We have now had more than 30 days to digest HRSA’s proposed 340B Drug Pricing Program Omnibus Guidance (“Proposed Guidance”), intended to clarify expectations and provide guidance on key issues in the 340B Program. There are several weeks remaining in the comment period on the Proposed Guidance, and there has already been much handwringing over some of the specific provisions. Does HRSA really intend to prohibit the use of 340B drugs to fill discharge prescriptions? Will HRSA really stand by its position that employees of covered entities do not become eligible to receive 340B drugs solely by being employees? Will HRSA actually limit access to 340B drugs to individuals who meet all of the components of the definition of “patient?”
Given that the D.C. District Court has yet to rule on HRSA’s authority to issue interpretive rules in the pending 340B orphan drug litigation, whether certain provisions in the Proposed Guidance will even be enforceable is an open question. But before the comment period closes, stakeholders may want to consider some of the clear winners, and just who is the biggest loser, under the Proposed Guidance. Continue Reading
Last month, the Arkansas State Medical Board’s Telemedicine Advisory Committee indicated that it was in the process of drafting a rule that would allow establishment of a physician-patient relationship through the use of real-time audiovisual communication rather than an in-person visit. This is a significant development given that the Arkansas telemedicine rules are among the most restrictive in the nation and signals that physicians in Arkansas are prepared to embrace telemedicine as a safe and cost-effective way to provide medical services to patients.
The Committee’s proposed rule follows on the heels of a telemedicine statute enacted by the Arkansas Legislature in April. The Telemedicine Act requires that telemedicine providers (i) are licensed in Arkansas (except for episodic consultation services), and (ii) have an existing professional relationship with the patient based on a prior in-person examination (except for certain consultations and cross-coverage arrangements with the patient’s regular provider). The Act includes a provision allowing the Arkansas State Medical Board to broaden the definition of telemedicine and the circumstances under which telemedicine can be used. Continue Reading
On September 29, 2015, our colleague, Alden Bianchi, posted the latest installment of the Affordable Care Act’s Reporting Requirements for Carriers and Employers on Mintz Levin’s Employment Matters blog. This weekly series highlights the complex reporting obligations outlined by the Affordable Care Act and explains the key requirements that carriers and employers must be aware of prior to the January 2016 reporting deadlines.
The most recent post (Part 11 out of a 24) discusses Notice 2014-69 issued by the Treasury Department and the Department of Health and Human Services as it applies to reporting 2015 coverage of “MV-Lite” Plans. Prior postings in this series are available here.
As HIPAA-regulated entities anxiously await the commencement of the Phase II HIPAA audit program, the Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) has issued a report critical of the Office for Civil Rights’ (OCR) HIPAA enforcement performance, effectively giving OCR “something to prove.”
The report, released on September 28, 2015, examines whether OCR — the office within HHS charged with enforcing HIPAA — is sufficiently exercising its oversight responsibilities. The OIG specifically focused on whether OCR is sufficiently overseeing covered entities’ compliance with HIPAA’s Privacy Rule. The OIG found a number of areas where OCR’s oversight is lacking. Continue Reading
Late on Friday afternoon the Centers for Medicare & Medicaid Services (CMS) announced publication of the proposed rule (the “Proposed Rule”) implementing substantial changes to the Medicare Clinical Laboratory Fee Schedule (MCLFS) made by the Protecting Access to Medicare Act of 2014 (PAMA). PAMA significantly revised how CMS will pay for clinical laboratory testing by tying reimbursement amounts to private payor rates as of January 1, 2017. Continue Reading
A Federal Judge found that the Department of Health and Human Services (DHHS) failed to comply with the Administrative Procedure Act (APA) when it cut hospital inpatient payments by 0.2% as part of its “two-midnight” rule. According to the DHHS Secretary, the pay cut was intended to offset the estimated $220 million it would cost to shift patients from outpatient to inpatient status under the rule, which allows Medicare to pay inpatient rates only if a patient stays in the hospital for two midnights.
Earlier this month, we discussed a memorandum issued by Deputy Attorney General Sally Quillian Yates of the U.S. Department of Justice (DOJ). This memorandum, referred to as the “Yates Memo,” reaffirms the Government’s commitment to prosecuting individuals and formally instructs prosecutors to focus on individual accountability when dealing with corporate misconduct. As we discussed, the Yates Memo sets forth certain criteria that must be satisfied in order for a corporation to receive so-called “cooperation credit.” Notably, the Yates Memo requires a corporation to identify all individuals involved in the corporate wrongdoing and provide all relevant evidence implicating those individuals.
Last week, the U.S. Department of Justice’s Assistant Attorney General in charge of the Criminal Division, Leslie R. Caldwell, spoke at the Global Investigations Review Conference in New York. Discussing the implication of the Yates Memo, AAG Caldwell stated, in part, that “…companies seeking cooperation credit must affirmatively work to identify and discover relevant information about culpable individuals through independent, thorough investigations. Companies cannot just disclose facts relating to general corporate misconduct and withhold facts about the responsible individuals. And internal investigations cannot end with a conclusion of corporate liability, while stopping short of identifying those who committed the criminal conduct.”
On our Securities Matters blog, our colleague Bridget Rohde discusses these and other remarks made by AAG Caldwell regarding the Yates Memo.
Next week, my colleague Karen Lovitch will be co-presenting a discussion on Hot Topics in Laboratory Compliance at the American Health Lawyers Association’s Fraud and Compliance Forum in Baltimore, Maryland. The presentation will focus on:
- The health care fraud enforcement climate for laboratories;
- Relevant state and federal fraud and abuse laws;
- Legal risks presented by interactions with health care professionals and other sales and marketing activities; and
- Legal and business risks related to interactions with patients, including collection of outstanding invoices.
Today the EU threw a huge wrench into one of the ways that personal data goes back and forth between EU countries and the U.S., as reported in Mintz Levin’s Privacy and Security Matters Blog. Companies that currently rely on the U.S.-EU Safe Harbor Program – as many in the health care industry do – need to think carefully and quickly about a back-up plan for these data transfers. Continue Reading
On Thursday Mintz Levin attorney Daria Niewenhous will be moderating an American Health Lawyers Association webinar entitled “Behavioral Health and ACOs—Challenges and Opportunities.” The webinar will address the integration of behavioral health services and primary care to manage population health. It will focus on the care improvements that can be realized by successfully integrating behavioral health into a patient-centered medical home and the legal and regulatory challenges associated with doing so. Additionally, the presenters will provide real life examples of a large ACO’s experience with integrating behavioral health and the impact on health outcomes and expense. Continue Reading