Intersect Healthcare Issues Public Comment on Centers for Medicare & Medicaid Services Proposed Rule

WASHINGTON, Oct. 19 -- Intersect Healthcare Inc., Towson, Maryland, has issued a public comment on the Centers for Medicare and Medicaid Services proposed rule entitled "Medicare Program: Medicare Coverage of Innovative Technology and Definition of Reasonable and Necessary". The comment was posted on Oct. 15, 2021:

The comment was co-signed by Brian McGraw, president; Raymond Kendall Smith Jr., chief physician advisor; and Denise Wilson, senior vice president of appeal services.

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Intersect Healthcare, Inc. (IHI) is pleased to submit its comments to the Centers for Medicare and Medicaid Services (CMS) about its proposal to repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary" (R&N) rule./1

IHI is a provider of denial and appeal management consulting and denial management technology for healthcare providers. Through their affiliate Denial Research Group, IHI also offers clinical appeal consulting to help providers protect their revenue, including medical necessity and coding audits, and QIO/FI/RAC/MIP Medicare & Medicaid appeals aimed at obtaining the proper DRG assignment and reimbursement.

In the proposal to repeal the MCIT/R&N rule, CMS expresses its concerns about whether it will retain authority as it renders coverage determinations for breakthrough devices, using the FDA's regulatory process and current data, as the MCIT pathway is designed to introduce breakthrough devices into the stream of healthcare commerce.

CMS acknowledges the overwhelming response to its proposed changes including a codified definition of "reasonable and necessary" where the meaning of "appropriate" is based on commercial health insurers' coverage policies rather than the standards in the practice of medicine. CMS also acknowledges concerns about how the changes to "appropriate" create more flexibility in the definition of "reasonable and necessary," in favor of commercial insurers.

Medicare Coverage of Innovative Technology (MCIT)

As a leader of innovative technology, IHI strongly supports efforts to use technology to better serve health systems and ultimately improve patient care.

The agency's proposed rule that introduces the MCIT pathway received favorable recognition from non-providers like manufacturers and top venture capital investment firms.

The agency takes issue with the possibility of providing coverage for those that do not fall within the Medicare population comprised of over 61 million beneficiaries./2

Based on the trend of increasing numbers in Medicare beneficiaries, regardless of the agency's methods for limiting coverage or the implement of the MCIT program, it is foreseeable that CMS coverage determinations will increase in the future because the Medicare population continues to grow.

As to the agency's concerns about providing coverage without determining that a Breakthrough Device would be reasonable and necessary treatment for the Medicare patients that have a particular disease or condition that the device is intended to treat or diagnose, IHI recommends the following considerations to CMS:

* Considering how technology may increase greater access to care and to determine whether the MCIT pathway serves this purpose.

* Gathering more data by conducting clinical trials where the treating physicians are involved as well as clinicians qualified to render an opinion on medical necessity.

* Conducting extensive clinical trials including using sample sizes where all the test subjects are Medicare beneficiaries, and comparing the results of groups involving test subjects with similar characteristics of the Medicare population.

Control: Sample size sharing similar characteristics of the Medicare population who receives the medical device.

Experimental: Sample size sharing similar characteristics of the Medicare population who do not receive the medical device.

* To determine whether the clinical trials show that the use of medical devices improved patients' condition.

Assuming the agency can coordinate with collaborating agencies like the Food and Drug Administration (FDA) or other relevant agencies, IHI emphasizes the importance of patient-focused healthcare to preserve the value of care, especially if this requires increasing access to care through technology.

Definition of "Reasonable and Necessary"

IHI strongly supports efforts to increase access to healthcare to ensure patients can receive the appropriate medical care, which stems from the standards in the practice of medicine.

Under the current definition, an item or service is deemed ''reasonable and necessary'' if it is (1) safe and effective; (2) not experimental or investigational; and (3) appropriate, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is:

* Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member;

* Furnished in a setting appropriate to the patient's medical needs and condition;

* Ordered and furnished by qualified personnel;

* One that meets, but does not exceed, the patient's medical need; and

* At least as beneficial as an existing and available medically appropriate alternative.

IHI recognizes that practices in healthcare will change and evolve over time; however, IHI strongly opposes the consideration of any criteria that contravenes the treating physician's clinical judgment when determining what is "reasonable and necessary." On one hand, CMS is a government agency whose public service mission is to ensure that "all CMS beneficiaries have achieved their highest level of health, and disparities in healthcare quality and access have been eliminated."/3

On the other hand, commercial insurers have a profit-making mission to implement systematic mechanisms that are profit-driven, which is different from public interest./4

To align with the mission of CMS, IHI urges the agency to adhere to a definition of "reasonable and necessary" that is patient-focused. IHI also urges the agency to recall that the legislative intent of Medicare clearly states, "the physician is to be the key figure in determining utilization of health services."/5

As such, given the distinct missions between CMS and commercial insurers, the commercial insurance aspects of the rule ultimately deviate from the treating physician's clinical judgment, facts in the medical record, and patient-centered practices for determining care that is "reasonable and necessary." IHI extends itself to the agency should CMS and its collaborative agencies require guidance on the implementation of the MCIT pathway using clinical evidence supported by the practice of medicine. IHI also supports the agency's repeal of a modified and codified definition of "reasonable and necessary." IHI appreciates the opportunity to comment on the proposal to repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary" (R&N) rule./6

If you have any questions or require additional information, please contact Chrysalis Borja, [email protected] or 410-252-4343 ext. 144.

Sincerely,

Brian McGraw, President

Dr. Raymond Kendall Smith, Jr., MD, SFHM, Chief Physician Advisor

Denise Wilson, MS, RN, RRT, Senior Vice President of Appeal Services

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Footnotes:

1/ See Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary," 86 Fed. Reg. 51326 (Sept. 15, 2021).

2/ See Total Number of Medicare Beneficiaries, State Health Facts, Kaiser Family Foundation, (2020) https://www.kff.org/medicare/state-indicator/total-medicare-beneficiaries/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D; see also Ben Umans, The Medicare Beneficiary Population, AARP Public Policy Institute, (2009), https://www.aarp.org/health/medicare-insurance/info-01-2009/fs149_medicare.html#:~:text=Currently%2C%2044%20million%20beneficiaries%E2%80%94some,to%2079%20million%20by%202030.

3/ See Mission, Vision & Our Work, CENTERS FOR MEDICARE & MEDICAID SERVICES, https://www.cms.gov/About-CMS/Agency-Information/OMH/about-cms-omh/mission-vision-our-work

4/ See Niharika Namburi and Prassan Tadi, Managed Care Economics, StatPearls, (Feb. 4, 2021), https://www.ncbi.nlm.nih.gov/books/NBK556053/

5/ See 1965 U.S.C.C.A.N. 1943, 1986; see also Hultzman v. Weinberger, 495 F.2d 1276, 1279 (3d Cir. 1974); see also Reading v. Richardson, 339 F.Supp.295, 300-01 (E.D. Mo. 1972); see also Kuebler v. Secretary, 579 F. Supp. 1436, 1440 (E.D.N.Y. 1984); see also Breeden v. Weinberger, 377 F. Supp. 734, 737 (M.D. La. 1974).

6/ See Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary," 86 Fed. Reg. 51326 (Sept. 15, 2021).

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The proposed rule can be viewed at: https://www.regulations.gov/document/CMS-2020-0098-0560

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