America's Health Insurance Plans Issues Public Comment on Centers for Medicare & Medicaid Services Notice
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On behalf of
Health insurance providers commend the administration's commitment to addressing high drug prices and improving drug cost transparency. As CMS implements the statutory provisions requiring PBM transparency for qualified health plans (QHPs) we offer recommendations below to ensure these statutory reporting requirements are implemented in manner that: (1) conforms to statute and regulation and clearly articulates obligations for various entities; (2) protects sensitive business information and patient confidentiality; and (3) allows enough implementation time for accurate and meaningful reporting.
I. Align to Statute and Regulation and Clarify Obligations
Section 1150A of the Social Security Act, as added by the Affordable Care Act (ACA), requires aggregate reporting of specified variables related to prescription drug coverage provided under a QHP sold on an exchange.
Regarding, which entity reports. The statute states:
(a) Provision of Information. --A health benefits plan or any entity that provides pharmacy benefits management services on behalf of a health benefits plan (in this section referred to as a "PBM") that manages prescription drug coverage under a contract with--
....
(2) a qualified health benefits plan offered through an exchange established by a State under section 1311 of the Patient Protection and Affordable Care Act, shall provide the information described in subsection (b) to the Secretary and, in the case of a PBM, to the plan with which the PBM is under contract with, at such times, and in such form and manner, as the Secretary shall specify.
Recommendations:
* Update the information collection request (ICR) to require information to be collected at the QHP issuer level rather than the plan level. The statute does not specify that information should be collected at the level of granularity proposed in the ICR, at the plan level.
* Update the ICR to require aggregate reporting rather than reporting at the National Drug Code (NDC) level. The statute requires aggregate reporting and references the percentage of "all prescriptions." The statute requires disclosure of the "aggregate amount" of rebates, discounts or price concessions, the "aggregate amount" of rebates, discounts or price concessions that are passed on to the plan, and the "the total number of prescriptions that were dispensed." This language articulates authority to collect aggregate information on prescription drugs but not on individual drugs at the NDC level.
* Exclude the reporting of bona fide services. The statute explicitly states that bona fide service fees are excluded from the aggregate reporting requirement for "rebates, discounts and price concessions" for both Part D sponsors and QHPs.
* Clarify reporting obligations for QHPs and PBMs respectively. Health insurance providers and PBMs need clear guidance on which entities are required to report data to CMS for the new ICR. The regulation implementing the statute, 45 CFR 156.295 references the QHP issuer in describing reporting obligations. In the ICR documents, it appears CMS is placing the reporting obligation on the PBM.
* Update the regulation to clarify that the QHP issuer may delegate this reporting to the plan's PBM. QHP issuers use a variety of vendors and partners to deliver benefits and analyze data. Regulations and guidance regarding QHP PBM reporting obligations should make it clear that nothing in federal regulations or guidance prevents the QHP from delegating this reporting responsibility to the PBM in contract.
* Finalize the proposed definitions of "price concessions" and "bone fide service fees." We strongly support the proposed definition of price concessions in the ICR which align to the definitions in the implementing regulation. We recently commented in response to the proposed 2021 Notice of Benefit and Payment Parameters recommending CMS define "price concessions" to conform to the definition in this ICR for purposes of medical loss ratio reporting.
II. Confidentiality & Patient Privacy
When
The importance of protecting confidential data is recognized in laws such as the Freedom of Information Act (FOIA), the federal Defend Trade Secrets Act, and trade secrets acts in individual states. These laws recognize the importance of protecting confidential information from public disclosure in order to avoid competitive harm.
Nevertheless,
As recognized by the
In Section I above, to better align the ICR with the statute and regulation we recommended requiring reporting at the QHP issuer level rather than plan-level; and requiring aggregate reporting rather than NDC-level. These changes are also needed to ensure sensitive business information and patient confidentiality are protected. Reporting at the NDC code level would reveal the discounts associated with specific drugs for specific plans. In a state with a small individual market, like
Recommendation:
* Ensure the confidentiality under the information submitted under this ICR. It is critical the ICR more directly address the confidentiality of data including issuer level reporting rather than the NDC-level. This would also include ensuring adequate procedural protections for the submitters of information, and consideration of the unintended consequences attendant with improper use or disclosure.
III. Implementation Timeline
These new reporting requirements will require data inputs from both the health insurance provider and the PBM that manages prescription drug benefits on behalf of the health insurance provider. Some of the data elements to be reported may not be currently tracked in the manner envisioned by CMS. As a rule of thumb, new reporting requirements should be known before plans are filed with state regulators for the first benefit for which the reporting is required.
When the final reporting requirements are published, QHP issuers and PBMs will need to work together to implement new processes and technology to gather information and report it in the required format. Health insurance providers and PBMs will also need to review their contracts and agree on how each entity will provided needed information to complete the reports. Once contracts are updated to reflect these agreements, health insurance providers and PBMs will need time to implement any new processes before the benefit year begins.
Recommendation:
* Designate 2022, or a later year, as the first benefit year this reporting will be required. As 2021 QHP product design are due to state regulators for review beginning in
We appreciate the opportunity to comment on this ICR and look forward to working with CMS as they implement requirements on drug cost transparency.
Sincerely,
Senior Vice President
Product, Employer and Commercial Policy
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Footnote:
1/ AHIP is the national trade association representing the health insurance community. AHIP's members provide health and supplemental benefits through employer-sponsored coverage, the individual insurance market, and public programs such as Medicare and Medicaid. AHIP advocates for public policies that expand access to affordable health care coverage to all Americans through a competitive marketplace that fosters choice, quality, and innovation.
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The notice can be viewed at: https://www.regulations.gov/document?D=CMS-2020-0008-0001
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