As Texas, Florida, and the Caribbean rebuild after the latest string of deadly hurricanes and prepare for the possibility of future storms, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) reminded health care providers of the importance of ensuring the availability and security of health information during and after natural disasters. OCR’s guidance is a good reminder to all health care providers – regardless of where they are located – of the applicability of the HIPAA Privacy and Security Rules during natural disasters and other emergencies.
Continuing its annual tradition, the U.S. Department of Justice (“DOJ”) and the U.S. Department of Health and Human Services (“HHS”) announced last week the largest ever health care fraud enforcement action by the Medicare Fraud Strike Force. As part of the national health care fraud takedown, the government charged 412 defendants with approximately $1.3 billion in alleged fraud. In addition to these charges, HHS Office of Inspector General (“OIG”) is in the process of excluding 295 health care providers from participating in federal health care programs.
We recently updated our chart that tracks state biosimilar substitution laws to include new laws in Iowa and Montana. These new laws bring the total number of states with biosimilar substitution laws to 27, plus Puerto Rico. The latest version of our chart can be found here. As with the laws we’ve seen before, both the Iowa and Montana biosimilar amendments mirror the state’s existing generic drug substitution laws. More specifically, they amend state pharmacy laws to allow, and in some situations require, the substitution of interchangeable biosimilars. Continue Reading New State Substitution Laws, and a Busy Spring for Biosimilars
The long-running test-referral prosecution against Biodiagnostic Laboratory Services, LLC (“BLS”), a New Jersey clinical blood testing laboratory; its owner and employees; and BLS’s referring physicians recently reached another milestone. In a criminal case that the U.S. Attorney’s Office for the District of New Jersey has called the “largest physician bribery case ever prosecuted,” resulting in 40 guilty pleas, BLS was sentenced on June 28, 2016 and ordered to forfeit all of its assets.
In addition, on June 30, 2016, the 27th BLS referring physician pleaded guilty to charges that he violated the Federal Travel Act by taking bribes from BLS. The physician admitted that, between April 2011 and June 2012, BLS paid him approximately $1,500 per month. This physician plea is another in the long line of individual criminal pleas, 38 of which are catalogued here. Continue Reading Biodiagnostic Laboratory Services Sentenced; Another Physician Pleads Guilty
As reported in yesterday’s Boston Globe, compared to national averages, Massachusetts physicians are less likely to receive payments or items of value from pharmaceutical companies and less likely to be heavy prescribers of brand-name drugs. The Globe article relates to a ProPublica analysis of physician prescribing patterns and payments from the pharmaceutical industry. To perform the analysis, ProPublica researchers tapped into two important sources of information about prescribers collected nationwide: information on payments received by physicians from pharmaceutical and device manufacturers (available through the Open Payments website) and Medicare Part D prescribing data. The analysis was limited to data from both sources for 2013 and 2014 (with only limited data available from Open Payments for 2013). Continue Reading Drug Company Payments and Prescribing Patterns Linked, Massachusetts Is An Outlier
With Halloween looming, a discussion of skeletons that may be lurking in a health care provider’s closet is timely. Many of our previous posts, as well as the monthly Qui Tam Updates published by our Health Care Enforcement Defense Group, have discussed a wide variety of state and federal health care fraud investigations and qui tam cases filed by relators under the False Claims Act (FCA). Here we have identified three skeletons worth clearing from the closet in an effort to avoid the frights that may follow from such enforcement actions and lawsuits.
The 60-Day Rule
As explained in a previous post, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule in February 2012 in an attempt to implement the “60-day rule,” which concerns a provider or supplier’s obligation to return overpayments, but CMS has had a frighteningly difficult time finalizing the regulations. However, the Office of Management and Budget received the final 60-day rule for review on October 21, 2015, and it has 90 days to review the final rule, although that time may be extended. Regardless of the timing of the final rule’s publication, health care providers should already be investigating and addressing any potential overpayments in accordance with the governing statute. Continue Reading Skeletons in the Closet? Beware of Potential Enforcement Actions
On Monday, during the annual meeting of the American Medical Association (AMA) House of Delegates, the delegates voted to table a proposed measure to adopt ethical guidelines for physicians who provide telemedicine services. The proposed guidelines, which were based on recommendations by the AMA’s Council on Ethical and Judicial Affairs (CEJA), focused on issues such as ensuring patient privacy and educating patients on the limitations of telemedicine.
Late last week, Texas telemedicine practitioners received a temporary reprieve from a new regulation issued by the Texas Medical Board (the “Board”) when a Texas federal court prohibited implementation of the new rule that would have prevented prescribing via telemedicine. The regulation’s suspension stems from an antitrust claim brought by a national telehealth provider, Teladoc, Inc. (“Teladoc”), and other plaintiffs against the Board alleging that the Board’s new regulation violates Section 1 of the Sherman Act and the Commerce Clause.
The injunction is the latest blow in a lengthy battle in Texas regarding the standards for appropriate telemedicine practice and is one of the first major cases challenging the actions of a state medical board in the wake of the Supreme Court’s decision in North Carolina State Board of Dental Examiners v. Federal Trade Commission, No. 13-354, slip op. (U.S. Feb. 25, 2015). In that case, the Supreme Court held that the antitrust laws would apply to – and the state action exemption would not protect – activities of state agencies or boards made up of market participants, absent active state supervision of the Board’s challenged conduct. (Further discussion of the case is available in the Mintz Levin Antitrust Alert, Feb. 26, 2015, “No Active State Supervision, No Antitrust Immunity for North Carolina State Dental Board”.)
Although the Board is a state agency “statutorily empowered to regulate the practice of medicine in Texas,” notably, it did not assert a state action immunity defense. The court found the absence of a state action defense significant and somewhat unusual, stating:
Significantly, in this case, the TMB declined to assert any immunity defenses, including Parker immunity, solely as to Plaintiffs’ application for a preliminary injunction. The normal deference afforded to a state under antitrust law is, therefore, not an issue in reviewing Plaintiff’s application for a preliminary injunction. The Court’s opinion is properly read through that narrow, and unusual, lens.
Teladoc Inc. v. Texas Medical Board, No. 1-15-CV-343-RP (W.D. Tex. May 29, 2015) (order granting preliminary injunction).
In the wake of the Supreme Court’s North Carolina Board of Dental Examiners decision, whether the Board asserts a state action immunity defense in future proceedings will undoubtedly be closely followed and analyzed, as will any basis asserted for the defense.
On April 8th I will be presenting in a Health Care Compliance Association webinar entitled “Hot Topics in Laboratory Compliance.” My co-presenter is Rob Rossi, Senior Vice President and Chief Compliance Officer, Calloway Laboratories. Rob is a seasoned laboratory industry veteran who also has served as General Counsel of a pathology laboratory and who has spent time in state government. Together we will offer legal guidance while taking into account the operational and business challenges laboratories face in today’s health care enforcement environment. Laboratories seem to be in the spotlight lately, as evidenced by the HHS OIG’s issuance of last year’s Special Fraud Alert on payments by laboratories to referring physicians and Advisory Opinion 15-04 addressing a proposed business arrangement between a laboratory and its physician practice clients. If you are interested in learning more about these issues, there is still plenty of time to register.
The Centers for Medicare & Medicaid Services (CMS) has announced the upcoming deadlines for the third round of new applications to the Medicare Shared Savings Program (MSSP). Accountable Care Organizations (ACOs) that ultimately are accepted into the MSSP would begin their three-year participation agreements with CMS on January 1, 2015 and join the over 360 existing ACOs currently in the MSSP or Pioneer ACO model. This timeline is very similar to last year’s schedule.
|Notice of Intent to Apply (NOI) Process||Deadlines|
|NOI Memo Posted to CMS Website||April 1, 2014|
|NOI Questionnaire Posted to CMS Website||May 1, 2014|
|NOI Submission Period||May 1, 2014 – May 30, 2014|
|NOI Deadline||May 30, 2014 at 8:00 p.m. EST|
|CMS User ID Forms Submission Period||May 6, 2014 – June 9, 2014|
|MSSP Application Posted to CMS Website||
May 30, 2014
|MSSP Application Submission Period||
July 1, 2014 – July 31, 2014
|MSSP Application Deadline||July 31, 2014 at 8:00 p.m. EST|
|MSSP Application Approval or Denial Decision Sent to Applicants||
|MSSP Application Denial Reconsideration review deadline||
15 Days from Notice of Denial