Medicaid drug rebate program reporting requirements

Given the breadth of the proposed definition of TPMO, the proposed changes may implicate a broad range of marketing organizations. If finalized, these changes would result in contract updates and new oversight obligations for plan sponsors and their FDRs.

Reinstatement of Detailed MLR Reporting: Under the prior administration, MLR reporting was significantly reduced, such that only a handful of data elements were required to be submitted to the government. CMS now proposes to reverse course on that change and reinstate the prior, more detailed, reporting requirements, beginning with MLR reporting for Contract Year CMS proposes to expand the MLR report to include expenditures related to certain supplemental benefits, such as dental, vision, hearing, transportation, remote access technologies, out-of-network services, meals and acupuncture.

CMS also proposes to codify several existing subregulatory requirements, including those relating to ID cards, disclaimers for Part D sponsors with limited access to preferred cost-sharing, and website-posted content related to the appointment of a representative and enrollment.

This provision relates to regulatory requirements for plans to cover services provided by non-contracted providers and to waive gatekeeper referral requirements, and does not explicitly apply to subregulatory flexibilities afforded to MA and Part D plans during the current PHE. Enrollee Participation in Plan Governance: Building on experience with other programs, such as the Medicare-Medicaid Financial Alignment Initiative and Programs of All-Inclusive Care for the Elderly, CMS proposes that MAOs offering one or more D-SNPs in a state would be required to establish and maintain one or more enrollee advisory committees to solicit direct input on ways to improve access to covered services, coordination of services and health equity.

Stakeholders should review this proposal and consider submitting their comments with that broader context in mind. This rule proposes that all SNPs, including D-SNPs, incorporate standardized questions on the topics of housing stability, food security and access to transportation as part of their HRAs.

The questions would be further detailed through subregulatory guidance. CMS proposes to begin enforcing this requirement in but also is considering a later date. These changes would take place in and subsequent years to afford plans and states time to ensure compliance. CMS indicates that if a state elects this option, CMS would provide greater transparency regarding quality performance, financial performance and provider networks.

Under current guidance, MAOs do not have to count Medicaid-paid amounts or unpaid amounts toward this limit. CMS believes that this approach disadvantages providers serving dual eligible individuals in MA plans, and proposes that the MOOP limit in an MA plan be calculated based on the accrual of all cost-sharing in the plan benefit, regardless of whether that cost-sharing is paid by the beneficiary, Medicaid or other secondary insurance or remains unpaid because of state limits on the amounts paid.

The proposed rule also includes two requests for information and a request for feedback on D-SNP data collection efforts:. CMS notes that while many plans relaxed prior authorization requirements in , many MAOs reinstated these requirements in CMS now seeks information about the effects of relaxation and reinstatement of prior authorizations on patient transfers during the PHE.

Building Behavioral Health Specialties Within MA Networks: MAOs are currently required to meet network adequacy requirements in connection with behavioral health providers, but CMS now seeks to increase its understanding about issues related to access to behavioral health specialties for enrollees in MA plans.

Specifically, CMS seeks stakeholder feedback on challenges MAOs face when building an adequate network of behavioral health providers.

CMS is interested in any stakeholder experience with implementing the data notification requirements and suggested improvements. Mara is an accomplished health care executive with a deep understanding of federal health care law and policy, including delivery system reform, physician payment and Medicare payment models.

As head of the Washington, DC, office, Mara Ankur J. Ankur has experience in both government and the private sector, where he has assisted clients to successfully navigate significant litigation and enforcement matters.

Emily R. Curran focuses her practice on healthcare regulatory and compliance issues in the managed care space. She counsels both for-profit and non-profit healthcare insurance companies on state and federal policy issues and advises clients on reimbursement issues that come into play when participating in government healthcare programs. Taylor Hood advises healthcare companies on a variety of litigation, regulatory and healthcare policy matters.

Taylor focuses his practice on issues that arise in the managed care sector for both payors and providers, including provider payments, health benefits and insurance practices. He also counsels clients in arbitration and before state medical boards, with experience before the Texas Medical Board. Skip to main content. New Articles. January 13, U. Arandia, Jr. Spooner U. Malveaux and Melanie L. Burd and Jeri L. Kinder and Jonathan D.

Wohlwend U. The Medicaid rebate program interacts with other programs that receive manufacturer discounts on drugs. As a condition of participation in the Medicaid Drug Rebate program, manufacturers must also participate in the federal B program.

The B program offers discounted drugs to certain safety net providers that serve vulnerable or underserved populations, including Medicaid beneficiaries. Because the B program is administered separately, as stipulated by federal law, states and safety net providers must ensure that manufacturers do not pay duplicative discounts for Medicaid beneficiaries.

To avoid charging manufacturers a duplicate discount, state Medicaid programs reference a list of safety net providers that provided drugs under B to Medicaid beneficiaries, and the Medicaid program will exclude their drug claims from their invoices to manufacturers. Although Medicaid best price and B ceiling prices are closely related, the rules states set for how they reimburse pharmacies may have implications for drug costs. The rebate program offsets Medicaid costs and reduces federal and state spending on drugs.

Net spending actually declined from The structure of the rebate program essentially creates an open formulary. When a manufacturer enters into a rebate agreement with HHS, Medicaid agrees to cover nearly all FDA-approved drugs from that manufacturer. This approach is different from private insurers who can enter into negotiations with manufacturers about whether or not drugs will be on their formularies, leveraging rebates for drugs that are included or covered with lower patient cost-sharing.

This challenge is particularly acute for new, blockbuster drugs that Medicaid programs must cover with little leverage to negotiate lower costs. Medicaid prices and the rebate program may have implications for prices paid by other payers. There has been increased attention by policymakers and the public to high list prices, with some brand name drugs launching with price tags of hundreds of thousands of dollars or more.

Amidst the discussion of high launch prices, analyses of potential solutions have highlighted the role of the MDRP in the larger drug pricing system. Medicare Part D rebates are not included in the best price calculation. An analysis from CBO was conducted in , shortly after the creation of the Rebate Program, and showed some initial price increases but found increases due to MDRP ceased within a few years. There is renewed policy interest in the MDRP as states and the federal government explore policies related to drug costs.

Proposals at both the state and federal level would make changes directly to the MDRP, and proposed changes to other programs may have implications for Medicaid as well. Because the MDRP is a complex program that has evolved over time, it contains some technical issues and provisions that lower the rebate amount paid for some drugs.

Policymakers are considering several changes to address these issues and increase the effective rebate amount. While these changes would produce savings for both the federal and state government, authority for undertaking them rests at the federal level, since the MDRP is in federal statute. Because of rising prices over time, a number of drugs have reached the rebate cap. Increasing or eliminating the cap would generate savings for the program and lower revenues for drug manufacturers.

Another policy proposal to increase the Medicaid rebate amount is to change the rebate calculation. Some manufacturers have reduced their rebate obligations by blending the price of an authorized generic with a brand name drug, which reduces the AMP of the brand drug.

Legislation enacted in Fall prohibits manufacturers from engaging in this practice. A third set of technical changes to MDRP relates to data and reporting. The rebate calculation relies on price data and product information submitted by manufacturers to CMS. Misclassified drugs or inaccurate price information in these files affects the rebate calculation. A number of policy proposals would strengthen price enforcement mechanisms at the federal level to improve the accuracy of information and ensure appropriate rebates are paid and allow for penalties for reporting inaccurate information.

Due to the structure of the MDRP, state levers to negotiate supplemental rebate agreements have primarily been limited to PDL placement. In addition, as statutory rebates have increased over time, state supplemental rebates have grown much more slowly and declined as a share of total rebates. Some policy proposals focus on increasing purchasing power to negotiate additional supplemental rebates.

As of fiscal year , at least 17 states had a uniform PDL for one or more drug classes. PBMs have been another area of focus for state efforts to increase supplemental rebates. Much activity in this area involves increased transparency about PBM practices by, for example, requiring PBMs to report their discounts, rebates and profits to the state to ensure that the state is receiving the maximum rebates possible.

Gainwell Care Management Service strikes the balance between improving quality and reducing total cost of care. It uses data derived by proven, industry-standard COTS products, such as the Johns Hopkins ACG System, and includes administrative and clinical information to achieve these ends — all without creating an additional resource burden on your organization. Because we recommend targeted as opposed to one-size-fits-all interventions, the cost of administration is reduced and the ability to realize a positive ROI is greatly enhanced.

Limiting this technique to services that the data reveals as high-cost and high-use not only reduces the administrative footprint and service cost, but also improves provider relations.

Prior authorization, as an example, can be an administrative burden for stressed provider practices. Care Management Service, part of our Medicaid Management Solutions, is an interoperable module characterized by automation, standardization and process maturity. The Medicaid Drug Rebate Program has been successful in significantly reducing federal and state spending on drugs. But there are opportunities for you to realize even greater value by maximizing drug rebate collections and minimizing dispute resolutions.

Through the Gainwell Drug Rebate Service, your organization can easily manage any combination of rebate policies, including various federal pharmacy and managed care programs, and federal and state supplemental programs. Enhanced business processes make it possible to modernize drug rebate invoicing and to quickly and accurately apply payments.

The solution supports fee-for-service, managed care and supplemental rebates. This cloud-based service is a key module of our Medicaid Management Solutions, a platform built on COTS software that supports interoperability in healthcare and combines automation, standardization and process maturity to support all aspects of Medicaid processing. Medicaid agencies must be more proactive about leveraging data to drive operational improvements and enhance health program outcomes.

With greater insight into data, you can improve policy decision-making and align better with federal reporting requirements. This dynamic tool enables your data analysts and information workers to interact with content-rich dashboards and multiple visualizations to discover metrics about your Medicaid population, such as eligibility, enrollment and participation, contractual SLAs, finance management and program expenditures.

Through our highly secure cloud and analytics platform your team can gather information from a variety of data sources.

The platform then combines your data with a range of pre-integrated assets — such as clinical data, T-MSIS and third-party data flows. Drilling into the data enables you to track how metrics trend over time so, for example, you can discover unusual trends for earlier intervention and mitigation.

Part of our Medicaid Management Solutions, inSight Analytics is one of a set of interoperable modules characterized by automation, standardization and process maturity.

Medicaid administration complexities increase as states grow their managed care organization MCO networks to deliver care to enrollees. Your organization can be more proactive in everything from cost-effectively managing multiple MCOs to tracking clients as they transition across MCO plans and to improving capitation processes.

We are a leader in delivering technology to cover all aspects of Medicaid management, claims and payments processes. Our Managed Care Service is one of the modules that comprise our Medicaid Management Solutions, a set of interoperable modules characterized by automation, standardization and process maturity. The service helps you relieve the escalating strain on MCO benefits coordination as they bring new populations, add new services and extend the geographic range of coverage.

Our cloud-based platform and SaaS approach, combined with our overarching services based on COTS software, are designed to help your organization better manage the present and prepare for the future.

Medicaid agencies face challenges in efficiently managing their prescription drug programs. Streamlining administrative and financial functions such as prior authorization, point-of-service claims and encounter processing is critical to reducing the complexities of the drug supply and payment chain. It is an essential component of our Medicaid Management Solutions, a wide-ranging set of modules that support interoperability in healthcare and combines automation, standardization and process maturity to support all aspects of Medicaid management, claims and payments.