backCMS Sets Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency – On April 22, 2024, CMS issued the Minimum Staffing Standards for Long-Term Care (LTC) Facilities and Medicaid Institutional Payment Transparency Reporting Final Rule (Final Rule), which imposes nurse staffing requirements in LTC facilities participating in Medicare or Medicaid. The Final Rule is intended to improve the safety and quality of care furnished to LTC facility residents.
The Final Rule consists of three core staffing proposals, which will be implemented in a staggered time frame, effective June 21, 2024:
- Ninety days after the publication date of the Final Rule (currently set for May 10, 2024) (Publication Date), facilities need to comply with enhanced facility assessment requirements. Enhanced facility assessment requirements include, among other things, (i) the use of evidence-based methods when planning for care of residents; (ii) the use of the facility assessment to assess the specific needs for each resident unit in the facility; and (iii) the development and maintenance of a staffing plan to maximize recruitment and retention of nursing staff.
- Two years after the Publication Date (three years for rural facilities), facilities are required to staff an RN onsite 24 hours a day, seven days a week, as compared to only eight hours a day, seven days a week.
- Three years after the Publication Date (five years for rural facilities), facilities will need to meet minimum nurse staffing standards of 3.48 Hours Per Resident Day (HPRD), of which 0.55 and 2.45 HPRD must be provided by registered nurses (RNs) and nurse aides (NAs), respectively. Facilities may use any combinations of RNs, Licensed Practical Nurses (LPNs), and Licensed Vocational Nurses (LVNs) for the remaining .48 HPRD.
For facilities that are unable to timely comply with the requisite changes, the Final Rule includes the possibility of a one-year hardship exemption if certain criteria are met, such as workforce unavailability, facility location, showing good faith efforts to hire and retain staff, and demonstrating a financial commitment to staffing through documentation of staffing expenditures relative to revenue. Facilities that fail to comply with the requirements would be subject to enforcement actions, including termination of Medicare or Medicaid provider agreements, denial of Medicare or Medicaid payments, and civil monetary penalties.
Additionally, CMS has finalized regulations requiring that states publicly report the percentage of Medicaid payments for services in nursing facilities and intermediate care facilities for individuals with intellectual disabilities that are spent compensating direct care workers and support staff.
The Final Rule is available here.
Reporter, Will Mavity, Los Angeles, + 1 213 218 4043, wmavity@kslaw.com.
OCR and CMS Issue Final Rule Aimed at Tackling Bias in Health Technology – On Friday April 26, 2024, the HHS Office for Civil Rights (OCR) and CMS issued a Final Rule implementing Section 1557 of the Affordable Care Act (ACA) to further advance protections against discrimination in health care. The Final Rule provides that covered entities must not discriminate against any individual on the basis of race, color, national origin, sex, age, or disability through the use of a broad range of tools and technologies, including artificial intelligence and machine learning.
The Final Rule applies to “covered entities,” which collectively refers to HHS, Title I entities, and health programs or activities that receive Federal financial assistance, including credits, subsidies, or contracts of insurance except where otherwise provided in Title I of the ACA.
The Final Rule adopts the term “patient care decision support tool” and defines it as “any automated or non-automated tool, mechanism, method, technology, or combination thereof used by a covered entity to support clinical decision-making in its health programs or activities” (hereinafter, “tool”).
The Final Rule provides that each covered entity has an ongoing duty to make reasonable efforts to identify uses of tools in its health programs or activities that employ input variables or factors that measure race, color, national origin, sex, age, or disability. For each such tool, the covered entity must make reasonable efforts to mitigate the risk of discrimination resulting from the tool’s use in its health programs or activities.
According to OCR, covered entities are “not required to obtain datasets or other attribute information from developers when purchasing or using tools.” However, they are required to consult publicly available sources or request information from the developer if they have reason to believe their tools are employing input variables based on a protected basis.
When analyzing whether a covered entity made “reasonable efforts to identify” tools that employ input variables based on a protected basis, OCR may consider a number of factors, including:
(1) the covered entity’s size and resources (e.g., a large hospital with an IT department and a health equity officer would likely be expected to make greater efforts to identify tools than a smaller provider without such resources);
(2) whether the covered entity used the tool in the manner or under the conditions intended by the developer and approved by regulators, if applicable, or whether the covered entity has adapted or customized the tool;
(3) whether the covered entity received product information from the developer of the tool regarding the potential for discrimination or identified that the tool's input variables include race, color, national origin, sex, age, or disability; and
(4) whether the covered entity has a methodology or process in place for evaluating the patient care decision support tools it adopts or uses, which may include seeking information from the developer, reviewing relevant medical journals and literature, obtaining information from membership in relevant medical associations, or analyzing comments or complaints received about patient care decision support tools.
Covered entities must comply with the patient care decision support tool rules within 300 days of July 5, 2024. The Final Rule is available here. The Press Release for the Final Rule is available here. The Fact Sheet for the Final Rule is available here. The Frequently Asked Questions for the Final Rule are available here.
Reporter, Jenna M. Anderson, Los Angeles, +1 213 443 4328, janderson@kslaw.com.
Agencies Extend Enforcement Discretion for QPA Calculation Compliance – On May 1, 2024, the Departments of HHS, Labor, and the Treasury (the Departments) published FAQs indicating that they would continue to permit health plans and issuers to calculate the Qualifying Payment Amount (QPA) under the No Surprises Act (NSA) using an invalidated methodology. The Departments will provide plans and issuers until November 1, 2024, to comply with the QPA calculation rules as modified by an August 24, 2023, ruling by a Texas federal district court.
In August 2023, Judge Kernodle of the Eastern District of Texas Federal District Court granted partial summary judgement to the Texas Medical Association and other provider-side plaintiffs in their challenge to aspects of federal rulemaking related to the method for calculating the QPA and some provisions related to the processing and dispute resolution for air-ambulance claims under the NSA. King & Spalding reported on this decision, commonly referred to as “TMA III,” in a previous issue of Health Headlines. In the October 2023 FAQs, the Departments indicated their plans to appeal the judgment, and stated that they would not be issuing interim guidance on how to calculate the QPA while the appeal is pending. Instead, the Departments instructed plans and issuers to “calculate QPAs using a good faith, reasonable interpretation of the applicable statutes that remain in effect after the TMA III decision.” CMS also indicated that it would exercise enforcement discretion from October 2023 to May 1, 2024, if health plans calculate the QPA incorrectly based on the invalidated QPA methodology. This exercise of enforcement discretion applied to QPAs incorrectly calculated for purposes of patient cost sharing, providing required disclosures with an initial payment or notice of denial of payment, and providing required disclosures and submissions under the Federal IDR process.
On May 1, 2024, when the enforcement discretion was set to expire, the Departments issued additional FAQs to indicate that they would continue to apply enforcement discretion for health plans and issuers that calculate the QPA under the vacated guidance. The Departments reported that plans and issuers requested additional time to come into compliance with TMA III ruling. The Departments stated that they will continue to assess the status of QPA calculations, but do not expect to extend enforcement discretion beyond November 1, 2024.
The FAQs are available here.
Reporter, Alana Broe, Atlanta, +1 404 572 2720, abroe@kslaw.com.