Wolters Kluwer Holiday

We will not be posting on October 9 in commemoration of Columbus Day. The Wolters Kluwer Legal and Regulatory U.S. Health Law Editorial Team wishes you a safe and happy holiday. We will resume our regular posting schedule on Tuesday, October 10.

House committee takes interest in ‘NotPetya’ malware attack fallout

House Energy and Commerce Committee leaders are concerned that a malware attack from late June 2017, known as “Petya” or “NotPetya,” may have lingering effects on Merck & Co, Inc. The leaders sent letters to Merck’s CEO and HHS Secretary Price expressing this concern and requesting additional information about the attack and the effects on the company.

NotPetya

The malware infection began on June 27, 2017, and spread across the world, infecting businesses from a variety of sectors. At the time of the attack, the extent of Merck’s vulnerability was not precisely known, although an employee reported that they were told to stop working and some computers appeared to be wiped and that all U.S. offices were affected by the attack. The committee letters referred to information provided in Merck’s second-quarter 2017 financial outlook, which stated that packing operations were mostly restored, formulation operations were partially restored, and active pharmaceutical ingredient operations were partially restored but bulk product was not yet being produced.

Patient risk

The committee’s interest in the matter stemmed from concern that patients may have been negatively impacted by manufacturing disruption. Although evidence of such risk was not present, the committee pointed to an announcement from the Centers for Disease Control and Prevention (CDC) that certain formulations of Merck’s Hepatitis B vaccine would not be available. The committee requested that Merck provide a formal briefing to the committee on the initial infection and Merck’s steps to recover and resume manufacturing by October 4, 2017. The committee also requested an HHS briefing on the agency’s steps to understand and respond to the situation as well as plans for addressing drug shortages or other consequences stemming from cyberattacks.

Dem leaders push for quick Graham-Cassidy CBO assessment; hearing scheduled

Democrats in both the House and Senate reacted quickly to the Graham-Cassidy legislation in requesting a full assessment from the Congressional Budget Office (CBO). The office stated that it is working on a preliminary assessment for the week of September 25, 2017, as early as possible. However, the CBO warned that point estimates on several matters will be unavailable for at least a number of weeks.

Graham-Cassidy legislation

Offered as an amendment to the American Health Care Act (AHCA) (H.R. 1628), the proposal would give more control to states over meeting their residents’ health care needs. The legislation would repeal the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) and fund a block grant program through the Children’s Health Insurance Program (CHIP) instead (see Sanders’ Medicare-for-all, Graham-Cassidy’s block grant legislation introduced in Senate, September 14, 2017).

Finance hearing

The Senate Finance Committee will conduct a hearing on the Graham-Cassidy amendment on September 25, 2017. Committee Chair Orrin Hatch (R-Utah) announced the hearing, stating that it would allow members on both sides of the issue to better understand policy. In light of the Finance Committee’s hearing announcement, Sen. Ron Johnson (R-Wis), chair of the Senate Homeland Security and Governmental Affairs Committee, has chosen to cancel his committee hearing.

CBO request and response

According to Rep. Nancy Pelosi (D-Calif), “Republicans are reportedly hoping to rush to a vote with only a scant budget assessment.” The letter to the CBO requested information on loss of coverage, premium and out-of-pocket cost increases, effect on those with pre-existing conditions, Medicaid cuts, marketplace stability, and state reform timelines. The CBO will be unable to provide estimates on the effects on the deficit, coverage, or costs in its preliminary assessment.

AMA chimes in 

Ahead of a CBO report, the American Medical Association (AMA) believes that the bill would destabilize markets and cause millions to lose coverage. The association reached out to Senate Majority Leader Mitch McConnell (R-Ky) and Minority Leader Chuck Schumer (D-NY) to oppose the amendment and all legislation that would jeopardize coverage. The AMA holds the position that any health reform proposals should ensure that those currently insured are able to maintain their coverage, and expressed its concerned that the conversion of the Medicaid program would limit federal support for needy patients.

$55M fraud scheme earns 84 months in prison

Involvement in a $55 million health fraud scheme earned a medical clinic owner 84 months in prison. She pleaded guilty in October 2015 to using her two Brooklyn, New York-based clinics, Prime Care on the Bay LLC and Bensonhurst Mega Medical Care PC to submit false and fraudulent claims to Medicare and Medicaid.

Scheme

According to the guilty plea, the owner and various co-conspirators paid kickbacks to induce patients to come to the clinics. She then submitted false claims for services induced by these kickbacks or provided by unlicensed staff. She also wrote checks from the clinics’ accounts to third-party companies that were ostensibly vendors, but were actually not providing services. These payments were used to generate cash for the kickbacks. The owner was ordered to forfeit over $29 million.

Several other co-conspirators have pleaded guilty to their part in the scheme. These include the former medical directors of both clinics, six therapists, three drivers, a former patient who received kickbacks, and the owner of several of the vendor companies used to launder funds.