Health Care

Every month, robocalls make up the majority of Do Not Call registry complaints at the Federal Trade Commission (FTC). The FCC estimated that in March 2018 approximately 3 billion robocalls were placed. In an effort to combat these illegal robocalls, the Senate Commerce Committee and the House Energy & Commerce Committee each held a hearing regarding these illegal robocalls and asked witnesses for ideas on how to combat this rampant problem.

As we wrote in a previous post, on March 16, 2018 the US Court of Appeals for the District of Columbia Circuit released its highly anticipated decision in ACA International v. Federal Communications Commission. Among other things, the DC Circuit set aside the Commission’s explanation of which devices qualified as Automatic Telephone Dialing Systems under the Telephone Consumer Protection Act. Though the decision has been out for less than two months, courts in the Ninth Circuit have taken notice.

On May 3, the Peer-to-Peer Alliance (P2P Alliance) filed a Petition for Clarification asking the FCC to clarify that P2P text messages to mobile numbers are not subject to TCPA restrictions. It explained that P2P messaging is often used by universities, nonprofits, businesses, and political organizations to communicate with individuals with whom they already have a relationship.

The North American Numbering Council (NANC), a federal advisory committee established by the FCC, delivered a call authentication report to the FCC on May 3. The report was developed by the Call Authentication Trust Anchor Working Group (CATA WG) and approved by NANC on April 27. It “details a framework for call authentication that can more quickly be established than various alternatives, while obtaining the broadest participation of industry.”

On April 23, the FCC and FTC hosted a joint expo aimed at stopping illegal robocalls through technological solutions. The expo showcased innovative technologies, devices, and applications that minimize or eliminate the number of illegal robocalls consumers receive. The expo was held one month after the FCC and FTC’s Joint Policy Forum on fighting illegal robocalls, and in between the Senate Commerce and House Energy & Commerce Committee hearings on the same topic.

Comments on the FCC’s Second Further Notice of Proposed Rulemaking (FNPRM) are due on June 7, and replies are due by July 9. The second FNPRM was adopted at the March Commission Meeting and seeks input on the adoption of a reassigned numbers database that businesses could check to avoid making unwanted calls to a new subscriber whose number was previously assigned to a consumer who had consented to receiving their calls.

On Tuesday, May 8th, the House held three hearings related to combating the opioid epidemic. The first hearing came out of the Energy and Commerce (E&C) Subcommittee on Oversight and Investigations, which examined opioid distribution and diversion by the pharmaceutical industry.

Back in late 2015, we blogged about the interesting twist in the $125 million Warner Chilcott settlement that a Massachusetts physician had been criminally charged with violating the Health Insurance Portability and Accountability Act (HIPAA). That physician has now been convicted of the HIPAA violation, as well as an unrelated charge of obstructing a federal health care investigation. 

This week, Congress is back in session with the House continuing its work on addressing the opioid crisis. There are three hearings and a markup on several pieces of legislation intended to address the ongoing epidemic.

Mintz Levin has updated the Mintz Matrix, a comprehensive summary of the data breach notification laws that now exist in all 50 states (South Dakota and Alabama finally caved and enacted their own laws). It’s critical that HIPAA-regulated entities monitor these state laws because they apply simultaneously, and often conflict with, HIPAA.

There are now multiple proposals in the House and Senate for substantive changes to the 340B Drug Discount Program. The odds of a legislative “fix” to 340B are increasing. But independent of congressional action, is CMS signaling that additional changes to 340B may be coming?

This week, the focus shifts back to the Congressional push around addressing the opioid epidemic after the President's speech on drug pricing was postponed. Both committees of jurisdiction in the House and Senate are moving on opioid legislation this week, so that has our immediate attention.

As we highlighted earlier this month, CMS released both the Contract Year 2019 Final Rules for Medicare Advantage and Part D (Final Rules) and the 2019 Call Letter. These documents are not typically released at the same time, so there is a lot of information for Medicare Advantage organizations and Part D plan sponsors to absorb.

Roughly around this time last year, the U.S. Supreme Court issued its ruling in Bristol-Myers Squibb v. Superior Court, 137 S. Ct. 1773 (2017), wherein the Court rejected the California Supreme Court’s finding of specific jurisdiction over mass tort claims filed by nonresidents.

In 2017, FDA issued only 44 Warning Letters to medical device establishments. Of those, 11 were related to pre-market issues, which include investigational device exemption violations or lack of approval or clearance.

On March 22, 2018, the Federal Communications Commission (FCC) adopted a Second Further Notice of Proposed Rulemaking (FNPRM) proposing the creation of a reassigned numbers database. Under the proposed rules, the FCC will ensure that a database is available to provide callers with the timely and comprehensive information they need to avoid calling reassigned numbers. The FNPRM also seeks comment on the kind of information that callers need from such a database, the best way for service providers to report this information, and whether the FCC should adopt a safe harbor from TCPA liability for callers who check the database.

The all-too-common story of a healthcare company declaring bankruptcy in the face of aggressive Medicare recoupment actions before the company even has a hearing before an Administrative Law Judge (ALJ) may get a new ending – at least in the Fifth Circuit.

On Monday, CMS published a number of policies changing the dynamics of the individual market, including the Benefit and Payment Parameters for 2019 Final Rule, guidance on hardship exemptions, and a bulletin on transitional (grandmothered) plans. When interpreting all of these policies it’s important to keep in mind the following: What is success? And who is defining it?

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.