Health Law & Policy Matters

Health Care Attorneys | Mintz Levin Law Firm

Department of Justice Criminal Division Will Increase its Review of False Claims Act Cases for Criminal Prosecution

Posted in Fraud & Abuse, State & Federal Audits, Investigations & Litigation

Written by Laurence J. Freedman and Samantha P. Kingsbury

On Wednesday, during a speech before the Taxpayers Against Fraud Education Fund conference in Washington, D.C., Leslie R. Caldwell, Assistant Attorney General for the Department of Justice’s (DOJ) Criminal Division, announced that her office will be stepping up its review of False Claims Act (FCA) qui tam complaints for potential criminal prosecution. She also invited potential qui tam relators (whistleblowers) to contact criminal authorities prior to filing qui tam complaints in the event there is potential criminal conduct.

 Ms. Caldwell stated that the Criminal Division has implemented a procedure so that all new qui tam complaints are shared by the Civil Division with the Criminal Division as soon as the cases are filed.  Under this process, she said, experienced prosecutors in the Criminal Fraud Section are immediately reviewing these qui tam complaints to determine whether to open a parallel criminal investigation. Ms. Caldwell noted that the Criminal Division has “unparalleled experience prosecuting health care fraud, procurement fraud and financial fraud” and that it will “bring that expertise to bear by increasing [its] commitment to criminal investigations and prosecutions that stem from allegations in False Claims Act lawsuits.”  Beyond its expertise, the Criminal Division has relationships with foreign governmental agencies and criminal investigative tools (e.g., search warrants, wire taps, undercover operations and confidential informants) that it will be able to contribute to FCA cases.

By reviewing FCA qui tam complaints immediately, the Criminal Division will be able to streamline the process of assessing these cases for possible criminal charges.  Ms. Caldwell also indicated that her division’s deeper involvement in FCA cases will mean a shift in priorities with respect to the types of defendants on which DOJ focuses its attention.  Specifically, Ms. Caldwell commented that “cases involving fraud by executives at health care providers, such as hospitals, are [ ] a high priority” and that DOJ may increasingly bring criminal charges against corporate entities.

ML Strategies Posts Weekly Health Care Update on September 15, 2014

Posted in Health Care Reform, Privacy & Security/HIPAA/HITECH, Telemedicine

ML Strategies has posted its weekly Health Care Update.  This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.

This week is National Health IT Week. While Congress has stalled on various health care legislative initiatives, Health IT and related policy areas, such as telehealth, have received growing attention and support as policymakers focus on the exploding industry’s ability to broaden access, lower costs, and re-define privacy.

Click here to read this week’s full Health Care Update.

NIST Vetting Guidance Valuable for Health Care Organizations Seeking to Use Third-Party Apps

Posted in Pharma & Medical Devices, Privacy & Security/HIPAA/HITECH

Written by:  Stephanie D. Willis

The mobile app and wearables market in health care is booming, most recently evidenced by Apple’s entry into the market with its widely-anticipated “HealthKit,” a purportedly secure platform that allows mHealth apps to share user’s health and fitness data with the new Health app and with each other.  But mobile apps, particularly those used by health care organizations, can allow unauthorized access to patients’ Protected Health Information if not evaluated for security and privacy risks.   For guidance on how to address these risks,  click here to see our post at Privacy & Security Matters on the draft Technical Considerations for Vetting 3rd Party Mobile Applications (the Vetting Report) issued by National Institute of Standards and Technology (NIST) in August 2014.

NIST is seeking comments on the Vetting Report until September 18th, so there is still time for organizations contemplating a third party mobile app vetting process to inform NIST of any gaps that remain to be addressed in the Vetting Report.  Regardless, all organizations, especially those in the health care industry, that want to use mobile app technologies in their operations should use the Vetting Report and NIST’s other guidance publications, in conjunction with the advice of experienced health care privacy counsel, to develop their own privacy and security evaluation processes to help weed out the mobile apps that may create risks of security incidents and breaches.

Upcoming Webinar on September 23, 2014: What Your Company Needs to Know to Protect Itself from FCPA Liability

Posted in Fraud & Abuse, Pharma & Medical Devices, State & Federal Audits, Investigations & Litigation

Please join us on September 23rd, 2014 at 1:00 p.m. for a webinar where we’ll discuss the recent statements from the Department of Justice and the U.S. Securities and Exchange Commission describing the susceptibility of pharmaceutical and medical device companies in regards to FCPA enforcement. Key questions that will be addressed include:

  • Why does the FCPA seem to attract government investigations into the practices of health care companies specifically, and what should my company be worried about?
  • What FCPA enforcement actions have the DOJ and SEC brought against health care companies in recent years, and what are the lessons learned from these actions?
  • Does the increased level of focus on China indicate a new trend of global anti-bribery enforcement?
  • What simple best practices can health care companies implement to reduce the chances of governmental FCPA scrutiny?

The discussion will be led by our colleagues in the FCPA Practice,  Paul Pelletier and Aaron Tidman.

We hope you can join us. Please click here to register.

Federation of State Medical Boards Releases Interstate Licensure Compact

Posted in Physicians, Telemedicine

Written by: Kate Stewart

As previously reported by the team from ML Strategies, one of the many telehealth developments to watch this year has been the Federation of State Medical Board’s (FSMB) Interstate Licensure Compact.   On September 5, the FSBM released its Interstate Licensure Compact model legislation (the “Compact”).  Under the Compact, a physician who is licensed in his or her home state and meets educational, certification, and disciplinary criteria would be eligible to apply to receive an expedited medical license in another state that has adopted the Compact. 

For many physicians engaged in interstate practice, particularly through telemedicine, the Compact would ease requirements for practicing across state lines.  However, the Compact would still require full medical licensure in each state in which the physician practices.  Some telemedicine proponents have, instead, argued for an interstate compact that would permit physicians using telemedicine to practice based on their home state licenses alone.  Additionally, the Compact, as drafted by the FSMB, would not alter states’ so-called consultation exceptions to medical licensure, whereby certain states permit out-of-state physicians who are merely consulting with in-state physicians to practice without obtaining an in-state license. 

State boards of medicine are not required to adopt the Compact, but physician and health care providers interested in telemedicine and interstate practice should monitor the states that do adopt it.  

ML Strategies Posts Weekly Health Care Update on September 8, 2014

Posted in Health Care Reform, Hospitals & Health Systems, Pharmacies, Physicians, Uncategorized

ML Strategies has posted its weekly Health Care Update.  This publication provides timely information on implementation of the Affordable Care Act (ACA), Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.

Among other newsworthy items, this edition of the Health Care Update summarizes reactions to the news that hackers breached’s security and uploaded malware to the website earlier this summer, provides details about the Department of Health and Human Services’ efforts to make the second enrollment period for the ACA’s health insurance exchanges run smoothly, and notes that the Federation of State Medical Boards finalized its model legislation to allow states to enter interstate medical licensure compacts.

Click here to read this week’s full Health Care Update.

Telehealth Momentum Continues: 46 Telehealth Bills Under Consideration in Congress

Posted in Payors & PBMs, Physicians, Telemedicine

Written by:  Theresa C. Carnegie and Ellen L. Janos

As members of Congress return from summer vacation, they will be facing at least 46 telehealth related bills covering a wide range of topics from reimbursement to physician licensure. The growing demand for telehealth reflects the important role telemedicine plays in reducing costs while also increasing quality, access, and satisfaction.  The health care and life sciences team from ML Strategies will be watching and reporting on all of these bills as well as the many public and private policy initiatives already underway.  To help stakeholders evaluate the current opportunities in this area, ML Strategies has put together a comprehensive Telemedicine and Health IT Alert.

Government Issues New Rules for Religious Employers, But Health Plans, TPAs, and PBMs are still on the Hook to Provide Contraceptive Coverage

Posted in Health Care Reform, Payors & PBMs, Pharma & Medical Devices, Pharmacies

Written by: Bridgette A. Wiley

The Affordable Care Act (“ACA”) requires that non-grandfathered health plans make preventive care and screenings available to their members at no cost (i.e. no deductibles, coinsurance, or co-payments). The Department of Health and Human Services (“HHS”) determined that contraceptive services, including all Food and Drug Administration (“FDA”)-approved contraceptives, are part of the essential preventive care that must be made available to women.

This requirement was met with protests from religious employers who believe that forcing them to offer and pay for contraceptive services violates their first amendment right to religious freedom. To address these concerns, the Department of Labor (“DOL”) and HHS promulgated regulations creating an exception to the contraceptive coverage mandate for religious employers that qualify as an “eligible organization.” An “eligible organization” is one that self-certifies that it is an “eligible organization” and therefore is not required to contract, arrange, pay or refer for coverage of contraceptive services for its plan members.  These regulations, discussed on our blog in greater detail here, result in a system where health plans and third party administrators (which include pharmacy benefit managers (“PBMs”) for the purpose of this regulation), must pay for these contraceptive services and then receive reimbursement for the services more than a year later, if at all.

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The Increasingly Murky World of 340B: What’s Next?

Posted in Health Care Reform, Hospitals & Health Systems, Payors & PBMs, Pharma & Medical Devices, Pharmacies

Written by: Ellyn L. Sternfield

For the past 18 months, health care providers and the pharmaceutical industry have been hoping for some clarity regarding 340B Drug Discount Program operations.  But things just keep getting murkier.

In a March 2013 article describing the history of the 340B Program, I wrote that “Twenty years after the 340B Program was created, there are competing views of its purpose. And those competing views frame the current pressures for 340B Program reform.”  And in a July 2013 post, I wrote that the heart of the controversy over the 340B Program operations comes down to purpose – Is the 340B Program intended to provide uninsured safety net patients with access to outpatient drugs, or is it intended to provide safety net providers with enhanced revenue to increase patient access to health services?   It is hard to bring clarity to 340B Program operations when there is intense disagreement as to the end the 340B Program is meant to achieve.

In January 2014, I predicted that the year 2014 would be a game-changer for the 340B Program, in part because of an on-going challenge by PhRMA to HRSA rules intended to implement the statutory Orphan Drug exception to 340B pricing, and in part because HRSA publicly declared its intent to issue an omnibus rule governing many aspects of 340B Program operations by the end of June 2014. 

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Health Care Providers Among Those at Risk from “Backoff” Malware

Posted in Privacy & Security/HIPAA/HITECH

If your health care organization swipes credit cards, such as for the collection of copayments, parking fees, or even gifts in a gift shop, you should read this important update regarding “Backoff” Malware, which includes practical steps for protecting your credit card data.   “Backoff” Malware is responsible for more than 1,000 breaches of credit card information, including the Target mega breach.  Check out the Mintz Levin Privacy and Security Matters blog for more information on this and other privacy and security issues.