This proposed rule clarifies and makes updates to details regarding this program that were finalized in

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1 2014 Ambulatory Surgery Center (ASC) and Outpatient Prospective Payment System (OPPS) A Summary of the Quality Provisions of the Proposed Rule Overview On July 8, 2013, the Centers for Medicare and Medicaid Services (CMS) released its Joint 2014 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgery Center (ASC) Payment System Proposed Rule. This summary discusses proposed updates and refinements related to the Hospital Outpatient Quality Reporting (OQR) Program, the ASC Quality Reporting (ASCQR) Program, and the Hospital Value Based Purchasing (VBP) Program. It also includes proposed revisions to the Quality Improvement Organization (QIO) regulations and changes to the Medicare Electronic Health Record (EHR) Incentive Program. CMS will accept comments on this proposed rule through September 6, The final rule is expected on or about November 1, 2013, with implementation of the new payments and policies beginning January 1, Hospital Outpatient Quality Reporting (OQR) Program (p. 450) Hospitals that fail to meet the Hospital OQR Program requirements will incur a 2.0 percentage point reduction to their annual payment update factor. Beneficiaries and secondary payers share in the reduction of payments to these hospitals. This proposed rule clarifies and makes updates to details regarding this program that were finalized in the CY 2013 OPPS/ASC final rule. Participation Requirements To participate successfully in the Hospital OQR Program, hospitals must meet administrative, data collection and submission, and data validation requirements. Hospitals must register online (via by July 31 of the year prior to the affected annual payment update in order to participate in the program (i.e., July 31, 2013 for purposes of the CY 2014 payment update). If a hospital has a Medicare acceptance date on or after January 1 of the year prior to the affected annual payment update, the hospital must register no later than 180 days from the date identified as its Medicare acceptance date. Reporting Deadlines For CY 2016, CMS proposes a 12 month reporting period for the calculation of the claims based measures that spans from July 1, 2013 through June 30, 2014, rather than the calendar year. This will permit alignment between the inpatient and outpatient claims based measures reported on the Hospital Compare Web site, and also allow CMS to post more recent data. For measures that must be submitted via the Web based tool on CMS' QualityNet site, hospitals would be required to submit aggregate level data between July 1, 2015 and November 1, 2015 with respect to the time period of January 1, 2014 to December 31, That is, hospitals would submit all the data required via the QualityNet Web site once annually during this data submission window. However, the data input forms on the QualityNet Web site will require hospitals to submit aggregate data represented by each separate quarter. Although CMS recognizes that aggregate level reporting may be less accurate than patient level reporting, the former minimizes hospital burden.

2 For the influenza vaccination measure, discussed below, hospitals must submit data to the National Healthcare Safety Network (NHSN) by May 15 th of the year in which the vaccination season has ended (e.g., for vaccinations given from October 1, 2014 to March 31, 2015, the submission deadline would be May 15, 2015). Finally, the deadline for patient level data submitted directly to CMS is about 4 months after the last day of each calendar quarter (i.e., on or around August 1, 2014 for services furnished during the first quarter of CY 2014 or January March 2014). Publication of Hospital OQR Program Data (p. 459) As required by statute, data submitted for the Hospital OQR Program are typically provided to hospitals for a preview period and then displayed on the Hospital Compare Web site: CMS publishes quality data by the corresponding hospital CMS Certification Number (CCN), and indicates instances where data from two or more hospitals are combined (e.g., in a situation in which a larger hospital has taken over a smaller hospital). CMS makes Hospital Inpatient Quality Reporting (IQR) and Hospital OQR data publicly available whether or not the data have been validated for payment purposes. When hospitals register for the program, they consent to the public reporting of their data. Proposed Removal of Two Chart Abstracted Measures from the OQR Program (p. 463) CMS proposes to remove two measures from the Hospital OQR Program for the CY 2016 payment determination and subsequent years: OP 19: Transition Record with Specified Elements Received by Discharged Emergency Department (ED) Patients due to hospital concern about the measure specifications, including potential privacy issues related to releasing certain elements of the transition record to either the patient being discharged from an ED or the patient s caregiver. This measure was suspended earlier while the measure developer, the AMA PCPI, worked to revise the specifications. However, CMS ultimately determined that the measure cannot be implemented with the degree of specificity needed to fully address the concerns of stakeholders without being overly burdensome (i.e., proposed refinements made data abstraction more challenging). Furthermore, all aspects for this transition record measure are currently required to meet the Medicare EHR Incentive Program s meaningful use core objective for hospitals to provide patients the ability to view online, download, and transmit information about a hospital admission. Therefore, if CMS were to keep this measure, hospitals would need to submit this data for both the Hospital OQR Program using chart abstraction and via attestation for the MU core objective. OP 24: Cardiac Rehabilitation Measure: Patient Referral from an Outpatient Setting. Last year, CMS had deferred data collection for this measure to January 1, 2014 encounters due to the unavailability of detailed abstraction instructions for data collection in time for the July 2012 release of the Hospital OQR Specifications Manual. It now proposes to remove the measure from the program due to continued difficulties with developing specifications for the HOPD setting. The measure specifications provided by the measure steward, the American College of Cardiology (ACC), identify the applicable care setting as a "Clinician Office/Clinic." CMS notes it is difficult to accurately identify the purpose of hospital outpatient visits, such as for evaluation and management purposes, using solely HOPD claims data. It is also difficult for hospitals to determine which particular clinic visit resulted in a cardiac rehabilitation referral for any given patient. Prepared by Hart Health Strategies, 7/18/13, Page 2

3 Proposed Measures for the CY 2016 OQR Payment Determination (p. 469) CMS is proposing five new measures for the OQR program, affecting payment in CY 2016, with data collection beginning in CY None of these new measures are claims based. They include: Influenza Vaccination Coverage among Healthcare Personnel (NQF #0431). This measure was also adopted for the ASC Quality Reporting Program for the CY 2016 and subsequent years payment determinations, as well as the Hospital IQR Program for the FY 2015 and subsequent years payment determinations. Data for this Healthcare Associated Infection (HAI) measure is submitted through the Center for Disease Control s National Healthcare Safety Network (NHSN). This measure allows the hospital to indicate those who are allergic to components of the vaccine or have other contraindications that would prevent them from getting vaccinated; those who decline the vaccination; and those with unknown vaccination status or who do not otherwise meet the definitions of the numerator. Specifications are available at: Endoscopy/Poly Surveillance: Appropriate follow up interval for normal colonoscopy in average risk patients (NQF #0658). This measure evaluates the percentage of patients aged 50 years and older receiving screening colonoscopy without biopsy or polypectomy who had a recommended follow up interval of at least 10 years for repeat colonoscopy documented in their colonoscopy report. The goal is to assess whether average risk patients with normal colonoscopies receive a recommendation to receive a repeat colonoscopy in an interval that is less than the recommended amount of years. This measure has time limited NQF endorsement for the ASC setting. This is a chart abstracted measure, and aggregate data (numerators, denominators, and exclusions) would be collected and submitted to CMS via an online tool. Specifications can be found at: Endoscopy/Poly Surveillance: Colonoscopy Interval for Patients with a History of Adenomatous Polyps Avoidance of Inappropriate Use (NQF #0659). This measure assesses the percentage of patients aged 18 years and older receiving a surveillance colonoscopy, with a history of a prior colonic polyp in previous colonoscopy findings who had a follow up interval of 3 or more years since their last colonoscopy documented in the colonoscopy report. This measure excludes patients with: medical reason(s) for an interval of less than 3 years (e.g., last colonoscopy incomplete, last colonoscopy had inadequate prep, piecemeal removal of adenomas, or last colonoscopy found greater than 10 adenomas); or documentation of a system reason(s) for an interval of less than 3 years (e.g., unable to locate previous colonoscopy report, previous colonoscopy report was incomplete). This measure has time limited endorsement from the NQF for the ASC setting. This is also a chart abstracted measure, where aggregate data (numerators, denominators, and exclusions) are collected and data submitted to CMS via an online tool. Specifications are available at: Complications within 30 Days following Cataract Surgery Requiring Additional Surgical Procedures. This outcome measure seeks to identify complications that are reasonably attributed to cataract surgery by evaluating the percentage of patients 18 years and older with a diagnosis of uncomplicated cataract who had cataract surgery and had any of a specified list of surgical procedures in the 30 days following surgery, which would indicate the occurrence of any of the following major complications: retained nuclear fragments, endophthalmitis, dislocated or wrong power IOL retinal detachment, or wound dehiscence. This measure has the timelimited endorsement of the NQF for the Ambulatory Care: Clinic setting (NQF #0564), but is currently not NQF endorsed for the ASC setting. The measure specifications can be found at: Prepared by Hart Health Strategies, 7/18/13, Page 3

4 Cataracts: Improvement in Patient s Visual Function within 90 Days Following Cataract Surgery (NQF #1536). This measure assesses the percentage of patients aged 18 years and older who had cataract surgery and had improvement in visual function achieved within 90 days following the cataract surgery. This measure is NQF endorsed for the ASC setting. Specifications are available at: These newly proposed measures would be added to the following current Hospital OQR Program measures: Median Time to Fibrinolysis (NQF #0287): *chart abstracted measure Fibrinolytic Therapy Received Within 30 Minutes (NQF #0288): *chart abstracted measure Median Time to Transfer to Another Facility for Acute Coronary Intervention (NQF #0290): *chart abstracted measure Aspirin at Arrival (NQF #0286): *chart abstracted measure Median Time to ECG (NQF #0289): *chart abstracted measure MRI Lumbar Spine for Low Back Pain (NQF #0514): *claims based measure Timing of Antibiotic Prophylaxis (NQF #0270): *chart abstracted measure Prophylactic Antibiotic Selection for Surgical Patients (NQF #0268): *chart abstracted measure Mammography Follow up Rates: *claims based measure Abdomen CT Use of Contrast Material: *claims based measure Thorax CT Use of Contrast Material (NQF #0513): *claims based measure Ability for Providers with HIT to Receive Laboratory Data Electronically Directly into their ONC Certified EHR System as Discrete Searchable Data (NQF #0489): *structural measure; Webbased data submission proposed for 2016 Cardiac Imaging for Preoperative Risk Assessment for Non Cardiac Low Risk Surgery (NQF #0669): *claims based measure Cardiac Rehabilitation Patient Referral From an Outpatient Setting (NQF #0643): *chartabstracted/claims based measure; proposed to be removed for 2016 payment determination Simultaneous Use of Brain CT and Sinus CT: *claims based measure Use of Brain CT in the Emergency Department for Atraumatic Headache: *claims based measure; public reporting of this measure continues to be deferred Tracking Clinical Results between Visits (NQF #0491): *structural measure; Web based data submission Median Time from ED Arrival to ED Departure for Discharged ED Patients (NQF #0496): *chartabstracted measure Transition Record with Specified Elements Received by Discharged ED Patients (NQF #0649): *chart abstracted measure; proposed to be removed for 2016 payment determination ED Patient Left Without Being Seen: * Web based data abstraction ED Head CT or MRI Scan Results for Acute Ischemic Stroke or Hemorrhagic Stroke who Received Head CT or MRI Scan Interpretation Within 45 minutes of Arrival (NQF #0661): *chart abstracted measure Door to Diagnostic Evaluation by a Qualified Medical Professional: *chart abstracted measure Prepared by Hart Health Strategies, 7/18/13, Page 4

5 Median Time to Pain Management for Long Bone Fracture (NQF #0662): *chart abstracted measure Safe Surgery Checklist Use: *structural measure; Web based data submission proposed for 2016 Hospital Outpatient Volume on Selected Outpatient Surgical Procedures: *structural measure; Web based data submission proposed for 2016 (procedure categories and corresponding HCPCS codes can be found at: 89&blobheader=multipart%2Foctet stream&blobheadername1=content Disposition&blobheadervalue1=attachment%3Bfilename%3D1r_OP26MIF_v+6+0b.pdf&blobcol= urldata&blobtable=mungoblobs) Technical specifications for existing measures are listed in the Hospital OQR Specifications Manual, which is posted on the CMS QualityNet Web site at: altemplate&cid= Ambulatory Surgical Center Quality Reporting (ASCQR) Program (pg. 518) Beginning with CY 2014 payment rates, annual updates will be reduced by 2.0 percentage points for ASCs that fail to meet the reporting requirements of the ASCQR Program. CMS previously adopted measures for the CY 2014, CY 2015, and CY 2016 payment determinations, and finalized some data collection requirements and reporting timeframes for these measures through the CY 2012 OPPS/ASC final rule. These measures are: ASC 1: Patient Burn* ASC 2: Patient Fall* ASC 3: Wrong Site, Wrong Side, Wrong Patient, Wrong Procedure, Wrong Implant* ASC 4: Hospital Transfer/Admission* ASC 5: Prophylactic Intravenous Antibiotic Timing* ASC 6: Safe Surgery Checklist Use** ASC 7: ASC Facility Volume Data on Selected ASC Surgical Procedures** (procedure categories and corresponding HCPCS codes are located at: &cid=12 ASC 8: Influenza Vaccination Coverage among Healthcare Personnel *** * New measure for the CY 2014 payment determination. ** New measure for the CY 2015 payment determination. ***New measure for the CY 2016 payment determination. Prepared by Hart Health Strategies, 7/18/13, Page 5

6 Proposed Additional ASCQR Program Quality Measures for the CY 2016 Payment Determination and Subsequent Years (pg. 522) CMS proposes 4 new quality measures for the CY 2016 payment determination and subsequent years, beginning with CY 2014 data collection. CMS selected measures that it felt could apply to both HOPDs and ASCs since many of the same surgical procedures are performed in both of these settings. It proposes to collect aggregate data (numerators, denominators, and exclusions) on all ASC patients for these proposed chart abstracted measures via an online tool available through the QualityNet Web site. These measures are the same measures being proposed for the 2016 Hospital OQR Program (see earlier descriptions) and include: Complications within 30 Days following Cataract Surgery Requiring Additional Surgical Procedures Endoscopy/Poly Surveillance: Appropriate follow up interval for normal colonoscopy in average risk patients (NQF #0658) Endoscopy/Poly Surveillance: Colonoscopy Interval for Patients with a History of Adenomatous Polyps Avoidance of Inappropriate Use (NQF #0659) Cataracts: Improvement in Patient s Visual Function within 90 Days Following Cataract Surgery (NQF #1536) CMS seeks public comment on these measures, on potential future measures, and on alternative data collection strategies, such as the collection of patient level data through registries or other third party data aggregators, and via certified EHR technology, along with the timing of doing so. Requirements Regarding Data Processing and Collection Periods for Claims Based Measures for the CY 2014 Payment Determination and Subsequent Years (pg. 549) For the CY 2015 payment determination and subsequent years, an ASC must submit complete data on individual claims based quality measures through a claims based reporting mechanism by submitting the appropriate QDCs on the ASC s Medicare claims. The data collection period for such claims based quality measures is the calendar year 2 years prior to a payment determination year. For the CY 2016 payment determination and subsequent years, CMS proposes to continue its policy that the minimum threshold for successful reporting be that at least 50% of claims meeting measure specifications contain QDCs. CMS intends to increase this percentage for future payment determinations. Since some ASCs have relatively small numbers of Medicare claims, for the CY 2016 payment determination and subsequent years, CMS proposes a minimum case volume of 240 Medicare claims (primary plus secondary payer) per year, which is an average of 60 per quarter). Those with fewer would not be required to participate in the ASCQR. Proposed Requirements for Data Submitted Via a CMS Online Data Submission Tool (pg. 555) For measures that rely on the online submission tool (Safe Surgery Checklist and ASC Facility Volume Data), CMS previously finalized that for the CY 2015 payment determination, ASCs would report data for these two measures between July 1, 2013 and August 15, 2013 for services furnished between January 1, 2012 and December 31, For the CY 2016 payment determination, CMS proposes that the data collection time period for these measures be the calendar year 2014 (January 1, 2014 to December 31, Prepared by Hart Health Strategies, 7/18/13, Page 6

7 2014) and that the data submission time period be January 1, 2015 to August 15, CMS proposes to increase the timeframe for data submission in order to align with the claims based and Web based reporting process, to ensure more current data, and to prevent the need for retrospective data collection by ASCs, which can be burdensome. For the 4 newly proposed Web based chart abstracted measures, the data collection time period for the CY 2016 payment determination would be January 1, 2014 to December 31, 2014 and the data submission time period for the collected data would be January 1, 2015 to August 15, CMS previously finalized the adoption of the Influenza Vaccination Coverage among Healthcare Personnel measure for the CY 2016 payment determination and determined that the data collection period would be from October 1, 2014 to March 31, In this rule, CMS further proposes that ASCs would have until August 15, 2015 to submit their influenza season data to NHSN, which is the latest date possible that will provide sufficient time for CMS to make the CY 2016 payment determinations. This date also aligns with the data entry deadline for measures entered via the CMS online tool. ASCQR Program Reconsideration Procedures for the CY 2014 Payment Determination and Subsequent Years (pg. 562) CMS previously adopted an informal reconsideration process for the ASCQR Program for the CY 2014 payment determination and beyond modeled after the processes used under the Hospital IQR and Hospital OQR Programs. CMS intends to complete these reviews and communicate results within 90 days following the deadline for submitting requests for reconsideration. Reconsideration determinations would be the final ASCQR Program payment determination. Hospital Value Based Purchasing (VBP) Program (p.514) The rule proposes to set performance and baseline periods for the catheter associated urinary tract infections (CAUTI), central line associated bloodstream infection (CLABSI), and surgical site infection (SSI) measures for the FY 2016 Hospital VBP Program. These 3 outcome measures will be reported via CDC s NHSN. The proposed performance period would be January 1, 2014 through December 31, 2014, and the proposed baseline period would be January 1, 2012 through December 31, The rule also proposes to create a second level independent CMS review process for hospitals that are dissatisfied with the result of existing review, corrections, and appeal processes. CMS intends to provide hospitals with its independent review decision within 90 calendar days following the receipt of the request. Proposed Revisions to the Quality Improvement Organizations (QIO) Regulations (pg. 570) CMS proposes to update these regulations based on the recently enacted Trade Adjustment Assistance Extension Act of 2011 (Pub. L , Section 261), which reduces spending by $330 million over the period. The legislation gives additional flexibility to the Secretary in the administration of the QIO program and modifies the provisions under which CMS contracts with QIOs. QIOs, generally staffed by health care professionals, review medical care, help beneficiaries with complaints about the quality Prepared by Hart Health Strategies, 7/18/13, Page 7

8 of care, and implement care improvements. The legislation makes several changes to the composition and operation of QIOs, including a modification to expand the geographic scope of QIO contracts and a lengthening of the contract period. Proposed Changes to the Medicare Electronic Health Record (EHR) Incentive Program (pg. 594) CMS proposes to provide a special method for making hospital based determinations for 2013 only in the cases of those eligible professionals (EPs) who reassign their benefits to Method II critical access hospitals (CAHs). CMS has been unable to make EHR payments to these EPs for their CAH II claims, or to take those claims into consideration in making hospital based determinations because of system limitations. Adopting this newly proposed method for 2013 will allow CMS to begin making payments based on CAH II one year earlier than it would be able to do under current regulations. CMS also proposes a minor clarification to the regulations concerning the cost reporting period used to determine the final EHR payments for hospitals. Prepared by Hart Health Strategies, 7/18/13, Page 8