Blue Cross Blue Shield Association Issues Public Comment on Centers for Medicare & Medicaid Services Notice

WASHINGTON, April 4 -- Kris Haltmeyer, vice president for legislative and regulatory policy in the Office of Policy and Representation at the Blue Cross Blue Shield Association, has issued a public comment on the Centers for Medicare and Medicaid Services' notice entitled "Pharmacy Benefit Manager Transparency for Qualified Health Plans". The comment was written on March 30, 2020, and posted on April 1, 2020:

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The Blue Cross Blue Shield Association (BCBSA) appreciates the opportunity to provide comments on the Pharmacy Benefit Manager Transparency for Qualified Health Plans (QHP) Paperwork Reduction Act (PRA) package, as issued in the Federal Register on Jan. 28, 2020.

BCBSA is a national federation of 36 independent, community-based and locally operated Blue Cross and Blue Shield companies (BCBS Plans) that collectively provide healthcare coverage for one in three Americans. For more than 90 years, Blue Cross and Blue Shield companies have offered quality healthcare coverage in all markets across America - serving those who purchase coverage on their own as well as those who obtain coverage through an employer, Medicare and Medicaid.

BCBSA supports transparency in the healthcare system, and in particular for prescription drugs, in a manner that upholds a competitive market. We appreciate CMS's efforts to preserve statutory confidentiality protections and minimize the burden on pharmacy benefit managers (PBMs) and Qualified Health Plan (QHP) issuers.

We provide the following recommendations to support an efficient data collection that protects proprietary and confidential information:

* Delay by one year the implementation of the reporting requirement. We understand CMS is proposing this information collection request applies to data from QHP policies and plans for the 2020 calendar year and would be reported in 2021. BCBSA is requesting this information collection be delayed for one year. PBMs and QHP issuers need additional time to establish policies and procedures for the collection, display and verification of information and data required under this PRA. In some instances, the primary concern for QHP issuers may be the need for time to modify contract terms with PBMs, and PBMs also may need time to modify contracts with manufacturers to ensure the transfer of data to support the accurate execution of this data request.

In addition, the burden of this new reporting requirement, with its demand on PBM and health plan staff and IT resources, would be compounded by CMS requirements for other regulatory initiatives and health plans' response to the COVID-19 pandemic.

* The Interoperability and Patient Access Final Rule requires health plans participating in public programs and offering QHPs, starting on Jan. 1, 2021, to provide patients with electronic access to their healthcare information using standard-based APIs.

* The Transparency in Coverage Proposed Rule, if finalized, would require health plans to: (1) provide cost information to members on all covered items and services; and (2) publish machine-readable files with specific payment amounts for every single item or service (including drugs and medical devices), within one year of publication of a Final Rule.

* BCBS Plans have made a systemwide commitment to ensure members can swiftly and smoothly access the right care in the right setting during the COVID19 pandemic. This commitment is absorbing Plan operations staff as they work to address the many challenges of covering a range of medical services, communicating with members, and adapting system capabilities to these changes in addition to adapting business operations for a remote workforce.

A one-year delay in the PBM Transparency for QHPs reporting requirements would allow PBMs and health plans to manage internal operational and IT resources to meet these regulatory and public health crisis demands.

* Support CMS collecting data from PBMs. BCBSA agrees with CMS that this reporting requirement should apply to PBMs administering benefits for QHP issuers. Health plans have access to pharmacy benefit data from their contracted PBMs, but the data is acquired and maintained by the PBM itself. Additionally, certain data are unique to PBMs, such as data related to rebates, bona fide service fees, amounts PBMs pay to pharmacies (e.g., bonus payments), and PBM spread amounts.

* Require data collection at the aggregate level and not at the National Drug Code (NDC) level. Sec. 1150A requires health benefits plans or PBMs to report on information with respect to the percentage of "all prescriptions" dispensed through different channels. The statute requires disclosure of the "aggregate amount" of rebates, discounts or price concessions attributable to the plan, the "aggregate amount" of rebates, discounts or price concessions passed on to the plan, and "the total number of prescriptions that were dispensed."/1

This language implies the Secretary of Health and Human Services has the authority to collect aggregate information on prescription drugs, but not data on individual drugs at the NDC level as proposed in the PRA. BCBSA recommends CMS limit the information collection accordingly.

* Require reporting at the QHP issuer level only and not at the plan level. We encourage CMS to collect aggregate data at the QHP issuer by Health Insurance Oversight System (HIOS) ID level, as opposed to the proposed reporting structure by QHP issuer by HIOS ID and plan level. BCBSA holds that the QHP issuer level of reporting meets the statutory requirement to submit information "with respect to services provided by a health benefits plan or PBM for a contract year."/2

In this subsection, the term "health benefits plan" refers to the QHP issuer, and the reporting should reflect submission of data at that level.

Should CMS proceed with a reporting structure at both the HIOS ID and plan level, we recommend a phased-in implementation. For example, CMS could require reporting at the HIOS ID level in the early years of implementation and expand to include plan-level data in future reporting years. CMS executed a similar strategy for the Transparency in Coverage reporting requirement (Section 1311(e)(3) of the Affordable Care Act) where health plans reported certain data elements at the issuer level in the early years and just recently expanded to reporting plan-level data. BCBSA believes a gradual implementation strategy is appropriate here, as well.

* Align the Affordable Care Act Medical Loss Ratio (MLR) terminology for price concessions with the terminology and definitions in this PRA. In the Notice of Benefit and Payment Parameters for 2021 Proposed Rule, CMS proposes changes to the MLR calculation as it relates to prescription drug rebates and other price concessions received and retained by PBMs. BCBSA understands the rationale behind the CMS proposal to include PBM-retained rebates and other price concessions in the Medical Loss Ratio (MLR) calculation. However, the term "other price concessions" as described in the Preamble is overly broad and would include fees paid by manufacturers for services the PBM provides to the manufacturer, such as providing information for manufacturer Food and Drug Administration (FDA) reporting and could even be read to include fees paid by the issuer to the PBM.

BCBSA recommends CMS align the definitions used in the MLR calculation with the definitions in statute (42 USC 1320b-23(b)(2)) and this PRA reporting requirement, including adding a definition of "bona fide service fees" consistent with what is finalized for this PRA reporting requirement.

* Support upholding the statutory confidentiality standards. BCBSA appreciates CMS' commitment via the Supporting Statement to maintain the confidential nature of these proprietary data as clearly outlined in the statute. We support protections against sharing information to certain government entities that disclose information identifying "a specific PBM, issuer, plan, or prices charged for drugs." This is critical to preserving the confidentiality of negotiations on drug prices and discounts between payers and manufacturers. We believe data reporting at an aggregate level and not at the NDC level, as described above, will help to preserve the confidentiality of these data and mitigate any unintended consequences associated with improper use or disclosure.

Thank you for considering our comments. We look forward to working with CMS in its efforts to bring about an efficient and secure reporting standard for PBMs. We welcome the opportunity to provide continuing feedback on how to establish the standards, definitions and forms for the data collection.

If you have any questions, please contact Paul Eiting, Director, Value-Based Policy, at 202.626.4832 or [email protected].

Sincerely,

Kris Haltmeyer

Vice President, Legislative & Regulatory Policy

Office of Policy and Representation

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Footnotes:

1/ 42 U.S.C. 1320b-23(b)

2/ Ibid

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The notice can be viewed at: https://www.regulations.gov/document?D=CMS-2020-0008-0001

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