Health Care

The Federal Communications Commission (“FCC”) is reconsidering several issues central to TCPA liability, including what equipment constitutes an automatic telephone dialing system ((“ATDS”) and who the “called party” is when a wireless number has been reassigned.

States may be starting to take aim at prescription automatic refill programs. Automatic refill programs have been proven to increase patient adherence, especially among patients with chronic conditions. However, regulators argue that automatic refill programs result in waste to the system, stockpiling, and federal program payment for unneeded prescriptions.

Late last month, Senators Grassley (R-IA), Brown (D-OH), and Blumenthal (D-CT) introduced the Fighting the Opioid Epidemic with Sunshine Act, a bill that would expand Physician Payment Sunshine Act reporting requirements to cover payments and other transfers of value made to advance practice nurses and physician assistants.

Congress is back in session for a four week work period. With the focus on opioids, there's the potential that meaningful legislation gets done. We will also continue monitoring state action as it relates to work requirements and other initiatives via 1115 waivers.

To date, 34 states (including D.C.) have adopted Medicaid expansion. Of the remaining 17 states, some are considering expanding Medicaid.

The May 2018 cyber security newsletter from the U.S. Department of Health and Human Services Office for Civil Rights (OCR) focused on a topic often overlooked by covered entities and their business associates: physical security.

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.