The Centers for Medicare & Medicaid Services (CMS) on July 13, 2021, released the calendar year (CY) 2022 Medicare Part B Physician Fee Schedule (MPFS) Proposed Rule, which also includes a number of provisions for the Medicare Quality Payment Program (QPP).
With a temporary COVID-19 Public Health Emergency (PHE)-related 3.75 percent payment boost expiring, the proposed CY 2022 MPFS conversion factor (CF) is $33.58, a $1.31 decrease from the CY 2021 PFS CF of $34.89. With the 2 percent Medicare sequester set to resume next year and additional Medicare payment cuts of up to 4 percent possible under pay-as-you-go rules to pay for the American Rescue Plan, providers could be facing up to 9 percent in payment cuts next year unless Congress intervenes.
Comments are due by 5 p.m. EDT on Sept. 13, 2021. A final rule is expected in early November.
For more information, access the following CMS resources:
This Holland & Knight alert summarizes a number of key provisions in the CY 2022 MPFS and QPP Proposed Rule. Unless otherwise noted, the provisions would go into effect on Jan. 1, 2022.
CMS proposes to retain all services added to the Medicare telehealth services list on a Category 3 basis until the end of CY 2023 to provide more time to collect data. CMS seeks comment on whether any of the services added on an interim basis to respond to the COVID-19 PHE, should be added on a Category 3 basis, summarized in Table 11. CMS rejected a number of proposals for new telehealth services by stakeholders, summarized in Tables 8-10. Here is an updated list of Medicare telehealth services, including those proposed in this rule.
CMS proposes that the home of a beneficiary would permanently qualify as an originating site and geographic restrictions would not apply to mental health telehealth services. However, the billing practitioner must have furnished an in-person service to the beneficiary within six months prior to the date of the telehealth service (other than for a diagnosed substance use disorder or co-occurring mental health disorder). The agency seeks comment on whether a different interval of time would be more appropriate and whether the required in-person service could also be furnished by another physician or practitioner of the same specialty/subspecialty within the same group. The distinction between the telehealth and non-telehealth mental health services would need to be documented in the patient's medical record.
CMS proposes to permit use of audio-only communication technology for home-based mental health telehealth services under certain conditions, including that the practitioner have the capacity to furnish two-way, audio/video telehealth services but is using audio-only technology because the beneficiary is unable or does not wish to use, or does not have access to two-way, audio/video technology. CMS would require a modifier to track audio-only services.
Finally, under the Consolidated Appropriations Act, a rural emergency hospital, which is a new Medicare provider type effective in 2023, will be added to the list of telehealth originating sites.
Opioid Use Disorder (OUD) Treatment Services
Updated payment rates will be posted with the final rule. CMS proposes to make the adjustment for take-home supplies of opioid antagonist medications subject to geographic adjustment and annual updating via the Medicare Economic Index. CMS proposes to clarify that payments for medications dispensed/administered as part of an adjustment to the bundled payment are considered duplicative if a claim for the same beneficiary on the same date of service was also separately paid under Medicare Part B or D. CMS proposes to create a new add-on code for a new, higher dose naloxone hydrochloride nasal spray product. The agency also proposes to permanently allow opioid treatment programs to furnish therapy and counseling services using audio-only telephone calls in cases where audio/video communication technology is not available to the beneficiary. After the COVID-19 PHE ends, providers would be required to document in the patient's medical record that the service was performed via audio only and why and affix Modifier 95 to claims for additional counseling and therapy services (outside of the weekly bundle) performed via telehealth.
COVID-19 Public Health Emergency (PHE)
CMS is soliciting comment on whether the temporary flexibility for direct supervision requirements to be met through virtual presence using real-time audio/visual technology should be further extended or be made permanent. The agency also seeks comment on additional, unreimbursed costs borne by providers due to the pandemic, such as vaccine administration, and how to develop an accurate, stable payment rate for administration of preventative vaccines under Medicare Part B more broadly, which have declined more than 30 percent since 2015.
Evaluation and Management (E/M) Visits
- Split/Shared Visits. CMS proposes to define as an E/M visit in a facility setting performed in part by a physician and non-physician provider (NPP) in the same group. CMS would modify its existing policy to allow physicians and NPPs to bill for split/shared visits for both new and established patients, initial and subsequent visits, critical care visits and certain Skilled Nursing Facility/Nursing Facility (SNF/NF) visits.The provider who performs the "substantive portion," (i.e., more than half) of the total time spent by the physician and NPP, would bill for the split/shared visit. Overlapping time spent by both providers would be counted once. For noncritical care visits, CMS would use the same list of activities used to select E/M visit level for time-based billing and seeks comment on whether this should differ for emergency visits.The billing practitioner would be required to sign and date the medical record identifying the two individual practitioners who performed the visit and attach a modifier indicating it is a split/shared visit. In a reversal of current policy, CMS proposes to allow practitioners to bill prolonged E/M visits as split/shared visits, excluding critical care.
- Critical Care Services. CMS proposes to adopt the Current Procedural Terminology (CPT) definition and list of bundled services for critical care services, which may be furnished on multiple days, are furnished in critical care settings (e.g., intensive care unit or emergency facility) and require the full attention of the physician or NPP (i.e., a practitioner cannot provide services to any other patient during the same period of time). The billing practitioner would report CPT code 99291 for the first 30-74 minutes of critical care services and would thereafter use CPT code 99292 for additional 30-minute increments. Noncontinuous time would be aggregated and the agency seeks comment on how to approach critical care services spanning multiple days. Critical care services could be furnished concurrently to the same patient on the same day by more than one practitioner in more than one specialty provided that it is not duplicative of other services and meets definitional requirements. Providers in the same specialty and in the same group may provide concurrent follow-up critical care on the same date provided that they use the code for subsequent time intervals. Time spent by more than one practitioner in the same group with the same specialty would be combined for purposes of meeting the time requirement to bill the initiating code. No other E/M visit could be billed for the same patient on the same date as a critical care service by the same practitioner, or by practitioners of the same specialty in the same group. Critical care visits could be furnished as split/shared visits and the policies above would generally apply except CMS would use a different list of qualifying activities, as described on pages 31-32 of the CPT Codebook. CMS also proposes to bundle critical care visits with global surgical codes. Practitioners would be required to document the total time critical care services were provided and role played by each practitioner and attest that any services furnished were medically reasonable and necessary.
- Teaching physician services. CMS proposes that when total time is used to determine the office/outpatient E/M visit level, only the time that the teaching physician was present can be included. After the COVID-19 PHE, CMS proposes that teaching physician presence requirements can be met through audio/video real-time communication technology only in residency training sites located outside of metropolitan statistical areas (MSAs), and must otherwise be in-person. Also, Level 4-5 E/M visits will no longer be included in the primary care exception, which must use medical decision-making, though the agency seeks comment on including time-based billing.
RHCs and FQHCs
CMS proposes to expand the definition of a rural health clinic (RHC) or federally qualified health center (FQHC) mental health visits to include encounters furnished through interactive, real-time telecommunications technology for mental health disorder, and to allow RHCs and FQHCs to furnish mental health visits using audio-only interactions in cases where beneficiaries are not capable of, or do not consent to, the use of devices that permit a two-way, audio/video interaction, in which case the 95 modifier should be applied. CMS seeks comment on whether to apply the in-person within six months prior requirement for RHCs and FQHCs.
Under the 2021 Consolidated Appropriations Act (CAA), starting April 1, 2021, all RHCs are subject to an updated payment limit per visit, which will gradually increase annually until 2028. In 2022, the rate is $113 per visit. In this rule, CMS proposes that an RHC will retain its provider-based status until the hospital with which they are affiliated submits a cost report with more than 50 beds, with certain COVID-19-related exceptions. For RHCs enrolled in Medicare after 2020, Medicare would no longer allow them to file consolidated cost reports. The CAA also authorizes RHCs and FQHCs to begin receiving payment for hospice physician services under the FQHC Prospective Payment System (PPS) or Rural Health Clinic All-Inclusive Rate (AIR) beginning next year. CMS proposes allowing RHCs and FQHCs to bill for transitional care management services furnished for the same beneficiary during the same service period, including those that span 30 days. The temporary authority to pay RHCs and FQHCs for furnishing distant site Medicare telehealth services expires when the PHE ends. While they will continue to be able to serve as an originating site, they will be paid under the RHC AIR or FQHC PPS. Finally, CMS is soliciting comment on making certain tribal-operating outpatient facilities/clinics eligible for payment at the Medicare outpatient per visit rate/AIR.
Valuing Specific Services
- Micrographic Dermatologic Surgery (MDS) and Adult Congenital Heart Disease (ACHD) Services. CMS proposes to crosswalk codes for these new specialties to the dermatology and cardiology code set, respectively.
- Physician Assistant (PA) Services. Under the CCA, effective Jan. 1, 2022, PAs are authorized to bill the Medicare program and be paid directly for their services, including incident to services. They may also reassign their billing rights and choose to incorporate as a group comprised solely of practitioners in their specialty and bill the Medicare program, as nurse practitioners do.
- Therapy Services. CMS is required by statute to apply a 15 percent payment reduction to occupational therapy services and outpatient physical therapy services that are provided, in whole or in part, by a physical therapist assistant (PTA) or occupational therapy assistant (OTA). The discount will be applied to the 80 percent of allowed charges, so the true discount would be 88 percent (due to the patient copay). CMS proposes a rate reduction for physical and occupational therapy services furnished in refinements to its de minimis policy and offers several scenarios to address confusion and mitigate perceived adverse incentives to avoid "leftover" minutes that could necessitate applying the modifier, and therefore reduced payment for the therapist's work.
- Medical Nutrition Therapy (MNT) and Related Services. To boost uptake of these services, CMS proposes payment parity with other NPPs for registered dietitians or nutrition professionals (at 85 percent of the PFS amount) and that Medicare would pay 100 percent of the Medicare-approved amount. The agency also proposes to clarify that MNT and Diabetes Self-Management Training (DSMT) services cannot be provided incident to the services of a billing physician or practitioner and cannot be furnished during Part A stays in hospitals or SNFs or during dialysis from an End Stage Renal Disease (ESRD) facilities.
- Additional Procedures Furnished During Colorectal Cancer Screening Tests. The CAA requires reducing Medicare coinsurance for certain colorectal cancer screening tests including flexible sigmoidoscopies, colorectal cancer screening tests and screening colonoscopies, regardless of whether there is a removal of tissue or other matter or another procedure performed in connection with and in the same clinical encounter as the screening test and it is later billed as a diagnostic test. The reduced coinsurance will be phased-in accordingly: CY 2020: 20 percent; CY 2023-2026: 15 percent; CY 2027-2029: 10 percent; CY 2030-onward: zero percent. Medicare will pay the difference.
- Chronic Pain Management Services. CMS seeks comment on whether to create separate coding and payment for medically necessary chronic pain management and opioid reduction services, particularly whether the costs would be best captured through an add-on or stand-alone code, in what healthcare settings and stages in treatment these transitions typically occur, and what types of practitioners furnish these services.
- Pulmonary Rehabilitation (PR), Cardiac Rehabilitation and Intensive Cardiac Rehabilitation Services. CMS proposes regulatory text changes to establish consistency in terminology, definitions and requirements. CMS proposes to add COVID-19 as a covered condition for PR provided certain conditions are met. To reduce burden, CMS also proposes to separate PR "physician standards" into "medical director standards" and "supervising physician standards" and remove the requirements that a physician have direct patient contact to review his or her treatment plan every 30 days.
- Medical Nutrition Therapy Services. CMS proposes to eliminate the requirement that the referral be made by a "treating" physician, stating referral by a physician is sufficient. The agency notes that the statute prevents extending referral privileges to NPPs. CMS proposes to update the glomerular filtration rate (GFR) eligibility criteria to remove the upper limit so that it meets the updated, widely accepted standard of moderate kidney disease.
Clinical Lab Pricing
CMS previously finalized an increased nominal specimen collection fee and associated travel allowance for the collection of COVID-19 testing for non-inpatients via new G-codes G2023 and 2024. The agency confirms this would conclude with the PHE. CMS proposes to update the clinical labor pricing according to the amounts summarized in Table 5 in conjunction with the final year of the supply and equipment pricing update. Anticipated impacts per specialty are summarized in Table 6. CMS seeks comment on its specimen collection fees and methodology for calculating travel allowance, including additional resources for COVID-19 tests. CMS also proposed to permanently allow use of electronic travel logs.
Coding Valuation and Corrections
CMS proposes to permanently adopt coding and payment for Healthcare Common Procedure Coding System (HCPCS) code G2252 (brief communication technology-based service, such as virtual check-in service), seeks comment on five CPT codes or code groups that were nominated by stakeholders as potentially misvalued (summarized in Table 7) and proposes valuations for 41 other codes/code groupings, summarized in Tables 13-18. In addition, the agency proposes technical changes including updating the price of six supplies and two equipment items, summarized in Table 16.
CMS is considering refining the Practice Expense (PE) methodology for emerging technologies such as artificial intelligence (AI) that may not appropriately qualify as indirect costs. For CY 2022, CMS proposes to establish values for emerging technologies by cross-walking them to existing CPT codes and solicits public comment to better understand the resource costs for these services.
Appropriate Use Criteria (AUC) for Advanced Diagnostic Imaging Services
CMS proposes to delay the effective date for the penalty phase to either Jan. 1, 2023, or the first January following the end of the COVID-19 PHE, whichever is later. CMS proposes to establish a separate HCPCS modifier to identify types of claims that are exempt from AUC requirements, including outpatient departments of critical access hospitals (CAHs), outpatient departments of Maryland hospitals participating in the Hospital Payment Program within the Maryland Total Cost of Care Model, inpatient admissions that are changed to outpatient status and those that identify Medicare as the secondary payer. The agency solicits advice in developing claims processing system edits and seeks feedback on whether claims that do not pass should be returned for possible correction and resubmission, or be denied.
CMS established two primary sets of HCPCS modifiers. The first should be included on the same claim line as the G-code identifying the clinical decision support mechanism (CDSM) that was consulted, and reports whether the imaging service adheres to the AUC (modifier ME), does not adhere (modifier MF) or if no AUC applies (modifier MG). The second set is used when the ordering professional does not consult a qualified CDSM. On these claims, no CDSM G-code would be reported and the HCPCS modifier would be included on the same line as the procedure code for the advanced diagnostic imaging service. Each modifier describes a type of significant hardship exception. Existing modifier QQ will be phased out before the penalty phase and modifier MH will be redefined to describe situations where the ordering professional is not required to consult AUC and the claim is not required to report AUC consultation information.
In addition to the previously finalized hardship exceptions, CMS would not require an AUC consultation when the furnishing professional performs additional services not reflected on the initial order because it is determined to be medically necessary, permission from the ordering professional cannot be obtained in expedient fashion and delaying it may negatively impact patient care. In these situations, the AUC consultation information from the original order is to be reported on the claim line for the additional service(s).
Removal of Select National Coverage Determinations
CMS proposes two National Coverage Determinations (NCDs) for removal: 1) enteral and parenteral nutritional therapy; and 2) positron emission tomography (PET) scans. The agency seeks comment on whether it should remove, retain or open a national coverage analysis for these two NCDs. CMS also expands on the criteria that it will consider when determining whether to remove an NCD, including when it believes local determinations would be more appropriate, when the technology is obsolete, or when it superseded by more recent policy, and seeks comment on specific NCDs it should consider for future removal.
Medicare Ground Ambulance Data Collection System
CMS proposes specific wording changes to the data collection questions to reduce confusion. Because of the COVID-19 pandemic, the agency delayed data collection. To collect data over multiple years (as was intended) CMS proposes to delay data collection and reporting for selected Year 3 organizations an additional year, to 2023 and 2024, which would align with Year 4 organizations. Year 1 and 2 organizations would collect data in 2022 and report in 2023. CMS will notify an eligible ground ambulance organization that it has been selected to report data for a year at least 30 days prior and will post a list of selected organizations on the CMS webpage. Ground ambulance organizations have five months into the reporting year to report their data. If they do not sufficiently report, they will receive a 10 percent payment penalty the following calendar year. CMS will begin publicly posting this data in 2024.
Medicare Diabetes Prevention Program (MDPP)
CMS proposes to shorten the program to one year by terminating ongoing maintenance sessions for beneficiaries that start on/after Jan. 1, 2022. However, the agency proposes to increase performance payments for beneficiaries that achieve the 5 percent weight loss goal and continue attendance during the first year to $661, which is broken down in Table 28. CMS also proposes to waive the $599 Medicare enrollment fee for all MDPP providers starting next year.
CMS proposes to expand the types of providers that can have their Medicare enrollment denied or revoked to include administrative or management services personnel such as billing or human resource specialists. If the revocation was due to adverse activity (sanction, exclusion or felony) against another personnel of the provider or supplier, it may be reversed if the provider/supplier terminates its business relationship with the individual within 30 days.
The agency also proposes to broaden its authority to deny an eligible professional's enrollment if he/she suspends his/her Drug Enforcement Administration (DEA) certificate in response to an order to show cause, as well as amendments to its criteria for revoking a provider or supplier's Medicare enrollment to broaden its authority and discretion over these matters. CMS proposes to explicitly codify contractors' authority to deny a claim should a provider or supplier fail to supply timely additional documentation in response to a prepayment or post-payment audit.
CMS also proposes several clarifications and changes to the process for rebutting Medicare deactivations. Specifically, providers/suppliers would typically have 15 calendar days from the date of written notice to submit a rebuttal. Rebuttals would have to be submitted in a written, signed and dated letter specifying any disputed facts/issues with reasoning plus any supporting documentation. Rebuttals would not suspend or postpone the deactivation's implementation in any way. If CMS does determine the deactivation was erroneous, it would be reversed. Failure to submit a complete rebuttal within the time frame would constitute a waiver of all rebuttal rights. Finally, CMS proposes that Independent Diagnostic Testing Facilities that have no beneficiary interaction, treatment or testing at their practice location would be partially or wholly exempt from the following requirements: carrying comprehensive liability insurance, obtaining and documenting a beneficiary's written clinical complaint; and posting standards in § 410.33(g).
Physician Self-Referral Updates
CMS proposes to revise the conditions for indirect compensation arrangements to include any unbroken chain of financial relationships in which the compensation arrangement closest to the physician (or immediate family member) involves anything other than services he/she personally performs, including arrangements for the rental of office space or equipment that would be subject to the prohibition of a percentage- or unit-based compensation formula. CMS also proposes to clarify the definition of "unit." The agency proposes that the ownership referral exception apply to COVID-19 vaccines, and seeks comment on whether it should remove the frequency limit requirement for all vaccines. Finally, CMS proposes to update the code list each quarter, along with an advance 30-day notice and comment period for each. CMS would publish the updated list to the Federal Register and CMS website.
Medicare Part B Drugs
Starting next year, manufacturers will be required to report each quarter average sales price (ASP) data for all national drug codes (NDCs) under the same U.S. Food and Drug Administration approval application for Part B drugs regardless of whether they have Medicaid drug rebate agreements. CMS proposes to include any item, service, supply or product payable under Part B as a drug or biological in existing drug pricing reporting requirements. CMS proposes not to exempt repackagers from this requirement. Consistent with the statute, if the U.S. Department of Health and Human Services (HHS) Secretary determines that a manufacturer has made a misrepresentation in the reporting of ASP data, a civil money penalty up to $10,000 may be applied for each price misrepresentation per day. CMS details the ASP payment limit calculation methodology, which uses a volume-weighted average of the average sales price, and proposes to use a "lesser of" ASP payment limit approach that either includes or excludes NDCs identified by HHS' Office of Inspector General (OIG) (excluding drugs on the drug shortage list). Pricing updates will be reflected beginning in the ASP pricing file two quarters following the OIG study publication.
CMS is soliciting comment on a more detailed framework for determining when a Section 505(b)(2) drug product could be assigned to multiple source drug codes, including when 1) a billing code descriptor for an existing multiple-source drug code describes the product, and 2) there are certain similarities to the products already assigned to the code, such as active ingredients, dosage form, salt form and other ingredients.
E-Prescribing for Covered Part D Drugs Under Medicare or Medicare Advantage Prescription Drug Plans
CMS encourages all providers to conduct e-prescribing as soon as feasible, but due to the pandemic, proposes to delay the e-prescribing compliance date from Jan. 1, 2022, to Jan. 1, 2023. Violators will receive a letter from CMS with a solicitation as to why they are not in compliance. At this time, CMS is not proposing payment penalties but will reevaluate in future rulemaking. CMS also proposes to extend the compliance deadline for Part D controlled substance prescriptions written for beneficiaries in long-term care facilities (excluding residents of nursing facilities covered under Part A) from Jan. 1, 2022, to Jan. 1, 2025.
The agency proposes several new exemptions for prescriptions where the prescriber and dispensing pharmacy are the same entity, those prescribed during a recognized emergency, those prescribed by a prescriber who prescribes 100 or fewer Part D controlled substance prescriptions annually, those for hospice enrollees and those for which a waiver is obtained from CMS for extraordinary circumstances (including lack of broadband access). Additionally, CMS proposes to establish a threshold in which prescribers would be considered compliant if they prescribe at least 70 percent of their Part D controlled substances prescriptions electronically (excluding those covered by an exception or waiver).
Open Payments Program
The Open Payments Program posts public information about the financial relationships between the pharmaceutical and medical device industry and providers. In this rule, CMS proposes several data requirement changes that would be effective for data collected in CY 2023 and reported in CY 2024, including: 1) adding a mandatory field to collect payment information such as check or wire numbers that would more easily identify payments to teaching hospitals; 2) adding the option to recertify annually when no records are being reported; 3) disallowing record deletions without a substantiated reason; 4) updating the definition of ownership and investment interest to align with the IRS definition; 5) adding a definition for physician-owned distributorship; 6) requiring reporting entities to disclose relationships they have with other companies; 7) disallowing publications delays for general payment records; 8) clarifying that the exception for short-term loans applies for 90 total (not consecutive) days; 9) removing the option to submit a general payment record so that all entities must submit an ownership record; and 10) requiring companies with reportable payments or transfers of value within the past two years to maintain up-to-date contact information within the Open Payments system.
Quality Payment Program
Merit-Based Incentive Payment System (MIPS)
CMS proposes to add certified nurse-midwives and clinical social workers to the list of MIPS eligible clinicians (ECs). Under statute, the weights of the four performance categories for 2022 are as follows: Quality: 30 percent; Cost: 30 percent; Improvement Activities: 15 percent; Promoting Interoperability: 25 percent. The maximum MIPS payment penalty is 9 percent; the bonus will depend on penalties collected. CMS proposes to raise the 2022 MIPS threshold to 75 points (from 60), and the exceptional performance threshold to 89 points. The agency seeks feedback on using 2021 benchmarks (based on 2019 data) for 2022 performance, and proposes in some circumstances to use data that is up to three years old if data is otherwise insufficient to set a benchmark.
CMS proposes to continue doubling the complex patient bonus due to the COVID-19 PHE to the 2021 performance year (which will impact 2023 payments) and to establish a new five-point floor for measures in their first or second performance period that are successfully reported (i.e., case minimum and data completeness requirements are met) as a way to incentivize reporting of new measures. However, the agency also proposes to make the complex patient bonus formula more stringent and incorporate social complexity factors, terminate the high-priority measure and end-to-end electronic prescribing bonuses, and remove the three-point floor for incomplete measures (except for small practices in certain cases). Proposed MIPS scoring policies for CY 2022 are summarized in Table 48. Weight redistributing policies are summarized in Tables 51 and 52.
CMS seeks feedback on several areas to improve the utility and transparency of the data it collects to more effectively drive improvement. CMS proposes to add facility affiliations beyond current hospital affiliations to publicly available physician compare tools and seeks feedback on publicly posting utilization data. The agency also seeks feedback on strategies to collect more comprehensive and actionable data on health disparities based on social risk factors, race and ethnicity across its reporting programs, as well as stakeholder opinions on stratifying quality measure data by race and ethnicity similar to Medicare Advantage Plans in the near-term. CMS wants to hear stakeholder thoughts on its four-pronged strategy to transition fully to digital quality measurement by 2025, which includes: 1) leveraging Fast Healthcare Interoperability Resources (FHIR)-based application programming interfaces (APIs) to advance standards for digital data; 2) leveraging end-to-end digital quality measures (dQMs); 3) leveraging data intermediaries to aggregate data across sources; and 4) aligning measures across federal programs, and private payer programs when possible. CMS expresses an interest in scaling back the number of data collection vendors and proposes a 25 MIPS participant minimum, along with other requirements.
In addition, CMS proposes the following performance category-specific changes:
- Quality: CMS proposes to maintain the data completeness threshold at 70 percent for 2022 before increasing it to 80 percent in 2023. The agency also proposes to delay its removal of Web Interface until 2023. As it does every year, CMS proposes changes to the quality measure inventory, including removing 38 measures, adding five new measures (including two administrative claims measures), substantive changes to 84 measures, and changes to the Web Interface measures set, all of which are summarized in Appendix 1. The agency notes that it will prioritize digital and electronic quality measures for future adoption.
- Cost: CMS proposes five new measures, including two chronic condition measures for asthma/chronic obstructive pulmonary disease (COPD) and diabetes, two procedural measures for melanoma resection and colon/rectal resection, and one acute inpatient measure for sepsis, which are summarized in Tables 41-42. The agency also proposes formal criteria for what would constitute a "substantial change" for cost measures, which would impact future benchmarking and scoring, a formal process for stakeholder development of new cost measures (including criteria for priority adoption), and a new policy in which cost measures would not be scored in instances where outside factors may impede their effective and reliable measurement.
- Improvement Activities: CMS proposes to add seven, modify 15 and remove six activities, summarized in Appendix 2. Many of these changes center around health equity. CMS proposes that 50 percent of clinicians in the group minimum would apply to subgroups. CMS proposes to require eight criteria (up from one), including two new criteria of not duplicating existing activities and going beyond standard clinical practice, plus six optional priority factors. CMS proposes to suspend immediately any activities that may pose a safety concern or are obsolete. To have the best chance of being implemented in the same year, CMS notes that nominations for new activities should be submitted by Jan. 5 of the performance year in which the submitter wants them adopted.
- Promoting Interoperability (PI): CMS proposes to retain the query of prescription drug monitoring program measure as optional with 10 bonus points for 2022 and seeks stakeholder feedback on future direction for the measure. CMS proposes to modify the provide patients electronic access to their health information measure to require that the information remains available indefinitely using any application effective starting in 2022 for encounter data from 2016 onward. CMS proposes to make the immunization registry and electronic case reporting measures both mandatory attestation-based measures (unless an exclusion is claimed) and retain the Public Health Registry Reporting, Clinical Data Registry Reporting and Syndromic Surveillance Reporting measures as optional worth up to five bonus points if at least one is reported. If clinicians do not report "yes" to both required measures, they would earn a zero for the entire PI category. The 2022 PI objectives and measures and scoring methodologies are summarized in Tables 44 and 46. The agency also proposes changes to attestation requirements, including adding a new statement certifying to an annual self-assessment using Safety Assurance Factors for EHR Resilience (SAFER) guidelines. CMS proposes to no longer require small practices to submit an application for the hardship exception, and would automatically reweight the PI category for small practices if no data is received. CMS seeks comment on whether to require certified nurse-midwives to report for the category in 2022 and would like other types of NPPs to report in the future, but will continue reweighting the category for NPPs in 2022. Finally, CMS seeks comment on the future design of the category to better align with the HL7 FHIR standard and better incentivize patient access through patient portals or other third-party applications such as OpenNotes.
Alternative Payment Model (APM) Performance Pathway (APP)
CMS proposes to allow subgroup reporting as a new option under the APP (and MVP) but not traditional MIPS starting in 2023. The agency also clarifies that facility-based scoring is not available at the APM Entity level under the APP. Tables 39 and 40 summarize the proposed 2022 APP measures set. Information on reporting changes for Medicare Shared Savings Program Accountable Care Organizations (MSSP ACOs) can be found below.
MIPS Value Pathways (MVPs)
CMS proposes to delay optional MVP reporting until 2023 and will start with seven MVPs related to Rheumatology, Stroke Care, Ischemic Heart Disease, Chronic Disease Management, Emergency Medicine, Lower Extremity Joint Repair and Anesthesia, summarized in Appendix 3. CMS proposes to sunset traditional MIPS and require MVP reporting by 2028. MIPS ECs would generally be able to participate in MVPs, with the exception of voluntary reporters, partial Qualified Participants (QPs) who opt-in, and those in virtual groups. Starting in 2023, vendors must support any MVPs applicable to the ECs for whom they submit MIPS data and reporting at the sub-group level.
Reporting at the subgroup level would be an option for multispecialty groups starting in 2023 for all categories except PI, which would be evaluated at the group level. Multispecialty groups will be required to report as subgroups starting in 2025. CMS would not limit the number of subgroups that an EC may participate in or under a given tax identification number (TIN), nor the size of a subgroup, but seeks comment on this and other potential criteria, such as same physical practice location and a possible threshold for subgroups to be defined as a single specialty, such as 75 percent of its clinicians. The MIPS low-volume threshold and special status designations1 would not apply to subgroups.
Subgroups that are MVP Participants must adhere to an election process that runs April 1 through Nov. 30 of each performance year. To report the Consumer Assessment of Healthcare Providers and Systems (CAHPS) for MIPS survey associated with an MVP, MVP entities must register by June 30 of such performance period. At the time of registration, an MVP participant must submit the following: selected MVP(s), population health measure; outcomes-based administrative claims measures (if applicable); list of associated TIN/National Provider Identifier (NPI) combinations; and a plain language name for the subgroup. CMS would assign each subgroup a unique identifier. If a subgroup's makeup changes, it would assigned a new subgroup identifier. Table 35 summarizes the registration process. Subgroups would also be able to apply for hardship exceptions.
The basic structure of MIPS, including the four performance categories, would apply to MVPs. CMS does not prescribe a certain number of measures for MVPs but says "to the extent possible" MVPs should include a maximum of 10 quality measures and improvement activities. Similar to MIPS, CMS would require one outcome measure or one high-priority measure that is relevant to the MVP. CMS will prioritize measures that are patient-reported or claims-based, particularly those that are population health or outcomes focused. All MVP participants would be evaluated on the Hospital Admission Rates for Patients with Multiple Chronic Conditions measure, which would not count as one of the four required quality measures. MVP reporters would be evaluated on whatever cost measures are listed for the MVP, which will be calculated by CMS based on claims data. MVP reporters would select either two medium-weighted improvement activities or one high-weighted improvement activity (half as many as traditional MIPS), or participate in a patient-centered medical home or comparable specialty practice. The full set of MIPS PI measures would apply. MVP reporting requirements are summarized in Table 34.
MVP scoring would generally mirror that of traditional MIPS, but the small practice bonus of up to six points would not be subject to the 10 percent cap under MVPs. CMS proposes to include comparative performance feedback to other similar MVP reporters and proposes to delay public posting of MVP data on compare tools for one year, as well as a one-to-two-year delay for new measures or activities. The agency seeks comments regarding the posting of sub-TIN information and intends for individual clinician, subgroup and group compare pages to be interconnected.
CMS proposes an annual maintenance process for MVPs in which stakeholders recommend updates to existing MVPs on a rolling basis. CMS seeks additional MVPs with corresponding cost and quality measures. The agency notes that not all have to be centered around a specific specialty, they can be more longitudinal, target a focused episode of care, specific patient populations or serve as an on-ramp to Alternative Payment Models (APMs).
Medicare Shared Savings Program (MSSP)
To reduce burden, CMS proposes to only require disclosure of prior participation in the MSSP and sample participant agreements if specifically requested. CMS would also no longer require submission of renewing participant agreements, unless there have been amendments. CMS clarifies that MSSP ACOs with preliminary prospective assignment would be required to provide written notice to all fee-for-service beneficiaries prior to or at their first primary care visit each year, whereas ACOs with prospective assignment would do so for all prospectively assigned beneficiaries. CMS seeks comment on whether it should reduce this patient notification requirement to once every five-year agreement period instead of annually. The agency also proposes to add to the list of primary care services used for beneficiary assignment.
CMS proposes to reduce required payment mechanism amounts in half and seeks comment on an alternative per beneficiary-based pricing approach. The agency would allow current ACOs to elect to decrease their amount without signing a new participation agreement. Moving forward, CMS would only require ACOs to update their repayment amount if the recalculated amount exceeds the previous amount by at least $1,000 and to count the number of assigned beneficiaries at the beginning of the performance year (rather than historical 12 months' worth of data).
CMS proposes to extend Web Interface as an alternative to reporting the three MIPS clinical quality measures (CQMs) through 2023, and seeks comment on extending it further. ACOs can also report both and receive the most favorable score. In either case, ACOs must administer a CAHPS for MIPS survey and be evaluated by CMS on two claims-based measures. For 2022, ACOs must report all 10 Web Interface measures but three will not have a benchmark and will not be scored. CMS proposes to replace the All-Cause Unplanned Admissions for Multiple Chronic Conditions for ACOs measure with the matching MIPS measure. The proposed MSSP measures set for 2022 can be found in Table 25. CMS proposes to freeze the quality performance standard at the 30th percentile across all measures through 2023 (instead of increasing it to 40 percent). As an added incentive to report CQMs, ACOs would only have to achieve the 30th percentile on a single measure. Table 24 summarizes reporting requirements and quality performance standards.
The agency also is soliciting comments in a number of areas, including addressing health disparities and promoting health equity, benchmarking (specifically removing an ACO's own beneficiaries from its own regional expenditure calculation) and risk adjustment, specifically alternatives to the current 3 percent cap on risk score growth over a five-year agreement period.
Advanced APM Incentive Payment Methodology
The CCA froze Qualified Participant (QP) thresholds at 2021/2022 levels for 2023-2024 payments. Starting with 2023 performance (impacting 2025 payments), QP thresholds will increase to 75 percent for the payment threshold and 50 percent for the patient count threshold (and 50 percent and 35 percent for the partial QP thresholds, respectively). Under the All-Payer Combination Option, ECs also have to meet separate Medicare minimums. The 2022 QP thresholds are listed in Table 63.
CMS clarifies that for each step in the APM incentive payment decision hierarchy, CMS would first search for TINs associated with the QP during the performance period, and if no such TIN was available, then it would search for TINs associated with the QP during the payment year.
1 MIPS special status includes ECs that are ambulatory surgical center-, facility- or hospital-based, those that are nonpatient-facing, those in a small practices and those located in a health professional shortage area or rural area.