Health Care

ML Strategies has posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.

In another effort to bring some clarity to its regulation of devices, the FDA has released draft guidance on how its risk-based framework applies to accessory devices ( the “Draft Guidance”). This development is welcome news for the mHealth community.

Once again, a pharmacy employee has filed a qui tam involving a drug discount program, alleging that the failure of the pharmacy to use the discounted pricing as the “usual and customary” price in Medicaid and Medicare Part D billings resulted in falsely inflated claims to those programs.

The Supreme Court heard oral arguments on January 13, 2015 in a government contracts whistleblower case that could have a far-reaching impact on more than just federal contractors.

New York became the 22nd state to sign into law legislation that will require commercial and Medicaid plans to provide coverage of telehealth and telemedicine services. The law, originally intended to take effect on January 1, 2015, will become effective on January 1, 2016.

On Wednesday January 28th, my colleague Dianne Bourque (a member in Mintz Levin’s Health Law practice), will be presenting a webinar on how to survive a HIPAA audit.  As luck would have it, January 28th is also international Data Privacy Day.

ML Strategies has posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.

Bloomberg BNA recently published a Health Care Fraud Report entitled Outlook 2015: Uptick Expected in Stark, Anti-Kickback FCA Cases, Self-Disclosures, which examines the top issues for health care providers and suppliers to watch in 2015.  

As reported in a recent Privacy and Security Matters post, we have updated the “Mintz Matrix,” a summary of the U.S. state data breach notification laws. The Mintz Matrix is an invaluable tool for reviewing state breach notification requirements, which may apply in addition to HIPAA in the event of a data breach.

On December 22, 2014, a federal district court in New Jersey found that Mylan Pharmaceuticals, Inc. (“Mylan”) alleged facts sufficient to plead an antitrust claim under Section 2 of the Sherman Act.

Earlier this week the OIG released an advisory opinion stating that a nonprofit organization’s proposed arrangement to provide copayment assistance to financially needy patients would not result in civil monetary penalties or administrative sanctions, even though it could potentially generate prohibited remunerations under the anti-kickback statute.

The Supreme Court announced it will be hearing King v. Burwell – a case which could determine the future scope and reach of the Affordable Care Act (ACA) – on March 4, 2015. 

The Nonprofit Revitalization Act brought sweeping changes to the laws that govern not-for-profit corporations in New York. Our colleagues Anthony E. Hubbard and Daniel E. Wilcox have authored an Advisory that provides an in-depth summary of key provisions of the Act that have recently gone into effect.

Although health care reform implementation via the Affordable Care Act (ACA) has focused mostly on federal changes to the health care marketplace, individual States are getting some much needed help to design and implement their own efforts to improve quality and lower health system costs.

The Office for Human Research Protections (OHRP) is extending the comment period for its Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care (Draft Guidance).

The American Telemedicine Association (ATA) is now accepting limited registrations for organizations that wish to gain ATA’s seal of approval for online medical services.

On December 4, 2014, CMS issued additional guidance regarding rewards and incentives programs (“RI Programs”). This guidance elaborates on whether an RI Program can target members with specific diseases, whether rewards can be tied to health outcomes, how to value rewards and incentives, and gives examples of appropriate and inappropriate rewards and incentives.

This year the Federal Trade Commission ("FTC") celebrated its centennial. Looking back on the FTC’s first 100 years, we have seen dramatic shifts in antitrust enforcement in the health care sector. 

A recently announced settlement between Anchorage Community Mental Health (“ACMHS”) and the U.S. Department of Health & Human Services Office for Civil Rights (“OCR”) emphasizes, once again, the importance of compliance with the Security Rule and keeping IT infrastructure up to date.

A recent opinion from the Connecticut Supreme Court illustrates that HIPAA is not the only law that covered entities and business associates must worry about if an unauthorized disclosure of protected health information (PHI) happens on their watch.