Market Access Achieving — and sustaining — market access requires a sound global strategy. You need to ensure you've identified the right patient, drug, dose and duration of treatment.
Tweet on Twitter In the Deficit Reduction Act DRACongress made major, controversial, and technically complex changes to Medicaid prescription drug pricing and pharmacy reimbursement. For pharmacies, the DRA changes represent significant cuts to Medicaid reimbursement — unless states act to mitigate the changes or increase dispensing fees to compensate for lower product reimbursement.
While CMS tried to mitigate the impact on pharmacies, studies by GAO, OIG, and pharmacy trade groups suggest that pharmacies could easily lose money with many drugs dispensed under Medicaid, with the biggest loss in generic drugs.
The changes also hold major implications for pharmaceutical companies. The new policies create new financial, operational, and compliance challenges.
They will require most drug makers to rethink pricing strategies and access the impact across all their classes of trade. Average Manufacturer Price AMPa calculation that has been a closely held secret under the law sincewill become transparent through monthly public reporting of AMP-based prices of every drug on sale in the U.
You may expect this to have some interesting effects on marketplace behavior and payor negotiations. And, of course, the changes will increase rebate payments to states. States will benefit from the resulting cost savings.
However, state Medicaid directors face strong pressure from community and chain pharmacies to compensate for lost revenue.
States also have concerns about the reliability of CMS and pharma industry data, especially in the first couple years given the big change in methodology, scope, and frequency of data reporting.
States must also make a variety of systems changes under short notice. Across the health care system, the DRA changes are further evidence of the increasing power of government policy on the pharmaceutical supply chain. Now that taxpayer-funded health programs pay for the majority of drugs, changes in Medicaid or Medicare drug policy are no longer limited to affected program.
Federal changes ripple throughout the industry, forcing changes in commercial practices and business strategy. Try to repeat that ten times fast. However, how this plays out has been highly controversial, leading to inconsistencies across manufacturers, numerous highly critical studies by the HHS Office of the Inspector General OIG and Government Accountability Office GAOallegations of gaming, and countless law suits against drug makers by U.
Most notably, the final rule: Excludes customary prompt pay discounts to wholesalers from the calculation of AMP.
Clarifies definition of retail class of trade and wholesaler and how to treat sales reimbursed by third party payors. Excludes sales to nursing homes and discounts, rebates, or prices to PBMs except when PBMs act as mail order pharmacies — an exception very controversial with retail pharmacies.
Defines many key terms for purposes of the Medicaid drug rebate program. Newly defined terms include retail pharmacy class of trade, customary prompt pay discounts, administrative and service fees, returned goods, average unit price, bona fide service fee, bundled sales, net sales, and manufacturer coupons.
Clarifies how manufacturers should account for price reductions and other pricing arrangements in calculating AMP. For twenty years, the federal rules have limited the amount state Medicaid programs may reimburse pharmacies for generic drugs.
Using a Federal Upper Limit FUL for each affected drug product, the idea is to help ensure the government is a prudent buyer and pays close to market levels.
However, that never worked well.Are you looking to improve your knowledge of pharmaceutical compliance and regulatory or other related topics? Check out all of our conferences on these topics and more! CBI has conferences for everyone in FDA-regulated industries.
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There is concern that the profit motive has led to emphasis on research that is aimed more at things like baldness and impotence, rather than various tropical diseases that affect millions upon millions of people in developing countries.
Unfortunately, while a . The federal B Drug Pricing Program provides access to reduced price prescription drugs to over 12, health care facilities certified by the U.S. Department of Health and Human Services (HHS) as "covered entities".
These clinics, centers and hospitals in turn serve more than 10 million people in all 50 states, plus commonwealths and territories. Ghana Pharmaceutical Pricing Study Policy Analysis and Recommendations David Sarley Hany Abdallah Raja Rao Peter Gyimah Joycelyn Azeez Bertha Garshong July Design programs and patient services that eliminate barriers and ensure your targeted patient population has seamless and affordable access to therapeutic products.
The Price of Global Health: Drug Pricing Strategies to Balance Patient Access and the Funding of Innovation (Second Edition) thoroughly examines and clearly articulates all factors that influence the process of setting drug prices. A thoughtful work on a difficult, widely misunderstood topic, the book is at the same time a fascinating read. Recent Medicaid Prescription Drug Laws and Strategies, A description of recent Medicaid federal requirements and archive state statutes that modify or reform policies affecting Medicaid prescription drugs. JUNE metin2sell.com Pricing On-Market Pricing Strategies over time to differentiate net pricing for specific payer channels or custom-ers, opportunities to improve financial.