As healthcare regulatory attorneys, we’ve seen firsthand the confusion and challenges that arise when health-related entities fall outside the purview of the Health Insurance Portability and Accountability Act (HIPAA). One crucial, newly released, regulation that often gets overlooked is the Federal Trade Commission’s (FTC) Health Breach Notification Rule (HBN Rule).…
In July 2021, the U.S. Departments of Health and Human Services, Labor, and the Treasury (the Departments) released an interim final rule, “Requirements Related to Surprise Billing, Part I” (Part I IFR). In October 2021, the Departments released a second interim final rule, “Requirements Related to Surprise Billing, Part II”…
On April 11th, 2022, New York became one of 25 U.S. states to grant permanent full practice authority to Nurse Practitioners (NP). The 2022 State of the State proposal additionally allows NPs with more than 3,600 hours of experience to practice without a contractual practice-agreement relationship with a doctor. With…
HIPAA itself does not contain a private right of action for individuals following unauthorized disclosures of medical information. Yet, HIPAA does not prohibit individuals from seeking remedies through state or other law. Each U.S. state’s tort law system can potentially allow individuals to pursue reparations when they are harmed by…
On April 6th, 2022, a HIPAA-regulatory Request for Information (RFI) was released by the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) soliciting feedback from the public for future rulemaking. The RFI seeks information on how the industry views “recognized security practices,” and on OCR’s compensating…
Participants in the healthcare industry have seen a multi-front threat related to their information security practices/healthcare data – increased enforcement and fines by the Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR); increased scrutiny from plaintiffs’ attorneys and State Attorneys General; and increased threats from malicious…
On April 22, 2022, the Department of Health and Human Services (“HHS”), in conjunction with several other federal agencies, filed a notice of appeal in opposition to a Texas federal judge’s summary judgment ruling regarding the No Surprises Act (“NSA”). The underlying lawsuit was filed by the Texas Medical Association…
In an effort to combat the COVID-19 public health emergency (PHE), the Dept. of Health and Human Services (HHS) developed the Uninsured Program to provide claims reimbursement to health care providers for: (1) testing uninsured individuals for COVID-19; (2) treating uninsured individuals with COVID-19; and (3) administering COVID-19 vaccinations to…
On February 23, 2022, the United States District Court for the Eastern District of Texas, Tyler Division, issued a Memorandum Opinion and Order,[1] which served to strike down certain portions of the federal No Surprises Act (“NSA”) related to the independent dispute resolution (“IDR”) process for resolving payment disputes between…
As of January 15, 2022, to increase access to free testing for many Americans, the Biden-Harris Administration has required private insurance companies and group health plans to cover over-the-counter COVID-19 tests approved by the U.S. Food and Drug Administration (FDA). Consumers of over-the-counter COVID-19 tests will be paid either up…