In a victory for Texas health care providers, in Baylor All Saints Medical Center dba Baylor Scott & White All Saints Medical Center‑Fort Worth et al. v. Xavier Becerra, case number 4:24‑cv‑00432, the United States District Court for the Northern District of Texas (“District Court”) has vacated a regulation
Hospitals & Health Systems
New HIPAA Requirements Place Additional Privacy Obligations on Covered Entities and Patients in an Effort to Protect Reproductive Health Care Information
By Whitney Phelps & Michael Menconi on
On April 22, 2024, the Office for Civil Rights (OCR) for the United States Department of Health and Human Services issued a Final Rule amending the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA). The Final Rule, which goes into effect on June 25, 2024, promulgates…
The Corporate Transparency Act: Key Considerations for Health Systems and Practice Management Companies (MSOs/DSOs)
In 2021, Congress enacted the Corporate Transparency Act (the “CTA”) to “better enable critical national security, intelligence, and law enforcement efforts to counter money laundering, the financing of terrorism, and other illicit activity.”[1] The CTA, which became effective January 1, 2024,[2] is described, in detail, in a series of Proskauer alerts compiled by Proskauer’s CTA Task Force. The CTA will create a national registry of the “beneficial owners” and “company applicants”[3] of millions[4] of entities across the country. A reporting company must disclose certain information about its beneficial owners and (for entities formed in 2024 and later) company applicants, including: (i) legal name; (ii) date of birth; (iii) residential address (or business address for certain company applicants); (iv) unique identifying number from a non-expired government-issued identification document; and (v) an image of such identification document.[5] In addition, states are following the Federal government’s lead and have adopted similar regulatory regimes; last month, for example, New York enacted the LLC Transparency Act, which comes into effect in December 2024.
Long Awaited Approval of the 1115 Waiver Amendment for New York State Medicaid – Just in Time for the Executive Budget State Fiscal Year (SFY) 2025
By Whitney Phelps & Michael Menconi on
On Tuesday, January 16, 2024, Governor Kathy Hochul released the SFY 2025 New York State Executive Budget (“Executive Budget”). While still subject to legislative approval, the Executive Budget incorporates the recently approved amendment (“Waiver Amendment”) to New York’s Medicaid Section 1115 Demonstration that includes $7.5 billion in Medicaid investments over…
Cybersecurity a Top Priority – HHS Publishes New Cybersecurity Performance Goals
The U.S. Department of Health and Human Services (“HHS”) has expanded upon its recent Healthcare Sector Cybersecurity Concept Paper (which we covered in a prior blog post), issuing cybersecurity performance goals (“CPGs”) for the healthcare and public health (“HPH”) sector. These CPGs aim to help healthcare organizations protect against…
HHS Publishes Roadmap of New Strategy for Cybersecurity in the Healthcare Sector
The U.S. Department of Health and Human Services (HHS) recently issued a strategy paper highlighting key aspects of its plan to revamp cybersecurity requirements in the healthcare industry. Citing a 93% increase in large data breaches in healthcare from 2018 to 2022 and a rapid increase in ransomware attacks against…
OIG Reaffirms Its Concern About “Carving Out” Federal Health Care Program Business
By Matthew J. Westbrook on
Last month, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services reaffirmed its longstanding position that an arrangement that “carves out” Federal health care program (FHCP) business is not dispositive with respect to whether such arrangement implicates the Federal Anti-Kickback Statute (AKS). Specifically, OIG…
The Saga of the No Surprises Act Continues to be … Surprising
We previously noted that the regulations implementing the No Surprises Act (“NSA”) appeared to be inconsistent with the NSA because they seemed to establish the qualifying payment amount (“QPA”) as the appropriate payment amount to be used in arbitrations by certified IDR entities (viz. the regulation-established independent dispute resolution (“IDR”) process) between plans and providers, and that the United States District Court for the Eastern District of Texas (“Texas District Court”) vacated portions of the NSA regulations relating to the QPA for purposes of the IDR process. The Federal government recently responded to the Texas District Court—by removing such portions of the NSA regulations.
Health Care Providers on Alert: Two Hospitals Penalized for Continuous Noncompliance with the Hospital Price Transparency Rule
By Matthew J. Westbrook on
We previously discussed the requirements of the Hospital Price Transparency Rule (“Rule”) on health care providers and health plans, as well as CMS’s proposal to increase penalties for a hospital’s failure to comply with the Rule. About a year and a half after the Rule became effective, CMS has now imposed its first set of civil monetary penalties (“CMPs”) on Northside Hospital Atlanta and Northside Hospital Cherokee, which have been fined $883,180 and $214,320, respectively.
The Rule requires, in part, hospitals to make public a machine-readable file containing a list of all standard charges for all items and services, such as, e.g., supplies, room and board, and use of the facility, among other items. See 45 C.F.R. § 180.40(a); id. at § 180.20. The Rule also requires hospitals to display shoppable services in a consumer-friendly manner. See id. at § 180.60(d)(2); id. at § 180.60(b). The goal of these specific requirements, in addition to those set forth in the remainder of the Rule, is to provide consumers with sufficient information about the charges for certain items and services by requiring health care providers and health plans to be publicly transparent about such charges.
Based on CMS’s CMP letters, dated June 7, 2022, Northside Hospital Atlanta and Northside Hospital Cherokee were non-compliant with the aforementioned specific requirements of the Rule. The chronology of events is important to understand how CMS ended up issuing its CMP letters.
Failure to Disclose Speakers at Protected QA Meeting Loses Protection for All Speakers
By Edward S. Kornreich on
Recently, in Siegel v. Snyder, Slip.Op. 07624, New York’s Appellate Division, Second Department interpreted New York’s peer review/quality assurance confidentiality statute in a manner that may require modifications to the standard documentation of such meetings. New York’s Education Law 6527(3) shields from disclosure “the proceedings [and] the records relating to performance of a medical or a quality assurance review function or participation in a medical . . . malpractice prevention program,” as well as testimony of any person in attendance at such a meeting when a medical or quality assurance review function or medical malpractice prevention program was performed (see Logue v Velez, 92 NY2d 13, 16-17). Public Health Law 2805-m(2) affords similar protection from disclosure for “records, documentation or committee actions or records” required by law, which includes peer review activity.