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CY 2017 Proposed Physician Fee Schedule (CMS-1654-P)

Summary of Key Provisions

July 15, 2016

The Centers for Medicare and Medicaid Services (CMS) on July 7 published a rule that updates the payment policies, rates, and quality provisions for services provided under the Medicare Physician Fee Schedule (PFS). The following is a summary of key provision of this proposed rule.

Executive Summary • CMS is accepting comments on the proposed rule through September 6, 2016. The final rule is

expected to be released in early November. • The Medicare Access and CHIP Reauthorization Act included annual fee schedule updates of 0.5

percent from July 2015 through 2019. • CMS is proposing to add a small number of codes for services that can be delivered via

telehealth. The new services are: End-Stage renal disease, advanced care planning services, and critical care consultations.

• CMS is proposing to begin making separate payment for services furnished using the psychiatric Collaborative Care Model (CoCM) beginning January 1, 2017.

• The Consolidated Appropriations Act of 2016 reduces the payment amounts under the PFS for the technical component (TC) of imaging services that are X-rays taken with film by 20% for services provided on or after January 1, 2017. CMS is proposing to establish a new modifier for claims for X-rays that are taken with film.

• CMS proposed to expand the duration and scope of the Diabetes Prevention Program model and to rename it the Medicare Diabetes Prevention Program (MDPP).

• CMS is proposing to publicly release Medicare Advantage bid data. CMS also is proposing to publically release Medicare Advantage and Part D drug plan medical loss ratios.

• CMS is proposing to allow physicians who participate in an Accountable Care Organization to report separately for Physician Quality Reporting System purposes.

• CMS is proposing to create a mechanism to use beneficiary attestations for assigning beneficiaries to ACOs.

• CMS is proposing to update the Value-Based Modifier (VM) informal review policies and establish how the quality and cost composites under the VM would be affected for the CY 2017 and CY 2018 payment adjustment periods.

• CMS is proposing changes to its Stark law regulations that place restrictions on lease arrangements between physician groups and hospitals for equipment owned by the physicians, leased to the hospitals and then used by the same physicians to treat patients at the hospital.

Table of Contents Executive Summary ....................................................................................................................................... 1

Medicare Telehealth (II. C) (Federal Register 46179) .................................................................................. 2

Improving Payment Accuracy for Primary Care, Care Management, and Patient-Centered Services (II. E) Federal Register 46200 ................................................................................................................................. 3

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Reducing Administrative Burden and Improving Payment Accuracy for Chronic Care Management (CCM) services CCM (II E. 4) (Federal Register 46205) ............................................................................................ 3

Appropriate Use Criteria for Advanced Diagnostic Imaging Services (III. C) Federal Register 46386.......... 4

Payment Incentive for Transition from Traditional X-Ray Imaging to Digital Radiography and other Imaging Services (II. J) (Federal Register 46224) .......................................................................................... 5

Procedures Subject to the Multiple Procedure Payment Reduction (MPPR) and the OPPS Cap (II. K) (Federal Register 46225) ............................................................................................................................... 6

Chronic Care Management (CCM) and Transitional Care Management (TCM) Supervision Requirements in Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) (III. A) Federal Register 46377 ............................................................................................................................................................ 6

Release of Part C Medicare Advantage Bid Pricing Data (III. E) (Federal Register 46396) ........................... 6

Part C and Part D Medical Loss Ratio (MLR) Data (III. E) (Federal Register 46403) ...................................... 8

Accountable Care Organizations Participants who Report PQRS Measures Separately (III. H) (Federal Register 46408) ............................................................................................................................................. 9

Proposed Expansion of the Diabetes Prevention Program (DPP) Model (III. J) (Federal Register 46413) ... 9

Medicare Shared Savings Program (III. K) (Federal Register 46418) .......................................................... 13

Alignment with the MACRA Quality Payment Program ......................................................................... 13

ACOs and Beneficiary Attestation ........................................................................................................... 13

ACO Quality Reporting ............................................................................................................................ 14

Quality Measures Validation Audit ......................................................................................................... 15

Value-Based Payment Modifier and Physician Feedback Program (III. L) (Federal Register 46442) .......... 15

Physician Self-Referral Updates (III. M) (Federal Register 46448) .............................................................. 16

Appendix I …………………………………………………………………………………………………………………………………………….18

Medicare Telehealth (II. C) (Federal Register 46179) CMS’ process for public submission of requests for adding services to the list of accepted Medicare telehealth services requires that qualifying requests fall into one of two categories. Category 1 includes services that are similar to professional consultations, office visits, and office psychiatry services that are currently on the list of telehealth services. Category 2 includes services that are not similar to the current list of telehealth services.

CMS determined that four services were sufficiently similar to End Stage Renal Disease (ESRD) related services currently on the telehealth list qualify as additions to the Medicare telehealth services on a Category 1 basis for CY 2017. Those services include CPT codes:

• 90967 (End-stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients younger than 2 years of age

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• 90968 (End-stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients 2-11 years of age

• 90969 (End-stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients 12-19 years of age)

• 90970 (End-stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients 20 years of age and older)

CMS did not propose adding Critical Care Evaluation and Management (E/M) codes to the list of Medicare telehealth services. However, persuaded by the requests that it recognize the potential benefit of critical care consultation services that are furnished remotely, CMS does think it advisable to create a coding distinction between telehealth consultations for critically ill patients and telehealth consultations for other hospital patients. It is proposing to make payment through new codes, GTTT1 and GTTT2, to describe critical care consultations furnished via telehealth. The services would be limited to once per day, per patient and would be valued relative to existing E/M services. CMS seeks comment on whether the new coding would create a helpful distinction between telehealth consultations for critically ill patients and telehealth consultations for other hospital patients.

CMS also included a proposal on how a Place of Service (POS) code for telehealth would be used under the fee schedule with the expectation that, if such a code is available, it would be used as early as January 1, 2017. CMS proposes that the providers furnishing telehealth services would be required to report the telehealth POS code to indicate that the billed service is furnished as a telehealth service from a distant site. It also proposes to use the facility Practice Expense Relative Value Units (PE RVUs) to pay for telehealth services reported by providers with the telehealth POS code. The POS code for telehealth would not apply to originating sites billing the facility fee. Using the telehealth POS code for telehealth services would not affect payment for telehealth services for practitioners that already use a facility POS when billing for telehealth services.

Improving Payment Accuracy for Primary Care, Care Management, and Patient-Centered Services (II. E) Federal Register 46200 CMS proposed making payment through the use of three G codes (GPPP1, GPPP2, and GPPP3) that parallel the new CPT codes, as well as a fourth G-code (GPPPX) to describe services furnished using a broader application of behavioral health integration in the primary care setting. CMS intends for these to be temporary codes (for perhaps only one year) and will consider whether to adopt and establish values for the new CPT codes under its standard process, presumably for CY 2018. CMS recognizes that there may be overlap in the patient populations for the proposed new G-codes. However, CMS noted that time spent by a practitioner or clinical staff cannot be counted more than once for any code (or assigned to more than one patient), consistent with PFS coding conventions.

CMS is proposing to begin making separate payment for services furnished using the psychiatric Collaborative Care Model (CoCM) beginning January 1, 2017.

Reducing Administrative Burden and Improving Payment Accuracy for Chronic Care Management (CCM) services CCM (II E. 4) (Federal Register 46205) CMS proposed recognizing for Medicare payment additional CPT codes within the Chronic Care Management family (for Complex CCM services) to reflect resources used in develop in plan of care.

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Currently, CMS requires billing practitioners to inform the beneficiary of several things: the availability of CCM services; that only one practitioner can furnish and be paid for these services during a calendar month; and the right to stop the CCM services at any time. CMS is now proposing to allow the practitioner to document in the beneficiary’s medical record that this information was explained and to note whether the beneficiary accepted or declined CCM services instead of obtaining a written agreement.

CMS also proposed to remove the language requiring beneficiary authorization for the electronic communication of his or her medical information with other treating providers as a condition of payment for CCM services. To simplify the current requirement to provide the beneficiary with a written or electronic copy of the care plan, the rules would simply indicate that a copy of the care plan must be given to the patient or caregiver. CMS stated that it believes beneficiaries should and must be provided a copy of the care plan, and that practitioners may choose to provide the care plan in hard copy or electronic form in accordance with patient preferences. CMS does not believe it is necessary to specify the format of the care plan that must be provided as a condition of CCM payment.

Appropriate Use Criteria for Advanced Diagnostic Imaging Services (III. C) Federal Register 46386 The Protecting Access to Medicare Act of 2014 (PAMA) directed CMS to develop an appropriate use criteria/clinical decision-support (AUC/CDS) program for advanced diagnostic imaging services. This program was mandated to be implemented in January 2017, but in earlier rulemaking CMS said it was not able to begin the implementation process. The new proposed rule suggests an implementation date of January 1, 2018.

CMS has proposed defining Clinical Decision Support Mechanism (CDSM) as an interactive, electronic tool for use by clinicians that communicates Appropriate Use Criteria (AUC) information to the user and assists them in making the most appropriate treatment decision for a patient’s specific clinical condition. A CDSM would incorporate specified applicable AUC sets from which an ordering professional could select. A CDSM may be a module within or available through certified EHR technology. If within or available through certified EHR technology, a qualified CDSM would incorporate relevant patient-specific information into the assessment of the appropriateness of an applicable imaging service. The applicable payment systems for the Medicare AUC program are the PFS, the prospective payment system for hospital outpatient department services, and the ambulatory surgical center payment systems.

CMS set the initial list of priority clinical areas as:

• Chest Pain (includes angina, suspected myocardial infarction, and suspected pulmonary embolism)

• Abdominal Pain (any locations and flank pain) • Headache, traumatic and non-traumatic • Low back pain • Suspected stroke • Altered mental status • Cancer of the lung (primary or metastatic, suspected or diagnosed) • Cervical or neck pain

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CMS encourages public comments on this proposed initial list of priority clinical areas, including recommendations for other clinical areas that should be included among the list of priority clinical areas. In particular, CMS is interested in comments on the above methodology or alternate options; whether the proposed priority clinical areas are appropriate, including information on the extent to which these proposed priority clinical areas may be represented by clinical guidelines or AUC in the future.

CMS proposed adding requirements that qualified CDSMs must provide ordering professionals aggregate feedback in the form of an electronic report on an annual basis (at minimum) regarding their consultations with specified applicable AUC.

CDSM must make available to ordering professionals, at a minimum, specified applicable AUC that reasonably encompass the entire clinical scope of all priority clinical areas. The rule further proposes that that qualified CDSMs must be able to incorporate specified applicable AUC from more than one qualified provider lead entities (PLE). In addition, the proposed rule specified that applicable AUC and related documentation supporting the appropriateness of the applicable imaging service ordered must be made available within the qualified CDSM and that the qualified CDSM must clearly identify the appropriate use criterion consulted if the tool makes available more than one criterion relevant to a consultation for a patient’s specific clinical scenario. CMS also is proposed that the qualified CDSM must provide to the ordering professional a determination, for each consultation, of the extent to which an applicable imaging service is consistent with specified applicable AUC or a determination of “not applicable” when the mechanism does not contain a criterion that would apply to the consultation.

CMS also proposed that the qualified CDSM must generate and provide to the ordering professional certification or documentation that documents which qualified CDSM was consulted, the name and NPI of the ordering professional that consulted the CDSM and whether the service ordered would adhere to applicable AUC. In addition, the proposed rule would require documentation on whether the service ordered would not adhere to such criteria, or whether such criteria was not applicable for the service ordered.

CMS proposed to require under §414.94(g)(1)(vi)(A) that this certification or documentation must be issued each time an ordering professional consults the qualified CDSM. The documentation or certification provided by the qualified CDSM must include a unique consultation identifier. In addition, the specified applicable AUC content within qualified CDSMs would be required to be updated at least every 12 months.

The rule also proposes that qualified CDSMs have a protocol in place to more expeditiously remove AUC that are determined by the qualified PLE to be potentially dangerous to patients and/or harmful if followed.

CMS also proposed that qualified CDSMs must make available for consultation specified applicable AUC that address any new priority clinical areas within 12 months of the priority clinical area being finalized by CMS.

Payment Incentive for Transition from Traditional X-Ray Imaging to Digital Radiography and other Imaging Services (II. J) (Federal Register 46224) The Consolidated Appropriations Act of 2016 reduces the payment amounts under the PFS for the technical component (TC) of imaging services that are X-rays taken with film by 20% for services

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provided on or after January 1, 2017. To implement this requirement, CMS proposed to establish a new modifier that would be required on claims for X-rays that are taken with film. The modifier would be required on claims for X-rays that are taken with film and on claims for the technical component of the X-ray services. This includes when the service is billed globally, as the PFS payment adjustment is made to the technical component.

The law also includes a 7% payment reduction for imaging services made under the PFS for X-rays that are taken with computed radiology during calendar years 2018, 2019, 2020, 2021 and 2022. For 2023 and beyond, the law requires a 10% reduction for imaging services taken using computed radiology, which is defined as cassette-based imaging that uses an imaging plate to create the image. CMS will address this reduction in future rulemaking.

Procedures Subject to the Multiple Procedure Payment Reduction (MPPR) and the OPPS Cap (II. K) (Federal Register 46225) The Consolidated Appropriations Act of 2016 revises the Multiple Procedure Payment Reduction (MPPR) for services provided on or after January 1, 2017. In 2012, CMS implemented a 25% MPPR reduction on the professional component (PC) of advanced imaging services. The reduction is applied when the same physician conducts multiple imaging procedures to the same patient, in the same session, on the same day. The Consolidated Appropriations Act of 2016 changes this payment reduction from 25% and to 5%. It also exempts any of the reduced expenditures that are associated with the 5% MMPR on the PC of imaging from the physician fee schedule’s budget neutrality requirements. Based on this statutory requirement, CMS proposed to implement the 5% reduction for services provided on or after January 1, 2017.

Chronic Care Management (CCM) and Transitional Care Management (TCM) Supervision Requirements in Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) (III. A) Federal Register 46377 To enable Rural Health Clinics (RHCs) and FQHCs to contract with third parties to furnish aspects of Chronic Care Management (CCM) and Transitional Care Management (TCM) services, CMS proposed to revise its regulations at §405.2413(a)(5) and §405.2415(a)(5) to state that services and supplies furnished incident to TCM and CCM services can be furnished under general supervision of a RHC or FQHC practitioner. The proposed exception to the direct supervision requirement would apply only to auxiliary personnel (such as a nurse, medical assistant, or anyone acting under the supervision of the physician) furnishing TCM or CCM incident to services. This would not apply to any other RHC or FQHC services.

Release of Part C Medicare Advantage Bid Pricing Data (III. E) (Federal Register 46396) Medicare Advantage Organizations (MAOs) use a bidding process to apply to participate in the Medicare Advantage (MA) program. The bids reflect the estimated costs to provide benefits to enrollees. CMS is proposing to release the data associated with these bids on an annual basis. CMS proposed to release publicly Medicare Advantage bid pricing data, subject to certain exclusions. Specifically, CMS is proposing to release the pricing related information that is detailed at 42 CFR 422.254(a)(1). That section requires that MA organizations submit the following as part of their bids:

• The aggregate monthly bid amount for each MA plan (other than a Medical Savings Plan) the organization intends to offer in the upcoming year in the service area.

• The plan type for each plan.

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• The monthly aggregate bid amount for the provision of all items and services under the plan. • The proportions of the bid amount attributable to:

o The provision of benefits under the original Medicare fee-for-service program option. o The provision of basic prescription drug coverage. o The provision of supplemental health care benefits. o The projected number of enrollees in each MA local area used in calculation of the bid

amount, and the enrollment capacity, if any, for the plan. o The actuarial basis for determining the monthly aggregate bid amount.

• A description of deductibles, coinsurance, and copayments applicable under the plan and the actuarial value of the deductibles, coinsurance, and copayments.

• Information on qualified prescription drug coverage. • The projected allowable costs and the portion of projected allowable costs attributable to

administrative expenses for MA organizations offering regional MA plans. • The total projected costs for providing rebatable integrated benefits. • For regional plans the relative cost factors for the counties in a plan's service area. • The enrollment capacity (if any) for the plan. • The amount of the MSA monthly premium for basic benefits under the original Medicare fee-

for-service program option. • The amount of the beneficiary supplemental premium, if any.

For Medicare Medical Savings Plans (MSA), CMS is proposing to release:

• The enrollment capacity (if any) for the plan. • The amount of the MSA monthly premium for basic benefits under the original Medicare fee-

for-service program option. • The amount of the plan deductible. • The amount of the beneficiary supplemental premium, if any.

CMS believes that releasing the bid pricing data will facilitate research to better understand the costs and utilization trend in the MA program and inform future policymaking.

The rule also proposes a timeframe for the release of the bid pricing data. The data would be released annually after the first Monday in October. The data release would be from contract years that are at least 5 years old. This information (listed above) is included in the MA Bid Pricing Tool (BPT), MSA BPTs, and End Stage Renal Disease-Special Needs Plans BPTs.

CMS is proposing to wait 5 years before release bid pricing data, as the agency believes this is an appropriate length for the bid pricing data to no longer be competitively sensitive. CMS is considering whether to release MA bid pricing data sooner than proposed 5-year data lag. This may include MA bid pricing data as recent as the previously-concluded MA contract year. CMS has requested comments on the proposed 5-year delay and whether a shorter time period would be sufficient, or if a longer delay is needed, to protect MAOs from any competitive harm from the disclosure of the bid data. CMS also is seeking comment on the relationship between the passage of time and the commercial sensitivity of each the bid data element. Those citing unfair competitive harm are required to provide evidence of the harm linked to particular bid data element and how each of these elements could be used by a competitor.

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CMS proposed to exclude some information that it collects to verify the actuarial bases of MA plan bids.

• Any narrative information regarding base period factors, manual rates, cost-sharing methodology, optional supplemental benefits, or other topics that require a narrative statement during the bid submission process would be excluded from the data release. CMS said it believes this information is proprietary and should remain protected from public disclosure.

• CMS also proposed to exclude any supporting documentation that the MAO submits to support the actuarial bases of MA plan bids. This may include text, spreadsheet, or email files that were not part of the BPT worksheet submission. CMS noted there is no standard data format for this information, so it would be operationally difficult to disclose. Also, CMS is concerned that the release of any supporting documentation would have a “chilling effect” on the type of information provided in future bidding.

• Any beneficiary or other individual (such as certifying actuaries and MA plan contacts) identifying information also would be excluded from the disclosure.

• CMS proposed to exclude bid review correspondence between CMS (and its contractors) and the MAO, and internal bid review reports.

CMS is not committing to a specific date for each annual release. CMS is seeking comment on whether the data should be released to the public at large or if it should be restricted to researchers who are subject to the agency’s data sharing procedures.

Part C and Part D Medical Loss Ratio (MLR) Data (III. E) (Federal Register 46403) CMS proposed to add new contract requirements to authorize release to the public certain medical loss ratio (MLR) data that is submitted by MAOs and Part D plan sponsors. Under current regulations, MLR requirements apply to the Part D program. As part of this requirement, Part C and Part D plan sponsors would be required to report the data needed to calculate and verify the MLR and any remittance amount. This includes data on revenue, claims, federal and state taxes and licensing or regulatory fees, totally monthly members, and plan specific data, such as the number of dual-eligible beneficiaries who are enrolled. Part C and Part D plan sponsors also must report the medical loss ratio numerator, the medical loss ratio denominator, a credibility adjustment, the unadjusted MLR, the adjusted MLR, incurred quality improvement expenses, non-claims costs, and any remittances due to CMS for the contract year.

CMS proposed to release, no earlier than 18 months after the end of the applicable contract year, Part C and D MLR data.

CMS proposed to exclude some information from public release. Any narrative information that Part D sponsors submit as part of their MLR reports would be excluded. Plan level data, such as base period experience data, plan IDs, plan member months, and Medicaid per member per month gains and losses would be excluded. Any beneficiary or other individual identifying information would not be released. In addition, CMS proposed to exclude any MLR review correspondence between the Part D plan and CMS.

CMS is seeking comment on the release of Part C and D MLR data. CMS specifically is interested if the data that would be released contains proprietary information and what safeguards may be appropriate. This may include recommendations on what information should be redacted and the length of time that

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such data remains commercially sensitive. CMS also is seeking suggestions for publicly reporting aggregations of MLR data instead of releasing it as reported by the plan sponsors. Comments should provide analysis and explanations on how a competitor may gain an unfair advantage from the release of a particular type of information.

Accountable Care Organizations Participants who Report PQRS Measures Separately (III. H) (Federal Register 46408) CMS proposed to remove the prohibition on Eligible Professionals (EPs) who are part of a group or a solo practice that participates in an Accountable Care Organization (ACO) to separately report quality measures for the 2018 Physician Quality Reporting System (PQRS) payment adjustment. Under current Medicare Shared Savings Program (MSSP) regulations, EPs in who participate in an ACO may not independently report for PQRS purposes apart from the ACO. This prohibition is designed to promote provider and supplier integration within the ACO.

For purposes of PQRS reporting for the CY 2018 payment adjustments, CMS proposed to allow EPs who bill under an ACO Taxpayer Identification Number (TIN) to have the option or reporting separately as individual EPs or group practices. Should the ACO fail to satisfactorily report on behalf of these EPs or group practices, this separately reported data would be used to determine whether the EPs or groups are subject to the 2018 PQRS payment adjustment.

CMS also proposes to allow this option for the 2017 PQRS payment adjustment. Given that the reporting period for the 2017 adjustment has closed, CMS proposed a secondary PQRS reporting period. A secondary reporting period of January 1, 2016 through December 31, 2016 will be available to report PQRS data to

CMS detailed at page Federal Register page 46408 how it proposes to use PQRS data reported by EPs for the CY 2018 Value-Based Modifier (VM) if the ACO does not successfully report data. CMS would determine whether the EPs are Category 1 or Category 2 under the VM. For those determined to be Category 1, CMS proposes to classify their quality composite for the CY 2018 VM payment adjustment as “average quality.”

CMS is requesting comment on this proposal.

Proposed Expansion of the Diabetes Prevention Program (DPP) Model (III. J) (Federal Register 46413) CMS proposed to expand the duration and scope of the DPP model and rename the model the Medicare Diabetes Prevention Program (MDPP). The MDPP will become effective January 1, 2018.

CMS proposed to designate MDPP services as “additional preventive services” available under Medicare Part B. CMS proposed that the MDPP be a 12-month program using the CDC-approved DPP curriculum, consisting of 16 core sessions over 16-26 weeks and the option for monthly core maintenance sessions over 6 months thereafter if the beneficiary achieves and maintains a minimum weight loss in accordance with the CDC Diabetes Prevention Recognition Program Standards and Operating Procedures.

During the first 6 months of the DPP intervention, each of the 16 core sessions must address one of the following curriculum topics. All topics must be addressed by the end of the 16 sessions.

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1. Welcome to the National Diabetes Prevention Program 2. Self-Monitoring Weight and Food Intake 3. Eating Less 4. Healthy Eating 5. Introduction to Physical Activity (Move Those Muscles) 6. Overcoming Barriers to Physical Activity (Being Active—A Way of Life) 7. Balancing Calorie Intake and Output 8. Environmental Cues to Eating and Physical Activity 9. Problem Solving 10. Strategies for Healthy Eating Out 11. Reversing Negative Thoughts 12. Dealing with Slips in Lifestyle Change 13. Mixing Up Your Physical Activity: Aerobic Fitness 14. Social Cues 15. Managing Stress 16. Staying Motivated, Program Wrap Up

The last 6 months of the DPP 12-month intervention must include at least one core maintenance session delivered in each of the 6 months (for a minimum of six sessions), and all core maintenance sessions must address different topics.

1. Welcome to the Second Phase of the Program 2. Healthy Eating: Taking It One Meal at a Time 3. Making Active Choices 4. Balance Your Thoughts for Long-Term Maintenance 5. Healthy Eating With Variety and Balance 6. Handling Holidays, Vacations, and Special Events 7. More Volume, Fewer Calories (Adding Water Vegetables and Fiber) 8. Dietary Fats 9. Stress and Time Management 10. Healthy Cooking: Tips for Food Preparation and Recipe Modification 11. Physical Activity Barriers 12. Preventing Relapse 13. Heart Health 14. Life With Type 2 Diabetes 15. Looking Back and Looking Forward

Beneficiaries who meet the coverage criteria would be able to enroll in the MDPP one time. Those beneficiaries who complete the 12 month program, and achieve and maintain a required minimum level of weight loss, would be eligible for additional monthly maintenance sessions for as long as the weight loss is maintained. The ongoing maintenance sessions will adhere to the same curriculum requirements as the core maintenance sessions.

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CMS proposed that any organization recognized by the CDC (preliminary or full recognition) to provide DPP services would be eligible to apply for enrollment in Medicare as a supplier beginning on or after January 1, 2017. MDPP suppliers would be subject to the enrollment regulations in 42 CFR part 424, which addresses Medicare conditions of payment. If an organization loses its CDC recognition status at any point, withdraws from the CDC recognition program at any point, or fails to move from preliminary to full recognition within 36 months of applying for CDC recognition, the organization would be subject to revocation of its Medicare billing privileges for MDPP services. DPP organizations would be eligible to reenroll in Medicare as an MDPP supplier if, after reapplying for CDC recognition, the organization again achieves preliminary recognition.

CDC-recognized organizations who are not already enrolled in Medicare (on the basis of being an existing Medicare provider or supplier) may apply to enroll any time on or after January 1, 2017. Existing Medicare providers and suppliers that wish to bill for MDPP services would have to inform CMS of their intention and satisfy all other requirements, but would not need to enroll a second time. They would be eligible to bill for MDPP services furnished on or after January 1, 2018.

CMS proposed requiring personnel who deliver MDPP services (coaches) to obtain a National Provider Identifier (NPI) to help ensure program integrity standards and is seeking public comment on requiring that coaches enroll in the Medicare program. MDPP suppliers must submit the active and valid NPIs of all coaches who would furnish MDPP services on behalf of the supplier as an employee or contractor. If active and valid NPIs of coaches are not supplied, or if the coaches fail to obtain or lose active and valid NPIs, the MDPP supplier may be subject to compliance action or revocation of supplier status.

If an MDPP supplier has its Medicare enrollment revoked or deactivated for reasons independent of DPRP recognition, that supplier would lose its ability to bill Medicare for MDPP services but would not automatically lose its DPRP recognition from the CDC. Existing Medicare providers and suppliers who lose CDC recognition would lose their Medicare billing privileges with respect to MDPP services, but may continue to bill for other non-MDPP Medicare services for which they are eligible to bill. MDPP suppliers that have their Medicare billing privileges revoked or that lose billing privileges for MDPP may appeal. CMS proposed to allow MDPP suppliers to provide MDPP services via remote technologies, but will use evaluation data to weigh the effectiveness of virtual vs. in-person service and may modify this proposal in the future.

Payment for MDPP services will be tied to the number of sessions attended and achievement of a minimum weight loss of 5% of baseline weight (body weight recorded during the beneficiary’s first core session). MDPP suppliers would be required to attest to beneficiary session attendance and weight loss at the time claims are submitted to Medicare for payment. Beneficiary attendance must be documented through paper or electronic means and each beneficiary’s weight must be measured and recorded every MDPP session the beneficiary attends. CMS plans to reimburse for MDPP services at the times and in the amounts set forth in the table below.

Core Sessions Payment per beneficiary (Non-cumulative)

1 session attended $25 4 sessions attended $50 $50 9 sessions attended $100 $100 Achievement of minimum weight loss of 5% from baseline weight

$160

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Achievement of advanced weight loss of 9% from baseline weight

$25 (in addition to $160 above)

Maximum Total for Core sessions $360 Maintenance Sessions (Maximum of 6 monthly sessions over 6 months in Year 1)

Payment per beneficiary (Non-cumulative)

3 Maintenance sessions attended (with maintenance of minimum required weight loss from baseline)

$45

6 Maintenance sessions attended (with maintenance of minimum required weight loss from baseline)

$45

Maximum Total for Maintenance sessions $90 Maximum Total for first year $450 Maintenance Sessions After Year 1 (minimum of 3 sessions attended per quarter/no maximum)

Payment per beneficiary (Non-cumulative)

3 Maintenance sessions attended plus maintenance of minimum required weight loss from baseline 6 Maintenance sessions attended plus maintenance of minimum required weight loss from baseline

$45 $45

9 Maintenance sessions attended plus maintenance of minimum required weight loss from baseline

$45

12 Maintenance sessions attended plus maintenance of minimum required weight loss from baseline

$45

Maximum total after first year $180

Claims for payment would be submitted following the achievement of core session attendance, minimum weight loss, maintenance session attendance, and maintenance of minimum weight loss. CMS is seeking comment on this payment structure.

In order to receive payment, MDPP suppliers would be required to submit claims to Medicare using standard claims forms and procedures. Claims would be submitted in batches that contain beneficiary Protected Health Information (PHI) and Personally Identifiable Information (PII), including the Health Insurance Claim Number (HICN). CMS also proposed to require MDPP suppliers to maintain a crosswalk between the beneficiary identifiers they submit to CMS for billing purposes and the beneficiary identifiers they provide to the CDC for the beneficiary level-clinical data. CMS also proposed that MDPP suppliers provide this crosswalk to the CMS evaluator on a regular basis.

MDPP services would be available for beneficiaries who:

• Are enrolled in Medicare Part B • Have, as of the date of attendance at the first Core Session, a body mass index (BMI) of at least

25 if not self-identified as Asian and a BMI of at least 23 if self-identified as Asian. • Have within the 12 months prior to attending the first Core Session a hemoglobin A1c test with

a value between 5.7% and 6.4%, or a fasting plasma glucose of 110-125 mg/dL, or a 2-hour post glucose challenge of 140-199 mg/dL (oral glucose tolerance test)

• Have no previous diagnosis of Type 1 or Type 2 diabetes (beneficiaries with previous diagnosis of gestational diabetes are eligible for MDPP)

• Does not have end-stage renal disease (ESRD)

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CMS is seeking comment on the quality metrics that should be reported by MDPP suppliers, and which factors should be considered in the selection of initial MDPP suppliers. If finalized, CMS through additional rulemaking will establish specific requirements of the MDPP, likely within a year.

Medicare Shared Savings Program (III. K) (Federal Register 46418) The proposed rule includes a number policies that would refine or update the Medicare Shared Savings Program (MSSP). The rule proposes changes to align the ACO program with the Quality Payment Program (QPP), which implements payment reforms enacted as part of the Medicare Access and CHIP Reauthorization Act (MACRA). CMS also proposed changes to how beneficiaries are assigned to ACOs. CMS is proposing changes to ACO quality reporting and the program’s quality validation audits. The rule also includes proposals to implement technical changes to merged and acquired TINs, the minimum savings rate (MSR), and the minimum loss rate.

Alignment with the MACRA Quality Payment Program Based on the recent proposed rule to implement the MACRA’s Quality Payment Program, CMS proposed modifications to the MSSP rule to align the two programs. CMS proposes to sunset the PQRS and EHR Incentive program for ACO participants beginning with quality reporting period 2017, which corresponds with payment year 2019. CMS also is proposing new regulations to assess an ACO EP’s use of Certified EHR Technology (CEHRT) and ACO reporting of select quality measures. CMS also is proposing modifications to the EHR measure title and specifications to align the proposed QPP criteria for determining Advanced Alternative Payment Model (APM) status.

• CMS is proposing to revise its regulations in several sections to indicate that reporting requirements for the VM, PQRS, and EHR Incentive programs for ACOs and EPs apply through the 2016 performance year.

• CMS is proposing to revise its regulations to require that ACOs must submit all the ACO CMS web interface measures required for the quality performance category under the Merit-Based Incentive Payment System (MIPS). This change simply aligns the regulatory text governing the MSSP with the QPP. This has no real reporting effects, correct?

CMS also noted that it believes that, beyond the proposals detailed above, the existing MSSP rules are sufficient for ACO Track 2 and ACO Track 3 models to qualify as eligible APMs under the QPP. However, CMS is considering requiring the EHR measure to be pay-for-performance in all performance years, including the first year of an ACO’s first agreement period – that is pay for reporting. CMS also is considering whether to require the EHR measure to remain P4P even when a new EHR measure is introduced or there are significant modifications for the measure. CMS is requesting comment on how to “best conform to the intent and spirit” of the QPP program to ensure clinicians are assured they are participating in an Advanced APM.

ACOs and Beneficiary Attestation CMS acknowledged the interest of patient advocacy groups to allow for beneficiary attestation. CMS believes that beneficiary attestation could strengthen the current assignment process.

CMS is proposing an automated mechanism for beneficiaries to voluntarily align with the provider or supplier that they believe is responsible for coordinating their overall care starting in 2017. This would make it possible for CMS to use beneficiary attestations for assigning beneficiaries to ACOS in all three

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tracks for the 2018 performance year. An eligible beneficiary would be assigned to an ACO based on the existing claims-based assignment process unless the beneficiary has designated a healthcare provider as responsible for their overall care. If an eligible beneficiary has made such a designation then the voluntary alignment would override the claims based assignment process. Under an automated process, beneficiaries would be able to modify their designation at any time.

CMS is proposing to incorporate voluntary assignment for ACOs in Track 1 and 2 on a quarterly basis. Beneficiaries who are not currently assigned to a Track 3 ACO and who voluntarily align with a healthcare provider that is in a Track 1 or Track 2 would be reflected in the next preliminary prospective or final assignment list.

However, CMS is concerned about the ability to implement the automated process in time for 2017. To address this concern, CMS is proposing to implement a voluntary process that would only be used if the automated process is not ready in time. Under this contingency plan, if by no later than spring 2017, CMS determines the automated process is not ready, CMS would implement a manual process to facilitate alignment with Track 3 ACOs for the 2018 performance year until the automated process is ready.

CMS does not intend for the voluntary process to be used by ACOs to target beneficiaries, or conversely avoid beneficiaries, who are expected to earn or be less likely to shared savings.

CMS is seeking comment on all aspects of this proposal.

ACO Quality Reporting To align the MSSP with the measures recommended by the Core Quality Measures Collaborative, CMS is proposing to add some the following measures:

• ACO-12 Medication Reconciliation Post-Discharge (NQF #0097). This measure addresses adverse drug events (ADEs) through medication reconciliation, which is an important aspect of care coordination.

• ACO-44 Use of Imaging Studies for Low Back Pain (NQF #0052). This measure reports the percentage of patients with a primary diagnosis of low back pain that did not have an imaging study (for example, MRI, CT scan) within 28 days of the diagnosis.

CMS is proposing to retire or replace the following measures:

• ACO-39 Documentation of Current Medications in the Medical Record. • ACO-21 Preventive Care and Screening: Screening for High Blood Pressure and Follow-up

Documented. • ACO-31 Heart Failure (HF): Beta-Blocker Therapy for Left Ventricular Systolic Dysfunction (LVSD). • ACO-33 Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB)

Therapy – for patients with CAD and Diabetes or Left Ventricular Systolic Dysfunction (LVEF<40%).

A table with the MSSP quality measure set and proposed changes is available at Appendix I of this summary.

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Quality Measures Validation Audit In the November 2011 PFS final rule, CMS finalized a proposal to retain the right to validate the data ACOs entered into the Web Interface. This process is known as the Quality Measures Validation audit. CMS is proposing four changes to the process.

CMS is proposing to revise the Quality Measure Validation audit by increasing the number of records audited per measure to achieve a high level of confidence that the true audit match rate is within 5 percentage points of the calculated result. CMS is not proposing a specific number of records that would be requested for the audit, but the agency does not anticipate more than 50 records will be requested per audited measure. Under current regulations, as few eight or as many as 30 records per audited measure may be reviewed.

CMS is proposing to modify the quality validation audit process so it is conducted in a single step, rather than the current multi-phased process. CMS also is proposing to calculate an overall audit match rate across all measures instead of assessing the ACO’s audit mismatch rate at the measure level. CMS is proposing not to give ACOs any credit for meeting the quality target for any measures if after the audit process there is a discrepancy greater than 10% between the quality data reported and the medical records provided. ACOs with an audit match rate of less than 90% may be required to submit a corrective action plan

Value-Based Payment Modifier and Physician Feedback Program (III. L) (Federal Register 46442) CMS is proposing to update the Value-Based Modifier (VM) informal review policies and establish how the quality and cost composites under the VM would be affected for the CY 2017 and CY 2018 payment adjustment periods. In earlier rulemaking, CMS established an informal inquiry process for physicians to review and identify any possible errors before the application of the VM. Based on its experience, CMS has learned that re-running Quality and Resource Use Reports (QRURs) and recalculating the quality composite is not always practical or possible. CMS also said this approach can create uncertainty that makes it difficult for groups and solo practitioners to make future plans. The proposed rule identifies three issues:

• Data integrity issues with PQRS data submitted via Electronic Health Records and Qualified Clinical Data Registries for the CY 2014 performance period.

• After the release of the 2014 Annual QRURs, CMS discovered a defect in the program used to identify claims from CY 2014, which is the performance period for the CY 2016 VM payment adjustment period. Claims from January 1 through January 11 were incorrectly omitted from the 2016 VM calculations.

• CMS discovered a flaw defect in the program used to specialty-adjust cost measures for the 2015 Mid-Year QRURs that resulted in incorrect CY 2016 VM calculations for about 13,800 TINs.

CMS’ stated goal in the proposed rule is to “close out” as many informal reviews as possible before the VM payment factor is calculated, “lend confidence” to the adjustment factor, “provide finality” for clinicians, and “minimize claims reprocessing.” To that end, the rule details several scenarios based on the category of VM participation. CMS is proposing two categories: Category 1 will include groups that meet the criteria to avoid the CY 2017 PQRS payment adjustment as a group practice that is participating in the PQRS Group Practice Reporting Option (GPRO) in CY 2015 and groups with at least 50% of its EPs meeting the criteria to avoid the CY 2017 PQRS payment adjustment as individuals.

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Category 1 also will include solo practitioners that meet the criteria to avoid the CY 2017 PQRS payment adjustment as individuals. Category 2 will include groups and solo practitioners who are subject to the CY 2017 VM and do not fall in Category 1.

If a TIN is initially classified as a Category 2 and subsequently (through PQRS or VM informal review process) is classified as Category 1, then CMS is proposing to classify the TIN’s quality composite as “average quality” instead of attempting to calculate the quality composite.

In cases where there is a systemic issue with any of a Category 1 TIN’s quality data that renders it unusable for calculate at TIN’s quality composite, CMS is proposing to classify the TIN’s quality composite as average quality.

If it is determined after the release of the QRUR that there is widespread claims data issues that impacts the calculate of the quality and/or cost composites for Category 1 TINs, CMS proposes to recalculate the quality and cost composites for the affected TINS.

The table below summarizes the proposals.

CMS is requesting comment on this proposal.

Physician Self-Referral Updates (III. M) (Federal Register 46448) The Stark Law places restrictions on lease arrangements between physician groups and hospitals for equipment owned by the physicians, leased to the hospitals and then used by the same physicians to treat patients at the hospital. Under the Stark Law, such leases are prohibited unless the arrangement complies with the equipment rental exception. CMS has addressed this exception a number of times in rulemaking. CMS requires that for the rental of office space or equipment to satisfy the exemption in the self-referral law, the rental charges must be set in advance, be consistent with fair market value, and not be based on the volume or value of any referrals or other business between the two parties. In the FY 2009 Inpatient Prospective Payment System (IPPS) final rule, CMS prohibited rental changes for the

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rental of office space or equipment that are determined through a formula on per-unit of service rental charges to the extend the charges reflect services provided to patients referred by the lessor to the lessee. CMS is concerned that the lessor has an incentive to profit from referring a higher volume of patients to the lessee.

In a recent case from the D.C. Circuit Court of Appeals, Council for Urological Interests v. Burwell, the court considered whether a “per-click” or “per-use” fee could be considered “set in advance” and otherwise meet the criteria for the exception. The court struck down a regulatory prohibition on per-click arrangements, but remanded under terms that would permit the restriction to be re-instated.

In this proposed rule, CMS is proposing a requirement that rental charges for the office space or equipment are not determined using a formula based on per unit of service rental charges, to the extent that such charges reflect services provided to patients referred by the lessor to the lessee. However, CMS is not proposing an absolute prohibition on rental charges based on units of service furnished. In general, per-unit of service rental charges for the rental of office space or equipment are permissible. CMS proposing to limit the general rule by prohibiting per-unit of service rental charges where the lessor generates the payment from the lessee through a referral to the lessee for a service to be provided in the rented office space or using the rented equipment. Under the proposed rule, per-unit of service rental charges for the rental of office space or equipment would be permissible, but only in those instances where the referral for the service to be provided in the rented office space or using the rented equipment did not come from the lessor.

Appendix I

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Appendix I

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Appendix I

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