Comments in response to “Request for Information; Reducing Administrative Burden To Put Patients Over Paperwork”


Secretary Azar and Administrator Verma,

Thank you for this opportunity to comment on the Request for Information concerning “Reducing Administrative Burden To Put Patients Over Paperwork,” CMS-6082-NC.   We appreciate your efforts to reduce unnecessary paperwork in order to “unleash the most powerful force in our healthcare system for improving health outcomes: The clinician-patient relationship.”

We write today to flag four targeted burdens that we feel are overdue for being addressed:

1) Revoke requirements that private contracts between Medicare patients and physicians opted-out of Medicare be resigned every two years.

The RFI asks for suggestions for streamlining of documentation requirements, and facilitating individual patient preferences. Making this change would accomplish both.

We ask that 42 C.F.R. § 405.415(h) be revised and (o) revoked in compliance with the administrative simplification directives of the Administration and statutes as revised by MACRA. In fact, if CMS is looking for a regulation to revoke in accordance with the Executive Order on “Reducing Regulation and Controlling Regulatory Costs,” which requires the elimination of two regulations for every new regulation, then 42 C.F.R. § 405.415(o) is an excellent regulation to consider for deletion.

The MACRA statute reduces regulatory burdens on physicians opted out of Medicare, but corresponding regulations that impact patients and their private contracts with opted-out physicians were not properly revised in past rulemaking.  It is not statutorily justified to require that a contract between a patient and opted-out physician be tied to a 2-year period. Patients and physicians should maintain the flexibility to agree upon any mutually desired contract length. Contracts should be allowed to remain in effect as long as the physician remains opted out of Medicare.

In addition, confusion exists in the patient and physician community regarding this requirement, partly due to inconsistent guidance provided by CMS and its contractors. Ending this requirement would be the best way to resolve the confusion.

The revision of 42 C.F.R. § 405.415(h) and revocation of (o) would also advance HHS goals of “reducing barriers to choice and competition and increasing the availability of high-quality care at affordable prices.”

2) Revise and clarify Medicaid rules harming Medicaid patients’ access to independent physicians

ACA Section 6401(b)(1) and the Cures Act Section 5005(b)(2) require physicians ordering and prescribing for Medicaid patients, or treating Medicaid Managed Care patients, to enroll in Medicaid, even when the physicians receive no payment directly from the Medicaid program. Enrollment of course requires paperwork but also binds the physician to myriad counterproductive rules and regulations that pile on even more paperwork burden.

This ACA requirement creates barriers for Medicaid patients who wish to self-pay to receive inexpensive, high-quality, medical care from a Direct Primary Care (or other 3rd party free physician) but wish to use their Medicaid benefits for prescriptions, labs, imaging or other needed diagnostics. It is particularly a problem for Medicaid patients seeking treatment for opioid addiction.

Medicaid patients are thereby losing flexibility to choose a doctor of their choicet. Blocking these patients’ ability to work with direct-pay physicians is harmful to these patients and is bad public policy as it increases costs to taxpayers.

In prior rulemaking, CMS has stated the following: “State Medicaid agencies may implement a streamlined enrollment process for those providers who only order or refer, that is, who do not bill for services, similar to the CMS–855–O process in the Medicare program.”

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However, some states still claim their hands are tied by CMS, and these states are refusing to allow cash-based physicians the opportunity to enroll solely for the purposes or ordering, referring, and prescribing. 

We ask CMS to clarify guidance and regulation to encourage and expand the ability of direct-pay practices to serve these patients, who are too often unable to obtain actual medical care within the Medicaid system.

In addition, certain states hold the position that independent, non-Medicaid-contracted physicians are summarily prohibited from privately contracting with cash-paying Medicaid patients.  We know of no federal regulation or statute prohibiting this, and we ask CMS to encourage states to allow increased freedom of physician choice for Medicaid patients.

We ask further that CMS encourage Congress to repeal the related statutes creating these impediments to care: ACA Section 6401(b)(1) [42 U.S.C. 1396a(kk)(7)(A)] and Cures Act Section 5005(b)(2) [42 U.S.C. 1396u–2(d)(6)].

CMS should use all available discretion to halt enforcement of these regulations while it works with Congress to end them.

3) Delay “Appropriate Use Criteria” (AUC) red tape that discourages and delays needed diagnostic testing.

We ask CMS to put the brakes on steps toward full implementation of the “Appropriate Use Criteria Program.”  Requiring physicians to consult a federally overseen “Clinical Decision Support” algorithm when choosing care for their patients not only creates more paperwork burden, but is an improper intrusion into the physician-patient relationship.  CMS has already exercised its discretion to delay enforcement of AUC mandates from 2018 to 2020, and it should do so again. Halting this program, while working with Congress to repeal it, is the right choice to protect patient choice and will also further the goals of CMS to reduce administrative burden.

4) Enforce existing CMS regulations that prohibit counter productive certification mandates on physicians and protect patient choice

One of the most underreported examples of administrative burdens that puts paperwork over patients are those imposed by The American Board of Medical Specialties and American Osteopathic Association, in collaboration with hospitals and insurers, in the form of costly and counterproductive “Maintenance of Certification” requirements on physicians. This anti-competitive behavior is blocking patient access to physicians of their choice and driving up costs for patients and taxpayers without any proven benefit. Nationwide these costs are estimated to be $5.7 billion over 10 years and 32.7 million lost physician-hours.

CMS has a longstanding “Condition for Participation” outlined at 42 CFR 482.12, that instructs Medicare participating hospitals to “Ensure that under no circumstances is the accordance of staff membership or professional privileges in the hospital dependent solely upon certification, fellowship, or membership in a specialty body or society.”

While current CMS interpretive guidance of this regulation, outlined in “Pub. 100-07 State Operations Provider Certification, 2008” essentially renders it unable to prevent improper mandatory Maintenance of Certification mandates, past enforcement was reportedly more protective in this regard.

In light of increased attention by courts, state legislatures, medical societies, the media, and others, we encourage HHS to reexamine and restore the role of 42 CFR 482.12 in curbing, what experts with Federal Trade Commission credentials describe as, “certification requirements that impose costly entry barriers for physicians” resulting in “limited quality benefits and information for consumers.”

Thank you for considering and acting on the above requests that aim to help CMS implement policies that put patients over paperwork. We would welcome questions or further discussion as needed.