Intersect Healthcare Issues Public comment on proposed rule from Centers for Medicare & Medicaid Services

WASHINGTON, October 19 – Intersection Santé Inc., Towson, Maryland, posted a public comment on the Medicare and Medicaid Service Centers proposal for a rule entitled “Health insurance program: health insurance coverage of innovative technologies and definition of what is reasonable and necessary”. The comment was posted on October 15, 2021:

The comment was co-signed by Brian mcgraw, President; Raymond Kendall Smith Jr., Chief Medical Officer; and Denise wilson, Senior Vice President of Appeal Services.

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Intersection Health, Inc. (IHI) is pleased to submit its comments to Medicare and Medicaid Service Centers (CMS) on its proposal to repeal Medicare Coverage for Innovative Technologies (MCIT) and the definition of the “Reasonable and Necessary” (R&N) rule ./ 1

IHI is a provider of denial and call management consulting and denial management technology for healthcare providers. Thanks to their affiliate Denial Research Group, IHI also offers clinical appeal counseling to help providers protect their income, including medical necessity and coding audits, and QIO / FI / RAC / MIP Medicare & Medicaid appeals to obtain attribution and clearance. appropriate reimbursement of DRGs.

In the proposed repeal of the MCIT / R&N rule, CMS expresses concerns about whether it will retain its authority when making coverage determinations for revolutionary devices, using the FDA current regulatory process and data, as the MCIT path is designed to introduce breakthrough devices into the flow of healthcare commerce.

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

Innovative Technology Health Insurance Coverage (MCIT)

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

The agency’s proposed rule that introduces the MCIT route has received favorable recognition from non-suppliers such as manufacturers and major venture capital firms.

The agency disputes the possibility of providing coverage to those outside the Medicare population of more than 61 million beneficiaries. / 2

Based on the trend of increasing numbers of Medicare beneficiaries, regardless of the agency’s methods of limiting coverage or the implementation of the MCIT program, it is predictable that CMS coverage determinations will increase. in the future as the Medicare population continues to grow.

Regarding the agency’s concerns about providing coverage without determining that a revolutionary device would be reasonable and necessary treatment for Medicare patients who suffer from a particular disease or condition that the device is intended to treat or diagnose, IHI recommends the following considerations to CMS:

* Consider how technology can improve access to care and determine if the MCIT path serves this purpose.

* Gather more data by conducting clinical trials where treating physicians are involved as well as clinicians qualified to advise on medical necessity.

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

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

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

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

Assuming that the agency can coordinate with collaborating agencies like the Food and drug administration (FDA) or other relevant agencies, the IHI stresses the importance of patient-centered health care to preserve the value of care, especially if it requires increased access to care through technology.

Definition of “reasonable and necessary”

The IHI strongly supports efforts to increase access to healthcare to ensure that patients can receive appropriate medical care, which derives from the standards of medical practice.

Under the current definition, an item or service is considered “reasonable and necessary” if it is (1) safe and effective; (2) non-experimental or experimental; and (3) appropriate, including the duration and frequency that are considered appropriate for the item or service, in terms of whether it is:

* Provided 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 medical needs and condition of the patient;

* Ordered and supplied by qualified personnel;

* The one who answers, but does not exceed, the medical need of the patient; and

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

The IHI recognizes that healthcare practices will change and evolve over time; however, the IHI strongly opposes taking into account any criteria that would contravene the clinical judgment of the attending physician in determining what is “reasonable and necessary”. On the one hand, CMS is a government agency whose public service mission is to ensure that “all CMS beneficiaries have reached their highest level of health and that disparities in the quality and access to health care health have been eliminated. “/ 3

On the other hand, commercial insurers have a lucrative mission to implement systematic and profit-oriented mechanisms, which is different from the public interest./4

To align with CMS’s mission, IHI urges the agency to adhere to a patient-centered definition of “reasonable and necessary”. The IHI also urges the agency to recall that the legislative intent of Medicare clearly states that “the physician must be the key figure in determining the use of health services. “/ 5

As such, given the separate missions between CMS and commercial insurers, the commercial insurance aspects of the rule ultimately deviate from the clinical judgment of the attending physician, the facts of the medical record, and patient-centered practice for determine what care is “reasonable and necessary.” “The IHI expands to the agency if CMS and its collaborative agencies need advice on implementing the MCIT pathway using clinical evidence supported by the practice of medicine. ‘agency repeal of amended and codified definition of “reasonable and necessary.” The IHI appreciates the opportunity to comment on the proposed repeal of Medicare Innovative Technologies (MCIT) coverage and rule definition. Reasonable and necessary “(R&N) ./ 6

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

Truly,

Brian mcgraw, President

Dr. Raymond Kendall Smith, Jr., MD, SFHM, Chief Medical Officer

Denise wilson, MS, RN, RRT, Senior Vice President of Call Services

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Footnotes :

1 / See Health insurance program; Innovative Technology Medicare (MCIT) Coverage and Definition of “Reasonable and Necessary”, 86 Fed. Reg. 51326 (September 15th, 2021).

2 / See Total number of health insurance beneficiaries, State of health, 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 population benefiting from health insurance, AARP Institute for Public Policy, (2009), https://www.aarp.org/health/medicare-insurance/info-01-2009/fs149_medicare.html#:~:text=Currently%2C%2044%20million%20beneficiaries%E2%80% 94some, at% 2079% 20million% 20by% 202030.

3 / See Mission, Vision and our work, MEDICARE & MEDICAID SERVICE CENTERS, 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, (February 4, 2021), https://www.ncbi.nlm.nih.gov/books/NBK556053/

5 / See 1965 USCCAN 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 (ED Mo. 1972); see also Kuebler v. Secretary, 579 F. Supp. 1436, 1440 (EDNY 1984); see also Breeden v. Weinberger, 377 F. Supp. 734, 737 (MD The. 1974).

6 / See Medicare program; Innovative Technology Medicare (MCIT) Coverage and Definition of “Reasonable and Necessary”, 86 Fed. Reg. 51326 (September 15th, 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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