Health Care

In January 2018, in the wake of the publication of the House Energy and Commerce Committee’s Review of the 340B Drug Discount Program, I wrote that it was too soon to know whether 2018 will be a game-changing year for the 340B Program. In sum, there were just too many moving parts to discern whether there was a path forward for legislative change.

Mintz Levin’s Health Care Enforcement Defense Group released its most recent Health Care Qui Tam Update yesterday. This Update analyzes 56 qui tam cases unsealed in October and November of last year. None of the 56 cases in this Update were unsealed within the statutorily-mandated 60 days, but one case was unsealed in 71 days.

On March 1, 2018, the Federal Communications Commission (“FCC” or “Commission”) released a draft Second Further Notice of Proposed Rulemaking (“FNPRM”) aimed at combatting illegal robocalls through use of a reassigned numbers database. The full Commission will vote on whether to adopt the FNPRM at its monthly meeting on March 22, 2018.

The U.S. Supreme Court’s Spokeo v. Robins decision held that plaintiffs do not have standing to sue under Article III based solely on technical violations of the Fair Credit Reporting Act. Ever since the Supreme Court’s 2016 decision in Spokeo, Inc. v. Robins, 136 S. Ct. 1536, defendants have filed motions to dismiss putative TCPA class actions for lack of subject-matter jurisdiction.

The U.S. Court of Appeals for the District of Columbia released its long-awaited opinion on the Telephone Consumer Protection Act (“TCPA”), reversing in part and upholding in part the Federal Communications Commission (“FCC”) 2015 TCPA Declaratory Ruling and Order (“2015 R&O”).

Congress has until Friday to finalize a government spending bill. Over the next couple of days it will decide whether to move forward with a number of consequential health care issues, market stabilization and drug pricing chief among them.

Last week, the Centers for Medicare & Medicaid Services (CMS) announced that new Medicare cards would be issued starting next month. As we previously reported, the government has been planning to revamp the card to reduce fraud.

On Monday, our colleagues Bruce Sokler and Farrah Short released a client alert: Attempted Monopolization Suit Based on Alleged Referral Steering Moves Forward with Court’s Acceptance as Plausible of a Geographic Market Limited to a Single Hospital.

Last week, the U.S. Attorney’s Office for the District of Massachusetts announced that it had entered into an agreement with a Massachusetts-based medical device manufacturer to settle allegations that the Company had violated the False Claims Act by purchasing lavish meals for physicians to induce them to use heart pumps manufactured by the Company.

This week, Congress returns to Washington with 11 days to finalize a government spending bill. Standing in the way are a number of unresolved health care issues, including drug pricing and market stabilization.

A private home health care agency’s attempted monopolization suit against a dominant public hospital system and its home health care agency will move forward following a federal district court’s denial of the defendant hospital’s Motion for Judgment on the Pleadings.

The Department of Justice ("DOJ") Antitrust Division recently announced plans to hold a series of public roundtable discussions to analyze the relationship between competition and regulation, and its implications for antitrust enforcement policy.

On February 22, the Wall Street Journal published an article about the tissue graft manufacturer MiMedx Goup, Inc. and its failure to report payments to physicians under CMS’s Open Payments Program established by the Centers for Medicare & Medicaid Services under the Patient Protection and Affordable Care Act (P.L. 111-148, Sec. 6002, amending Social Security Act Sec. 1128G), also known as the Physician Payments Sunshine Act (PPSA).

Congress has three weeks to finalize an omnibus spending package. There are a number of issues that are expected to come up, including market stabilization and drug pricing, among other issues. There's also activity at the state level on Medicaid waivers and work requirements. We cover this and more in this week's preview.

The Department of Justice (DOJ) recently intervened in a False Claims Act (FCA) case that raises a variety of interesting allegations, including payment of kickbacks by a compounding pharmacy to contracted marketing companies in the form of percentage-based compensation, to TRICARE beneficiaries in the form of co-payment waivers, and to physicians who submitted prescriptions without seeing patients.

CMS has slowly but surely been providing additional guidance to Medicare Plans (Medicare Advantage and Part D plans) regarding steps they can and should take to address the opioid epidemic as it relates to their beneficiaries. CMS’s most recent guidance to Plans regarding the opioid epidemic was included in the Advance Notice and Call Letter.

Congress is back in session and will begin its work in finalizing a final spending bill for fiscal year 2018. Both chambers are considering new ways to address the opioid crisis, and we should expect a renewed push around gun control and mental health.

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) recently announced a $100,000 settlement with a company that is no longer in business. Filefax, Inc. (Filefax) was an Illinois company that provided storage and delivery services for medical records held by covered entities.

As we predicted in our year-end post on civil and criminal enforcement trends, 2018 is already off to strong start in opioid-related enforcement against individual providers and associated practices. 

When a business is faced with a TCPA or a privacy class action, getting rid of the lawsuit is its number one priority. This is why it is important to entrust the case to highly experienced counsel, well versed in defending class actions. Together, the lawyers and the clients can work on developing the best approach for defending against TCPA allegations. The strategy varies widely, depending on the merits of the case and whether the plaintiff and their lawyers are open to an early and reasonable settlement. In many such cases, however, an early offer of judgment (a “Rule 68” offer) should continue to be a part of the case strategy from its early stage.