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McBrayer Blogs
FDA Issues Guidance for Mobile Medical Apps
Just so you know, that iPhone or iPad you have with you may be an FDA-regulated medical device. More precisely, the apps on the device may meet the definition of a medical device under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”).[1] In February of this year, the FDA released a revised set of guidance concerning how it will apply regulatory oversight to mobile apps, addressing the growing number and potential uses of these apps as they proliferate alongside rapidly changing mobile technology. More >
OIG Guidance for Healthcare Boards
In April, the Office of the Inspector General for the U.S. Department of Health and Human Services (“OIG”), in conjunction with the American Health Lawyers Association, the Association of Healthcare Internal Auditors, and the Health Care Compliance Association, released “Practical Guidance for Health Care Governing Boards on Compliance Oversight.” Rather than merely discussing aspirational goals or stating governing principles, the guide lives up to its name in giving practical suggestions for how health care governing boards oversee compliance programs, a true product of a partnership between the OIG and associations that represent those regulated by the office. The document stressed new compliance challenges for healthcare governing boards, such as value-based payment systems and the effect of ever-expanding publicly available data (under the Sunshine Rule, for instance). The guidance covered specific topic areas of concern, each of which will be discussed briefly. More >
Wellness Programs and the EEOC, Part Two
Tuesday’s post discussed recent Equal Employment Opportunity Commission (“EEOC”) litigation concerning employer-sponsored wellness programs. Today’s discussion turns toward further guidance recently issued by the EEOC to assist employers in ensuring that their wellness plans are compliant with federal law. More >
Wellness Programs and the EEOC, Part One
On May 29, 2013, the U.S. Department of Labor, the U.S. Department of the Treasury, and the U.S. Department for Health and Human Services finalized rules regarding wellness programs offered in conjunction with group health plans. These changes were made in light of the Affordable Care Act (“ACA”). Prior to the enactment of the ACA, HIPAA provisions generally prohibited group health plans and group health insurance issuers from discriminating against individual participants and beneficiaries in eligibility, benefits, or premiums based on a health factor. The exception to the general rule allows premium discounts, rebates, or modifications to otherwise applicable cost-sharing systems (including copayments, deductibles, or coinsurance) in return for adherence to certain programs promoting health or preventing disease. More >
HIPAA Rules and Procedures in the Event of a Data Breach, Part Two
My last post focused on the discovery and investigation of a data security breach to determine if breach notification is needed. Today’s post now turns to the requirements of breach notification triggered by a data security breach. More >
HIPAA Rules and Procedures in the Event of a Data Breach, Part One
As discussed in my prior post, recent massive data breaches at major retailers and health insurance providers paint a bleak picture of modern data and emphasize the importance of strong security safeguards and plans for handling suspected security breaches for electronic protected health information (“ePHI”). In the healthcare context, a security breach of a covered entity or a Business Associate’s (BA) data security system triggers the Security Rule and can trigger certain breach notification requirements under Health Insurance Portability and Accountability Act (“HIPAA”) and Health Information Technology for Economic and Clinical Health Act (“HITECH”). This post will discuss the investigation needed to determine whether a breach has taken place, while the next post will discuss the necessary notifications in the event of a breach. More >
Pharmacists: Aren’t you really providers already? – Part Two
The first part of this article discussed pharmacist provider status and argument both for and against it. Today’s post now turns to regulatory hurdles, developments towards provider status and the acknowledgment of changing roles in the pharmacist workforce. More >
Pharmacists: Aren’t you really providers already? - Part One
While the passage of the Patient Protection and Affordable Care Act (“ACA”) ushered in a new era of access to health care, it only served to exacerbate a growing crisis in the provision of health care – lack of providers. As of April 2015, the Health Resources and Services Administration lists the population of the United States that lives within a health professional shortage area (“HPSA”) for primary care as 103,847,716, with 1,023,989 of those living in Kentucky.[1] This shortage calls for a reimagining of ways that non-physician providers can fill the care gap, and the debate surrounding the provider status of pharmacists with regard to federal health care programs is evidence of a changing mindset. More >
Five Things to Know about Transitional Care Management
Tuesday’s post discussed the basics of Transitional Care Management (“TCM”), but today’s post will focus on five things that providers should know about TCM. More >
HEALTHCARE NEWS ALERT: Congress Passes Repeal of Sustainable Growth Rate
In a 92-8 vote on Tuesday, the Senate passed a bipartisan measure to repeal the Medicare payment formula known as the Sustainable Growth Rate. This bill was part of a deal negotiated in the House between House Speaker John Boehner and Minority Leader Nancy Pelosi in March, and it was approved with equally overwhelming numbers in that chamber. President Obama is expected to sign the legislation, which prevents health care providers from receiving a 21 percent cut in Medicare reimbursement rates. The bill will also fund the Children’s Health Insurance Program and community health centers for two further years. To pay for the bill, high-income seniors will cover more of their Medicare costs out of pocket, and Medigap plans will require basic co-payments. More >
