Federal policy on the table for 2020 would encourage health insurance coverage for medication-assisted treatment (MAT) -- a vital step forward in addressing opioid misuse and addiction, the AAFP recently told HHS.
But the Academy is pushing for an even bolder move to address this serious national epidemic.
The Feb. 19 letter(5 page PDF) to CMS Secretary Alex Azar, signed by Board Chair Michael Munger, M.D., of Overland Park, Kan., was sent in response to the proposed rule(www.govinfo.gov) "HHS Notice of Benefit and Payment Parameters for 2020," which was published in the Jan. 24 Federal Register.
The proposed rule sets parameters for payment, cost-sharing and insurance exchange user fees. It also aims to reduce the cost of prescription drugs and change standards for eligibility, enrollment and exemptions, among other things.
Compulsory MAT coverage was one of several adjustments the Academy urged CMS to consider before the rule is finalized.
- Responding to HHS' Notice of Benefit and Payment Parameters for 2020, the Academy called on CMS to require insurers to offer comprehensive coverage of medication-assisted treatment and counseling.
- The AAFP's letter also reminded regulators that frequent formulary changes create confusion and frustration for patients and physicians, and it urged caution when allowing midyear formulary updates.
- Further, the Academy expressed concern about pharmaceutical manufacturers' rebates and coupons.
"The AAFP calls on HHS to require comprehensive coverage of MAT and counseling, as recommended by the FDA,(www.fda.gov) in all public and private health insurance plans," the letter said.
The proposed rule encourages insurers to provide comprehensive coverage of MAT, a move the Academy supported by pointing to its position paper on chronic pain management and opioid misuse, and referring to guidelines from federal and state authorities as well as other professional organizations.
"The AAFP encourages HHS to consult these resources and work toward a nationwide, comprehensive coverage of drugs used in MAT," the letter said.
The AAFP also opposed limits on MAT duration and reminded HHS that the FDA and the Substance Abuse and Mental Health Services Administration acknowledge that the course of MAT may need to be lifelong.
Midyear Formulary Changes
CMS has proposed allowing midyear formulary changes when a generic equivalent of a prescription drug becomes available, a move that would let insurers remove the equivalent brand drug from their formulary or move it to a different cost-sharing tier. Enrollees seeking coverage for a removed drug would be allowed to appeal.
The AAFP agreed with the proposal to permit the addition of generic equivalents to formularies midyear, but only in a way that allows greater choice in prescribing -- not to force a midyear change to a generic drug.
"The AAFP urges caution on the use of mandatory generic substitution and removing equivalent brand drug(s) from the formulary," the Academy responded. "The AAFP believes patients should not be changed to a new product based solely on economic considerations, especially if a patient's current prescription regimen is stable."
Moreover, said the Academy, brand-name drugs should never be moved to a higher cost-sharing tier in the middle of a year.
"Formularies must be stable, since frequent changes create confusion and frustration for patients and physicians, leading to noncompliance, adverse reactions, increased costs and erosion of patients' confidence," the letter said.
Prescription Drug Substitution
CMS asked for comments on existing standards for therapeutic substitution, as well as reference-based pricing for prescription drugs.
"The AAFP strongly opposes efforts to permit therapeutic substitution," the Academy replied.
Further, "the AAFP opposes the repeal or dilution of any state or national anti-substitution laws or regulations governing the filling of the prescription from the physician by a pharmacist, particularly when a prescription includes a 'dispense as written' clarification."
The AAFP noted that medication-substitution protocols such as step therapy, along with drug formularies that "encourage cost containment without consulting physicians or assessing patients' medical histories," undermine the doctor-patient relationship.
Reference-based pricing, meanwhile, could increase consumer out-of-pocket costs, the AAFP cautioned. "It is well known that increasing patient cost-sharing is associated with declines in medication adherence, which in turn is associated with poorer health outcomes."
Cost-sharing Requirements for Generic Drugs
Citing AAFP policy on generic drugs, the letter reiterated the Academy's opposition to mandatory generic substitution while repeating its strong support for the elimination of a key administrative burden: prior authorization for generic drugs.
CMS' proposed rule, however, would allow plans that cover both a brand-name prescription drug and its generic equivalent to consider exempting the brand drug from the essential health benefit (EHB) mandate, with some exceptions.
The AAFP noted that under the proposed rule, a plan could decide that the difference in cost-sharing between a brand and generic drug would not count toward annual cost-sharing limits, a move that would allow lifetime and annual dollar limits on these brand drugs.
The Academy objected, saying that such a rule would violate patient protections.
"The AAFP does not support removing brand drugs from EHBs, even if they are substituted by generic equivalents," the letter said. "Further, the AAFP does not support imposing lifetime and annual dollar limits on brand-name drugs. Nor does the AAFP support ignoring the entire amount paid for brand drugs or the difference in cost-sharing between brand and generic drugs in the calculation of a patient's annual limitation on cost sharing."
Drug Manufacturers' Coupons
To attract new users of brand-name drugs, pharmaceutical companies have long offered coupons and rebates directly to consumers -- marketing that experts say(insight.kellogg.northwestern.edu) drives up prices for insurers, who pass along that cost to patients.
CMS' proposed rule would allow insurers not to count direct support offered by drug manufacturers -- such as coupons and rebates -- toward annual cost-sharing limits. The idea, the agency said, was to promote prudent choices by physicians and patients based on the true costs of drugs, as well as pharmaceutical price competition.
The Academy's response emphasized the importance of drug-pricing transparency.
"Coupons entice patients to obtain the brand-name drug because the patient's out-of-pocket costs are reduced, yet health insurers are still forced to pay for the brand-name drug," the letter said. "They in turn likely push the cost of paying for expensive brand name drugs to patients through increased premiums. Ultimately, the patient pays more, just in a different way."
The letter referred to the AAFP's policy on patient-centered formularies, which points out that manufacturers' discounts and rebates may lead to compromised care and excessively high premiums.
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