The House Ways and Means and Energy and Commerce Committees have released, in two parts, budget reconciliation legislation, the first steps of Congress’ proposal to “repeal and replace” the Affordable Care Act. Reconciliation legislation is limited to budget-related provisions and restricts legislators’ ability to address fully all of the repeal and replacement provisions that we [&hellip… Continue Reading »
The U.S. Court of Appeals for the Third Circuit has vacated a district court’s dismissal of a data breach class action filed against Horizon Healthcare Services Inc., in the wake of the 2013 theft of two computer laptops containing unencrypted personal information of Horizon Healthcare plan members. The decision potentially expands the circumstances under which [&hellip… Continue Reading »
Changes are imminent for the Affordable Care Act and a range of other laws and regulations affecting the health care industry. Ballard Spahr attorneys established a Health Care Reform Initiative in 2008 to monitor and analyze health care reform developments. This Health Care Reform Dashboard was a product of that initiative. We intend to continue following [&hellip… Continue Reading »
The Equal Employment Opportunity Commission (EEOC) has issued guidance reminding employers that it is illegal under the Americans with Disabilities Act (ADA) and other laws to discriminate against an employee simply because he or she has a mental health condition. This includes firing an employee, rejecting an employee for a job or promotion, and forcing [&hellip… Continue Reading »
President Obama has signed into law the 21st Century Cures Act. Enacted with overwhelming bipartisan support, the Cures Act: Authorizes more than $6.3 billion in funding for medical research and drug development programs; Provides for new programs and increased funding for mental health treatment and substance use disorder programs; and Includes various Medicare provisions sought [&hellip… Continue Reading »
The Office of Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) has posted an alert (and a follow-up alert) warning health plans, health care providers, and their vendors of a mock communication involving the OCR audit program under the Health Insurance Portability and Accountability Act (HIPAA). The email falsifies HHS departmental letterhead [&hellip… Continue Reading »
The Office of Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) has posted an alert (and a follow-up alert) warning health plans, health care providers, and their vendors of a mock communication involving the OCR audit program under the Health Insurance Portability and Accountability Act (HIPAA). The email falsifies HHS departmental [&hellip… Continue Reading »
The IRS has extended the deadline for furnishing 2016 Forms 1095-C and 1095-B to individuals by 30 days to March 2, 2017. The reprieve offers welcome relief to employers, health insurers, and other plan sponsors who would otherwise have been required to distribute these forms under the Affordable Care Act (ACA) by January 31, 2017. [&hellip… Continue Reading »
The Centers for Medicare and Medicaid Services (CMS), an agency within the U.S. Health and Human Services Department, recently issued a final rule prohibiting nursing homes and other long-term care facilities from utilizing pre-dispute arbitration agreements, as a requirement for participating in Medicare and Medicaid programs. We predicted that the rule would face legal challenges [&hellip… Continue Reading »
The U.S. Departments of Labor, Health and Human Services, and the Treasury have issued a set of Frequently Asked Questions and Answers that, among other things, implement certain of the recommendations included in a report issued by the White House Mental Health and Substance Use Disorder Parity Task Force. This guidance manifests the administration’s continuing [&hellip… Continue Reading »
Cloud service providers that process electronic protected health information (ePHI) are business associates under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), even if the PHI is encrypted and the cloud service provider is not able to view it. This unequivocal determination, made in recent guidance by the U.S. Department of Health and [&hellip… Continue Reading »
The Centers for Medicare and Medicaid Services (CMS), an agency within the U.S. Health and Human Services Department, has issued a final rule that includes prohibiting nursing homes and other long-term care facilities from utilizing pre-dispute arbitration agreements, as a requirement for participating in Medicare and Medicaid programs. The rule would not apply to already-existing [&hellip… Continue Reading »
As we start looking forward to 2017, and as many employers head into annual enrollment periods this fall, it is necessary to account for changes in the law that have a significant impact on health benefit plans. This short list of significant developments may help you prepare for what is coming: Affordable Care Act (ACA) Reporting. The [&hellip… Continue Reading »
The Federal Trade Commission (FTC) has issued an Opinion and Final Order finding that the data security practices of LabMD, Inc. were unreasonable, and therefore constituted an unfair act or practice in violation of Section 5 of the FTC Act. In so holding, the FTC vacated a November 2015 Initial Decision by the FTC’s chief [&hellip… Continue Reading »
The U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced an agreement with Catholic Health Services of the Archdiocese of Philadelphia (CHCS), settling allegations that CHCS violated the Health Insurance Portability and Accountability Act (HIPAA) Security Rule by failing to protect electronic protected health information (ePHI). This is the first enforcement [&hellip… Continue Reading »
The Office of Civil Rights (OCR) of the Department of Health and Human Services has moved forward with Phase 2 of its Health Insurance Portability and Accountability Act of 1996 (HIPAA) audit program. On Monday, July 11, 2016, OCR sent emails to 167 covered entities (including health plans, health care, and health care clearinghouses) notifying them [&hellip… Continue Reading »
The U.S. Department of Health and Human Services (HHS) has issued final regulations under Section 1557 of the Affordable Care Act (ACA) which prohibit discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs and activities. To be subject to these nondiscrimination rules, the health program or activity [&hellip… Continue Reading »
Handing the Federal Trade Commission (FTC) its first defeat in a federal court hospital merger challenge in more than a decade, a federal district court judge yesterday denied the joint request of the FTC and the Attorney General of Pennsylvania for a preliminary injunction to prevent Penn State Hershey Medical Center (Hershey) and PinnacleHealth System [&hellip… Continue Reading »
The Federal Trade Commission (FTC), in partnership with other federal agencies, has released an online tool that provides developers legal guidance for the creation of mobile health applications (apps). Companies that are developing mobile health applications should refer to the guide as a starting point for determining the type of security features they want and/or [&hellip… Continue Reading »
The Office of Civil Rights (OCR) of the Department of Health and Human Services has begun Phase 2 of its audit program under the Health Insurance Portability and Accountability Act (HIPAA). In this phase, OCR will: · Collect contact information from covered entities and their business associates; · Audit selected covered entities and, later, business [&hellip… Continue Reading »
ERISA does not allow a state to compel a self-insured group health plan to compile and report medical claims data for inclusion in a state-wide all-payer health care database, the U.S. Supreme Court has ruled in a landmark decision. In Gobeille v. Liberty Mutual Insurance Co., the Supreme Court backed the contention of Liberty Mutual [&hellip… Continue Reading »
The Food and Drug Administration’s (FDA) most recent draft guidance focuses on cybersecurity in postmarket medical devices and makes recommendations for identifying, assessing, and responding to cybersecurity vulnerabilities. The draft guidance, issued January 22, 2016, applies to medical devices that contain software (including firmware) and software that is a medical device. The draft guidance follows [&hellip… Continue Reading »
