Health Care

On May 6th, we posted about the possibility that the Department of Justice (“DOJ”) might dramatically increase False Claims Act (“FCA”) penalties after the Railroad Retirement Board (“RRB”) nearly doubled the per-claim penalties it imposed under the FCA.

On June 17, the Texas Medical Board (“Board”) filed a brief with the Fifth Circuit Court of Appeals reiterating that the Board’s rulemaking processes are protected under the state action immunity doctrine, noting that the case could significantly impair state agencies in carrying out their governmental functions.

On Monday, the U.S. Supreme Court issued summary dispositions vacating the judgments in three cases brought under the False Claims Act ("FCA"). The Court remanded the cases back to their respective circuit courts for reconsideration in light of the Court's decision in Universal Health Services, Inc. v. United States ex rel. Escobar, 579 U. S. ___ (2016).

Like many before it, this year has been one to watch in government health care fraud enforcement efforts. In September 2015, the Department of Justice (DOJ) released the “Yates Memo,” which reaffirmed the government’s commitment to investigating and prosecuting culpable individuals in cases involving suspected corporate fraud.

After waking to news that the UK had voted to leave the EU, our London-based colleague Susan Foster provided insight on what the Brexit will mean for UK data protection laws.

Federally-funded clinical trials conducted at multiple sites will move to a single Institutional Review Board (IRB) review scheme under a new National Institutes of Health (NIH) Policy.The NIH has finalized its policy to have a single IRB (sIRB) of record conduct the required ethics review for multi-site studies.

On June 28 at 1:00pm ET, please join me and my Mintz Levin colleagues, Joshua Briones and Russell Fox, for our webinar, “A Year Since the FCC's Declaratory Ruling — Critical Issues and Latest Trends on TCPA.”

Earlier this month, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced the release of three YouTube videos and an infographic on individuals' rights to access health information.

Last Friday afternoon CMS released its eagerly anticipated final rule (the Final Rule) implementing the Protecting Access to Medicare Act of 2014 (PAMA), which, together with the Final Rule, will make sweeping changes to the rate-setting process under the Medicare Clinical Laboratory Fee Schedule (MCLFS).

Earlier today, my colleagues Tom Crane and Larry Freedman released a Health Care Enforcement Defense Advisory regarding the Supreme Court's long-awaited, unanimous decision in Universal Health Services v. United States ex rel. Escobar (“Escobar”).

The NYS Department of Health (DOH) has proposed new guidelines for the provider contract submission and review process to reflect Value Based Payment arrangements pursuant to the New York State Value Based Payment (VBP) Roadmap (Roadmap) and the Regulatory Impact Subcommittee.

A unanimous Supreme Court issued its long-awaited and closely watched decision today on the scope of the False Claims Act (“FCA”), and the Court affirmed the FCA’s long reach. Universal Health Services, Inc. v. United States ex rel. Escobar et al., No 15-7.

On Tuesday, June 14, 2016, the U.S. District Court for the Northern District of Illinois declined to temporarily block the proposed merger of Advocate Health Care Network and NorthShore University HealthSystem in the Chicago area, handing the FTC its second hospital merger loss this year.

CMS issued a final rule, published in the Federal Register on Friday, June 10, 2016, updating how the performance of ACOs participating in the Medicare Shared Savings Program (MSSP) is measured and compensated. 

A popular weapon used to contain health care expenditures is the creation by payors and employers of tiered provider networks, which by differentiated co-pays attempt to steer insureds to less expensive choices.

As discussed in our recent post, states have turned up the heat on drug companies through both legislation and voter initiatives that would require drug companies to disclose their pricing mechanisms for certain high-cost drugs.

Is your company trying to understand the Department of Labor’s (DOL) new white-collar overtime rule before the rule’s December 1st effective date?  My colleagues from Mintz Levin’s Employment, Labor, and Benefits group are hosting a one-hour webinar on June 21, 2016 at 2pm (ET) to discuss the DOL’s recently released overtime rule.

The next six weeks are shaping up to be the final work period before the summer recess, with both chambers scheduled to leave D.C. by July 15th for party conventions followed by the August recess.

Thus far, 2016 has been a relatively quiet year for the 340B program at the federal level. Neither Congress nor the Health Resource and Service Administration (HRSA) has shown an appetite to take on the issues plaguing the program.