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Finalized Nursing Staff Standards Will Impact Most Long-Term Care Facilities

On April 22, 2024, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will require long-term care facilities (LTCFs) to satisfy minimum nurse staffing standards with the goal of addressing patient quality of care and safety concerns. The final rule is anticipated to result in approximately 80% of LTCFs needing to add nursing staff. LTCFs will also be required to conduct periodic assessments of their resources and capabilities and to make staffing adjustments as needed to address residents’ acuity.

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2024 Chart of Healthcare Regulations

During this election year, McDermottPlus is actively monitoring annual regulations that federal agencies are expected to release, as well as “ad hoc” regulations that will be released at the discretion of federal agencies.

This chart displays health-related regulations that may be issued this year, organized by federal agency and date of potential release.

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CMS Approves New York 1115 Medicaid Redesign Waiver

On January 9, 2024, the Centers for Medicare and Medicaid Services (CMS) approved the New York State (NY) 1115 Medicaid waiver “Medicaid Redesign Team” (MRT). The MRT is a long-standing waiver in NY that has continuously evolved to improve the administration, structure and financing of the NY Medicaid program; enhance Medicaid beneficiaries’ access to services; and improve health outcomes across the state. The recently approved waiver represents the next step in Medicaid redesign in NY and builds on the previous Delivery System Reform Incentive Payment (DSRIP) program.

This article reviews the major initiatives included in the MRT, components of the MRT that were excluded from the approval, implications for stakeholders and more.

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2024: The Year of the Telehealth Cliff

What does December 31, 2024, mean to you? New Year’s Eve? Post-2024 election? Too far away to know?

Our answer: December 31, 2024, is when we will go over a “telehealth cliff” if Congress fails to act before that date, directly impacting care and access for Medicare beneficiaries. What is this telehealth cliff?

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Medicare Drug Price Negotiation Program and Drug Pricing Reform: Eligible Drugs to Know and Understanding What’s Next

On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022 (IRA), which contains prescription drug pricing reform provisions. The three main Medicare prescription drug pricing reform provisions included are as follows:

  • Drug Price Negotiations: Allows the federal government to negotiate for a select number of vaccines and/or drugs
  • Inflation-Based Rebates: Mandates that manufacturers pay a rebate to the federal government when the list prices of Part B or Part D drugs grow at a faster rate than the inflation rate
  • Part D Benefit Redesign: Implements an out-of-pocket maximum for beneficiaries at $2,000 and redistributes liability among manufacturers, health plans, patients and the federal government across phases of the Part D benefit starting in 2024.

Leveraging data from the Centers for Medicare and Medicaid Services’ (CMS’s) Medicare Drug Spending Dashboard and FDA databases, McDermott+Consulting has identified the potential list of drugs subject to negotiations.

This information is particularly valuable for pharmaceutical companies, health plans, patients, pharmacies and other stakeholders as they evaluate and consider the implications of this legislation. In less than one year, on September 1, 2023, the Health and Humans Services (HHS) Secretary will publish the first list of selected drugs subject to drug price negotiations. Understanding the statutorily mandated negotiations framework, timeline and potential drugs that may be included is critical to support stakeholders’ efforts to obtain optimal outcomes.

This report describes the drug price negotiation program, an implementation timeline for drug price reforms from the IRA and information on which drugs are likely to be first subject to price negotiation.

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Trump-Era Medicare Program Under Increased Scrutiny

A Trump administration-era Medicare program is under increased scrutiny from progressive Democrats. According to this Politico article, the program is a “direct contracting model” that allows private companies to participate in Medicare. Some Democrats, however, say the program is opening up a lane for Medicare privatization.

“There’s a dynamic with the left that [the Center for Medicare & Medicaid Innovation] [has] to deal with for sure,” said McDermott+Consulting’s Mara McDermott.

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Proposed Rule on MA and Part D Would Reinstate Historical Requirements, Make Changes to Prescription Drug Payment Structure

On January 6, 2022, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule regarding Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs, marking the Biden administration’s first proposed rule on these topics. The proposed rule includes proposed changes to the manner in which pharmacy price concessions are accounted for in the Part D benefit, the timing of network adequacy reviews for Medicare Advantage Organization (MAO) applicants, and new rules regarding oversight of third-party marketing organizations. The proposed rule also reverses course on some policy changes that were initiated under the prior administration, including changes related to medical loss ratio (MLR) reporting and past performance evaluations. The proposed rule includes proposed policy updates for Dual Eligible Special Needs Plans (D-SNPs) and a few provisions related to the ongoing COVID-19 public health emergency (PHE).

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After High Court Loss, OSHA Looks to Other COVID-Curbing Means

The US Supreme Court’s January ruling that stayed enforcement of the US Occupational Safety and Health Administration’s (OSHA) shot-or-test mandate may limit some employers from introducing their own vaccination, testing or mask requirements. However, in this Bloomberg Law article, McDermott Partner Michelle Strowhiro said employers might still want to consider implementing portions of the standard—so long as state and local limits let them.

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Fifth Circuit Brings Enforcement Back into the Mix: The Latest Court Moves with the CMS Vaccination Mandate

A flurry of litigation in federal district and appellate courts has led to an even split between states in which the COVID-19 vaccine mandate issued by the US Centers for Medicare and Medicaid Services (CMS) may be implemented and states in which such implementation has been prevented. Additional appeals are expected shortly; however, the practical effect of these decisions on enforcement of the CMS mandate remains uncertain.

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