RADIOLOGY SUMMARY McKesson Business Performance Services. Nicholas Parish, Compliance Program Manager



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Centers for Medicare & Medicaid Services (CMS) Revisions to Payment Policies under The Physician Fee Schedule, And other revisions to Part B For CY 2016; Final Rule RADIOLOGY SUMMARY McKesson Business Performance Services Nicholas Parish, Compliance Program Manager The Business Management Services business unit is one of several business units within McKesson Technology Solutions. We refer to ourselves as BPS or Business Performance Services for internal communications and certain external communications, such as media releases. PST Services, Inc. is the legal entity BPS uses with contracts with its clients or third party vendors.)

The Centers for Medicare & Medicaid Services (CMS) published in the Federal Register their annual Physician Fee Schedule, Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2016. Known as the Physician Fee Schedule (PFS) Final Rule it proposes updates to payment policies and payment rates on or after January 1, 2016 (CY. The Final Rule finalizes many of the changes in medical practice and relative value units proposed in the CY 2016 Proposed Rule. CMS accepted comments on the Final Rule until 5:00 p.m. December 29, 2015. Additionally, CMS has posted a Fact Sheet related to policy and payment changes and quality reporting programs. To view the PFS Final Rule, as published in the Federal Register click here To view the PFS Final Rule Fact Sheet, click here This review of the CMS Final Rule will provide the various sections that were listed in the ruling that may affect or be of interest to the specialty of Radiology. It will not include a comprehensive review of all components of the proposed rule. This document is for informational use only and it is not intended to provide legal advice or counseling on the various rulings from CMS. If the reader has concerns or questions they should consult with their compliance and/or legal counsel for advice. CY 2016 Physician Fee Schedule (PFS) Final Rule - Payment Rates Congressional Action Recently, Congress passed and the President signed into law significant changes to the Social Security Act. Among the changes were the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), changes to the Protecting Access to Medicare Act of 2014 (PAMA) and Achieving a Better Life Experience Act of 2014 (ABLE). MACRA provided the much anticipated repeal of the Sustainable Growth Rate (SGR) formula. Replacing the SGR under MACRA will be an annual update of 0.5% through 2019. 1 For years 2020 through 2025, no update will be applied and physicians will have the ability to add to their revenue through the Merit-based Incentive Payment System (MIPS). 2 Under MIPS, physicians and non-physician practitioners (NPPs) will receive annual incentive based payment increases or decreases based on their performance in a prior period. MIPS will attempt to bring together three incentive programs that are already in existence, the Physician Quality Reporting System (), the Value-Based Modifier (VBM), and Meaningful Use. After 2018, will be phased out and replaced by MIPS. A physician s composite score will come from four categories: quality, resource use, meaningful use, and clinical practice improvement activities. The CY2015 Final Rule had called for the transitioning of 10 and 90-day global periods to 0 days. MACRA prohibits that transition and instructs the Secretary to gather information using the rule making process and requesting input from physicians. PAMA established targeted reductions in the Physician Feed Schedule (PFS) resulting from adjustments of misvalued codes. The target was originally set at 0.5% per year of estimated expenditures for CY 2017 through 2020. 3 A provision of ABLE accelerated the application of the target to CYs 2016-2018 with a 1.0% target for 2016 and 0.5% each for CYs 2017 and 2018. 4 Background on the Physician Fee Schedule payment method Since 1992, Medicare has paid for the services of physicians, NPPs, and certain other suppliers under the PFS. This payment system pays for covered physicians services furnished to a beneficiary enrolled under Medicare Part B. The payment calculation for the PFS, in general, is based on a relative value unit (RVU) assigned to each of the designated physician services to capture the amount of work involved in the services. This includes the direct and indirect (overhead) practice expenses (PE) and the malpractice (MP) insurance expenses typically involved in furnishing the 1 2 3 4 42 US Code. 1395w-4(d)(18). Revisions to Payment Policies under the Physician Fees Schedule and other Revisions to Part B Final Rule for CY Fed. Reg. 220, (November 16, 2015) (to be codified at 42 CFR Parts 405, 410, 411, 414, 425, 495 et al.). 2016, 80. Page 70891. Ibid. Ibid.

services. The higher the number of RVUs assigned to a service produces a higher payment for that given service. The RVUs for a particular service are then multiplied by a fixed-dollar conversion factor (CF) and a geographic practice cost index (GPCI) adjustment factor to determine the payment amount for each service. The current formula used for this calculation is expressed as: Payment = [(RVU work x GPCI work) + (RVU PE x GPCI PE) + (RVU Malpractice x GPCI Malpractice)] x CF. 5 The CY 2016 MPFS conversion factor is set at $35.8279, which reflects the Budget Neutrality Adjustment of -0.9998, a Target Recapture Amount of -0.9923 and the MACRA mandated Update Factor of +1.005 update factor specified under MACRA. These numbers are reflected in the Table 60 copied below from the Final Rule. 6 TABLE 60: Calculation of the CY 2016 PFS Conversion Factor Conversion Factor in effect in CY 015 35.9335 Update Factor 0.5% (1.005) CY 2016 RVU Budget Neutrality Adjustment -0.02 percent 0.9998) CY 2016 Target Recapture Amount -0.77 percent 0.9923) CY 2016 Conversion Factor 35.8279 CMS indicates that the most widespread specialty impacts of the RVU changes result from two factors, the Misvalued code Initiative, (with noted impacts to radiation therapy centers and radiation oncology), and the technical improvement to the malpractice (MP) RVU. 7 Selected specialties from Table 62 of the Final Rule are reproduced below showing the projected impact for CY 2016. The allowed charges are based on CY 2014 utilization and CY 2015 rates and include deductibles and coinsurance. Table 62: CY 2016 PFS Estimated Impact on Total Allowed Charges by Specialty 8 Total Impact of Impact of Impact of PE Combined Specialty Allowed Work RVU MP RVU RVU Changes Impact Chrg (mil) Changes Changes Total $89020 0% 1% 0% 0% IR Radiology $298 0% 1% 0% 1% Nuclear Medicine $46 0% 0% 0% -1% Radiation Oncology $1,776 0% -2% 0% -2% Radiology $4,494 0% 0% 0% 0% IDTF $725 0% 0% 0% 0% Port X-Ray Supplier $106 0% 1% 0% 1% IR Pain Management $720 0% 0% 0% 0% Rad Therapy Centers $52 0% -2% 0% -2% There are two principle factors driving RVU changes, the Misvalued Code Initiative and the technical refinement of malpractice RVU. 9 Selected procedures from Table 63 of the Final Rule are reproduced below showing the impact of the CY 2016 Final Rule on certain high volume procedures. The 2015 conversion factor of 35.9335 and the 2016 conversion factor of $35.8279 were used in the calculations for both the facility and non facility rates. The procedures selected by CMS represent high volume procedures and were selected... for [the] sake of illustration from among the most commonly furnished by a broad spectrum of specialties. 10 5 6 7 8 9 Ibid at 70890 Ibid at 71357 Ibid at 71359 Ibid at 71358-78359 Ibid at 71359. 10 Ibid at 71359.

TABLE 63: Impact on CY 2016 Payment for Selected Procedures 11 CPT Mod Descriptor Facility CY 15 16 % Change Non Facility CY 15 16 % Change 71010 Chest x-ray 1 vw NA NA NA 22.64 22.57 0 71010 26 Chest x-ray 1 vw 9.35 9.32 0% 9.34 9.32 0% 77056 Mammogram Both Breasts NA NA NA 116.42 117.44 0% 77056 26 Mammogram Both Breasts 44.56 44.43 0% 44.56 44.43 0% 77057 Mammogram Screening NA NA NA 83.01 83.12 0% 77057 26 Mammogram Screening 35.93 35.83 0% 35.93 36.83 0% 77427 Radiation Tx management x5 187.57 187.84 0% 187.57 187.84 0% In the Proposed Rule CMS had identified 118 CPT codes as potentially misvalued and 103 of them made to the Final Rule. 12 A portion of Table 8 from the Final Rule, showing CMS identified codes is reproduced below. To see the entire table including all potential radiology codes, please see page 70914 of the PFS Final Rule. Table 8: Proposed Potentially Misvalued Codes Identified Through High Expenditure by Specialty Screen 13 HCPC Short Descriptor HCPC Short Descriptor 10022 FNA w/image 70544 MRA head w/o dye 27370 Injection for knee x-ray 70549 MRA neck w/o&w dye 36215 Place catheter in artery 71010 Chest x-ray 1 vw frontal 36556 Insert non-tunnel cv cath 71020 Chest x-ray 2 vw frontal&lat 36569 Insert PICC cath 71260 CT thorax w/dye 36620 Insert catheter artery 75710 Artery x-ray arm/leg 51702 Insert temp bladder cath 75978 Repair venous blockage 55700 Biopsy of prostate 77263 Radiation therapy planning 70491 CT soft tissue neck w/dye 77334 Radiation treatment aid(s) 70543 MRI orbit/face/neck w/o&w dye 78306 Bone imaging Whole Body Relative Value Unit (RVU) Changes to Direct Practice Expense (PE) Inputs for Digital Imaging Services CMS finalized its proposal to increase the PE for the PACS workstation from $2,501 to $5,557. 14 The higher price reflects the cost on the submitted invoices and not the proxy cost used previously. Phase in of reductions. CMS finalized its proposed implementation of the PAMA requirement that specifies if total RVUs for a procedure would be decreased by 20% or more the Work, PE, and MP RVUs would be phased in over a two year period. This means there is a 19% cut off. If the total reduction in RVU is 19% or less, then the reduction will take place all in one year. If a 20% or larger reduction, everything in excess of 19% will be in the second year. This applies to procedures that are not new or revised. 15 PAMA required the phase in 2017 but ABLE shifted to 2016 implementation. 16 11 Ibid at 71359-71360 12 Ibid at 70914 Ibid at 70914. 14 Ibid at 70899. 15 Ibid at 70927. 16 Ibid.

RUC Recommended Changes for Radiation Therapy. Based on RUC recommendations for the increased utilization of equipment, the CMS finalized the proposal to change the default utilization rate for the single linear accelerator for radiation treatment delivery services from 50% to 70%. This translates into presumed utilization of 35 hour per week instead of the previous 25 hours per week. 17 Other PAMA Provisions Quality Incentives To Promote Patient Safety and Public Health in Computed Tomography Diagnostic Imaging 18. PAMA included Quality Incentives to Promote Patient Safety and Public Health in Computed Tomography (CT) Diagnostic Imaging. 19 Following PAMA s statutory requirements, CMS finalized a 5% reduction of the Technical Component (TC) of CT procures performed in a nonfacility Place of Service that does not meet certain standards. CT procedures performed on systems that fail to comply with the National Electrical Manufacturers Association (NEMA) Standard XR-29-CT-2013 entitled Standard Attributes on CT Equipment Related to Dose Optimization and Management 20 will see the 5% reduction in CY 2016. In CY 2017 and following the reduction, will be 15%. CPT codes affected will be: 70450 70498, 71250 71275, 72125 72133, 72191 72194, 73200 73206, 73700 73706, 74150 74178, 74261 74263, and 75571-75574. 21 Appropriate Use Criteria (AUC) for Advanced Diagnostic Imaging (ADI) Services 22 PAMA also mandates that CMS establish a program to promote the use of appropriate use criteria (AUC) for advanced diagnostic imaging services. 23 In general, AUC are a set of individual criteria that present information in a manner that links a specific clinical condition or presentation, one or more services, and an assessment of the appropriateness of the service(s). Evidence-based AUC for imaging can assist clinicians in selecting the imaging study that is most likely to improve health outcomes for patients based on their individual context. 24 There are four major components of the AUC program under section 1834(q) of the Social Security Act, each with its own implementation date: (1) Establishment of AUC by November 15, 2015 (section 1834(q)(2)); (2) mechanisms for consultation with AUC by April 1, 2016 (section 1834(q)(3)); (3) AUC consultation by ordering professionals and reporting on AUC consultation by furnishing professionals by January 1, 2017 (section 1834(q)(4)); and (4) annual identification of outlier ordering professionals for services furnished after Jan. 1, 2017 (section 1834(q)(5)). 25 The proposed rule focuses on the first two components. CMS will not implement the mechanisms in the 2016 Final Rule, instead it will be a discussion item in the CY 2017 rule making. To further the statutory requirement of the AUC to reduce excessive imaging while promoting evidenced based care, PAMA requires CMS to develop a new Medicare program requiring physicians use AUC when ordering ADI procedures. The specific procedures included are diagnostic magnetic resonance imaging, CT, and nuclear medicine including positron emission tomography (PET) and other diagnostic tests it may add on at a later date. It specifically excludes x- ray, ultrasound, and fluoroscopy. PAMA is establishing timelines for creating a new Medicare AUC program for ADI and putting it on a fast track. The number of clinicians impacted by the scope of this program is massive as it will apply to every physician and practitioner who orders applicable diagnostic imaging services. This crosses almost every medical specialty and could have a particular impact on primary care physicians since their scope of practice can be quite vast. We believe the best implementation approach is one that is diligent, maximizes the opportunity for public 17 Ibid at 70950. 18 Ibid at 70930. 19 Ibid. 20 Ibid at 70931. 21 Ibid at 70930. 22 Ibid at 71102. 23 Ibid. 24 Ibid. 25 Ibid at 71103-71104.

comment and stakeholder engagement, and allows for adequate advance notice to physicians and practitioners, beneficiaries, AUC developers, and CDS mechanism developers. 26 (Emphasis added.) Priority Clinical Areas The Final Rule builds on the concept of Priority Clinical Areas to identify outlier professionals. Clinical Decision Support mechanisms (CDS) would be built to support and help choose AUC, (Appropriate Use Criteria). An outlier professional would be an ordering practitioner that has a pattern of imaging orders that fall outside the AUC. Beginning January 1, 2017, ordering professionals must consult applicable AUC using a qualified CDS mechanism when ordering applicable imaging services for which payment is made under applicable payment systems, and that furnishing professionals must report the results of this consultation on Medicare claims. 27 PAMA also provides for identification of outlier providers from the claims. We are proposing to identify priority clinical areas of AUC that we will use in identifying outlier ordering professionals. Although there is no consequence to being identified as an outlier ordering professional until January 2020, it is important to allow ordering and furnishing professionals as much time as possible to use and familiarize themselves with the specified applicable AUC that will eventually become the basis for identifying outlier ordering professionals. 28 Other Provisions of the Final Rule Low Dose Computed Tomography (LDCT) Lung Screening CMS has previously approved LDCT for lung screening but had not issued a code for billing Medicare. The Proposed Rule failed to provide a code for this service however the Final Rule identifies G0297 Low dose CT scan (LDCT) for lung cancer screening. 29 Effective CY 2016 the new code will be valued the same as 71250 except for the work RVU. The G0297 work RVU is valued at 0.52 v. the 1.02 for the 71250. 30 This is consistent with the value suggested in the Proposed Rule. Incident to Proposals CMS clarified certain aspects of the incident to provisions. Incident to services are physician services and supplies that are commonly provided without charge or included in the physician s bill. 31 These services and supplies must be: Furnished in a noninstitutional setting to noninstitutional patients An integral, though incidental, part of the service of a physician (or other practitioner) in the course of diagnosis or treatment of an injury or illness. Furnished under direct supervision (as specified under 410.26(a)(2)) of a physician or other practitioner eligible to bill and directly receive Medicare payment. Furnished by a physician, a practitioner with an incident to benefit, or auxiliary personnel. 32 Incident to services require direct supervision of the auxiliary personnel by the physician. The Final Rule specifies that the direct supervision be provided by the physician (or practitioner) that bills for the service. 33 Additionally, CMS specified that the auxiliary personnel must comply with all state laws and not be excluded from Medicare. 34 Stark Referral The physician self-referral law: (1) prohibits a physician from making referrals for certain designated health services (DHS) payable by Medicare to an entity with which he or she (or an immediate family member) has a financial relationship, unless the requirements of an applicable exception are satisfied; and (2) the entity from filing claims with Medicare (or billing another individual, entity, or third party payer) for those DHS furnished as a result of a prohibited 26 Ibid at 71107. 27 Ibid at 71106. 28 Ibid. 29 Ibid at 70974. 30 Ibid. 31 Ibid at 71065. 32 Ibid. 33 Ibid at 71066. 34 Ibid.

referral. 35 To view the updated list of Designated Health Services click here. The finalized clarifications to the Self- Referral law are: Recruitment and Retention: The ACA expanded access to healthcare coverage to those previously uninsured, increasing the need for primary care providers, including nonphysician practitioners, particularly in remote and underserved areas. CMS is establishing a new exception to permit payment to independent physicians in compensating nonphysician practitioners in geographic area of the hospital, FQHC or RHC providing remuneration 36. Per-Click: CMS references the decision in the DC Circuit Court decision to reconsider the prohibition on per-click payment arrangements. They state the regulation was remanded to Secretary Burwell and is considering options to comply with the court. 37 Split Billing Arrangements: Responding to written inquiries to CMS regarding a court decision (U.S. ex rel. Kosenske v. Carlisle HMA, 554 F.3d 88 (3d Cir. 2009)), CMS clarified its position on split bill arrangements. Split billing is where a physician performs DHS services in a hospital on hospital patients and the physician bills for the professional fee while using the resources of the hospital, (staff, exam room etc). CMS determined that this does not constitute remuneration from the hospital. 38 Locum Tenens: Revised definition Locum Tenens to remove reference to stand in the shoes as this language is unnecessary and can be construed with other compensation arrangements. 39 Updating Physician-Owned Hospital Requirements: The ACA established new restrictions on physician-owned hospitals, including setting a baseline physician ownership percentage that they cannot exceed and requiring them to state on their websites and in their advertising that they are owned by physicians. CMS finalized its proposals to update the regulations to clarify that a broad range of actions comply with the website and advertising requirements. CMS also finalized conforming changes that better align the regulations to the statute so that the baseline physician ownership percentage includes all physicians rather than only those physicians who refer to the hospital. 40 Other Guidance on Physician Self-referral of Designated Health Services Clarifying that compensation paid to a physician organization cannot take into account the referrals of any physician in the physician organization, not just a physician who stands in the shoes of the physician organization, and that employees and independent contractors need not sign arrangements between the physician organization and a DHS entity; Clarifying that the writing required in many of the exceptions to the physician self-referral law s referral and billing prohibitions can be a collection of documents (as opposed to a single formal contract) and making the terminology that describes types of arrangements consistent throughout the regulations; Clarifying that the term of a lease or personal service arrangement need not be in writing if the arrangement lasts at least 1 year and is otherwise compliant; Allowing expired leasing and personal services arrangements to continue indefinitely on the same terms if otherwise compliant; Allowing a 90-day grace period to obtain missing signatures without regard to whether the failure to obtain the signature was inadvertent; Clarifying that DHS entities can give to physicians items used solely for one or more of the purposes identified in the statute; Clarifying that a financial relationship does not exist when a physician provides services to hospital patients in the hospital if both the hospital and the physician bill independently for their services; Updating obsolete language in the exception for ownership in publicly traded entities to allow over-the-counter transactions and removing unnecessary language from the definition of a locum tenens physician; Clarifying the geographic service area for the FQHCs and RHCs using the physician recruitment exception; and 35 Ibid at 71342. 36 Ibid at 71369. 37 ibid at 71301. 38 Ibid at 71321. 39 Ibid at 71325. 40 Ibid at 71334-71335.

Correcting a drafting error so that the retention exception indicates that retention payments based on physician certification may be no more than 25 percent of the physician s current annual salary averaged over 24 months (as opposed to no more than 24 months). 41 Physician Compare The 2016 PFS final rule continues the phased approach to public reporting on Physician Compare. CMS will continue to make all 2016 individual EP and group practice measures available for public reporting. All for measures for groups of two or more EPs who meet the specified sample size requirements and collect data via a CMSspecified certified Consumer Assessment of Healthcare Providers and Systems () vendor are available for public reporting. In addition, all Accountable Care Organization (ACO) measures, including for ACOs, are available for public reporting. CMS is also finalizing the following proposals: To include Certifying Board, and specifically add American Board of Optometry (ABO) Board Certification and American Osteopathic Association (AOA) Board Certification. To include an indicator on profile pages for individual eligible professionals (EPs) who satisfactorily report the new Cardiovascular Prevention measures group in support of the Million Hearts initiative; To continue making individual-level QCDR measures available for public reporting, and, new to 2016, to publicly report group-level QCDR measures; To publicly report an item (or measure)-level benchmark derived using the Achievable Benchmark of Care (ABC ) methodology. More on this item below; To include in the downloadable database the Value Modifier tiers for cost and quality, noting if the group practice or EP is high, low, or neutral on cost and quality; a notation of the payment adjustment received based on the cost and quality tiers; and an indication if the individual EP or group practice was eligible to but did not report quality measures to CMS; and To publicly report in the downloadable database utilization data for individual EPs. Consistent with existing policies, all data must meet the public reporting standards measures must be statistically accurate, valid, reliable, and comparable and must resonate with consumers. For individual and group-level measures, CMS will publicly report all measures submitted, reviewed, and deemed valid and reliable in the Physician Compare downloadable file. However, not all measures will be included on the Physician Compare profile pages. 42 CMS did not finalize the proposed rule to include a visual indicator on profile pages for group practices and individual EPs who receive an upward adjustment for the value modifier. 43 Physician Compare Benchmark CMS is finalizing our proposal to publicly report an item-level benchmark for group practice and individual EP measures using the ABC methodology. The benchmark will be stratified by reporting mechanism to ensure comparability and reduce the interpretation burden for consumers. Benchmarks are important to ensuring that the quality data published on Physician Compare are accurately understood. A benchmark allows consumers to more easily evaluate the published information by providing a point of comparison between groups and between individuals. On Physician Compare, the benchmark will be displayed as a five-star rating. CMS will conduct analysis and stakeholder outreach around the star attribution methodology prior to public reporting in 2017. 44 41 Fact Sheet from CMS, Proposed policy, payment, and quality provisions changes to the Medicare Physician Fee Schedule for Calendar Year 2016 (October 30, 2015) 42 Ibid 43 Ibid 44 Ibid.

Physician Value-based Payment Modifier The Value-based Payment Modifier (Value Modifier) provides for differential payments under the PFS to physicians, groups of physicians, and other eligible professionals (EPs) based on the quality and cost of care they furnish to beneficiaries enrolled in the traditional Medicare Fee-for-Service (FFS) program. Under the Value Modifier, performance on quality and cost measures can translate into increased payment for physicians and other EPs who provide high quality, efficient care and decreased payment for low-performing physicians and other EPs who underperform. The Value Modifier is set to expire at the end of CY 2018, as a new comprehensive program, required by MACRA, called the MIPS begins in CY 2019. The final policies established in this rule are intended to help provide a smooth transition from the Value Modifier to MIPS. 45 This year, CMS is finalizing the following key provisions: To apply the Value Modifier to nonphysician EPs who are Physician Assistants (PAs), Nurse Practitioners (NPs), Clinical Nurse Specialists (CNSs), and Certified Registered Nurse Anesthetists (CRNAs) (and not to other nonphysician EP types) in groups and to PAs, NPs, CNSs, and CRNAs who are solo practitioners, in the CY 2018 payment adjustment period; To apply the quality-tiering methodology to all groups and solo practitioners that meet the criteria to avoid the downward adjustment under the. Groups and solo practitioners would be subject to upward, neutral, or downward adjustments derived under the quality-tiering methodology, with the exception that PAs, NPs, CNSs, and CRNAs in groups consisting of nonphysician EPs and PAs, NPs, CNSs, and CRNAs who are solo practitioners will be held harmless from downward adjustments under the quality-tiering methodology in CY 2018; To continue to set the maximum upward adjustment under the quality-tiering methodology for the CY 2018 Value Modifier at: +4.0 times an adjustment factor (to be determined after the conclusion of the performance period), for groups of physicians with ten or more EPs; +2.0 times an adjustment factor, for groups of physicians with between two to nine EPs and physician solo practitioners; and +2.0 times an adjustment factor for groups that consist of nonphysician EPs and solo practitioners who are PAs, NPs, CNSs, and CRNAs; and To set the amount of payment at risk under the CY 2018 Value Modifier to -4.0 percent for groups of physicians with ten or more EPs, -2.0 percent for groups of physicians with between two to nine EPs and physician solo practitioners, and -2.0 percent for groups that consist of nonphysician EPs and solo practitioners who are PAs, NPs, CNSs, and CRNAs. To waive application of the Value Modifier for groups and solo practitioners, as identified by their Taxpayer Identification Number (TIN), if at least one EP who billed for PFS items and services under the TIN during the applicable performance period for the Value Modifier participated in the Pioneer ACO Model, Comprehensive Primary Care Initiative (CPCI), or other similar Innovation Center model (such as Comprehensive ESRD Care Initiative, Oncology Care Model (OCM), and the Next Generation ACO Model) during the performance period, beginning with the CY 2017 payment adjustment period; To use CY 2016 as the performance period for the CY 2018 Value Modifier and continue to apply the CY 2018 Value Modifier based on participation in the by groups and solo practitioners; Beginning with the CY 2017 payment adjustment period, we are increasing the minimum episode size for the Medicare Spending per Beneficiary measure to be included in the Value Modifier to 125 episodes for all groups and solo practitioners. Also, beginning with the CY 2017 payment adjustment period, for solo practitioners and groups with two to nine EPs, we are finalizing that the All-Cause Hospital Readmissions measure will not be used in the quality composite calculation for the Value Modifier. These changes are being made to be consistent with our policy to only use measures that have moderate to high reliability. To not apply the automatic downward adjustment applicable to TINs that do not meet the criteria to avoid the downward adjustment under, when determines on informal review that at least 50 percent of the TIN s EPs meet the criteria to avoid the downward payment adjustment. Also, we note that if the group was initially determined to have not met the criteria to avoid the downward payment adjustments and consequently was initially subject to the automatic downward adjustment under the Value Modifier, then we do not 45 Ibid.

expect to have data for calculating their quality composite, in which case they would be classified as average quality. 46 Medicare Shared Savings Program In this Final Rule CMS finalized the proposed policy changes to specified portions of the Shared Saving Program. The Medicare Shared Savings Program (Shared Savings Program) was established to promote accountability for a patient population, coordinate items and services under parts A and B, and encourage investment in infrastructure and redesigned care processes for high quality and efficient service delivery through provider and supplier participation in an ACO. 47 The changes include: Adding a measure of Statin Therapy for the Prevention and Treatment of Cardiovascular Disease in the Preventive Health domain of the Shared Savings Program quality measure set to align with updated clinical guidelines and reporting; Preserving flexibility to maintain or revert measures to pay for reporting if a measure owner determines the measure no longer aligns with updated clinical practice or causes patient harm; Clarifying how -eligible professionals participating within an ACO meet their reporting requirements when their ACO satisfactorily reports quality measures; and Amending the definition of primary care services to include claims submitted by Electing Teaching Amendment hospitals and to exclude certain claims for services furnished in Skilled Nursing Facilities. 48 Modifications to the Physician Quality Reporting System CMS noted the 2018 payment adjustment will be the final adjustment to be issued under. Beginning with CY 2019 the adjustments for quality reporting along with other factors will be made under the Merit-Based Incentive Payment System (MIPS). This is in accordance with MACRA requirements. 49 The Physician Quality Reporting System () encourages individual eligible professionals (EPs) and group practices to report information on the quality of care to Medicare. The requirements we are finalizing reflect CMS intent to continue implementing the by finalizing requirements for the 2018 payment adjustment consistent with the requirements for the 2017 payment adjustment. CMS establishes the same criteria for satisfactory reporting that was established for the 2017 payment adjustment, which is generally to require the reporting of nine measures covering three National Quality Strategy domains. If an individual EP or group practice does not satisfactorily report or satisfactorily participate in for 2016, a 2% negative payment adjustment will apply to covered professional services furnished by that individual EP or group practice during 2018. CMS makes changes to the measure set to add measures where gaps exist, as well as to eliminate measures that are topped out, duplicative, or are being replaced with a more robust measure. There will be 281 measures in the measure set and 18 measures in the GPRO Web Interface for 2016. Also, as recently authorized under MACRA, CMS is adding a reporting option that will allow group practices to report quality measure data using a Qualified Clinical Data Registry (QCDR). 50 CMS finalized their proposals for the CY 2018 VM to include all of the GPRO reporting mechanisms available to groups for the reporting periods in CY 2016 and all of the reporting mechanisms available to individual EPs for the reporting periods in CY 2016. These reporting mechanisms are described in Tables 27 and 28 of this final rule with comment period. 46 Ibid 47 Ibid 48 Ibid 49 Ibid 50 Ibid

Additionally, we are finalizing our proposal to use all of the quality measures that are available to be reported under these various reporting mechanisms to calculate a group or solo practitioner s VM in CY 2018 to the extent that a group (or individual EPs in the group, in the case of the 50 percent option ) or solo practitioner submits data on these measures. These quality measures are described in Table 29 through 42 of this final rule with comment period. 51 Tables 27 and 28 are reproduced below from the PFS Final Rule. TABLE 27: Summary of Requirements for the 2018 Payment Adjustment: Reporting Criteria for the Satisfactory Reporting of Quality Measures Data via Claims, Qualified Registry, and EHRs and Satisfactory Participation Criterion in QCDR 52 Reporting Period Measure Type Measures Measures Measures Measures Groups measures and/or non- measures reportable via a QCDR Reporting Mechanism Claims Qualified Registry Direct EHR Product or EHR Data Submission Vendor Product Qualified Registry Qualified Clinical Data Registry (QCDR) Satisfactory Reporting/Satisfactory Participation Criteria Report at least 9 measures, covering at least 3 of the NQS domains AND report each measure for at least 50 percent of the EP s Medicare Part B FFS patients seen during the reporting period to which the measure applies. Of the measures reported, if the EP sees at least 1 Medicare patient in a face-to-face encounter, the EP will report on at least 1 measure contained in the cross-cutting measure set. If less than 9 measures apply to the EP, the EP would report on each measure that is applicable), AND report each measure for at least 50 percent of the Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measures with a 0 percent performance rate would not be counted Report at least 9 measures, covering at least 3 of the NQS domains AND report each measure for at least 50 percent of the EP s Medicare Part B FFS patients seen during the reporting period to which the measure applies. Of the measures reported, if the EP sees at least 1 Medicare patient in a face-to-face encounter, the EP will report on at least 1 measure contained in the cross-cutting measure set. If less than 9 measures apply to the EP, the EP would report on each measure that is applicable, AND report each measure for at least 50 percent of the Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measures with a 0 percent performance rate would not be counted. Report 9 measures covering at least 3 of the NQS domains. If an EP s direct EHR product or EHR data submission vendor product does not contain patient data for at least 9 measures covering at least 3 domains, then the EP would be required to report all of the measures for which there is Medicare patient data. An EP would be required to report on at least 1 measure for which there is Medicare patient data. Report at least 1 measures group AND report each measures group for at least 20 patients, the majority (11 patients) of which are required to be Medicare Part B FFS patients. Measures groups containing a measure with a 0 percent performance rate will not be counted. Report at least 9 measures available for reporting under a QCDR covering at least 3 of the NQS domains, AND report each measure for at least 50 percent of the EP s patients. Of these measures, the EP would report on at least 2 outcome measures, OR, if 2 outcomes measures are not available, report on at least 1 outcome measures and at least 1 of the following types of measures resource use, patient experience of care, efficiency/appropriate use, or patient safety. 51 Revisions to Payment Policies under the Physician Fees Schedule and other Revisions to Part B Final Rule for CY Fed. Reg. 220, (November 16, 2015) (to be codified at 42 CFR Parts 405, 410, 411, 414, 425, 495 et al.). 2016, 80 Page 71293 52 Ibid at 71148.

Table 28: Summary of Requirements for the 2018 Payment Adjustment Group Practice Reporting Criteria for Satisfactory Reporting of Quality Measures Data via GPRO 53 Group Reporting Measure Reporting Practice Satisfactory Reporting Criteria Period Type Mechanism Size 25-99 EPs; 100+ EPs (if For does not apply) 25-99 EPs that elect for ; 100+ EPs (if for applies) 2-99 EPs; 100+ EPs (if for does not apply) 2-99 EPs that elect For ; 100+ EPs (if For applies) 2-99 EPs; 100+ EPs (if For does not apply) GPRO Measures in the Web Interface GPRO Measures in the Web Interface + for Measures Measures + for Measures Web Interface Web Interface + CMS Certified Survey Vendor Qualified Registry Qualified Registry + CMS Certified Survey Vendor Direct EHR Product or EHR Data Submission Vendor Product Report on all measures included in the web interface; AND populate data fields for the first 248 consecutively ranked and assigned beneficiaries in the order in which they appear in the group s sample for each module or preventive care measure. If the pool of eligible assigned beneficiaries is less than 248, then the group practice must report on 100 percent of assigned beneficiaries. In other words, we understand that, in some instances, the sampling methodology we provide will not be able to assign at least 248 patients on which a group practice may report, particularly those group practices on the smaller end of the range of 25 99 EPs. If the group practice is assigned less than 248 Medicare beneficiaries, then the group practice must report on 100 percent of its assigned beneficiaries. A group practice must report on at least 1 measure for which there is Medicare patient data. The group practice must have all for survey measures reported on its behalf via a CMS certified survey vendor. In addition, the group practice must report on all measures included in the Web Interface; AND populate data fields for the first 248 consecutively ranked and assigned beneficiaries in the order in which they appear in the group s sample for each module or preventive care measure. If the pool of eligible assigned beneficiaries is less than 248, then the group practice must report on 100 percent of assigned beneficiaries. A group practice will be required to report on at least 1 measure for which there is Medicare patient data. Please note that, if the for survey is applicable to a group practice who reports quality measures via the Web Interface, the group practice must administer the for survey in addition to reporting the Web Interface measures. Report at least 9 measures, covering at least 3 of the NQS domains. Of these measures, if a group practice sees at least 1 Medicare patient in a face-to-face encounter, the group practice would report on at least 1 measure in the cross-cutting measure set. If less than 9 measures covering at least 3 NQS domains apply to the group practice, the group practice would report on each measure that is applicable to the group practice, AND report each measure for at least 50 percent of the group s Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measures with a 0 percent performance rate would not be counted. The group practice must have all for survey measures reported on its behalf via a CMS certified survey vendor, and report at least 6 additional measures, outside of the for survey, covering at least 2 of the NQS domains using the qualified registry. If less than 6 measures apply to the group practice, the group practice must report on each measure that is applicable to the group practice. Of the additional measures that must be reported in conjunction with reporting the for survey measures, if any EP in the group practice sees at least 1 Medicare patient in a face-to-face encounter, the group practice must report on at least 1 measure in the crosscutting measure set. Report 9 measures covering at least 3 domains. If the group practice s direct EHR product or EHR data submission vendor product does not contain patient data for at least 9 measures covering at least 3 domains, then the group practice must report all of the measures for which there is Medicare patient data. A group practice must report on at least 1 measure for which there is Medicare patient data. 2-99 EPs that Direct EHR The group practice must have all for survey measures 53 Ibid at 71148-71149.

(Jan 1- elect For ; 100+EPs (if For applies) Measures + for 2+ EPs measures and/or on- measures reportable via a QCDR Product or EHR Data Submission Vendor Product + CMS Certified Survey Vendor Qualified Clinical Data Registry (QCDR) reported on its behalf via a CMS certified survey vendor, and report at least 6 additional measures, outside of for, covering at least 2 of the NQS domains using the direct EHR product or EHR data submission vendor product. If less than 6 measures apply to the group practice, the group practice must report all of the measures for which there is Medicare patient data. Of the additional 6 measures that must be reported in conjunction with reporting the for survey measures, a group practice would be required to report on at least 1 measure for which there is Medicare patient data. Report at least 9 measures available for reporting under a QCDR covering at least 3 of the NQS domains, AND report each measure for at least 50 percent of the group practice s patients. Of these measures, the group practice would report on at least 2 outcome measures, OR, if 2 outcomes measures are not available, report on at least 1 outcome measures and at least 1 of the following types of measures resource use, patient experience of care, efficiency/appropriate use, or patient safety. The information contained herein is deemed accurate, but its accuracy is not guaranteed or warranted by McKesson Business Performance Services. The materials contained herein have been abridged from the statutory sources and should not be construed or relied upon for legal advice. Readers are urged to consult legal counsel concerning particular situations and specific legal questions. To ensure compliance with requirements imposed by the IRS, we inform you that this message is not intended to be used, and cannot be used, by the addressee or any other person for the purpose of avoiding penalties that may be imposed under the Internal Revenue Code. CPT is a registered trademark of the American Medical Association (AMA). The AMA is the owner of all copyright, trademark and other rights to CPT and its updates.