Health Care

HHS's Office of Medicare Hearings and Appeals (OMHA) has long faced a backlog in Medicare appeals to Administrative Law Judges (ALJs). In an effort to address this backlog, OMHA established a Settlement Conference Facilitation (SCF) process.

In a previous blog, we reviewed pending and approved 1115 waivers in 11 states. These reviews provide an overview of 1115 waiver applications, including a focus on work requirements, lock-outs, changes in coverage structures, repealing the Medicaid IMD exclusion, and other behavioral health initiatives.  

Recently the U.S. Department of Justice (DOJ) issued a statement that it had intervened in a False Claims Act (FCA) case against Insys Therapeutics, Inc. and consolidated five separate qui tam cases into one case, U.S. ex rel Guzman v. Insys Therapeutics, Inc., filed in the U.S. District Court for the Central District of California.

This week, the House is set to vote on Right to Try legislation which has gained the support of FDA Commissioner Scott Gottlieb. In the Senate, the HELP Committee will review the Pandemic and All-Hazards Preparedness and Advancing Innovation Act, or PAHPA, along with rural health care issues, which the Senate Finance Committee also happens to be looking at this week.

On Wednesday May 9th, I was floored when the Administration released the Spring 2018 Unified Agenda of Regulatory and Deregulatory Actions, which contained this nugget: by December 2018, HRSA will publish its 340B Omnibus Guidance. Readers of our blog know that, as we predicted, this so-called Mega-Guidance was withdrawn in January 2017 without ever seeing the light of day.

In less than 10 days, the European Union will begin enforcing its General Data Protection Regulation (GDPR) which will apply to any company that collects, processes, or uses EU-origin personal data, regardless of where the company is located.

This week, the House Energy & Commerce Committee will hold its second round markup of opioid-related legislation. While they remain on pace for passage by Memorial Day, the timing will be determined by how smooth the markup this week goes.

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.”

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.

On Friday, after weeks of delay, the President finally delivered his Drug Pricing Speech and released the HHS Blueprint detailing the Trump Administration's plan to lower drug prices and reduce out-of-pocket costs.

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 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.

Businesses engaged in human drug compounding, both traditional pharmacies and the more recently created outsourcing facilities, have been on quite a roller coaster ride since congressional enactment of the Drug Quality and Security Act (DQSA) approximately four-and-a-half years ago.

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.

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.

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. 

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.

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?