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Aimed Monthly, Volume 3, Issue 5

Welcome to Volume 3, Issue 5 of Aimed Monthly. This month’s issue includes the latest advocacy and regulatory developments regarding nonmedical switching, step therapy, prior authorization, value and innovation, and drug pricing.

Highlights

Aimed Alliance Leads Efforts to Oppose Louisiana Bill that Permits Nonmedical Switching

On May 25, 2021, Aimed Alliance and 19 other patient advocacy groups and health professional organizations sent a letter to members of the Louisiana House of Representatives in opposition to SB 181, which would allow health plans to engage in nonmedical switching of stable patients. The bill allows plans to drop medications or increase out-of-pocket costs after patients are already locked in for a plan year. Plan modifications are tied to drug price increases that the plan may already have known about before the plan year has started. Additionally, the language creates conflict, or at the very least, ambiguity with Louisiana’s current nonmedical switching law. While SB 181 does not amend the nonmedical switching statute, the language implies that SB 181 is applicable to stable patients since the bill contains a 30-day notice requirement. Yet, notice is only relevant to stable patients. Read our letter here.
Letter to Cigna on $500 Debit Card Program

On May 14, 2021, Aimed Alliance sent a letter to Cigna expressing concerns over its $500 debit card program. Under the program, stable patients with psoriasis and psoriatic arthritis receive an inducement of $500 to switch from one biologic medication to another, a form of nonmedical switching. As we noted in our letter, the debit card program is intended solely to incentivize stable patients to switch to a new drug, regardless of their financial situation or whether their health care professional has determined that the new drug is appropriate for their individualized needs. We recommended to Cigna that, should it seek to offer assistance to patients in need, it should do so by assisting them to afford their currently prescribed medication, which is in patients’ best interest, rather than coercing a switch that is in the insurer’s best interest. Read our letter here.
Aimed Alliance Weighs in on Pennsylvania Step Therapy and Prior Authorization Bill and New Jersey Step Therapy Bill

On May 10, 2021, Aimed Alliance sent a letter to Pennsylvania legislators in support of HB 225 and SB 225. These bills would limit health plans’ use of step therapy and prior authorization requirements in favor of patient access and individualized care. For example, the bills prohibit health plans from imposing preauthorization requirements on treatment in a manner that would disrupt a stable patient’s continuity of care. Additionally, step therapy protocols must be developed based on clinical practice guidelines, developed by independent experts, and rooted in high-quality studies, research, and medical practice, among other criteria. Furthermore, the bills seek to establish clear step therapy exception processes that defer to the prescribing professional’s expertise and knowledge of the patient, ensuring patients receive treatment based on their unique circumstances. These bills also seek to reduce unnecessary delays in patient care by requiring that health plans accept preauthorization paperwork electronically. They contain provisions requiring health plans to report certain data on use of step therapy to the Insurance Department, which encourages compliance with the law. These added protections will be crucial in ensuring the professional-patient relationship is respected and in preventing delays in individualized treatment.
 
Additionally, on May 7, 2021, Aimed Alliance sent a letter in support of New Jersey A4815, which would establish similar patient protections for step therapy protocols. Read our letter here.
Fact Sheet on H.R. 3

Aimed Alliance has created a new fact sheet dedicated to H.R. 3, otherwise known as the Elijah E. Cummings Lower Drug Costs Now Act, a piece of pending legislation that could be included in the new federal infrastructure bill. The bill includes a variety of provisions aimed at lowering prescription drug prices and patient costs in Medicare and private markets, ranging from price negotiations to out-of-pocket caps. Some of the provisions, including the out-of-pocket cap for Medicare beneficiaries, allow beneficiaries to spread out cost-sharing throughout the year, and reinvestment in innovation could lead to strong patient outcomes, increasing prescription availability while providing direct relief to patients. However, other provisions could harm patients by leading to higher initial drug prices, decreased incentives to innovate, and the loss of an estimated eight to 15 fewer drugs in the next 10 years. Read more here.
Letter in Support of Connecticut Bill Prohibiting the Use of QALYs

On May 4, 2021, Aimed Alliance submitted a letter in support of Connecticut HB 6242 to members of the Connecticut legislature. The bill would prohibit the use of dollars-per-quality adjusted life year (QALY) or similar measures to limit coverage or reimbursement in health plans. Insurers use QALYs to justify limitations on patient access to treatment, and ignore the patients’ and practitioners’ valuation of treatment, treating the patient’s health and life as a commodity. The use of QALYs can lead to discrimination based on age or health status, as QALYs unfairly favor younger and healthier populations, and do not account for the possibility of disease remission. This leaves patients undervalued by their health plans, even if they achieve long-term stability without disease progression. Read the letter here.
Letter Urging HHS to Reinstate Ban on Step Therapy

Aimed Alliance joined 57 other patient advocacy groups and professional associations in a letter to the U.S. Department of Health and Human Services (HHS). The letter asked the agency to reinstate a ban on Medicare Advantage plans for using step therapy for Part B drugs. The letter was spearheaded by the American Academy of Ophthalmology.

Legislative Update


West Virginia Passes Drug Rebate Law

On April 9, 2021, West Virginia Governor Jim Justice signed HB 2263 into law, which requires pharmacy benefit managers to pass 100 percent of all drug rebates to the patient. It states that the value of the pharmacy benefit manager’s rebate must be subtracted from the patient’s cost-sharing requirement for each prescription drug at the point of sale. The law broadly defines a rebate as “any and all payments that accrue to a pharmacy benefits manager or its health plan client, directly or indirectly, from a pharmaceutical manufacturer, including, but not limited to, discounts, administration fees, credits, incentives, or penalties associated directly or indirectly in any way with claims administered on behalf of a health plan client.” The new law will become effective on Jun 28, 2021.

Copay Accumulator Programs
  • Tennessee: On May 12, 2021, Tennessee Governor Bill Lee signed HB 619 and SB 1397 into law, making Tennessee the ninth state to enact copay accumulator protections. The law requires insurers to include cost sharing amounts paid by or on behalf of an enrollee when calculating the enrollee’s contribution to an applicable cost sharing requirement.
  • Connecticut: On May 18, 2021, the Connecticut House passed S.B. 1003, which is currently awaiting the governor’s signature. The bill requires also health plans and pharmacy benefit managers to count third party payments toward the plan enrollee’s cost-sharing requirements.  

Nonmedical Switching Legislation
  • New York: New York state legislature passed S.4111 and A.4668, which are currently awaiting the governor’s signature. The bills prohibit plans from making mid-year formulary changes that will negatively impact plan enrollees resulting in nonmedical switching.
  • Connecticut: On May 25, 2021, the Connecticut House of Representatives passed H.B. 6622, which prohibits also prohibits certain negative midyear formulary changes. In particular, the bill prohibits plans from removing a prescription drug from the formulary or increasing cost-sharing for the prescription drug above $40 per month after the plan year has begun.

Colorado Price Control Legislation

On May 7, 2021, the Colorado senate passed SB 21-175, a bill that would create a drug affordability review board that could set arbitrary price controls for prescription medications. The bill prohibits plans from covering prescriptions that exceed the price cap set by the board. The board has the freedom to determine the methodology for establishing price caps, which could be inconsistent with how patients value the medications. If drug manufacturers and the board disagree on price caps, patients could lose access to their medications.

Events

In Case You Missed It


PhRMA Challenges the Medicaid Best Price Rule
 
On May 21, 2021, PhRMA filed a lawsuit against the Centers for Medicare and Medicaid Services (CMS) challenging the Medicaid Best Price Drug Rule. The rule requires copay assistance to be counted toward the calculation of a prescription medication’s best price if a health plan has implemented a copay accumulator program. This would disincentivize drug manufacturers from providing copay assistance to vulnerable patients who may not be able to afford medically necessary treatments. This limit on copay assistance would be compounded with the medical and financial difficulties imposed on patients by copay accumulator programs, which increase financial strain on patients and can lead to decreased medication adherence. In its lawsuit, PhRMA argues that CMS violated the Administrative Procedure Act and misinterpreted the word “price” and misinterprets the spirit of the law by essentially taxing manufactures for providing assistance to patients. 

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