Agency Information Collection Activities: Proposed Collection; Comment Request

AGENCY:

Centers for Medicare & Medicaid Services, HHS.

ACTION:

Notice.

SUMMARY:

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: The necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

DATES:

Comments must be received by February 7, 2017.

ADDRESSES:

When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:

1. Electronically. You may send your comments electronically to http://www.regulations.gov. Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments.

2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number __, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:

1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.

2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov.

3. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT:

Reports Clearance Office at (410) 786-1326.

SUPPLEMENTARY INFORMATION:

Contents

This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES).

CMS-R-10 Advance Directives (Medicare and Medicaid) and Supporting Regulations

CMS-10487 Medicaid Emergency Psychiatric Demonstration (MEPD) Evaluation

CMS-10116 Conditions for Payment of Power Mobility Devices, including Power Wheelchairs and Power-Operated Vehicles

CMS-10219 Healthcare Effectiveness Data and Information Set (HEDIS®) Data Collection for Medicare Advantage

CMS-10275 CAHPS Home Health Care Survey

Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

Information Collection

1. Type of Information Collection Request: Extension of a previously approved collection; Title of Information Collection: Advance Directives (Medicare and Medicaid) and Supporting Regulations; Use: The advance directives requirement was enacted because Congress wanted individuals to know that they have a right to make health care decisions and to refuse treatment even when they are unable to communicate. Steps have been taken at both the Federal and State level, to afford greater opportunity for the individual to participate in decisions made concerning the medical treatment to be received by an adult patient in the event that the patient is unable to communicate to others, a preference about medical treatment. The individual may make his preference known through the use of an advance directive, which is a written instruction prepared in advance, such as a living will or durable power of attorney. This information is documented in a prominent part of the individual's medical record. Advance directives as described in the Patient Self-Determination Act have increased the individual's control over decisions concerning medical treatment. Sections 4206 of the Omnibus Budget Reconciliation Act of 1990 defined an advance directive as a written instruction recognized under State law relating to the provision of health care when an individual is incapacitated (those persons unable to communicate their wishes regarding medical treatment).

All states have enacted legislation defining a patient's right to make decisions regarding medical care, including the right to accept or refuse medical or surgical treatment and the right to formulate advance directives. Participating hospitals, skilled nursing facilities, nursing facilities, home health agencies, providers of home health care, hospices, religious nonmedical health care institutions, and prepaid or eligible organizations (including Health Care Prepayment Plans (HCPPs) and Medicare Advantage Organizations (MAOs) such as Coordinated Care Plans, Demonstration Projects, Chronic Care Demonstration Projects, Program of All Inclusive Care for the Elderly, Private Fee for Service, and Medical Savings Accounts must provide written information, at explicit time frames, to all adult individuals about: (a) The right to accept or refuse medical or surgical treatments; (b) the right to formulate an advance directive; (c) a description of applicable State law (provided by the State); and (d) the provider's or organization's policies and procedures for implementing an advance directive. Form Number: CMS-R-10 (OMB control number: 0938-0610); Frequency: Yearly; Affected Public: Business or other for-profits; Number of Respondents: 39,479; Total Annual Responses: 39,479; Total Annual Hours: 2,836,441. (For policy questions regarding this collection contact Jeannine Cramer at 410-786-5664.)

2. Type of Information Collection Request: Extension of a previously approved collection; Title of Information Collection: Medicaid Emergency Psychiatric Demonstration (MEPD) Evaluation; Use: Since the inception of Medicaid, inpatient care provided to adults ages 21 to 64 in institutions for mental disease (IMDs) has been excluded from federal matching funds. The Emergency Medical Treatment and Active Labor Act (EMTALA), however, requires IMDs that participate in Medicare to provide treatment for psychiatric emergency medical conditions (EMCs), even for Medicaid patients for whose services cannot be reimbursed. Section 2707 of the Affordable Care Act (ACA) directs the Secretary of Health and Human Services to conduct and evaluate a demonstration project to determine the impact of providing payment under Medicaid for inpatient services provided by private IMDs to individuals with emergency psychiatric conditions between the ages of 21 and 64. We will use the data to evaluate the Medicaid Emergency Psychiatric Demonstration (MEPD) in accordance with the ACA mandates. This evaluation in turn will be used by Congress to determine whether to continue or expand the demonstration. If the decision is made to expand the demonstration, the data collected will help to inform both CMS and its stakeholders about possible effects of contextual factors and important procedural issues to consider in the expansion, as well as the likelihood of various outcomes. Form Number: CMS-10487 (OMB control number: 0938-NEW); Frequency: Annually; Affected Public: Individuals and households; State, Local and Tribal governments; Business and other for-profits and Not-for-profits; Number of Respondents: 93; Total Annual Responses: 1,944; Total Annual Hours: 2,046. (For policy questions regarding this collection contact Vetisha McClair at 410-786-4923.)

3. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Conditions for Payment of Power Mobility Devices, including Power Wheelchairs and Power-Operated Vehicles; Use: We are renewing our request for approval for the collection requirements associated with the final rule, CMS-3017-F (71 FR 17021), which published on April 5, 2006, and required a face-to-face examination of the beneficiary by the physician or treating practitioner, a written prescription, and receipt of pertinent parts of the medical record by the supplier within 45 days after the face-to-face examination that the durable medical equipment (DME) suppliers maintain in their records and make available to CMS and its agents upon request. Form Number: CMS-10116 (OMB control number: 0938-0971); Frequency: Yearly; Affected Public: Private Sector—Business or other for-profits; Number of Respondents: 46,000; Number of Responses: 72,500; Total Annual Hours: 14,434. (For policy questions regarding this collection contact Stuart Caplan at 410-786-8564.)

4. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Healthcare Effectiveness Data and Information Set (HEDIS®) Data Collection for Medicare Advantage; Use: We use the collected data to: Monitor Medicare Advantage organization performance, inform audit strategies, and inform beneficiary choice through their display in our consumer-oriented public compare tools and Web sites. Medicare Advantage organizations use the data for quality assessment and as part of their quality improvement programs and activities. Quality Improvement Organizations and our contractors use HEDIS® data in conjunction with their statutory authority to improve quality of care. Consumers use the information to help make informed health care choices. In addition, the data is made available to researchers and others as public use files at www.cms.hhs.gov. Form Number: CMS-10219 (OMB control number: 0938-1028); Frequency: Yearly; Affected Public: Private sector—Business or other for-profit and Not-for-profit institutions; Number of Respondents: 576; Total Annual Responses: 576; Total Annual Hours: 184,320. (For policy questions regarding this collection contact Lori Teichman at 410-786-6684.)

5. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: CAHPS Home Health Care Survey; Use: The national implementation of the Home Health Care Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Survey is designed to collect ongoing data from samples of home health care patients who receive skilled services from Medicare-certified home health agencies. The data collected from the national implementation of the Home Health Care CAHPS Survey will be used for the following purposes: (1) To produce comparable data on the patients' perspectives of the care they receive from home health agencies, (2) to create incentives for agencies to improve the quality of care they provide through public reporting of survey results, and (3) to enhance public accountability in health care by increasing the transparency of the quality of care provided in return for the public investment. Sampling and data collection will be conducted on a monthly basis. Survey results will be analyzed and reported on a quarterly basis, with publicly reported results based on one year's worth of data.

As part of this information collection request for the national implementation of Home Health Care CAHPS, CMS is also requesting approval to conduct a randomized mode experiment with a sample of home health agencies. The mode experiment compared the responses to the survey across the three proposed modes to determine whether adjustments are needed to ensure that the data collection mode does not influence the survey results. In addition, data from the mode experiment will be used to determine which, if any, patient characteristics may affect the patients' rating of the care they receive and, if so, develop an adjustment model of those data based on those factors. CMS worked with RTI, the federal contractor to recruit approximately 100 home health agencies to participate in the mode experiment. The mode experiment included approximately 23,000 home health care patients.

Form Number: CMS-10275 (OMB control number: 0938-1066); Frequency: Quarterly; Affected Public: Individuals and households and the Private sector (Business or other for-profit and Not-for-profit institutions); Number of Respondents: 2,715,890; Total Annual Responses: 2,715,890; Total Annual Hours: 699,440. (For policy questions regarding this collection contact Lori Teichman at 410-786-6684.)