81 FR 51199 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality Federal Register Volume 81, Issue 149 (August 3, 2016)
Agency for Healthcare Research and Quality
Federal Register Volume 81, Issue 149 (August 3, 2016)
| Page Range | 51199-51201 | |
| FR Document | 2016-18392 |
[Federal Register Volume 81, Number 149 (Wednesday, August 3, 2016)] [Notices] [Pages 51199-51201] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-18392] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Agency for Healthcare Research and Quality, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``The Patient-Centered Medical Home (PCMH) Items Demonstration Study.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. DATES: Comments on this notice must be received by October 3, 2016. ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email at [email protected]. Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer. FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected]. SUPPLEMENTARY INFORMATION: [[Page 51200]] Proposed Project The Patient-Centered Medical Home (PCMH) Items Demonstration Study This study is being conducted by AHRQ through its contractor, RAND, pursuant to AHRQ's statutory authority to conduct and support research on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of health care services and with respect to quality measurement and improvement. 42 U.S.C. 299a(a)(1) and (2). Method of Collection The patient-centered medical home (PCMH) is a model for delivering primary care that is patient-centered, comprehensive, coordinated, accessible, and continuously improved through a systems-based approach to quality and safety. As primary care practices across the United States seek National Committee for Quality Assurance (NCQA) recognition as patient-centered medical homes (PCMH), they can choose to administer the Consumer Assessment of Healthcare Providers and Systems (CAHPS[supreg]) Clinician and Group (CG-CAHPS) survey with or without the PCMH supplemental item set (AHRQ, 2010; Hays et al., 2014; Ng et al., 2016; Scholle et al., 2012). NCQA offers a special patient experience distinction to practices that opt to use the PCMH CAHPS items set in their CG-CAHPS survey tool. While over 11,000 practices, representing an estimated 15-18% of primary care physicians, are currently recognized for PCMH by NCQA (NCQA, 2015), fewer than 3% of them submit patient experience surveys to NCQA when applying for recognition under NCQA's PCMH recognition program. Despite the rapid movement toward PCMH primary care transformation and the increasing use of PCMH CAHPS items, little is known about the ways in which practices are using these CAHPS data and the PCMH supplemental item information (about access, comprehensiveness, self- management, shared decision making, coordination of care, and information about care and appointments) to understand and improve their patients' experiences during PCMH transformation. The PCMH Items Demonstration Study will investigate:How practices across the U.S. use CAHPS and the PCMH item set during PCMH transformation, How practices assemble and select items for inclusion in their patient experience surveys (e.g. core, PCMH, supplemental, and custom items), Primary care practice leaders' perspectives on NCQA PCMH Recognition and CAHPS Patient Experience Distinction, Effects of changes made during PCMH transformation on patient experiences reported on CAHPS surveys and any PCMH items, and Associations between PCMH transformation and patient experience scores. To achieve the goals of this project the following data collections will be implemented: (1) Office Manager Questions administered via phone about the participating practice's characteristics to describe the type of practices in the study and to understand how practice characteristics influence PCMH transformation and patient experience. (2) Physician Interviews administered via phone with the lead PCMH clinical expert about the details, decisions and processes of PCMH transformation, NCQA PCMH Recognition and CAHPS Patient Experience Distinction and their use of patient experience data during the transformation process. (3) PCMH-A Assessment Tool to be completed by the lead PCMH clinical expert (before or after the interview on the standardized form via fax or email) to collect validated metrics on the ``PCMH-ness'' of the practice. (4) CAHPS Patient Experience Data Files, which are patient-level, de-identified CAHPS patient experience data covering the period of PCMH transformation for the participating practice. These data are collected independently of this study by the practice (or network) via its current vendor. We will work with the PCMH clinical expert, or a designated person who handles data, in each of the participating practices to submit these CAHPS data files securely to RAND to understand CAHPS patient experience trends and associations with PCMH implementation during the practice's PCMH journey. Characterizing the use of CAHPS and PCMH items by primary care practices will provide important insight into the activities practices conduct during PCMH transformation to improve patient experience scores. This information may be useful in supporting practices that lag behind their peers, learning from practices with outstanding records of patient experience, and providing recommendations that may be used to refine the content of the CAHPS survey items. Estimated Annual Respondent Burden Table 1 shows the estimated annualized burden and cost for the respondents' time to participate in this data collection. These burden estimates are based on tests of data collection conducted on nine or fewer entities. As indicated below, the annual total burden hours are estimated to be 179 hours. The annual total cost associated with the annual total burden hours is estimated to be $16,899. The PCMH Items Demonstration Study will recruit 150 practices including the participating practices' office managers and one physician/lead PCMH clinical expert. We will recruit and administer the Office Manager Questions by phone to 150 office managers, recruit all sampled physicians by sending them a recruitment packet that includes a cover letter, an AHRQ endorsement letter and an information sheet, and then administer the Physician Interview protocol questions by phone to 150 physicians, and 150 physicians will self-administer the PCMH-A Assessment Tool. We have calculated our burden estimate for Office Manager Questions asked during physician recruitment using an estimate of 3-5 questions a minute as the Office Manager Questions are closed-ended survey questions. The Office Manager Questions contains 17 questions and is estimated to require an average of 5 minutes; this estimate is supported by the information gathered during a pilot of these questions. For the Physician Interview, we have calculated the burden estimate to require an average of 40 minutes per interview. For the PCMH-A Assessment Tool, we calculated our burden using a conservative estimate of 4.5 items per minute. Prior work suggests that 3-5 items on an assessment tool can typically be completed per minute, depending on item complexity and respondent characteristics (Berry, 2009; Hays & Reeve, 2010). The PCMH-A Assessment tool contains 36 items and is estimated to require an average completion time of 8-10 minutes. Participating practices will be asked to submit any available CAHPS Patient Experience data files (e.g. submission of de-identified data including a data dictionary via encrypted transfer) for the period of time covering their NCQA PCMH Recognition history. Each practice will have an average estimate of 3 CAHPS Patient Experience data files to submit per one submission, which we based on the average number of years of PCMH history of the sample. In addition, we conservatively estimate [[Page 51201]] that half of the control practices (25/50) administer CG-CAHPS data, as this percentage is unknown; while 90% of the participating current and past CAHPS practices (90/100) will submit CAHPS data, yielding 115 submissions of CAHPS patient experience data files. As indicated below, the annual total burden is estimated to be 179 hours. Exhibit 1--Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of responses Hours per Total burden Data collection task Number of respondents per respondent response hours ---------------------------------------------------------------------------------------------------------------- Office Manager Questions.......... 150.................. 1.................... 5/60 12.5 Physician Interview............... 150.................. 1.................... 40/60 100 PCMH-A Assessment Tool............ 150 (same physicians 1 (same person as 15/60 37.5 as above). above). CAHPS Patient Experience Data 115.................. 1 per practice....... 15/60 28.75 Files. ----------------------------------------------------------------------------- Total......................... 415.................. 1.................... 75/60 178.75 ---------------------------------------------------------------------------------------------------------------- + The same respondent completes the Physician Interview and PCMH-A Assessment Tool and submits the CAHPS Patient Experience Data Files. Exhibit 2--Estimated Annualized Cost Burden ---------------------------------------------------------------------------------------------------------------- Number of Total burden Average hourly Total cost Data collection task requests hours wage rate * burden ---------------------------------------------------------------------------------------------------------------- Office Manager Questions........................ 150 12.5 \a\ $57.44 $718.00 Physician Interview............................. 150 100 \b\ 97.33 9,733.00 PCMH-A Assessment Tool.......................... 150 37.5 \b\ 97.33 3,649.88 CAHPS Patient Experience Data Files............. 115 28.75 \b\ 97.33 2,798.24 Total....................................... 300 178.75 55.48 16,899.12 ---------------------------------------------------------------------------------------------------------------- + The same respondent completes the Physician Interview and PCMH-A Assessment Tool and submits the CAHPS Patient Experience Data Files. * Occupational Employment Statistics, May 2015 National Occupational Employment and Wage Estimates United States, U.S. Department of Labor, Bureau of Labor Statistics. http://www.bls.gov/oes/current/oes_nat.htm. \a\ Based on the mean wages for General and Operations Managers, 11-1021 within Healthcare Support Occupations, the occupational group most likely tasked with completing the Office Manager Questions. \b\ Based on the mean wages for Physicians and Surgeons, 29-1060, the occupational group most likely tasked with completing the Physician Interview, PCMH-A Assessment Tool, and submitting the CAHPS Patient Experience Data Files. Request for Comments In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record. Sharon B. Arnold, Deputy Director. [FR Doc. 2016-18392 Filed 8-2-16; 8:45 am] BILLING CODE 4160-90-P
![Federal Register / Vol. 81, No. 149 / Wednesday, August 3, 2016 / Notices 51199
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asabaliauskas on DSK3SPTVN1PROD with NOTICES
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![Federal Register / Vol. 81, No. 149 / Wednesday, August 3, 2016 / Notices 51201
that half of the control practices (25/50) the participating current and past of CAHPS patient experience data files.
administer CG–CAHPS data, as this CAHPS practices (90/100) will submit As indicated below, the annual total
percentage is unknown; while 90% of CAHPS data, yielding 115 submissions burden is estimated to be 179 hours.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of Hours per Total burden
Data collection task Number of respondents responses per response hours
respondent
Office Manager Questions ......................................... 150 ................................... 1 ......................................... 5/60 12.5
Physician Interview .................................................... 150 ................................... 1 ......................................... 40/60 100
PCMH–A Assessment Tool ....................................... 150 (same physicians as 1 (same person as above) 15/60 37.5
above).
CAHPS Patient Experience Data Files ..................... 115 ................................... 1 per practice ..................... 15/60 28.75
Total .................................................................... 415 ................................... 1 ......................................... 75/60 178.75
+ The same respondent completes the Physician Interview and PCMH–A Assessment Tool and submits the CAHPS Patient Experience Data
Files.
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Average
Number of Total burden Total cost
Data collection task hourly wage
requests hours burden
rate *
Office Manager Questions ............................................................................... 150 12.5 a $57.44 $718.00
Physician Interview .......................................................................................... 150 100 b 97.33 9,733.00
PCMH–A Assessment Tool ............................................................................. 150 37.5 b 97.33 3,649.88
CAHPS Patient Experience Data Files ............................................................ 115 28.75 b 97.33 2,798.24
Total .......................................................................................................... 300 178.75 55.48 16,899.12
+ The same respondent completes the Physician Interview and PCMH–A Assessment Tool and submits the CAHPS Patient Experience Data
Files.
* Occupational Employment Statistics, May 2015 National Occupational Employment and Wage Estimates United States, U.S. Department of
Labor, Bureau of Labor Statistics. http://www.bls.gov/oes/current/oes_nat.htm.
a Based on the mean wages for General and Operations Managers, 11–1021 within Healthcare Support Occupations, the occupational group
most likely tasked with completing the Office Manager Questions.
b Based on the mean wages for Physicians and Surgeons, 29–1060, the occupational group most likely tasked with completing the Physician
Interview, PCMH–A Assessment Tool, and submitting the CAHPS Patient Experience Data Files.
Request for Comments comments will become a matter of describes FDA’s policy regarding the
public record. regulation of medical x-ray imaging
In accordance with the Paperwork equipment that are subject to
Reduction Act, comments on AHRQ’s Sharon B. Arnold,
requirements in the Federal Food, Drug,
information collection are requested Deputy Director.
and Cosmetic Act (the FD&C Act) and
with regard to any of the following: (a) [FR Doc. 2016–18392 Filed 8–2–16; 8:45 am] FDA’s regulations that apply to medical
Whether the proposed collection of BILLING CODE 4160–90–P devices and electronic products. The
information is necessary for the proper draft guidance also provides
performance of AHRQ health care recommendations to industry on how to
research and health care information DEPARTMENT OF HEALTH AND comply with the applicable
HUMAN SERVICES requirements. This draft guidance is not
dissemination functions, including
whether the information will have Food and Drug Administration final nor is it in effect at this time.
practical utility; (b) the accuracy of DATES: Although you can comment on
AHRQ’s estimate of burden (including [Docket No. FDA–2016–D–2049]
any guidance at any time (see 21 CFR
hours and costs) of the proposed Medical X-Ray Imaging Devices 10.115(g)(5)), to ensure that the Agency
collection(s) of information; (c) ways to Conformance With International considers your comment on this draft
enhance the quality, utility, and clarity Electrotechnical Commission guidance before it begins work on the
of the information to be collected; and Standards; Draft Guidance for Industry final version of the guidance, submit
(d) ways to minimize the burden of the and Food and Drug Administration either electronic or written comments
collection of information upon the Staff; Availability on the draft guidance by November 1,
respondents, including the use of 2016.
automated collection techniques or AGENCY: Food and Drug Administration,
ADDRESSES: You may submit comments
asabaliauskas on DSK3SPTVN1PROD with NOTICES
other forms of information technology. HHS.
ACTION: Notice of availability. as follows:
Comments submitted in response to
Electronic Submissions
this notice will be summarized and SUMMARY: The Food and Drug
included in the Agency’s subsequent Administration (FDA or Agency) is Submit electronic comments in the
request for OMB approval of the announcing the availability of the draft following way:
proposed information collection. All guidance entitled ‘‘Medical X-Ray • Federal eRulemaking Portal: http://
Imaging Devices Conformance With IEC www.regulations.gov. Follow the
Standards.’’ This draft guidance instructions for submitting comments.
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Document Created: 2016-08-02 23:44:08
Document Modified: 2016-08-02 23:44:08
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on this notice must be received by October 3, 2016. | |
| Contact | Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected] | |
| FR Citation | 81 FR 51199 |
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