Health Care

This week, focus turns to the Senate as the House overwhelmingly passed its opioid package known as H.R. 6 last week (see our previous coverage here). The Senate will look to combine its various proposals into one package for floor consideration and what passes will provide a timeline for reconciling the House and Senate packages.

The government is focusing on opioids.  Whether it be program policies, enforcement, or legislation, combating the opioid epidemic continues to be a major focus for government officials.  It is also a major piece of the health care legislation moving in both the House and the Senate.

Thousands of laboratories nationwide will be happy to hear that Florida, which licenses in-state as well as out-of-state laboratories, has repealed its laboratory licensure requirements. As of July 1, 2018, laboratories doing business in Florida need only maintain CLIA certification.

A lot has happened since we last addressed new biosimilar developments in January 2018. In the intervening months, there have been many significant developments related to FDA’s implementation of an efficient regulatory program for biosimilar products and the abbreviated BLA (aBLA) review process.

Privacy and security compliance obligations for health care companies remain hot topics this spring. Health care companies must now contend with data breach laws in all 50 states as well as keeping on top of federal HIPAA developments.

On June 19,  the Health Policy Consensus Group, which is a group led by former Sen. Rick Santorum (R-PA) and composed of several conservative think tanks, released a white paper proposal to repeal and replace the Affordable Care Act (ACA).

It has been a few weeks since the publication of the Trump Administration’s Blueprint to Lower Drug Prices, and Secretary Azar’s  Request for Information (RFI) on the Blueprint.  We previously posted about the Blueprint’s focus on the 340B Drug Discount Program.

Welcome to the third week of this four week stretch. This week, the House will continue to vote on a number of proposals to address the opioid crisis.

Earlier this week, I moderated a panel discussion at an event hosted by the New York chapter of the Health Information and Management Systems Society (HIMSS). The panel was comprised of private sector health information technology and security experts and was tasked with discussing challenges related to the interoperability and security of health information systems.

On Thursday June 14, 2018, the US Court of Appeals for the Federal Circuit ruled against two health plans seeking risk corridors payments from the federal government. Inside contains more detailed information on the program.

Many provisions of the Affordable Care Act (“ACA”) have been the subject of litigation over the last decade, with several high-profile Supreme Court cases including: NFIB v. Sebelius, King v. Burwell, and Burwell v. Hobby Lobby. One of the more overlooked topics of litigation has been the ACA’s “Risk Corridors” program.

Last week, Mintz’s Health Care Enforcement Defense Group published a new Qui Tam Update, which analyzes 60 health care-related False Claims Act qui tam cases unsealed in December 2017 and January 2018 and the trends they reflect.

Our previous post discussed the decision in Marshall v. CBE Group, Inc., which completely rejected the FCC’s broad interpretation of an ATDS and found in favor of the defendant. Since then, another district court in the Ninth Circuit has followed suit, but three others in the Eleventh Circuit have concluded that the FCC’s 2003 Order survives ACA Int’l. It could behoove some TCPA defendants to seek stays while this circuit split is sorted out or until after the FCC clarifies its position on the ATDS issue following ACA Int’l.

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.

This week the Senate Finance Committee will mark up its opioid package. Additionally, the HELP Committee will hear from Secretary Azar on the Administration's effort to lower prescription drug prices. For our complete review and what else to watch for this week.

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.