However, privately negotiated rates take into account a number of unique circumstances between a private payer and a hospital and are not an appropriate benchmark for fee-for-service Medicare payments. We continue to urge the agency to engage with stakeholders, including providers, in developing any modifications. We also appreciate that CMS is continuing to review comments on proposed changes related to Medicare-funded residency slots and we look forward to working with them to develop a workable policy to help ease current physician shortages and strengthen the health care delivery system.
We have worked closely with the hospital field and the federal government to encourage vaccination to help protect both our patients and health care workforce from the virus. Breadcrumb Home News Headline.
Aug 01, - PM. Finally, CMS finalized its proposal to exclude individuals receiving hospice or palliative care or treatment for cancer; individuals who are residents of long-term care facilities, intermediate care facilities for the intellectually disabled, or facilities that dispense frequently abused drugs through a contract with a single pharmacy; or other individuals that the state elects to exempt from the application of the minimum standards for DUR Programs.
In addition to implementing the SUPPORT Act, under the authority of section of the Social Security Act, the Final Rule adds minimum standards for DUR reviews related to medication assisted treatment MAT and identification of Medicaid beneficiaries who could be at high risk of opioid overdose for consideration of naloxone co-prescribing or co-dispensing.
CMS finalized a modification to the proposed provision in order to include therapies that are not naloxone-based e. As always, it is important that you carefully review this regulation in light of considerations that may be relevant to your organization and specific drugs. See more ». This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies.
Click here to read more about how we use cookies. To embed, copy and paste the code into your website or blog:. Importantly, certain provisions of the Final Rule have delayed effective dates: Permitting the reporting of multiple Best Price BP figures for value-based purchasing arrangements VBPs —January 1, New drug utilization data requirements for state Medicaid programs Apart from making the foregoing changes to the MDRP regulation, the Final Rule also seeks to combat opioid-related fraud, misuse, and abuse, by adding minimum standards for state Medicaid Drug Utilization Review DUR programs.
Send Print Report. Hogan Lovells. Ken Choe. Alice Valder Curran. Elizabeth Halpern. Samantha Marshall. Kathleen Peterson. Drug Pricing. Commenters suggested that CMS promulgate rules around issues such as increased data collection responsibilities, monitoring burden, patient-specific portability challenges, and patient monitoring associated with the outcomes or evidence-based evaluation under the VBP arrangement.
CMS declined to do so, although it noted the importance of these issues and recommended that manufacturers, plans, and Medicaid programs consider these issues when contracting. AMP, including base date AMP, will take into account the full price paid to the manufacturer even if the payment is made in installments. Surprisingly, CMS opted to require the manufacturer premium payment to be included in Best Price calculations, although the warranty payment made by the third party to a provider or plan in the event that the drug did not meet certain clinical or performance measures is exempt from Best Price and AMP calculations.
As was expected, CMS received many comments on its controversial proposal to require that multiple Best Prices be reported. CMS analyzed its statutory and regulatory authority to permit the concept, and as noted above, adopted the Proposed Rule without material modification. Many comments challenged the complexity and costs associated with creating VBP models, but CMS noted that these arrangements were voluntary for manufacturers, plans, providers, and states, and expressed its view that if the arrangements were too complex or costly they would not have to be used.
Summary: The VBP provisions of the Final Rule represent a major opportunity for manufacturers who wish to pursue novel pricing arrangements. For the first time, manufacturers who were unable to adopt bundled pricing arrangements to accommodate value-based arrangements in drug pricing will be able to able to enter into Best Price-aware VBP arrangements.
CMS has given manufacturers, patients and plans significant flexibility to design their VBP arrangements.
We expect a wide range of arrangements to emerge in the coming years, implementing a number of different VBP models.
The Final Rule makes good on that plan. Manufacturers of oral solid dosage form products will very likely see increased MDRP rebates and lower B ceiling prices on many NDCs beginning January 1, , when application of the alternative URA calculation is significantly expanded.
We foresee significant changes to lifecycle planning, perhaps even reduced enthusiasm for new strengths and dosage forms, as a result of these changes to the MDRP regulations.
CMS brushed that concern aside:. Had Congress intended to limit the definition of line extension to only those drugs for which a slight alteration had been made, we believe they would have included that requirement in the statute… Congress could have included language that excluded new formulations that were innovative or provided significant benefits to patients…. CMS appropriately recognized that under the Medicaid statute, a new strength or dosage form of a drug is entitled to a new base date AMP.
We would argue that this explicit statutory arrangement entitles new strengths and new dosage forms to be beyond the reach of an aggressive interpretation of the vague alternative URA provision. Despite the fact that the alternative URA calculation requires consideration of all strengths of the original drug, the Final Rule makes new strengths themselves line extensions.
Commenters rightly noted the circular tension of conflating calculation inputs and results. First, the manufacturer must identify all potential initial brand name listed drugs by their respective NDCs by considering all strengths of the initial brand name listed drug…. The initial brand name listed drug may therefore change quarter-to-quarter for a line extension. Implementation of the Final Rule will be operationally complex and burdensome.
Thus, a liquid solution dosage form may be a line extension of a pill or tablet. These definitional changes are applicable prospectively from January 1, Importantly, this prospective application applies only to when the rebate calculation is conducted, not to when initial brand name listed drugs or line extensions are introduced.
Although manufacturers will not be required to apply the regulatory definitions and oral solid dosage form requirement when calculating rebates for periods prior to the effective date of the final rule, the definitions become effective for all drugs that are on the market as of and following that effective date. Thus, beginning with the first quarter of , products introduced years ago may be deemed to be initial brand name listed drugs and line extensions subject to the alternative URA.
Short of divesting or withdrawing one or both of the products from the market before , manufacturers may not be able to avoid the increased MDRP and B liability that flows from these amendments to the regulations. Many manufacturers assumed that all rebates paid under supplemental rebate agreements were excludable. Once CMS approves either template, rebates provided for under agreements entered into between states and manufacturers are exempt from Best Price.
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