Drug Substitution Language In E-Health Record Regs Concerns PhRMA

The Pharmaceutical Research and Manufacturers of America and drug manufacturers offer comments on HHS’ proposed next-stage requirements for electronic health records, which physicians and hospitals will have to meet in order to qualify for incentive payments for the meaningful use of EHRs.

The Pharmaceutical Research and Manufacturers of America is questioning whether language in the draft criteria for stage 3 of the meaningful use rules for electronic health records (EHR) implies that formulary checks as part of electronic prescribing could lead to unnecessary therapeutic substitution.

In comments on the proposed rule, PhRMA notes that in the stage 2 requirements, there is a criterion that more than 50% “of all permissible prescriptions written by [eligible professionals] are compared to at least one drug formulary and transmitted using certified EHR technology.” The stage 3 draft proposal modifies the criterion to follow drug formulary with “(reviewed for generic substitutions).”

The addition of the parenthetical clause is raising a red flag for the industry association.

“While PhRMA does not oppose substitution of A/B-rated generics for their brand equivalents, we suggest the [Health IT Policy Committee] omit the parenthetical, which as written could be read to encourage not simply the use of the generic equivalent but therapeutic substitution (dispensing of a different chemical entity within the same drug class),” the group wrote in its comments. “Additionally, we are concerned that added ‘reviewed for generic substitution’ implies that the sole purpose of a formulary review is to check for generic substitutions.”

PhRMA said that formulary checks serve other purposes, such as “determining if the medicine would be covered by the patient’s insurance and the applicable copayment or cost sharing. Information about coverage and cost sharing can help patients and physicians select the most appropriate treatment,” and recommended that the parenthetical be removed.

The meaningful use incentive program was included in the 2009 American Recovery and Reinvestment Act as a way to encourage physicians and hospitals to adopt and use electronic health records (Also see "Adoption Of E-Health Records Gets Stimulus Of Medicare Rewards, Penalties" - Pink Sheet, 2 Mar, 2009.). Eligible providers and hospitals receive bonus Medicare or Medicaid payments by adopting EHRs and demonstrating meaningful use through meeting criteria developed by the Office of the National Coordinator for Health Information Technology and implemented through the Centers for Medicare and Medicaid Services.

In separate comments, Pfizer Inc. expressed concerns regarding the formulary checks in EHR e-prescribing, particularly about the availability of accurate formularies from which decisions are made.

“Pfizer remains concerned about providers’ abilities to readily access formularies and the level of accuracy delivered at the point of care,” the company said in comments on the draft stage 3 proposal. “Today, patient-specific formularies are not often available to the provider, either because the health plan does not participate in a national e-prescribing network or the health plan has not made the patient’s specific electronic formulary readily available through a particular physician’s certified EHR product.”

Pfizer also noted that there is no formulary and benefits standard for certified EHR technology and suggested one be created “that will provide formulary data based on an individual patient’s insurance benefit.” The company added that information is not provided in a uniform fashion, and maintained that sometimes information is presented in a way that does not necessarily offer health care providers a complete picture about a patient’s formulary. As an example, it described an unnamed EHR that shows a drug product with a picture of a face with a red frown, which on the EHR could mean one of three things – the drug is a tier 3 drug on the formulary, it has a $40 copay or it requires prior authorization.

The company “believes this is a real gap in the formulary data provided at the point of care, and the industry needs a standard to support real-time access to up-to-date formulary information similar to the information pharmacy benefit managers provide to pharmacies.”

Comments from GlaxoSmithKline PLC also suggested the agency move up planned future criteria on automatic electronic prior authorization functions into the final standard.

“Although early pilot testing revealed that an e-Prior Authorization standard was not market-ready to integrate with the e-prescribing standard, there is consistent demand from EPs [eligible professionals] and a renewed interest in completing the NCPDP standard,” GSK wrote in its comments. “A recommendation by the [Health IT Policy Committee] for stage 3 would bring all stakeholders together to finalize the existing draft standard.”

In its comments, the e-prescribing vendor Surescripts also called for e-prior authorization to be included, as a menu item that eligible providers will have the option to follow to demonstrate meaningful use.

Adverse Event Reporting

The stage 3 meaningful use proposal includes a provision that EHRs be able to transmit adverse event information to FDA, though no specific details are offered on how this is to be accomplished (Also see "Adverse Event Reporting Included In Draft Electronic Health Record Standards" - Pink Sheet, 16 Aug, 2012.).

PhRMA offered its support of the concept but suggested additional actions to clarify how it can be enacted.

“Because patient safety is of the upmost importance to biopharmaceutical companies, adverse event reporting is a critical activity that is undertaken with great care,” PhRMA wrote in its comments. “While PhRMA supports reducing the burden on physicians by enabling adverse event reporting through EHRs, we believe a few areas need to be addressed as part of implementation in order to help ensure that drug safety efforts involving companies and FDA effectively protect patients.”

The association’s recommendations include:

• Reporting through EHRs should be fully consistent with reporting through FDA’s MedWatch program. Lack of coordination could result in conflicting drug safety data for medicines, which would interfere with effective regulation.
• HHS needs to clearly define who is responsible for the integrity of the data in the EHR.
• As currently envisioned, the sponsor does not have access to EHRs to enable tracking of adverse events. While the FDA does publicly report adverse events, those reports do not include all of the information that the FDA receives. In order to perform effective pharmacovigilance, companies need all adverse event data submitted to respond to adverse events. Therefore, PhRMA recommends that HHS should provide companies either (a) access to the EHRs to enable adverse event tracking or (b) adverse events should be reported by health care professionals to sponsors in addition to the FDA/Centers for Disease Control and Prevention.
• EHR requirements need to be aligned with all FDA data standards efforts.

Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, identified adverse event reporting as an area where EHRs could help FDA’s oversight of the pharmaceutical industry (Also see "EHRs A Tool For Drug Label Communications, Adverse Event Reporting And Adherence – FDA’s Woodcock" - Pink Sheet, 27 Feb, 2012.).