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Federal Register / Vol. 86, No. 9 / Thursday, January 14, 2021 / Rules and Regulations III. Collection of Information Requirements Under the Paperwork Reduction Act of 1995, we are required to provide 60day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget OMB for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506c2A of the Paperwork
Reduction Act of 1995 requires that we solicit comment on the following issues:
The need for the information collection and its usefulness in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection burden.
The quality, utility, and clarity of the information to be collected.
Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
We solicited public comment on each of the section 3506c2A-required
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issues for the following sections of this document that contain information collection requirements ICRs.
To derive average costs, we used data from the U.S. Bureau of Labor Statistics May 2018 National Occupational Employment and Wage Estimates for all salary estimates https www.bls.gov/
oes/current/oes131041.htm, released May 2019. In this regard, the table that follows presents the mean hourly wage, the cost of fringe benefits calculated at 100 percent of salary, and the adjusted hourly wage.

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TABLE 1NATIONAL OCCUPATIONAL EMPLOYMENT AND WAGE ESTIMATES FOR MCIT
Occupation title
Occupation code
Mean hourly wage $/hr
Fringe benefit $/hr
Adjusted hourly wage $/hr
Compliance Officer

131041

34.86

34.86

69.72

As indicated, we are adjusting our employee hourly wage estimates by a factor of 100 percent. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly from employer to employer. Nonetheless, there is no practical alternative and we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method.
The proposed coverage pathway allows for a voluntary participation and therefore necessitates that manufacturers of breakthrough devices notify CMS of their intent to enter the MCIT pathway. Therefore, the burden associated with notifying CMS is the time and effort it would take for each of the organizations to send CMS an email or letter. We anticipate two MCIT
pathway participants in the first year based upon the number of medical devices that received FY2020 NTAP and were non-covered in at least one MAC
jurisdiction by LCDs and related articles.
We estimate notifying CMS of intent to participate in MCIT would involve 15
minutes at $69.72 per hour by a compliance officer. In this regard, we estimate 15 mins per notification at a cost of $17.43 per organization 0.25
hours $69.72. In aggregate, we estimate 0.5 hours 0.25 hours 2
submissions at $34.86 $17.43 2
submissions.
After the anticipated initial 2
submitters, over the next 3 years we expect 3 submitters in year 2, 4
submitters in year 3, and 5 submitters in year 4 to notify CMS of interested in the MCIT pathway. We expect this increase in submitters each year to level off at
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this point. In this regard, we estimate the same 0.25 hours per submission at a cost of $17.43 per organization.
Similarly, in aggregate, we estimate, for year 2 0.75 hours at $52.29 an hour, for year 3 1.0 hour at $69.72 an hour, and for year 4 1.25 hours at $87.15 an hour.
The proposed requirements and burden will be submitted to OMB under control number 0938NEW.
IV. Regulatory Impact Statement This final rule makes Medicare coverage policy updates pursuant to the authority at section 1862a1A of the Act. We are using regulatory action per the October 3, 2019 Executive Order on Protecting and Improving Medicare for Our Nations Seniors to create a swift Medicare coverage pathway to allow beneficiaries across the nation to access breakthrough devices after FDA market authorization and define reasonable and necessary.
We have examined the impact of this final rule as required by Executive Order 12866 on Regulatory Planning and Review September 30, 1993, Executive Order 13563 on Improving Regulation and Regulatory Review January 18, 2011, the Regulatory Flexibility Act RFA September 19, 1980, Pub. L. 96354, section 1102b of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 March 22, 1995; Pub. L. 1044, Executive Order 13132 on Federalism August 4, 1999, the Congressional Review Act 5 U.S.C. 8042, and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs January 30, 2017.
Executive Orders 12866 and 13563
direct agencies to assess all costs and
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benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits including potential economic, environmental, public health and safety effects, distributive impacts, and equity. A regulatory impact analysis RIA must be prepared for major rules with economically significant effects $100 million or more in any 1 year.
This final rule reaches the economic threshold and thus is considered a major rule.
CMS considered several alternatives for defining reasonable and necessary.
These alternatives included not defining the term in regulation, define the term as finalized in this rule commercial insurer coverage may be considered under the Medicare program, and define the term as commercial insurer coverage being the sole determinant of coverage under the Medicare program.
Given the direction in E.O. 13890 to clarify standards we proposed and finalized in regulation, the definition of the term reasonable and necessary.
The definition we are finalizing provides consistency and flexibility regarding the role of commercial insurer coverage in the Medicare program and the majority of public comments did not support the commercial payer alternative without more public engagement. We believe the final rule is consistent with what the public requested.
The impact of defining reasonable and necessary is hard to quantify without knowing the specific items and services that would be included in future NCDs and LCDs and the criteria that CMS will use for determining
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