions for which the use of medical marijuana is authorized;
- define the maximum 60-day supply that a patient may legally posses (10 ounces of finished leaf product);
- define the bone fide physician patient relationship required for a physician to certify a patient for medical marijuana use. The regulations also prohibit a physician from certifying immediate family members;
- adopt a framework for municipal involvement and oversight in regulating medical marijuana, provided that local regulations do not conflict with state law; and
the requirement that Registered Marijuana Dispensary (RMD) applicants maintain $500,000 in an escrow account to demonstrate financial viability and instead require applicants to demonstrate at least $500,000 of liquid capital available for the first RMD location, and $400,000 for additional locations under common ownership.
Although “Medical Marijuana Treatment Center” (MMTC) was the term given to these entities under the law, the Council amended the regulatory definitions to provide that MMTCs will be known as “Registered Marijuana Dispensaries” or “RMDs.” The Council believes that this better reflects the nature of the activities taking place at these locations, which do not provide on site clinical treatment services.
The final regulations also provide that they shall not be construed to limit the scope of practice of a nurse practitioner pursuant to M.G.L. c. 112, s. 80I. Added by Chapter 224 of the Acts of 2012 (effective November 4, 2012), Section 80I provides that, when a law or rule requires a certification by a physician, when relating to physical or mental health, that requirement may be fulfilled by a nurse practitioner. However, Section 80I also states that it is not to be construed to expand the scope of practice of nurse practitioners. At its May 8 meeting, at least one Public Health Council member noted that the regulations, which also require that a physician have a bona fide physician patient relationship to certify that a patient qualifies to obtain marijuana for medical use, seemed unclear as to whether or not nurse practitioners can provide this certification. DPH staff responded that its intent is to leave it to the Board of Registration in Nursing, which licenses nurse practitioners, to determine if certifying patients for medical marijuana registration is within a nurse practitioner’s scope of practice. DPH expects the Board will take up this issue quickly.
Despite the passage of final regulations, it will be several months before RMDs are open in the state. We will be posting additional analyses of the regulations, including information regarding the RMD application and approval process, in the coming weeks. Meanwhile, additional information, including Medical Marijuana FAQs, and the Department of Public Health Medical Marijuana Working Group’s Memorandum to the Public Health Council can be found at the Executive Office of Health and Human Services Medical Marijuana Page.
When acquiring a health care company doing business abroad, there is no such thing as being too thorough with anti-corruption due diligence. The Department of Justice and the Securities and Exchange Commission have the health care industry on their radar screens for FCPA enforcement. Even if your company conducts business ethically, before, during, and after an acquisition, you can take on civil or criminal risk as a result of successor liability. Continue Reading
Written by: Ellen L. Janos
The American Telemedicine Association (ATA) wrapped up its 2013 Annual Meeting in Austin, Texas on Monday. Over 5,000 people attended the ATA’s largest annual meeting ever. The extraordinary advances in technology over the past few years coupled with increasing consumer and provider engagement are fueling an explosion of public and private telemedicine and internet-based health initiatives.
The issues addressed at the ATA’s State Policy Summit for state policy decision-makers, telehealth service providers, and technology vendors are expected to shape the future growth of telemedicine and internet based health initiatives. The telemedicine industry is saddled with woefully outdated physician licensure laws, and regulations and policies that were developed decades ago to address the abuses surrounding the prescribing of controlled substances over the internet. It will be imperative that state medical boards and other state policy makers review and revise outdated licensing and prescribing rules to ensure that telemedicine, a critical piece of the overall effort to ensure that patients have access to high quality, cost effective health care, can flourish. To see what regulatory initiatives your state policy makers are considering, visit the ATA’s State Telemedicine Policy Center.
ML Strategies has posted its weekly Health Care Reform Update. This publication provides timely information on implementation of the Affordable Care Act, and other state and federal administrative and legislative activities related to health care reform. Click here to read this week’s Update.
Understanding the complexities of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules is often a challenge for health care providers and consumers. Recognizing the widespread confusion surrounding the interpretation of the rules, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released new tools to educate providers and consumers about HIPAA. Continue Reading