81 FR 37596 - 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 112 (June 10, 2016)
Agency for Healthcare Research and Quality
Federal Register Volume 81, Issue 112 (June 10, 2016)
| Page Range | 37596-37598 | |
| FR Document | 2016-13841 |
[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)] [Notices] [Pages 37596-37598] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-13841] ----------------------------------------------------------------------- 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: ``Survey of Hospital Quality Leaders.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on February 10, 2016 and [[Page 37597]] allowed 60 days for public comment. AHRQ received no substantive comments. The purpose of this notice is to allow an additional 30 days for public comment. DATES: Comments on this notice must be received by July 11, 2016. ADDRESSES: Written comments should be submitted to: AHRQ's OMB Desk Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by email at [email protected] (attention: AHRQ's desk officer). FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected]. SUPPLEMENTARY INFORMATION: Proposed Project Survey of Hospital Quality Leaders The Consumer Assessment of Healthcare Providers and Systems (CAHPS[supreg]) Hospital Survey (HCAHPS) was first implemented on a voluntary basis in 2006 to assess patients' experiences with care. Today, hospitals subject to the Inpatient Prospective Payment System (IPPS) annual payment update provisions are required to collect and submit HCAHPS data in order to receive their full annual payment update. In addition, HCAHPS performance was added to the calculation of the value-based incentive payment in the Hospital Value-Based Purchasing (Hospital VBP) program, beginning with discharges in October 2012. The FY 2015 Hospital VBP program links 30% of the Inpatient Prospective Payment System hospitals' payment from CMS to HCAHPS performance. Despite the high stakes associated with HCAHPS scores, little is known about the ways in which hospitals are using HCAHPS data and supplemental information about patient experience to understand and improve their patients' experiences. This research has the following goals: (1) To characterize the role of HCAHPS in hospitals' efforts to improve patient experiences (2) to identify the types of quality improvement activities that hospitals implement to improve their HCAHPS scores (3) to describe hospitals' perspectives on HCAHPS (4) to determine the types of information collected by hospitals beyond those required for Hospital VBP This study is being conducted by AHRQ through its contractor, the RAND Corporation, pursuant to AHRQ's statutory authority to conduct and support research on healthcare and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of healthcare services and with respect to quality measurement and improvement. 42 U.S.C. 299a(a)(1) and (2). Method of Collection Survey of Hospital Quality Leaders: this survey will elicit information from approximately 500 hospital quality leaders in a variety of hospital settings, including high- and low-performing hospitals, facilities of varying sizes, and hospitals representing all nine geographic Census divisions. Hospital quality leaders will be asked to provide information about the use of HCAHPS in their hospital, with questions addressing all of the substantive areas identified in the goals section above. Characterizing hospitals' use of HCAHPS data will provide important insight into the activities hospitals conduct to improve patient experience scores. This information may be useful in supporting hospitals who lag behind their peers, learning from hospitals with outstanding records of patient experience, and providing recommendations that may be used to refine HCAHPS survey content. 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 294 hours. The annual total cost associated with the annual total burden hours is estimated to be $14,708. Table 1 shows the estimated annualized burden for the respondents' time to participate in this data collection. The Survey of Hospital Quality Leaders will be administered to 500 individuals. Prior work suggests that 3-5 items can typically be completed per minute, depending on item complexity and respondent characteristics, (Hays & Reeve, 2010; Berry, 2009). We have calculated our burden estimate using a conservative estimate of 4.5 items per minute. The survey contains 159 items and is thus estimated to require an average administration time of 35 minutes. As indicated below, the annual total burden hours are estimated to be 294 hours. Table 1--Estimated Annualized Burden Hours and Cost -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average Collection task Number of responses per Hours per Total burden hourly wage Total cost respondents respondent response hours rate * burden -------------------------------------------------------------------------------------------------------------------------------------------------------- Survey of Hospital Quality Leaders...................... 500 1 .59 294 $49.96 $14,708 ----------------------------------------------------------------------------------------------- Totals.............................................. .............. .............. .............. 294 .............. 14,708 -------------------------------------------------------------------------------------------------------------------------------------------------------- * Based upon mean hourly wages, ``National Compensation Survey: All United States December 2009--January 2011,'' U.S. Department of Labor, Bureau of Labor Statistics. 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 [[Page 37598]] comments will become a matter of public record. Sharon B. Arnold, Deputy Director. [FR Doc. 2016-13841 Filed 6-9-16; 8:45 am] BILLING CODE 4160-90-P
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III. How does the comparative i. Subgroup analysis: age, race/ in Ledema; qualitative reduction in
effectiveness of treatment vary by ethnicity, sex, body weight, CEAP LE pain; improvement in LE venous
patient characteristics, including age, classification, VCSS classification, hemodynamics/reflux severity as
sex, risk factors, comorbidities, severity of disease, anatomic measured by air plethysmography,
characteristics of disease, anatomic segment affected (e.g., iliofemoral, duplex ultrasonography, or invasive
segment affected, and characteristics of infrainguinal), known malignancy, venography; venous wound healing,
the therapy (e.g., exercise intensity, type presence of LE ulcer recurrent ulceration, patient-
of mechanical compression)? A. KQ 3: A symptomatic or reported quality of life (including
IV. What are the comparative safety symptomatic adults(over age 18) AVVQ), repeat intervention, LE
concerns associated with each treatment with the diagnosis of LE chronic amputation E
strategy (e.g., adverse drug reactions, venous thrombosis/obstruction B. Adverse effects of treatment,
bleeding)? Do the safety concerns vary (including post-thrombotic including: adverse drug reactions;
by patient subgroup (age, sex, race, risk syndrome): bleeding (including intracranial
factors, comorbidities, anatomic i. Subgroup analysis: age, race/ bleeding); venous wound infection;
segment, or disease severity)? ethnicity, sex, body weight, CEAP contrast nephropathy; radiation-
classification, VCSS classification, related injuries; exercise-related
PICOTS (Population, Intervention, Villalta score, severity of disease, harms; periprocedural
Comparator, Outcome, Timing, Setting) anatomic segment affected (e.g., complications (vessel dissection,
KQ 1: Diagnosis iliofemoral, infrainguinal), known vessel perforation, and AV fistula),
malignancy, presence of LE ulcer thrombophlebitis, venous
I. Population(s): II. Interventions:
A. Adults (over age 18) with the thrombosis (including stent
A. KQ 2: lifestyle interventions (e.g ., thrombosis), venous
diagnosis of LE varicose veins, LE smoking cessation, leg elevation,
chronic venous insufficiency/ thromboembolic events (including
weight reduction, exercise), medical PE), and death
incompetence/reflux, and/or LE therapy, local skin care/wound V. Timing:
chronic venous thrombosis/ care, mechanical compression A. Studies with all durations of
obstruction (including post- therapy, and invasive procedures followup will be included in the
thrombotic syndrome) (i.e., surgical and endovascular review; for symptomatic patients,
II. Diagnostic Measures: procedures) we will attempt to categorize
A. Air plethysmography, LE venous i. Medical therapies: diuretics, studies into those that evaluate
duplex ultrasonography (with and aspirin, pentoxifylline, short-term (≤30 days), intermediate-
without compression), invasive prostacyclins, zinc sulfate ter m (31 days to 6 months), and
venography, magnetic resonance ii. Invasive surgical/endovascular long-term (≤ 6 months) events.
venography, computed tomographic procedures: sclerotherapy (liquid, VI. Settings:
venography, serum D-dimer testing, foam, glue), radiofrequency A. Any
Villalta score ablation, thermal ablation, chemical
III. Comparators: Sharon B. Arnold,
ablation, ambulatory phlebectomy,
A. Diagnostic modalities listed above transilluminated powered Deputy Director.
(air plethysmography, LE duplex phlebectomy, venous ligation, [FR Doc. 2016–13761 Filed 6–9–16; 8:45 am]
venous ultrasonography [with and venous excision BILLING CODE 4160–90–P
without compression], invasive B. KQ 3: lifestyle interventions (e.g.,
venography, magnetic resonance smoking cessation, leg elevation,
venography, computed tomographic weight reduction, exercise), medical DEPARTMENT OF HEALTH AND
venography, serum D-dimer testing, therapy, local skin care/wound HUMAN SERVICES
Villalta score) will be compared to care, mechanical compression
one another therapy, and invasive procedures Agency for Healthcare Research and
IV. Outcomes: (i.e., surgical and endovascular Quality
A. Sensitivity, specificity, positive procedures)
predictive value, negative Agency Information Collection
i. Medical therapies: anticoagulants Activities: Proposed Collection;
predictive value, inter -rater including warfarin, apixaban,
reliability, internal consistency, test Comment Request
rivaroxaban, edoxaban, and
-retest reliability, false positives, dabigatran; diuretics AGENCY: Agency for Healthcare Research
false negatives, and positive and ii. Invasive surgical/endovascular and Quality, HHS.
negative likelihood ratios for each procedures: endovenous ACTION: Notice.
diagnostic measure listed above angioplasty/stenting, ultrasound
will be compared accelerated thrombolysis for SUMMARY: This notice announces the
V. Timing: chronic DVT (EkoSonic® intention of the Agency for Healthcare
A. Not applicable endovascular system), surgical Research and Quality (AHRQ) to request
VI. Settings: thromboembolectomy that the Office of Management and
A. All clinical settings, including III. Comparators: Budget (OMB) approve the proposed
information collection project: ‘‘Survey
asabaliauskas on DSK3SPTVN1PROD with NOTICES
inpatient and outpatient A. Specific treatments will be
compared to other included of Hospital Quality Leaders.’’ In
KQs 2–3: Treatment
treatments as described above or to accordance with the Paperwork
I. Population(s): no treatment (placebo or usual care) Reduction Act, 44 U.S.C. 3501–3521,
A. KQ 2: A symptomatic or IV. Outcomes: AHRQ invites the public to comment on
symptomatic adults (over age 18) A. Changes on standardized symptom this proposed information collection.
with the diagnosis of LE varicose scores (Villalta score, CEAP This proposed information collection
veins and/or LE chronic venous classification, AVVQ score, and was previously published in the Federal
insufficiency/incompetence/reflux: VCSS score); qualitative reduction Register on February 10, 2016 and
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![37598 Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices
comments will become a matter of Medicare beneficiaries. The proposed This demonstration may also help
public record. demonstration will begin in Illinois not prevent improper payments in
earlier than August 1, 2016, will begin geographic areas where HHA providers
Sharon B. Arnold,
in Florida not earlier than October 1, are known to have a high incidence of
Deputy Director. 2016, and will begin in Texas not earlier fraud. The improper payment rate for
[FR Doc. 2016–13841 Filed 6–9–16; 8:45 am] than December 1, 2016. The HHA claims has been increasing over
BILLING CODE 4160–90–P demonstration will begin in Michigan the past several years, and fraud is one
and Massachusetts not earlier than factor contributing to the increase. It is
January 1, 2017. Providers in each state important to note that while all
DEPARTMENT OF HEALTH AND will be notified by the appropriate payments made as a result of fraud are
HUMAN SERVICES Medicare Administrative Contractor considered ‘‘improper payments,’’ not
prior to the start of the demonstration in all improper payments constitute fraud.
Centers for Medicare & Medicaid
the state. Additionally, CMS will utilize CMS’ Comprehensive Error Rate Testing
Services
other educational efforts to announce (CERT) program, which measures
[CMS–6069–N] the program to stakeholders. Medicare’s improper payment rate,
This demonstration will evaluate an estimates the payments that did not
Medicare Program; Pre-Claim Review additional method that may assist with meet Medicare coverage, coding, and
Demonstration for Home Health the investigation and prosecution of billing rules. The fiscal year (FY) 2015
Services fraud in order to protect the Medicare Department of Health and Human
AGENCY: Centers for Medicare & Trust Funds from fraudulent actions Services Agency Financial Report
Medicaid Services (CMS), HHS. and improper payments. We believe this reported that the CERT program’s
demonstration will bolster the efforts calculated 2015 improper payment rate
ACTION: Notice.
that CMS and its partners have taken in for HHA claims increased to 59.0
SUMMARY: This notice announces a 3- implementing a series of anti-fraud percent from the 2014 rate of 51.4
year Medicare pre-claim review initiatives in these states and will percent and the 2013 rate of 17.3
demonstration for home health services provide valuable data that CMS working percent. The increase in the 2015
in the states of Illinois, Florida, Texas, with its law enforcement partners, can improper payment rate was primarily
Michigan, and Massachusetts where use to combat the submission of due to ‘‘insufficient documentation’’
there have been high incidences of fraud fraudulent claims to the Medicare errors, specifically, insufficient
and improper payments for these program. One such anti-fraud initiative documentation to support the medical
services. is the use of temporary moratoria on the necessity of the services. Similar
enrollment of new home health documentation errors have also
DATES: This demonstration will begin in
providers that were put in place in the occurred in previous years. For
Illinois no earlier than August 1, 2016, Miami and Chicago that and were example, the 2014 CERT report found
in Florida no earlier than October 1, subsequently expanded to the Fort that the majority of home health
2016, and in Texas no earlier than Lauderdale, Detroit, Dallas, and payment errors occurred when the
December 1, 2016. The demonstration Houston metropolitan areas. These narrative portion of the face-to-face
will begin in Michigan and temporary moratoria prohibit the new encounter documentation did not
Massachusetts no earlier than January 1, enrollment of home health providers to sufficiently describe how the clinical
2017. help CMS prevent and combat fraud, findings from the encounter supported
FOR FURTHER INFORMATION CONTACT: waste, and abuse in these locations. the beneficiary’s homebound status and
Jennifer McMullen, (410) 786–7635. We also believe the data collected need for skilled services.
Questions regarding the Medicare Pre- from this demonstration will assist with Due to the substantial increase in
Claim Review Demonstration for Home a second initiative, the Health Care improper payments and concerns raised
Health Services should be sent to Fraud Prevention and Enforcement by the home health industry, relating to
HHPreClaimDemo@cms.hhs.gov. Action Team (HEAT) Task Force, implementation of the face-to-face
SUPPLEMENTARY INFORMATION: created by the Department of Health and encounter documentation requirement,
Human Services and the Department of we made Medicare HHA payment
I. Background and Legislative
Justice (DOJ), and the Heat Task Force’s policy changes in an effort to simplify
Authority
ongoing fight against Medicare fraud. the face-to-face encounter regulations.
Section 402(a)(1)(J) of the Social The HEAT Task Force uses resources Specifically, as of January 1, 2015, a
Security Amendments of 1967 (42 across the government to help prevent separate narrative is no longer required
U.S.C. 1395b–1(a)(1)(J)) authorizes the and stop fraud, waste, and abuse in the as part of the face-to-face
Secretary to develop demonstration Medicare and Medicaid programs. Since documentation. Rather, the certifying
projects that ‘‘develop or demonstrate 2007, the HEAT Task Force of the DOJ physician’s or the acute/post-acute care
improved methods for the investigation has charged more than 2,300 defendants facility’s medical record(s) for the
and prosecution of fraud in the with defrauding Medicare of more than patient must contain sufficient
provision of care or services under the $7 billion and convicted approximately documentation to substantiate eligibility
health programs established by the 1,800 defendants of felony health care for home health services.
Social Security Act’’ (the Act). fraud offenses. In addition, the data Despite these recent changes, we
According to this authority, we will resulting from this demonstration could continue to see cases in which the
asabaliauskas on DSK3SPTVN1PROD with NOTICES
implement a Medicare demonstration provide investigators and law medical record does not support
that establishes a pre-claim review enforcement with important information eligibility for the home health benefit,
process for home health agencies to determine how to focus their which constitute ‘‘insufficient
(HHAs) to assist in developing investigation activities to identify and documentation’’ errors. Moreover, we
improved procedures for the combat home health fraud, and in so note that the recent regulatory changes
identification, investigation, and doing, protect the Medicare Trust Funds do not address HHA errors in home
prosecution of Medicare fraud occurring from fraudulent actions and improper health billing other than those related to
among HHAs providing services to payments. the face-to-face narrative requirement.
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Document Created: 2018-02-08 07:35:42
Document Modified: 2018-02-08 07:35:42
| 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 July 11, 2016. | |
| Contact | Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected] | |
| FR Citation | 81 FR 37596 |
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