02.2013.CMS-10302 Supporting Statement Part A

Supporting Statement – Part A

Supporting Statement For Paperwork Reduction Act Submissions

A. Background

Section 1861(t)(2)(B)(ii)(I) establishes certain published compendia as authoritative references for determining if a substance is a drug or biological under the fee-for-service Medicare program. In the CY 2010 Physician Fee Schedule proposed rule issued on July 13, 2009, the Office of Clinical Standards and Quality (OCSQ) revised 42 C.F.R. § 414.930 Compendia for determination of medically‑accepted indications for off‑label uses of drugs and biologicals in an anti‑cancer chemotherapeutic regimen, which provided a definition of “compendium” and explained a process for making additions and deletions to the list to statutorily recognized compendia for this use. The revisions to 42 C.F.R. § 414.930 definition include: 1) the current definition of compendium in 42 C.F.R. § 414.930 section (a) is amended by the addition of the sentence “A compendium has publicly transparent processes for evaluating therapies and for identifying potential conflicts of interests.”; 2) the current section “(a) Definition” is renamed “(a)(1) Definitions”; 3) the definition of a publicly transparent process for evaluating therapies is added as a new section (a)(2); and 4) the definition of a publicly transparent process for identifying potential conflicts of interest is added as a new section (a)(3). In addition, the process for listing compendia for determining medically‑accepted uses of drugs and biologicals in anti‑cancer treatment in (b)(1) of 42 C.F.R. § 414.930 is amended to exclude any entity that does not fully meet this modified regulatory definition of compendium.

B. Justification

1 . Need and Legal Basis

Congress enacted the Medicare Improvement of Patients and Providers Act (MIPPA). Section 182(b) of MIPPA amended Section 1861(t)(2)(B) of the Social Security Act (42 U.S.C. 1395x(t)(2)(B)) by adding at the end the following new sentence: ‘On and after January 1, 2010, no compendia may be included on the list of compendia under this subparagraph unless the compendia has a publicly transparent process for evaluating therapies and for identifying potential conflicts of interest.’ We believe that the implementation of this statutory provision that compendia have a “publicly transparent process for evaluating therapies and for identifying potential conflicts of interests” is best accomplished by amending 42 C.F.R. §414.930 to include the MIPPA requirements and by defining the key components of publicly transparent processes for evaluating therapies and for identifying potential conflicts of interests. Therefore, we revised 42 C.F.R. § 414.930 Compendia for determination of medically‑accepted indications for off‑label uses of drugs and biologicals in an anti‑cancer chemotherapeutic regimen in CY 2010 Physician Fee Schedule to comply with MIPPA Section 182 (b).

2. Information Users

On and after January 1, 2010, all currently listed compendia are required to comply with these provisions to remain on the list of recognized compendia. In addition, any compendium that is the subject of a future request for inclusion on the list of recognized compendia will be required to comply with these provisions. No compendium can be on the list if it does not fully meet the standard described in section 1861(t)(2)(B) of the Act, as revised by section 182(b) of the MIPPA.

3. Use of Information Technology

One-hundred percent of the currently recognized compendia publishers post their conflict of interest policies and their process for evaluating off-label chemotherapeutic therapies done on or after January 1, 2010 on their website. Since all of the provisions in our revision of §414.930 are currently being practiced by compendia publishers and posted on their website, we expect the burden to maintain compliance to be minimal.

4. Duplication of Efforts

This information collection does not duplicate any other effort and the information cannot be obtained from any other source.

5. Small Businesses

This collection of information does not impact small businesses or other small entities.

6. Less Frequent Collection

The collection of this data occurs each time a compendia advisory committee or experts convene to make an off-label recommendation for an anticancer drug or biologic. If the information is not collected, OCSQ cannot meet our responsibility to uphold the intent of MIPPA 182(b).

7. Special Circumstances

• The respondent (i.e. the compendia publisher) is required to retain all materials mentioned under section (a)(2) 42 C.F.R. §414.930, the definition of a publicly transparent process for evaluating therapies available to the public, for a period of not less than 5 years, which includes availability on the compendium’s Web site for a period of not less than 3 years.

• The respondent (i.e. the compendia publisher) is required to retain all information mentioned under section(a)(3) of 42 C.F.R. §414.930, the definition for a publicly transparent process for identifying potential conflicts of interest, available to a bona fide member of the public for a period of not less than 5 years.

8. Federal Register/Outside Consultation

The 60-day Federal Register notice published on March 15, 2013 (78 FR 16507). There were no comments.

9. Payments/Gifts to Respondents

No payment or gifts will be provided to respondents.

10. Confidentiality

CMS shall be assured that all applicable patient confidentiality, privacy, and other Federal laws are complied with, including the Standards for Privacy of Individually Identifiable Health Information (Privacy Rule). In addition, the disclosure of financial conflicts of interests for individuals with a substantive role in compendia recommendation decision making and their immediate family members will only be available to bona fide members of the public by request.

11. Sensitive Questions

No questions of a sensitive nature are included in this data collection.

12. Burden Estimates (Hours & Wages)

CFR Section	Information we are requesting	Respondents (minimum – maximum)	Responses (minimum – maximum)	Burden per Response (hours)	Annual Burden (hours)
§414.930	Internal or external request for listing of therapy recommendation including criteria used to evaluate the response	10-845	75-100	1	75-100
§414.930	A listing of all evidentiary materials reviewed or considered by compendia pursuant to a response	10-845	75-100	1	75-100
§414.930	A listing of all respondents	10 -845	75-100	1	10-845
§414.930	Minutes and voting records of meetings for the review and disposition of the response	10-845	300-400 (based on 75-100 responses requiring 4 meetings per year)	6	1800-2400
§414.930	Direct or indirect financial relationships between respondents and the manufacturer or seller of the drug or biological being reviewed by compendia	10-845	75-100	1	10-845
§414.930	Ownership or investment of respondents and the manufacturer or seller of the drug or biological being reviewed by compendia	10-845	75-100	1	10-845

Totals

10-845

75-100

11

1980-5135

In the table above, respondents refers to the number of those who substantially participate in a compendium’s recommendations and their immediate family members, and responses refers to the number of requests a compendium receives per year for inclusion of a therapy in their publication. Based on our estimate, the burden we derived for all our conflict of interest and transparency provisions above, the total burden would range from 1950 hours per compendium with 75 responses to 2600 hours per compendium with 100 responses. The variation in responses is due to the varying size of compendia publications and different processes used by compendia publishers to generate a recommendation. In our estimate we also found that the total burden from respondents would range from 30 hours per compendium with 10 respondents to 2535 hours per compendium with 845 respondents. The variation in respondents depends on a compendium’s use of internal or external staff to generate compendia recommendations. Therefore, based on these burden totals, the total burden hours per compendium to comply with our conflict of interest and transparency provisions ranges from 1980 hours (a compendium with 75 responses and 10 respondents) to 5135 hours (a compendium with 100 responses and 845 respondents). In order to capture the maximum burden for an individual compendium, we are using the highest total hour estimate, 5135 hours, per compendium to comply with our conflict of interest and transparency provisions. In addition, all these provisions could be managed by an executive administrative assistant at an hourly rate of $34.14 per hour based on the average salary of $71,020 obtained from the Department of Labor.

13. Capital Costs

The capital costs associated with the collection of material and information is negligible for compendia publishers because they all have the existing infrastructure, currently maintained company websites, to accommodate these provisions. Any costs for compendia publishers to comply with these provisions would be captured in their general operating costs.

14. Cost to Federal Government

No annualized cost to the Federal government will be incurred.

15. Changes to Burden

There are no program changes or adjustments to the collection.

16. Publication/Tabulation Dates

There are no publication or tabulation dates.

17. Expiration Date

CMS would like an exemption from displaying the expiration date of these collection requirements for compendia publishers because it is effective on and after January 1, 2010 on a continuing basis as mandated by MIPPA 182(b).

18. Certification Statement

There are no exceptions to the certification statement.

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