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Telehealth: Regulatory Questions Amid Legislative Uncertainty

One year on from the end of the COVID-19 public health emergency, the Medicare restrictions on telehealth that Congress waived to allow for and expand the use of telehealth and other forms of virtual care are set to expire. Congress has already acted twice to extend the waivers, most recently in the Consolidated Appropriations Act, 2023, which extended them until the end of this calendar year. Thus, starting on January 1, 2025, these waivers will disappear without further Congressional action. The uncertainty about whether Congress will again extend the telehealth waivers (and for how long) will create numerous questions and cause confusion for health plans, patients and providers.

Read more about the issues that may arise here.




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Exploring the Virtual Care Policy Landscape One Year Post-PHE

May 11, 2024, marked one year since the end of the COVID-19 public health emergency (PHE), and not much has changed in Medicare telehealth policy. We are still operating under temporary waivers and flexibilities and, as a result, many pandemic-era virtual care policies are facing a cliff on December 31, 2024. This looms large during a contentious election year in which legislating has grown increasingly difficult.

This +Insight explores the virtual care policy landscape one year after the end of the PHE, and describes the actions Congress and federal agencies must take for such pandemic-era policies to continue.

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The ACA 1557 Final Regulations: Plans and Plan Sponsors as Covered Entities

In a recent On the Subject (available here), we reported on the impact of the final rule (final rule) interpreting Section 1557 of the Affordable Care Act (ACA) on self-funded group health plans that contract with licensed health insurance issuers to provide administrative services. That article considered instances in which neither the plan sponsor nor the group health plan was a covered entity for Section 1557 purposes. This post starts by assuming that either the plan sponsor or the group health plan is or at least may be a covered entity.

Section 1557 prohibits discrimination on the basis of race, color, national origin, sex, age or disability, or any combination thereof, in a health program or activity, any part of which is receiving federal financial assistance. The final rule makes clear an employer’s employment practices, including the sponsorship of a group health plan, are not generally subject to the rule. Thus, an employer does not become subject to Section 1557 by simply offering a group health plan, and a group health plan is not a covered entity where it does not receive federal financial assistance. The preamble cites examples of plans that may (or may not) receive federal financial assistance: Employer Group Waiver Plans (EGWPs), Medicare Advantage plans and Medicare Part D plans.

Plan Sponsor/Covered Entity

There are clearly instances in which a plan sponsor is itself a covered entity for Section 1557 purposes. This is the case wherever the plan sponsor is itself principally engaged in providing or administering health programs and activities (e.g., a hospital that accepts Medicare). Where that is the case, all the entities’ operations are also subject to Section 1557. The reference to “all” an entities’ operations usually conjures up images of separate legal entities under common control (e.g., a subsidiary or affiliate of the plan sponsor). But is the covered entity’s group health plan part of the covered entity’s operations? (See, e.g., T.S. v. Heart of CarDon, LLC, holding that Section 1557 applies to all the activities of a covered entity plan sponsor, including its group health plan, regardless of whether the group health plan itself received federal financial assistance.) In the context of the final rule, we are not sure that it matters. The plan sponsor is itself a covered entity that is subject to, and will need to comply with, Section 1557 irrespective of the status of the plan.

Part D and EGWPs

According to the preamble to the final rule, EGWPs, Medicare Advantage plans and Part D plans are covered entities where the plan receives federal financial assistance. EGWPs are types of Medicare Advantage plans or Part D prescription drug plans that qualify for waivers of certain Medicare regulations. Prior to the 2003 Medicare Modernization Act, employer-sponsored Part D coverage was the primary source of coverage for retirees. EGWPs, which came later, provided a more flexible alternative for employers seeking the benefits that could be captured through waivers. Whether the EGWP, Medicare Advantage plan or [...]

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Medicare Coverage of Wegovy Raises Questions Regarding the Affordability and Accessibility of Novel Medications

The Centers for Medicare & Medicaid Services (CMS) announced in March that it would allow health plans under Medicare Part D (the Medicare prescription drug benefit) to cover Wegovy and other weight-loss medications if they receive Food and Drug Administration (FDA) approval for an additional medically accepted indication.

In Wegovy’s case, the FDA recently approved an additional indication “to reduce the risk of major cardiovascular events (such as cardiovascular death, non-fatal myocardial infarction, or non-fatal strokes) in adults with established cardiovascular disease and either obesity or overweight” in combination with a reduced caloric diet and increased physical activity. As a result, Wegovy can be available for Medicare beneficiaries who have an established cardiovascular disease and are either overweight or obese. Part D coverage is still not available for weight-loss medications in beneficiaries who do not have the additional medically accepted indication.

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CMS Releases FY 2025 IPPS Proposed Update

On April 10, 2024, the Centers for Medicare & Medicaid Services (CMS) posted the Hospital Inpatient Prospective Payment System (IPPS) proposed update for fiscal year (FY) 2025, along with proposed policy and regulation changes. The proposed rule would update Medicare payment policies and quality reporting programs relevant for inpatient hospital services, and build on key agency priorities, including advancing health equity and improving the safety and quality of care.

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CMS Issues Guidance on Usage of AI in Making Coverage Determinations

On February 6, 2024, the US Centers for Medicare & Medicaid Services (CMS) issued a letter to all Medicare Advantage (MA) organizations and Medicare-Medicaid plans. The letter covered frequently asked questions and answers related to the coverage criteria and utilization management requirements in the CMS Final Rule issued on April 5, 2023.

Among the FAQs was guidance related to the use of artificial intelligence (AI) and other technologies to assess coverage decisions. CMS wrote, “An algorithm or software tool can be used to assist MA plans in making coverage determinations, but it is the responsibility of the MA organization to ensure that the algorithm or artificial intelligence complies with all applicable rules for how coverage determinations by MA organizations are made.” For example, in a decision to terminate post-acute care services, an algorithm or software tool can be used to predict the potential length of stay, but that prediction alone cannot be used as the basis to terminate services.

CMS also expressed concern that algorithms and AI technologies can exacerbate discrimination and biases, emphasizing that MA organizations must comply with nondiscrimination requirements of Section 1557 of the Affordable Care Act.




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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?

Read more here.




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Remote Monitoring and Digital Therapies: CMS Updates Coverage and Payment Policies

In recent years, the Centers for Medicare & Medicaid Services (CMS) has expanded payment for remote monitoring services in an effort to pay for non-face-to-face services that improve care coordination for Medicare beneficiaries. On November 2, 2023, CMS released the calendar year 2024 final rule for services reimbursed under the Medicare Physician Fee Schedule. In the final rule, CMS clarified certain guidance for remote monitoring services, finalized separate reimbursement for remote monitoring provided by rural health centers and federally qualified health centers, and discussed a recent request for information for digital therapies.

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Doctors Question Medicare Quality Program as More Face Steeper Penalties

A Medicare program designed to incentivize high-quality care via physician bonuses is in doubt as providers say it’s caused more trouble than it’s worth. According to this Axios article, the Merit-Based Incentive Payment System has created a disparity between bonus winners and losers, and this disparity is only expected to grow.

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Patients May Not Feel Benefits of Medicare Drug Price Negotiations

The Biden administration recently announced a list of Medicare-covered drugs that will be subject to price negotiations. The administration said the negotiations—a reality thanks to the Inflation Reduction Act—will benefit nearly nine million seniors.

However, according to this Insider article, some drug-policy analysts seem unconvinced by the administration’s claims.

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