Centers for Medicare & Medicaid Services Archives

CMS Issues FAQs to Aid Pharmacies in Preparing for Medicare Part B Coverage of PrEP Medications

by Gregory E. Fosheim, Monica Wallace, Emily Jane Cook and Jae Hyun Lee | Jun 26, 2024 | Hospitals & Health Systems, Life Sciences, Managed Care

As we previously advised, the Centers for Medicare & Medicaid Services (CMS) is preparing to issue a national coverage determination (NCD) for pre-exposure prophylaxis (PrEP) using antiretroviral drugs to prevent HIV under Medicare Part B. In response to questions from stakeholders, CMS released FAQs on June 25, 2024, to guide pharmacies through certain enrollment and billing intricacies.

Specifically, pharmacies are instructed that no new Medicare enrollment is needed if pharmacies are already enrolled in Medicare as a Part B pharmacy or a durable medical equipment, prosthetic, orthotics and supplies (DMEPOS) supplier. However, if the pharmacy is not currently enrolled in Medicare, they should consider enrolling as a Part B pharmacy rather than a DMEPOS supplier so that they are not subject to the supplier standards, accreditation and surety bond requirements.

CMS also provides pharmacies with appropriate ICD-10 CM diagnosis codes and J-codes to include with claims and instructs pharmacies that the date the drug is picked up or mailed should be entered as the date of service. Finally, recognizing that some pharmacies will fill orders for injectable PrEP to be administered by qualified practitioners, pharmacies may include a claim for the supplying fee along with a claim for the drug where appropriate. CMS anticipates that the final NCD will be posted and effective in late September 2024. The NCD is expected to be similar to the proposed NCD published on July 12, 2023.

CMS Advises Preparatory Steps for Anticipated PrEP Coverage Transition to Medicare Part B

by Monica Wallace, Emily Jane Cook, Gregory E. Fosheim and Jae Hyun Lee | Apr 25, 2024 | Life Sciences

On April 15, the Centers for Medicare & Medicaid Services (CMS) released a fact sheet on the potential national coverage determination (NCD) for pre-exposure prophylaxis (PrEP) using antiretroviral drugs to prevent HIV. CMS did not announce any coverage changes in the fact sheet but is providing advance information to avoid any possible disruptions to beneficiaries should the NCD be issued.

We are closely monitoring this issue and will provide further updates regarding the coverage details and additional guidance in the NCD once it is issued.

Under the proposed NCD, PrEP drugs (which may be covered under Medicare Part D and subject to beneficiary cost-sharing obligations) would be transitioned to Medicare Part B, with no beneficiary cost-sharing obligations. CMS also proposes to cover HIV screening tests and counseling visits under Medicare Part B. This would be consistent with most commercial health insurance and Medicaid plans, which, under the Affordable Care Act, must cover PrEP drugs (oral or injectable), laboratory tests and related clinical visits without cost sharing when prescribed by a healthcare provider.

If the proposed change for PrEP drugs occurs, pharmacies will need to be enrolled in Medicare Part B as either a durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) supplier (CMS-855S) or as a Part B pharmacy supplier (CMS-855B). Pharmacies not already enrolled should consider doing so in preparation for the final NCD, as Part B coverage will be effective at the time the final NCD is posted. Pharmacies enrolled in Part B with the provider type [...]

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Managed Care Spotlight: 2020 Year in Review and 2021 Outlook

by McDermott Will & Emery | Jan 29, 2021 | Hospitals & Health Systems

The past year saw significant developments in managed care regulation at the federal and state levels and we anticipate the rapid pace of change will continue through 2021. In this webinar, we analyzed the most significant legal developments affecting health plans in 2020 and explored what to expect in 2021. Our thought leaders discussed the impact of managed care regulations on a broad range of industry subsectors, from plans and providers to vendors and pharmacy benefit managers.

PROGRAM INSIGHTS

The Biden administration seeks to set a tone of order and predictability in its COVID-19 relief and response efforts. These efforts include a swath of executive orders on topics such as data aggregation, support for the National Guard and strategies for vaccine distribution. The acting secretary of Health and Human Services also recently sent a letter to state governors stating that the agency will likely extend the public health declaration—and its attendant regulatory flexibilities—through 2021.
The direct contracting model is the next step in the evolution of the Medicare accountable care organization portfolio. The model allows participating organizations to take on a greater level of financial risk, including the Centers for Medicare & Medicaid Services’ version of global capitation. The direct contracting global or professional options may be particularly attractive to managed care organizations, because these options allow new entrants with low or no fee-for-service beneficiaries.
The coming year will likely see a continued trend toward financial risk assumption in value-based contracting. Within this trend, there are two common variations. [...]

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Bills Ban Gag Clauses in Pharmacy Contracts

by Judith Wethall and Karen Owen Gibbs | Oct 18, 2018 | FDA, Hospitals & Health Systems, Reimbursement

On October 10, 2018 President Trump signed two bills that ban “gag clauses” in pharmacy contracts. Congress passed the two bills—one for Medicare prescription drug plans (“Know the Lowest Price Act”) that will go into effect in January 2020, and another for commercial employer-based and individual policies (“Patient Right to Know Drug Prices Act”) effective immediately—by almost unanimous vote in September 2018.

While many states have already prohibited the use of these clauses, this is the first such action on a federal level.

Gag clauses are sometimes found in contracts between pharmacies and insurance companies, pharmacy benefit managers or group health plans and bar pharmacists from telling customers that they could save money by paying cash for their prescriptions rather than using their health insurance. If pharmacists violate the gag rule, they risk penalties and/or contract termination. Under the new legislation, pharmacists are not required to tell patients about the lower cost option, but they also cannot be contractually prohibited from engaging in the cost conversation.

The legislation is consistent with the position of the Centers for Medicare & Medicaid Services (CMS), which, in May of this year, issued guidance stating that “gag clauses” are unacceptable in the Medicare Part D program.

Medicare Hearings and Appeals: Litigation, New Initiatives, and Opportunities to Exit the Backlog

by McDermott Will & Emery | Jun 14, 2018 | Fraud & Abuse, Health Controversies, Managed Care

Providers continue to face a massive Medicare appeals backlog before the Office of Medicare Hearing and Appeals (OMHA). Pending appeals number in the hundreds of thousands and the current average processing time for an appeal is over three years, with newly filed appeals likely to reach closer to five. While OMHA and Medicare reimbursement appeals face endemic issues, new developments and alternative programs may present strategic opportunities for providers and chip away at the backlog.

Regulatory changes from the U.S. Department of Health and Human Services (HHS) have come into play and are designed to provide clarity, reduce delays, and streamline the appeal process. For example, HHS has recently revamped the OMHA case processing manual, “deputized” OMHA attorney adjudicators, and determined that some decisions from the Departmental Appeals Board (the appellate level above OMHA) will now be precedential.

Additionally, OMHA and the Centers for Medicare & Medicaid Services (CMS) have initiated new programs that provide alternatives to the traditional appeals procedure with the goal of reducing the backlog. These include 1) the OMHA Settlement Conference Facilitation alternative dispute resolution process; 2) the Statistical Sampling Initiative; 3) CMS’s Low Volume Appeals settlement options, and 4) CMS’s Formal Telephone Discussion Demonstration for Durable Medical Equipment providers. Further, recent Federal Circuit court cases, including American Hospital Association, et al v. Thomas Price, may significantly impact the Medicare appeals process.

During the AHLA Annual Meeting on Monday, June 25, McDermott lawyer and former OMHA attorney advisor, Nicholas Alarif, and Amanda Axeen, the [...]

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