Click here to reference the proposal.
Per the ophthalmologists:
Tables 123 (page 1180) and 134 (page 1264) provide CMS estimates for physicians. Overall, 53 percent will experience a delta between negative 1 percent and positive 1 percent in overall reimbursement.
As always, CMS takes an extensive look at RVUs.
Potentially Misvalued RVUs
CMS provides extensive commentary regarding potentially misvalued RVUs. The chart of the RVUs that CMS will target can be found on page 221, and they include:
Many of the proposed telehealth provisions focus on behavioral health. For example, CMS discusses the concept of “audio only” as it relates to behavioral health.
CMS noted on page 108:
“Based upon an initial review of claims data collected during the PHE for COVID-19, which describe audio-only telephone E/M services, we observed that the audio-only E/M visits have been some of the most commonly performed telehealth services during the PHE, and that most of the beneficiaries receiving these services were receiving them for treatment of a mental health condition.”
Telehealth: Direct Supervision of Diagnostic Tests
CMS proposed several concepts related to non-face-to-face diagnostic tests (beginning on page 112).
“We continue to seek information on whether this flexibility should be continued beyond the later of the end of the PHE for COVID-19 or CY 2021. Specifically, we are seeking comment on the extent to which the flexibility to meet the immediate availability requirement for direct supervision through the use of real-time, audio/video technology is being used during the PHE, and whether physicians and practitioners anticipate relying on this flexibility after the end of the PHE. We are seeking comment on whether this flexibility should potentially be made permanent, meaning that we would revise the definition of “direct supervision” at § 410.32(b)(3)(ii) to include immediate availability through the virtual presence of the supervising physician or practitioner using real-time, interactive audio/video communications technology without limitation after the PHE for COVID-19, or if we should continue the policy in place for a short additional time to facilitate a gradual sunset of the policy. We are soliciting comment on whether the current timeframe for continuing this flexibility at § 410.32(b)(3)(ii), which is currently the later of the end of the year in which the PHE for COVID-19 ends or December 31, 2021, remains appropriate, or if this timeframe should be extended through some later date to facilitate the gathering of additional information in recognition that, due to the ongoing nature of the PHE for COVID-19, practitioners may not yet have had time to assess the implications of a permanent change in this policy. We also seek comment regarding the possibility of permanently allowing immediate availability for direct supervision through virtual presence using real-time audio/video technology for only a subset of services…”
Telehealth: Permanent Medicare Additions
CMS noted that none of the requests listed below received by the February 10 submission deadline met their Category 1 or Category 2 criteria (page 79) for permanent addition to the Medicare telehealth services (page 82).
Per CMS on page 88:
“We determined that these services did not meet the Category 1 criteria for addition to the Medicare telehealth services because they are therapeutic in nature and in many instances involve direct physical contact between the practitioner and the patient. In assessing the evidence that was supplied by stakeholders in support of adding these services to the Medicare telehealth services list on a Category 2 basis, we concluded that it did not provide sufficient detail to determine whether all of the necessary elements of the service could be furnished remotely, and whether the objective functional outcomes of ADL and IADL for the telehealth patients were similar to those of patients receiving the services in person. As we stated above when discussing the request to add certain biofeedback services to the telehealth list, we do not believe ADLs and IADLS alone are sufficient to demonstrate clinical benefit to a Medicare beneficiary. We have enumerated above some examples of the types of clinical benefits we would consider when evaluating services using the Category 2 criterion. Therefore, we do not believe the supplied information demonstrates that the services meet either the Category 1 or the Category 2 criteria.”
CMS went on to add:
“We are not proposing to add these services to the Medicare telehealth services list. We continue to encourage commenters to supply sufficient data for us to be able to see all measurements/parameters performed, so that we may evaluate all outcomes.”
Beginning on page 89, CMS provided commentary. “We received requests to temporarily add Neurostimulators, CPT codes 95970 -95972, and Neurostimulators, Analysis-Programming services, CPT codes 95983 and 95984, to the Medicare telehealth services list using the Category 3 criteria (see Table 10).”
“We do not yet have sufficient information to adjudicate whether these services are likely to meet the category 1 or category 2 criteria given additional time on the Medicare telehealth services list, without having evaluated the full data, and we encourage commenters to submit all available information, when available, for future consideration. As a result, we are not proposing to add these services to the Medicare telehealth list of services on a Category 3 basis at this time.”
Telehealth: Temporary Public Health Emergency
CMS indicated that the original plan was to remove several physical therapy and hospital inpatient telehealth services once the public health emergency ends. However, due to the uncertainty, CMS is proposing to extend them until the end of CY 2023.
See page 92 for the commentary and page 93 for the chart of services.
Telehealth: Same or Similar Specialty?
Congress’ final legislation of 2020 included several telehealth provisions, and this CMS rule proposes the regulations for the law.
Per CMS on page 102:
“We are also seeking comment on whether the required in-person, non-telehealth service could also be furnished by another physician or practitioner of the same specialty and same subspecialty within the same group as the physician or practitioner who furnishes the telehealth service. We note that the language in the CAA states that the physician or practitioner furnishing the in-person, non-telehealth service must be the same person as the practitioner furnishing the telehealth service.”
Direct Payments of Physician Assistants
The agency also proposes to allow Medicare Part B to directly pay physician assistants starting in 2022, among other policy changes.
E/M: Shared E/M
Per the American College of Cardiology:
“Several proposals that take into account the recent changes to E/M visit codes, which took effect Jan. 1 and are explained in the AMA CPT Codebook. Specifically, the rule proposes a number of refinements to current policies for split (or shared) E/M visits, critical care services, and services furnished by teaching physicians involving residents.”
CMS’s commentary begins on page 241.
In this payment proposal, CMS is proposing (page 244):
“We are proposing to define a split (or shared) visit as an E/M visit in the facility setting that is performed in part by both a physician and an NPP who are in the same group, in 24 2021 CPT Codebook, p.7. accordance with applicable laws and regulations. We propose to add this definition to a new section of our regulations at § 415.140.”
CMS went on to add:
“Additionally, we propose to define split (or shared) visits as those that:
- Are furnished in a facility setting by a physician and an NPP in the same group, where the facility setting is defined as an institutional setting in which payment for services and supplies furnished incident to a physician or practitioner’s professional services is prohibited under our regulation at § 410.26(b)(1).
- Are furnished in accordance with applicable law and regulations, including conditions of coverage and payment, such that the E/M visit could be billed by either the physician or the NPP if it were furnished independently by only one of them in the facility setting (rather than as a split (or shared) visit).”
CMS goes on to make several other proposals related to documentation, critical care and other items.
E/M & Teaching Physicians
CMS’s commentary begins on page 269. Per CMS:
“Under our regulation at § 415.172 and absent a public health emergency (PHE), if a resident participates in a service furnished in a teaching setting, a teaching physician can bill for the service only if they are present for the key or critical portion of the service. For residency training sites that are located outside a metropolitan statistical area, PFS payment may also be made if a teaching physician is present through audio/video real-time communications technology (that is, “virtual presence”). In the case of E/M services, the teaching physician must be present during the portion of the service that determines the level of service billed.”
CMS went on to add:
“We are proposing 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. We believe it is appropriate to include only the time of the teaching physician because the Medicare program makes separate payment for the program’s share of the resident’s graduate medical training program, which includes time spent by a resident furnishing services with a teaching physician, under Medicare Part A.”
Appropriate Use Criteria for Advanced Imaging
CMS’s commentary begins on page 383. Per CMS:
“We are also proposing to begin the AUC claims processing systems edits and payment penalty phase of the program on the later of January 1, 2023, or the January 1 of the year after the year in which the PHE for COVID-19 ends. We invite the public to submit comments on these clarifications and proposals.”
As a reminder, the outliers that will be addressed by AUC include:
- Coronary artery disease (suspected or diagnosed).
- Suspected pulmonary embolism.
- Headache (traumatic and non-traumatic).
- Hip pain.
- Low back pain.
- Shoulder pain (to include suspected rotator cuff injury).
- Cancer of the lung (primary or metastatic, suspected or diagnosed).
- Cervical or neck pain
Billing for PAs & NPs
CMS’s commentary begins on page 272.
“Section 403 of the Consolidated Appropriations Act, 2021 (CAA) (Pub. L. 116-260, December 27, 2020), amends section 1842(b)(6)(C)(i) of the Act to remove the requirement to make payment for PA services only to the employer of a PA effective January 1, 2022. With the removal of this requirement, PAs will be authorized to bill the Medicare program and be paid directly for their services in the same way that NPs and CNSs do. Effective with this amendment, PAs also may reassign their rights to payment for their services, and may choose to incorporate as a group comprised solely of practitioners in their specialty and bill the Medicare program, in the same way that NPs and CNSs may do. We note that the amendment made by section 403 of the CAA changed only the statutory billing construct for PA services. It neither changed the statutory benefit category for PA services, including the requirement that PA services are performed under physician supervision, at section 1861(s)(2)(K)(i) of the Act, nor did it change the statutory payment percentage applicable to PA services specified in section 1833(a)(1)(O) of the Act.”
CMS is using this payment proposal to create the regulatory process for the new law:
“We are proposing to amend pertinent sections of our regulations to reflect the amendment made by section 403 of the CAA. Specifically, we are proposing to amend § 410.74(a)(2)(v) to specify that the current requirement that PA services must be billed by the PA’s employer in order to be covered under Medicare Part B is effective only until January 1, 2022. We are also proposing to amend § 410.150(b) to redesignate the current requirements in paragraph (b)(15) as § 410.150(b)(15)(i), and to amend that paragraph to provide that Medicare payment is made for PA services to the qualified employer of the PA for services furnished prior to January 1, 2022. In § 410.150, we further propose to add a new paragraph (b)(15)(ii) to state that, effective for services furnished on or after January 1, 2022, payment is made to a PA for their professional services, including services and supplies furnished incident to their services. We would conform this new paragraph with the regulation at § 410.150(b)(16) regarding to whom payment is made for NP or CNS services. As such, the proposed new paragraph at § 410.150(b)(15)(ii) would provide that payment will be made to a PA for professional services furnished by a PA in all settings in both rural and non-rural areas; and that payment is made only if no facility or other provider charges or is paid any amount for services furnished by a PA. We also intend to update our program manual instructions to reflect the statutory change made by section 403 of the CAA and the changes to our regulations.”
Critical Care Visits & Global Surgery
CMS examines billing for PAs and NPs as it relates to global surgery on page 266. Per CMS:
“As we have made clear in previous rulemaking, we are continuing to assess values for global surgery procedures (84 FR 2452), including in particular the number and level of preoperative and postoperative visits, which can include critical care services. Because this work is still ongoing, we are proposing to bundle critical care visits with procedure codes that have a global surgical period.”
CMS’s commentary begins on page 273.
“We are implementing the third and final part of the amendments made by section 53107 of the Bipartisan Budget Act (BBA of 2018) (Pub. L. 115-123, February 9, 2018). The BBA of 2018 added a new section 1834(v) of the Act. Section 1834(v)(1) of the Act requires CMS to make a reduced payment for physical therapy and occupational therapy services furnished in whole or in part by physical therapist assistants (PTAs) and occupational therapy assistants (OTAs) at 85 percent of the otherwise applicable Part B payment for the service, effective January 1, 2022.”
Physician Self-Referral Updates: Rental Units
CMS provides commentary related to physician self-referral updates beginning on page 611.
“First, we are proposing to revise § 411.354(c)(2)(ii), which identifies when aggregate compensation to a physician results in an indirect compensation arrangement (if the other conditions of § 411.354(c)(2) are met), to more precisely address the concerns and effectuate the policies that we articulated in the MCR final rule. Specifically, we are proposing to revise the regulation to include as a potential indirect compensation arrangement any unbroken chain of financial relationships in which the compensation arrangement closest to the physician (or immediate family member of the physician) involves compensation for anything other than services that he or she personally performs. This would include arrangements for the rental of office space or equipment that meet the other conditions of the regulation at § 411.354(c)(2), which would be subject to, among other requirements, the prohibition on percentage-based and unit-based (often referred to as “perclick”) compensation formulas at § 411.357(p)(1)(ii) in the exception for indirect compensation arrangements (or the requirements of another applicable exception).”
“Second, following the publication of the MCR final rule, we received inquiries from stakeholders requesting clarification on the term “unit” in § 411.354(c)(2)(ii)(A). We are proposing to define the term “unit” for purposes of applying the regulation. We are also proposing to define “services that are personally performed” for purposes of applying proposed § 411.354(c)(2)(ii)(A)(4).”
CMS went on to state:
“We continue to believe that arrangements involving unit of service-based compensation for the rental of office space or equipment, whether direct or indirect, may pose a significant risk of program abuse, and are proposing revisions to § 411.354(c)(2)(ii) that would ensure that the prohibition on certain unit of service-based compensation formulas for the rental of office space or equipment applies to all compensation arrangements that include them.”
Physician Self-Referral Update: Compensation Arrangements
CMS also examined compensation arrangements in relation to employed physicians. Per CMS:
“To facilitate compliance with the physician self-referral law as it applies to indirect compensation arrangement, we are proposing a new regulation at § 411.354(c)(2)(ii)(B)(2) that expressly identifies the unit to consider for purposes of applying the regulation at § 411.354(c)(2)(ii)(A) and determining the existence of an indirect compensation arrangement that must satisfy the requirements of an applicable exception. Under proposed § 411.354(c)(2)(ii)(B)(2), for purposes of applying § 411.354(c)(2)(ii)(A), the individual unit is: (1) time, where the compensation paid to the physician (or immediate family member) is based solely on the period of time during which the services are provided; (2) service, where the compensation paid to the physician (or immediate family member) is based solely on the service provided; and (3) time, where the compensation paid to the physician (or immediate family member) is not based solely on the period of time during which a service is provided or based solely on the service provided.”
Electronic Prescribing for Controlled Substances
TOA often finds that few individuals recognize that Congress passed a law that requires electronic prescribing for controlled substances under the Medicare Part D program (Section 2003 of the SUPPORT Act generally mandates that the prescribing of a Schedule II, III, IV, or V controlled substance under Medicare Part D be done electronically in accordance with an electronic prescription drug program beginning January 1, 2021, subject to exceptions, which the Secretary may specify).
CMS provides commentary related to rule proposals for this law beginning on page 633.
In relation to compliance action, CMS stated on page 641:
“Section 2003 of the SUPPORT Act mandates that EPCS for Part D controlled substances begin on January 1, 2021. Due to this statutory mandate coupled with the aforementioned advantages provided by EPCS, we encourage all prescribers to adopt EPCS as soon as is feasible for them. However, as stated in our CY 2021 PFS final rule, we recognize that although EPCS is ultimately more efficient, implementing EPCS takes additional time and resources. It is for this reason that, in our CY 2021 PFS final rule, we finalized a policy stating that CMS would not take compliance actions before January 1, 2022.”
In the 2022 Physician Fee Schedule proposal, CMS is proposing:
“We propose to extend the compliance deadline for Part D controlled substance prescriptions written for beneficiaries in long-term care (LTC) facilities, excluding beneficiaries who are residents of nursing facilities and whose care is provided under Part A of the benefit, from January 1, 2022, to January 1, 2025.”
CMS also proposes:
“Specifically, we are proposing to revise § 423.160(a)(5) to specify that 70 percent of all prescribing under Part D for Schedule II, III, IV, and V controlled substances be done electronically per calendar year, excluding from that calculation any prescriptions issued while a prescriber falls within an exception or a waiver.”
The law also gives CMS the ability to create exemptions, and CMS is proposing the following exemptions:
- Therefore, we propose to adopt at § 423.160(a)(5)(i) the EPCS exception listed in section 1860D-4(e)(7)(B)(i) of the Act, for prescriptions issued where the prescriber and dispensing pharmacy are the same entity. We seek comment on this proposal
- After reviewing the current PDE data and the costs associated with implementing EPCS, we propose to exempt prescribers who prescribe 100 or fewer Part D controlled substance prescriptions per year
- We believe that the exception listed in the statute, which includes economic hardship, technological limitations that are not reasonably within the control of the prescriber, and other exceptional circumstances, includes prescribers who are overwhelmed due to having to treat patients during a pandemic or a natural disaster such as a hurricane, flood, or earthquake.
- After considering this issue, we believe that an exception for a prescription made for an individual enrolled in hospice would be inappropriate for several reasons.
Beginning on page 663, CMS looks at the definition of a POD.
“The preamble of the 2013 Open Payments final rule (78 FR 9458) discusses physicianowned distributorships (PODs), as a subset of group purchasing organizations (GPOs), but does not provide a specific definition for this type of entity. Reporting entities currently have the ability to self-identify as a POD when registering with Open Payments, but due to the lack of a definition of the term “physician-owned distributorship” or “POD,” this designation is not required. We believe that the disclosure of an entity’s status as a POD is essential to the transparency that is central to the program, and will also help clear up confusion about whether PODs are required to report. Accordingly, we propose to include the definition of a POD as set out at § 403.902 as a subset of either an applicable manufacturer or applicable GPO.”
CMS also goes on to propose:
“We are also proposing to include language at § 403.908(c)(4) to require PODs to selfidentify when registering or recertifying.”
CMS went on to state:
“Furthermore, to better align the Open Payments program with the updated definition of ownership and investment interest at § 411.354(b)(3) (see 85 FR 77587), we are including the exceptions for titular ownership and employee stock ownership programs (ESOPs) that are qualified under IRS regulations for consistency in application.”
AI Impact on Diagnostic Test Results?
CMS indicated that it would like feedback on the following item:
Comment on Solicitation on Separate PFS Coding & Payment for Chronic Pain Management
CMS’s commentary begins on page 211.
“We believe that creating separate or add-on payment for care and management for people with pain might provide opportunities to better leverage services furnished using telecommunications technology and non face-to-face care while expanding access to treatment for pain. Such an additional payment could potentially be effective in preventing or reducing the need for acute services such as fall avoidance, and reduce the need for treatment for mental disorders such as depression, anxiety, and sleep disorders which may occur in some individuals with pain. There is also reason to believe that addressing chronic pain (for example, pain that lasts more than 3 months) early in its course may result in averting the development of “highimpact” chronic pain in some individuals, where they experience at least one major activity restriction (for example, unable to work, go to school, perform household chores).”
Quality Payment Program (MIPS/APP)
CMS is not proposing major changes to the Alternative Payment Model Performance Pathway (APP) for 2022.
For the Merit-Based Incentive Payment System (MIPS) in 2022, it will be more difficult to avoid the 9 percent payment penalty that will be paid out in 2024.
Some of the MIPS’ highlights include:
- CMS is proposing to increase the 2022 threshold for passing increase from 60 points to 75 points.
- CMS’s proposed 2022 cost category weight would be 30 percent, which is an increase from 20 percent in 2021.
- CMS’s proposed 2022 quality category weight would be 30 percent, which is a decrease from 40 percent in 2021.
Two other high-level items of interest related to MIPS include:
- Proposed scoring changes for the quality category that would end bonus points for end-to-end reporting and high-priority measures.
- CMS is proposing to end the three-point floor for scoring measures (some small practices would be exempt).
Click here to view an overview from the American College of Cardiology.
MIPS Value Pathways (MVPs)
Per the American College of Cardiology:
“CMS proposes seven MVPs to be available with the beginning of the 2023 performance period, including rheumatology, stroke care and prevention, heart disease, chronic disease management, lower extremity joint repair (e.g., knee replacement), emergency medicine, and anesthesia.”