Part D

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The Centers for Medicare and Medicaid Services (CMS) requested an audit by the Office of Inspector General (OIG) of Medicare Part D eligibility verification transactions (E1) transactions. The OIG recently released its report which found that the majority of the providers evaluated used E1 transactions for some inappropriate purpose other than to bill for a prescription or to determine drug coverage billing order.

What are E1 transactions and why is this information disturbing?
Continue Reading OIG Audit Finds that Majority of Part D Providers Surveyed Used E1 Transactions for Potentially Inappropriate Purposes

The Centers for Medicare and Medicaid Services (CMS) announced a final rule, to be published on May 23, 2019, amending the Medicare Advantage program (Part C) and Prescription Drug Benefit program (Part D) regulations. According to CMS, the purpose of the rule is to lower drug prices and reduce out-of-pocket expenses in the Medicare…

On February 6, 2019, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a proposed rule (Proposed Rule) that would amend the safe harbor regulations under the Federal Anti-Kickback Statute. The Proposed Rule is intended to “address the modern prescription drug distribution model” and make sure that the safe harbors “extend only to arrangements that present a low risk of harm to the Federal health care programs and beneficiaries.” Specifically, in the Proposed Rule OIG proposes to alter the definition of  “discounts” under the so-called “discounts safe harbor” at 42 C.F.R. § 1001.952(h) to exclude from protection any reductions in price or other remuneration offered by pharmaceutical drug manufacturers to pharmacy benefit managers (PBMs), Part D plan sponsors, or Medicaid managed care organizations. Additionally, the Proposed Rule proposes and solicits comment on two new safe harbor provisions: one aimed at reducing the price of pharmaceuticals where reductions in price are reflected at the point of sale to a beneficiary, and a second that would protect certain fixed fee services arrangements between manufacturers and PBMs.
Continue Reading HHS Proposes to Amend AKS Safe Harbors to Exclude PBM Rebates and Incentivize Consumer Drug Discounts

The Centers for Medicare and Medicaid Services (CMS) announced a Proposed Rule to amend Medicare Advantage (MA) regulations and Prescription Drug Benefit program (Part D) regulations.  The Proposed Rule was published on November 30, 2018. The Proposed Rule is intended to help lower drug prices for health and drug plans and reduce out-of-pocket costs for MA and Part D enrollees. Major provisions include: Providing Plans with increased flexibility in managing drug formularies. Current policy requires Part D formularies to include all drugs in the following categories: (1) antidepressants; (2) antipsychotics; (3) anticonvulsants; (4) immunosuppressants for treatment of transplant rejection; (5) antiretrovirals; and (6) antineoplastics; except in limited circumstances. The Proposed Rule includes three exceptions, allowing: (1) broader use of prior authorization and step therapy; (2) exclusion of drugs that are only a new formulation of an existing single-source drug or biological product, regardless of whether the older formulation remains on the market; and (3) exclusion of drugs with a price increase beyond an inflation-based threshold relative to a baseline month and year.
Continue Reading CMS Proposes Revised Prescription Drug Regulations to Lower Drug Prices and Reduce Out of Pocket Expenses

On April 2, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule, updating Medicare Advantage (MA) and the prescription drug benefit program (Part D).  The Final Rule includes, among other provisions:

  • Preclusion List Requirements for Prescribers in Part D and Individuals and Entities in Medicare Advantage, Cost Plans, and PACE: The Final Rule eliminates the MA and Part D prescriber and provider enrollment requirement.  Instead, CMS is compiling a “Preclusion List” of prescribers, individuals, and entities that: (1) are currently revoked from Medicare, under an active reenrollment bar, or have engaged in behavior for which CMS could have revoked enrollment in Medicare and (2) in addition, CMS determines their underlying conduct to be detrimental to the best interests of the Medicare program. The Preclusion List will be made available to MA plans and Part D prescription drug plans, which must deny payment for claims submitted by, or associated with prescriptions written by prescribers and providers on the list.
  • Eliminating “Meaningful Difference” Requirements: Beginning with CY 2019 bid submissions, CMS has eliminated the requirement that MA plans offered by the same organization in the same county comply with the “meaningful difference” requirements, which limit the variety of plans an MA organization can offer in the same county. The Final Rule eliminates the “meaningful difference” requirement for PDP Enhanced Alternative (EA) benefit designs offered by the same organization in the same region, but does not change this requirement between PDP Basic and EA prescription drug plan offerings.
  • Medicare Advantage Uniformity Requirements Flexibility: As an option for all MA plans, the Final Rule allows the plans to reduce cost sharing for certain covered benefits, offer specific tailored supplemental benefits, and offer different deductibles for beneficiaries that meet specific medical criteria.

Continue Reading CMS Updates Medicare Advantage and Part D (Prescription Drug Benefit)

In a Draft Call Letter issued February 1, 2018, the Centers for Medicare & Medicaid Services (CMS) announced that it is considering a number of new strategies to address opioid overutilization within the Medicare Part D program.  CMS is particularly concerned with chronic overuse among beneficiaries taking high levels of prescription opioids (e.g., beneficiaries prescribed opioids with a 90 morphine milligram equivalent (MME) dose or higher per day), beneficiaries with multiple prescribers, and “opioid naïve” patients (i.e., patients newly prescribed opioids).

CMS’s strategies include consideration of a 7-day supply limit for initial fills of prescription opioids for the treatment of acute pain, potentially paired with a daily dose maximum (e.g., a limit of 50 MME).  According to CMS, this type of restriction may reduce the number of leftover opioid pills available to an opioid naïve patient, which in turn can reduce the risk that the patient develops an “affinity” for opioids that can lead to misuse and diversion.  CMS also proposes that Medicare Part D sponsors implement formulary-level opioid safety edits at the point-of-sale (POS) at pharmacies of 90 MME, which could only be overridden by a sponsor, and which may be paired with a 7-day supply allowance for initial opioid prescriptions for the treatment of acute pain.


Continue Reading CMS Considers 7-Day Limit on Initial Opioid Prescriptions under Part D

On December 11, 2017, the Health and Human Services Office of Inspector General (OIG) posted a favorable Advisory Opinion, permitting a proposed pilot Program involving a collaboration between a pharmaceutical manufacturer (the Requestor), a trade association (Association), a Medicare Advantage Part D plan (MA Plan), a Hospital System, and a Vendor.  As proposed, the program would provide new technology to allow real-time access to patient discharge information for use by MA Plan pharmacists who conduct medication therapy management (MTM) services. 
Continue Reading OIG Advisory Opinion Allows Pilot Collaborative Program Proposed by Pharmaceutical Manufacturer for Medication Therapy Management Interventions