Medicare Part D Archives - HEALTH & LIFE SCIENCES NEWS

CMS Sneaks 340B Billing Proposals into Medicare Physician Fee Schedule: What 340B Stakeholders Need to Know

by Emily Jane Cook | Jul 23, 2024 | 340B, Reimbursement

On July 10, the Centers for Medicare & Medicaid Services (CMS) released the 2025 Medicare Physician Fee Schedule (MPFS) proposed rule, which includes proposals related to identification of Medicare Part B and Part D claims for 340B drugs in order to exclude them from inflation-related Medicare drug rebates established under the Inflation Reduction Act. Because MPFS is not often on the radar for 340B stakeholders, we want to make sure that folks are aware of the 340B-related provisions in the proposed rule and the deadline for submitting comments. We have excerpted the relevant pages of the MPFS proposed rule for ease of reference (the entire proposed rule is well over 2,000 pages and available here. The proposed rules are generally consistent with guidance materials previously released by CMS.

As described in more detail below, the CMS proposals would eventually require claims-level information reporting to exclude Medicare Part D 340B claims and use claim modifiers to exclude Part B claims. ALL 340B-covered entities are now expected to report claim-line modifiers for separately payable Medicare Part B drugs under guidance that was effective January 1, 2024.

Comments are due on September 9, 2024. We note that in light of the recent US Supreme Court decision in the Loper Bright case and the end of the Chevron doctrine, 340B stakeholders should consider submitting comments (both in support of the proposals and with alternatives that CMS should implement). Legal challenges to whatever rules CMS ultimately implements should be expected, and the [...]

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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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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.