On September 23, 2013, the U.S. Food and Drug Administration (the “FDA” or the “Agency”) issued long-awaited final guidance for developers of mobile medical or health applications (or “mobile medical apps”) used on smartphones and other mobile devices. The final guidance reflects a tailored approach by the Agency to analyzing mobile medical apps, and represents an important step in narrowing the field of interpretation of the current laws.
In almost all corporate transactions, the first piece of written documentation the parties exchange and execute (after a non-disclosure agreement) is a letter of intent or term sheet (“LOI”), which is intended to summarize the main deal points. And as many corporate transactions involve entities organized in Delaware, these documents often select Delaware as the governing law.
CMS seeks to recover from providers $125 million in alleged overpayments for services to beneficiaries who are belatedly identified as ineligible (incarcerated/unlawfully present). In this post, Sheppard Mullin examines the recovery process CMS has put in place, noting CMS procedural shortcomings and reviewing some substantive defenses available to providers facing such demands.
On July 16, 2013, the Centers for Medicare and Medicaid Services (CMS) announced the first year results from its Pioneer Accountable Care Organization (ACO) program. The program, launched by the CMS Innovation Center, is part of the Affordable Care Act’s efforts to promote lower cost, high quality, coordinated care for Medicare beneficiaries. In 2012, there were 669,000 beneficiaries assigned to the program.
The U.S. Department of Health & Human Services, Office of Inspector General (OIG) recently issued Advisory Opinion No. 13-03, declining a clinical laboratory company’s proposed plan to provide various laboratory services to physician practice groups for those patients of the physician practices not covered by a federal healthcare program. Although the proposed arrangement only includes patients who are not covered by federal health care programs, the OIG opined that the physician practices would receive prohibited remuneration and that the proposed arrangement could affect the decision-making of the practices’ physicians, leading to prohibited referrals for laboratory services covered by a federal healthcare program.
On July 11, 2013, the U.S. Department of Health and Human Services (HHS) announced that it had reached a $1.7 million dollar resolution agreement with insurer WellPoint Inc., following a security breach that left the personal information of 612,402 individuals exposed and available to unauthorized computer users. Between October 23, 2009, and March 7, 2010, access to protected health information, including the names, dates of birth, addresses, social security numbers, and health information of applicants was made vulnerable after a system upgrade failed to comply with Health Insurance Portability and Accountability Act (HIPAA) requirements. WellPoint is an Indianapolis-based managed health care insurer that serves approximately 65.3 million individuals through its subsidiaries.
The Obama Administration announced on Tuesday that it is delaying implementing a key component of the Affordable Care Act for a year following complaints from the private sector about reporting requirements. The so-called “employer mandate”, which penalizes employers with more than 50 employees if they fail to provide a minimum standard of affordable health insurance, was set to kick in in 2014, but now will take effect in 2015, the Treasury Department announced in a blog post late Tuesday. The delay not only allows the Administration time to ease concerns among business owners, but also takes a controversial component of the law off the table before the 2014 midterm elections. Enactment of the Affordable Care Act is expected to be a topic of debate in campaigns over the next few years, but Democrats running for the House and Senate in 2014 won’t have to answer questions about a newly applied employer mandate.
On June 3, 2013, the Departments of Health and Human Services (HHS), Labor (DOL), and the Treasury (collectively, the Departments) published joint final regulations in the Federal Register implementing the Affordable Care Act (ACA) requirements for wellness programs. More specifically, the final rule applies to group health plans that offer wellness programs with a financial reward component to employees for improving their health or impose financial penalties for not participating in wellness programs or for choosing to smoke. The final regulations will be effective August 2, 2013, and will apply to group health plans for plan years beginning on or after January 1, 2014.
The Affordable Care Act enables the establishment of Health Benefit Exchanges of several types, including (i) State-based, (ii) State-Federal partnerships and (iii) Federally Facilitated Exchanges. The purpose of the Exchanges is to, among other things, “provide competitive marketplaces for individuals and small employers to directly compare available private health insurance on the basis of price, quality and other factors.
In theory, the information provided by the exchanges will “give small businesses the same purchasing clout as larger businesses.” Those goals are laudable and hard to quarrel with–anyone who has tried to buy individual health insurance knows that the available information on comparability of insurance plans is at best insufficient and at worst opaque.
Will bundled payments lead to restructuring of our primary care healthcare delivery system? Healthleaders has a great article discussing the vision for healthcare delivery system reengineering proposed by Thomas H. Lee, MD, the network president of Partners Healthcare and Michael E. Porter, PhD, Bishop William University Professor at the Harvard Business School. The two advocate for a revamping of our understanding of “primary care” doing away with the distinction between primary and specialty care in favor of an integrated care delivery model focused on patients. Lee and Porter propose grouping patients into categories and matching comprehensive physician services with patients. They promote embracing the bundled payment method of payment by insurers to provide incentive for these comprehensive services. The article specifically identifies several groups, including CareMore, as having already begun to transition into this coordinated care model.