As the conflict between 340B over the scope of the 340B drug discount program enters its fourth year, Covered Entities are increasingly turning to state law for relief from restrictions on contract pharmacies because Congress and federal agencies have been unable to make meaningful progress. The…
Each year, entities regulated under HIPAA must report breaches affecting less than 500 individuals to the Department of Health and Human Services (“HHS”) within sixty days following the end of each calendar year. This means that the deadline to report to HHS these type of breaches occurring in 2023…
CMS published a final rule, effective January 1, 2026, implementing additional processes to advance interoperability as well as to improve prior authorization processes. The changes to prior authorization will require: (1) Medicare Advantage, Medicaid Fee-for-Service (“FFS”) and Medicaid Managed…
In the digital age, where information is constantly being generated, the concepts of privacy are rapidly evolving, especially in the healthcare sector. This transformation has significant implications for both healthcare providers and patients.
In this episode of the Krieg DeVault Podcast…
The United States Office of Inspector General (“OIG”) published a unified compliance resource tool on November 6, 2023. While the General Compliance Program Guidance (“GCPG”) does not provide new substantive content, it does provide a single source of information relating to some of the greatest…
On November 2, 2023, parties including the American Hospital Association (“AHA”) sued the U.S. Department of Health and Human Services (“HHS”) Office of Civil Rights (“OCR”) in a federal court in Texas. In their complaint they challenge the enforcement of an OCR guidance bulletin (the, “Bulletin”),…
As part of CMS’ annual Medicare OPPS and ASC Final Rule, it finalized new Medicare coverage of intensive outpatient program (“IOP”) services performed in hospital outpatient departments, CMHCs, FQHCs, and RHCs. Coverage begins January 1, 2024. This new coverage is intended to address the gap…
On October 30, President Biden issued his Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence, along with a companion Fact Sheet issued by the White House. The Executive Order establishes the federal government’s priorities with respect to Artificial…
On August 2, 2023, CMS published the fiscal year 2024 Inpatient Psychiatric Facilities Prospective Payment System (“IPF PPS”) Final Rule. One of the included regulatory changes was to the permitted timing for a hospital to convert a rehabilitation or psychiatric unit from “non-excluded” to…
The Centers for Medicare and Medicaid Services (“CMS”) recently suspended a key procedure for resolving payment disputes between out-of-network providers and health facilities against insurers under the No Surprises Act. The procedure is the Independent Dispute Resolution (“IDR”) process. It…
The U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) recently concluded its investigation into Yakima Valley Memorial Hospital (“Yakima”). The matter illustrates the need to limit access to private health information (“PHI”) to those members of the workforce with a need…
After the passage of transformative legislation and the announcement of groundbreaking new administrative processes, the Professional Licensing Agency (PLA) is poised to undergo a rapid modernization. This evolution will be much broader in scope and implemented at a faster pace than the norm for…
