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Submitted Electronically Via Federal Rulemaking Portal: www.regulations.gov
Center for Medicare & Medicaid Services
Department of Health and Human Services
P.O. Box 8016
Baltimore, MD 21244-8016
RE: Interoperability and Patient Access Proposed Rule
To Whom It May Concern:
The U.S. Chamber of Commerce (the “Chamber”) submits these comments to the Centers for Medicare and Medicaid Services (“CMS”) in response to the Proposed Rule, which is intended to move the health care ecosystem in the direction of interoperability, and to improve the access to and quality of information that Americans need to make informed health care decisions.
According to CMS, this “proposed rule is the first phase of proposed policies centrally focused on advancing interoperability and patient access to health information.” (Emphasis added.) While the Chamber strongly supports efforts to advance interoperability and improve patient access to health information, we encourage CMS to take a more measured approach.
We are concerned about the tremendously expansive scope of the Proposed Rule and some of the very problematic components within, including:
- The disclosure of private contract terms and negotiated reimbursement rates.
- The questionable ability to ensure patient information is protected and secure when it is given to/managed by third parties that are not Health Insurance Portability and Accountability Act (“HIPAA”) covered entities.
- The unrealistic timeframe, which suggests that these requirements would affect plans beginning in 2020.
IMPROVE PATIENT ACCESS TO MEDICAL AND CLINICAL INFORMATION, NOT NEGOTIATED CONTRACT RATES
The Chamber urges CMS to reconsider the breadth of the Proposed Rule. Like CMS, the business community has long favored “putting patients at the center of their health care and ensuring that they have access to their health information.” However, we strongly oppose a regulation that would mandate the disclosure of negotiated contract rates and terms between private entities in a competitive market such as health care. Instead, we encourage CMS to focus on improving access to health information that is meaningful and helpful to consumers and patients.
We support the core policy principle: every American should be able to see, obtain, and use all electronically available information that is important (rather than relevant) to their health, their care, and their choices. Individuals should have information about their current and past medical conditions and care received, and the Chamber supports efforts to enable better aggregation of this information rather than forcing patients to log into different provider portals. Individuals should also have information about the services they receive, results of tests and diagnoses as well as information about the out-of-pocket costs they are responsible to cover. However, the patient does not need to know the negotiated rate that the carrier has privately contracted to pay the provider. This information is not important (or even relevant) to individual’s health, care or choices and on the contrary it would likely lead to increased costs.
As a business organization committed to free markets and competition, we are also mindful that transparency of trade secrets and fee arrangements often has a perverse impact on price. As the Federal Trade Commission appropriately articulates, “…transparency is not universally good. When it goes too far, it can actually harm competition and consumers. Some types of information are not particularly useful to consumers, but are of great interest to competitors.” Disclosing negotiated payment rates would unbalance leverage during negotiations, hinder market competition, and increase prices; this requirement is also inconsistent with existing Medicare Advantage and Part D non-interference statutory frameworks. Instead, there are other ways to provide useful information to consumers without disclosing contracted information or trade secrets.
DATA PRIVACY AND SECURITY CONCERNS
The Chamber is very concerned about the security of open application program interfaces (“open APIs”) and the disparate application of HIPAA liability and protections in the Proposed Rule between issuers and APIs. We urge CMS to extend a safe-harbor to issuers that appropriately transmit data as required. Carriers should not be held liable for a security breach that occurs due to actions taken by a third party and should not be responsible for ensuring that a third party complies with its privacy and security obligations under state and federal law. Additionally, CMS should make it clear that insurers may delay and/or deny certain apps that are suspected of or proven to be bad actors.
In addition to creating safe-harbors for issuers, we urge CMS to consider possible ways to limit the way APIs can disseminate, use and possibly sell the information they receive. The Chamber is very concerned that this data may be sold and used inappropriately.
PROPOSED TIMING IS UNREALISTIC
We were heartened when CMS recently announced that “based on public comments received on this proposed rule, we will adjust the effective dates of our policies to allow for adequate implementation timelines as appropriate.” We appreciate CMS’ willingness to adjust implementation timelines and urge modifications be made in the Final Rule because the timeline in the Proposed Rule is unworkable. CMS would require Medicare Advantage organization and qualified health plan issuers in the Federally-facilitated Exchange to meet the proposed requirements beginning January 1, 2020. Medicaid managed care plans would have a few more months, until July of 2020, in order to comply. It is neither reasonable nor possible for health plans to develop and sufficiently test an API in that period, particularly given the sensitivity of the information that the API would handle. Therefore, we urge CMS to adopt a timeframe whereby these proposals be effective no earlier than January 1, 2022 and to clarify in the Final Rule precisely what actions plans must complete by the effective date.
The Chamber shares the goal of the improving access to information that is important to individuals but urges CMS to address our three thematic concerns. In the interest of ensuring that the information collected and made available is helpful to patients and does not increase prices, we urge CMS to focus first on aggregating health information and medical/clinical data as opposed to privately negotiated contractual terms and reimbursement amounts. Additional safe-harbors must be extended to insurers and greater protections are necessary to ensure that data is not improperly disseminated. Finally, CMS must extend the timeframe to allow for end-to-end testing. We look forward to continuing to work together to advance and improve patient access to important and meaningful health information.
Vice President, Health Policy
U.S. Chamber of Commerce