RADAR on Specialty Pharmacy

  • MA Stakeholders Urge CMS to Adjust End-Stage Renal Disease Payment Rates in 2021

    Responding to the two-part Advance Notice proposing rate and risk adjustment changes for Medicare Advantage plans in 2021, insurers and other stakeholders expressed concern that payment rates for serving members with end-stage renal disease (ESRD) who will newly enter the MA program will not suffice.

    The 21st Century Cures Act, signed into law in 2016, lifted a ban on ESRD patients enrolling in MA plans, which currently only serve those patients when they are diagnosed during the year. Part II of the Advance Notice stated that CMS will use fee-for-service Medicare reimbursement and enrollment data for beneficiaries in dialysis status from 2014 to 2018 to develop state-based ESRD MA benchmarks for 2021 (RMA 2/20/20, p. 1).

  • News Briefs

    Walgreen Co. and Kroger Co. can continue to pursue a lawsuit (No. 19-1730) over Remicade (infliximab) against Janssen Biotech Inc. and its parent company, Johnson & Johnson, according to a decision by the U.S. Court of Appeals. The lawsuit claims that Janssen “used its size and bargaining power in the broader pharmaceutical market to enter into exclusive contracts and anticompetitive bundling agreements with health insurers that suppressed generic competition to Remicade, which in turn allowed Janssen to sell Remicade at supracompetitive prices.” The decision overturns a ruling by the U.S. District Court for the Eastern District of Pennsylvania (D.C. No. 2-18-cv-02357), which ruled in Janssen’s favor in March 2019. View the decision at https://bit.ly/2Tx21pa.

    The U.S. Preventive Services Task Force (USPSTF) gave a B grade to screening for hepatitis C infection in people between the ages of 18 and 79. The Affordable Care Act mandates that private insurers cover preventive services with a USPSTF grade of A or B. View the recommendation at https://bit.ly/38kjMxx.

  • New FDA Specialty Approvals

     Feb. 10: The FDA granted final approval to Eagle Pharmaceuticals, Inc.’s Pemfexy (pemetrexed) for the treatment of people with locally advanced or metastatic nonsquamous non-small cell lung cancer in combination with cisplatin; locally advanced or metastatic nonsquamous non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy, as maintenance treatment; locally advanced or metastatic nonsquamous non-small cell lung cancer after prior chemotherapy; and malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery in combination with cisplatin. The drug, to which the FDA granted tentative approval in 2017, is a branded alternative to Eli Lilly and Company’s Alimta (pemetrexed). The two drugmakers reached a settlement in patent litigation on Dec. 13, 2019, that will allow Pemfexy to launch with a three-week supply on Feb. 1, 2022, then an uncapped entry on April 1, 2022. Dosing for the intravenous injection depends on the indication. For more information, visit https://bit.ly/2vkZBSi.

     Feb. 18: The FDA approved a new dosage form for Procysbi (cysteamine bitartrate) for the treatment of people at least one year old with nephropathic cystinosis. The Horizon Pharma plc drug is now available in delayed-release oral granules, as well as capsules. The granules, also known as microbeads, will be available in packets of 75 mg and 300 mg strengths in the first half of 2020. The agency initially approved the capsule in 1994. Dosing is weight-based. Website Drugs.com lists the price of 250 75 mg delayed-release capsules as $26,454. Visit www.procysbi.com.

  • White Bagging Can Pose Array of Logistical, Contractual and Communication Issues

    As the practice of white bagging grows, Elan Rubinstein, Pharm.D., principal at EB Rubinstein Associates, tells AIS Health that the approach has many potential issues that should be addressed in payer contracts with specialty pharmacies and providers:

     “If a drug is administered to the patient as prescribed and as supplied under white bagging by the specialty pharmacy, how is the payer informed — via a billing that shows administration of the drug’s J-code and administered number of HCPCS [i.e., Healthcare Common Procedural Coding System] units, but with an indicator that this is for information purposes, not for reimbursement to the practice? If so, does the payer match up the specialty pharmacy billing with the provider billing to validate that the drug was administered as prescribed?”

  • Experts Vary on Challenges, Benefits of White Bagging

    As health plans seek to have more control over their spending on provider-administered specialty drugs, many physicians are pushing back, as seen most recently with BlueCross BlueShield of Tennessee’s (BCBST) new program (see story, p. 1). But at least one survey of commercial payers shows that mandating the use of a specialty pharmacy to acquire these therapies is replacing the longstanding approach, a trend that respondents anticipate will continue even though industry experts vary on the benefits and challenges of such an approach.

    Providers traditionally have acquired therapies they administer through a practice known as buy and bill, by which they will purchase a drug from a wholesaler or distributor, keep it in their office and administer it to patients as needed, submitting a claim to the payer afterwards. Through this approach, providers can make a profit by marking up the drug.

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