Last week, the Ninth Circuit affirmed a physician’s conviction for conspiracy to distribute an adulterated device with intent to defraud or mislead in violation of Section 331(k) of the federal Food, Drug and Cosmetic Act (FDCA). The physician – who dubbed his own practice “The McDonald’s of Urology” because of the high volume of patients he treated – reused plastic needle guides meant for single-use to conduct prostate biopsies on his patients over a period of several months.
HHS update: Looking toward audits and increased enforcement
The Department of Health and Human Services and its Office of Civil Rights (OCR) are capping off a very active 2016. In the last 6 months, the OCR has released a new audit protocol, announced new rounds of HIPAA audits, and stepped up enforcement. The flurry of activity comes after a prolonged period of anticipation in which Covered Entities and Business Associates were working to ensure that their data protection practices comply with the new set of HIPAA Omnibus rules. The OCR has made clear that it is not focused merely on large institutions or hospital systems. In August, the OCR announced that breaches affecting fewer than 500 individuals will be subject to investigation by its regional offices. Thus, even entities with small incidents or small amounts of protected health information (PHI), such as employee health plans, could see a higher rate of enforcement and a higher possibility of major fines if they fail to comply with HIPAA. Also within the OCR’s sights are Business Associates, as the Omnibus rule empowered the OCR to directly investigate and enforce Business Associates’ compliance with HIPAA’s requirements that the Omnibus rule extended to these entities.
Judge declines to certify order for appeal in Texas Teladoc case
On August 15, 2016, United States District Judge Robert Pitman denied the motion of the Texas Medical Board (“TMB”) to certify order for an immediate appeal of the court’s decision not to dismiss the Teladoc case. The court previously denied the TMB’s attempt to have the case against it dismissed, which was brought by Teladoc challenging the TMB’s adoption of a rule requiring physicians prescribing certain medications to first see patients face to face.
Administrative dispute resolution process is proposed to resolve 340B drug pricing program disputes
On August 11 the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking (RIN 0906-AA90) that would implement an administrative dispute resolution (ADR) process that would apply to all drug manufacturers and covered entities that participate in
CMS investment in preventing healthcare fraud brings $42 billion return
CMS’s annual report demonstrates that the government is becoming increasingly effective at ferreting out fraud and abuse from the healthcare system. With a 12-to-1 return on investment, the government will likely continue to make fighting healthcare fraud a priority.
Senate advances comprehensive opioid bill for President to sign
On July 13, 2016, the Senate passed by 92-2 vote the Comprehensive Addiction and Recovery Act of 2016 (S. 524), a comprehensive set of 18 bills targeting the opioid crisis, which bill the U.S. House of Representatives approved in a 407-5 vote on July 8, 2016.
CMS proposes rule regarding changes to Medicare appeals procedures
The Centers for Medicare and Medicaid Services (CMS) has promulgated a proposed rule that makes numerous revisions to the appeals process for Medicare claims. If finalized, this proposed rule will mainly clarify the existing regulations regarding the Medicare appeals process. It will, however, also add two key concepts to help streamline the appeals process.
SCOTUS strikes down Texas abortion law requiring nearby admitting privileges and imposing ASC requirements
In one of the most closely watched cases of this term, a divided Supreme Court struck down Texas’s abortion law, finding that it constituted an undue burden on a woman’s right to obtain an abortion.
Senate agriculture committee reaches deal on national GMO labeling bill
On June 23, 2016, the Senate Agriculture Committee agreed to a bipartisan deal that would set a national standard for GMO labeling. The National Bioengineered Food Disclosure Standard would amend The Agricultural Marketing Act of 1946 by setting forth mandatory disclosure requirements for GMO food products, while providing a variety of options to the industry on how to provide consumers with this required information. The deal comes a week before Vermont’s own version of a mandatory GMO labeling law is set to take effect. If the bipartisan bill is passed, then the national standards would pre-empt Vermont’s law. Industry groups are showing support for the bill as they want to avoid the challenges of complying with varying state GMO labeling requirements. The race is now on to get the bill passed in the Senate before the July 1 effective date of the Vermont law; however, the House of Representatives is on break until July 5, which guarantees delaying the possibility of any passage of the bill into law until after the Vermont law goes into effect.
House bill addresses reduced payments to new off-campus hospital outpatient departments
On May 18, 2016, the U.S. House of Representatives Ways and Means Committee introduced the Helping Hospitals Improve Patient Care Act of 2016 (Act) to exempt certain newly-enrolled provider-based, off campus hospital outpatient departments (HOPDs) from reduced payments under the Bipartisan Budget Act of 2015 (BBA).