Tag Archives: pharma

Using prescription drug data for identifying missing diagnoses and for medical management in the Medicare Advantage market

Even though the Centers for Medicare and Medicaid Services does not use prescription data in assigning risk scores, Rx data can still be a valuable resource for Medicare Advantage (MA) plans. Because the revenue for an MA plan each year is based on member diagnoses incurred in the prior year and submitted within 13 months of the end of that period, MA plans have a meaningful period of time to ensure complete and accurate coding as well as to identify members for disease management and potential drug adherence outliers. Milliman consultants Corey Berger and Brooks Conway provide perspective in this paper.

Pharmacy benefits: Carve-in or carve-out?

Employers and other plan sponsors have the option of carving in or carving out their pharmacy benefit programs from their medical benefits. There are a number of important factors that should be considered when deciding whether or not to carve out pharmacy benefits. This article identifies the advantages and disadvantages of both options and raises important questions to consider when contemplating a move to carve-out.

Definitions

Carved-in
When the pharmacy carve-in approach is used, the employer contracts directly with the medical health plan vendor for medical and pharmacy benefits. The vendor will either administer the program in-house or contract with a pharmacy benefits manager (PBM) vendor to process pharmacy claims and administer the pharmacy program. Because the employer contracts directly with the medical health plan vendor, there is no direct relationship with the PBM.

A pharmacy carve-in is typically used under the fully insured model. In 2015, the Pharmacy Benefit Management Institute (PBMI) reported 23% of smaller employers (less than 5,000 lives) and 7% of larger employers (greater than 5,000 lives) were fully insured. Under the fully insured model, the employer pays a premium to the insurer and the insurer assumes the risk of the total claims amount rather than the employer.

Carve-out
When the pharmacy carve-out approached is used, employers contract directly with a PBM vendor to administer their pharmacy benefits program.

A pharmacy carve-out is typically used under the self-insured model. In 2015, PBMI reported 77% of smaller employers and 93% of larger employers were self-insured. Under the self-insured model, the employer assumes the risk and benefits from managing costs. Pharmacy stop-loss insurance may be purchased to mitigate the risk of total claims amounts going over a certain threshold. A pharmacy carve-out can also be used with the fully insured model, although this is less common.

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State laws limit the interchangeability of biosimilars

sarah-burnettBiosimilars have been on our radar for a while. With Europe leading the way, this fall marks 11 years of the European Medicines Agency’s biosimilars guidelines with 20 biosimilars approved corresponding to seven different reference drugs. As part of the Patient Protection and Affordable Care Act (ACA) in 2010, President Obama amended the Public Health Service Act (PHS Act) to create an abbreviated Biologic License Application (BLA) regulatory process for biosimilars, which has yet to catch on for a variety of reasons.

Key challenges in the U.S. regulatory environment remain for establishing interchangeability for biosimilars. Drug interchangeability allows for substitution for the less expensive biosimilar version of the brand-name biologic (reference drug). The U.S. Food and Drug Administration (FDA) can classify biosimilars as interchangeable. However, state legislatures can regulate the substitutability by requiring a biosimilar in question to be first approved as interchangeable by the FDA. These regulatory hurdles thus create limits at the prescriber level to prevent substitution. So far, only two products have gained full FDA approval yet are not considered interchangeable; it is estimated that many more biosimilars are currently in development.

Before biosimilars flood the market en masse, states were taking measures to assure their regulation. In the United States, 23 states and Puerto Rico have passed legislation in the past three years to regulate the substitutability of biosimilars. The National Conference of State Legislators outlines the substitution laws for each state with an enacted law here. The common threads to the legislation are summarized below:

FDA approval. All biosimilar products seeking substitutability status must be approved by the FDA. The FDA has yet to approve a biosimilar as an interchangeable drug.

Prescriber decides. Substitution of a biosimilar for another product can be prohibited by the prescriber. In such cases, “dispense as written” or “brand medically necessary” must be noted on the prescription.

“Notification” versus “communication.” Previous legislation in 2013 and 2014 required that prescribers be notified of legally permitted substitutions made at a pharmacy. In 2015, language regarding “notification” was adjusted to allow certain “communications” to be sufficient for drug substitutions. These “communications” included notation in an electronic medical record, pharmacy benefit management (PBM) files, or pharmacy records shared with prescribers. The purpose of this language change was to allow prescribers to monitor their patients without causing unnecessary access barriers.

Patient notification. Certain states require that patients be notified of a drug substitution. Stricter versions of these regulations require explicit patient consent before any substitution is made. Documentation of notification and consent are possible barriers to adoption of approved biosimilars.

Records. Any biologic product substitution must be accompanied by records in the prescriber’s medical practice and at the pharmacy.

Immunity. In certain states, laws provide protection to pharmacists who substitute a biologic product in compliance with the state’s laws.

Web lists. States must keep an up-to-date list of permissible interchangeable products that is publicly available.

Cost or pricing. Legislation exists requiring pharmacists to explain the cost or price of a biologic and its interchangeable biosimilar. Five states require that a substitution must have the lowest cost.

Understanding the extent of the state and federal laws regarding substitutability can help employer groups and pharmacy programs estimate the potential cost impact for their organizations. Milliman has done previous research on cost savings for employer groups that take up biosimilars. As more biosimilars are approved, there will be more competition for high-priced biologics and additional drug choices will be available at more affordable prices.

To learn more about Milliman’s pharmacy benefits consulting services, click here.

Regulations impact group retiree pharmacy benefit plans

An evolving regulatory landscape is influencing the financial value of Employer Group Waiver Plans (EGWPs) and Retiree Drug Subsidy (RDS) plans. Plan sponsors should monitor the effect that new and proposed rules may have on their group retiree pharmacy benefits. In this article, Milliman actuaries Michelle Angeloni and Tracy Margiott discuss trends and changes affecting EGWPs and RDS plans as highlighted in Figure 2 below.

Figure 2 - group retiree pharmacy benefits market

Are your pharmacy benefits being adjudicated properly?

While almost all pharmacy benefit manager (PBM) contracts include audit provisions, many plan sponsors underestimate the value of auditing their PBMs, which can help recover funds lost through overpayments or system errors. Recovered losses mean that a typical pharmacy benefit audit claim can more than pay for itself, but at the very least ensures plan sponsors that they are meeting fiduciary responsibilities in the area of managing their PBM contracts. Milliman’s Brian Anderson offers more perspective in this article.

Reproduced with permission from Benefits Magazine, Volume 51 Number 5, May 2014, pages 22-27, published by the International Foundation of Employee Benefit Plans (www.ifebp.org), Brookfield, Wisconsin. All rights reserved.