Health Care

Congress will continue its work in addressing the opioid crisis this week with a hearing in the Senate Finance Committee. There were reports last week that Congress will also consider legislation around telemedicine, which is sure to capture stakeholders attention.

Last month, the Department of Health and Human Services’ Office of Inspector General (OIG) released its latest report on compliance with the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post, the DSCSA requires enhanced security and accountability for prescription drugs throughout the U.S. pharmaceutical supply chain.

In a previous blog, we reviewed pending and approved 1115 waivers in 8 states. We also highlighted the trends we see in 1115 waivers, such as changes to coverage requirements, a time limit on how long certain beneficiaries can receive Medicaid coverage, lock-outs if an individual fails to pay a premium or meet the work requirement, and drug testing requirements.

In March, the Medicaid and CHIP Payment and Access Commission (MACPAC) released its biannual report to Congress. MACPAC is an independent congressional agency that advises Congress on issues relating to Medicaid. In its report, the Commission made a three part recommendation in regards to streamlining Medicaid managed care authorities.

This week, Congress returns from recess with its eyes set on addressing the opioid crisis. We expect to see some form of bipartisan legislation considered between now and Memorial Day. We will also see Congress dive into appropriations which will eat up plenty of time, not to mention nominations of Cabinet officials and appointments to the federal bench.

In March, the Medicare Payment Advisory Commission (MedPAC) released its biannual report to Congress on matters affecting the Medicare program. MedPAC is an independent congressional agency that advises Congress on issues relating to Medicare.

Earlier this week, Mintz Levin’s Privacy & Security Matters blog posted an update that Alabama has become the 50th state to enact a data breach notification law.

On March 29, 2018, the Attorney General of California filed an antitrust action against Sutter Health and its affiliates (“Sutter”) alleging Sutter engaged in various anti-competitive conduct in violation of California’s Cartwright Act.[1]  According to the Complaint, healthcare costs in California have rapidly increased, and prices in Northern California are higher than in other areas of the State.

Earlier this week, CMS released both the Contract Year 2019 Final Rules for Medicare Advantage and Part D (Final Rules) and the 2019 Call Letter. CMS also released fact sheets for the Final Rule and the Call Letter.

In early January, Idaho Governor Butch Otter signed an executive order (EO) directing the state’s Department of Insurance (DOI) to “seek creative options” to expand “access” to health insurance coverage for Idahoans.

As of March 2018, there are twenty-four Medicaid 1115 waivers pending CMS approval.   Medicaid 1115 waivers, Research and Demonstration Projects, give states experimental, pilot, or demonstration projects likely to assist in promoting the objectives of Medicaid.

Mintz and ML Strategies will host the 3rd Annual Pharmacy & Pharmaceutical Industry Summit on May 8, 2018! This year's summit will take place in Boston and we are thrilled to announce that Massachusetts Governor Charlie Baker will be the keynote speaker. 

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.

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”).

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.

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.