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Through several recently published rules, the Centers for Medicare & Medicaid Services (CMS) is making it possible for Medicare beneficiaries to have greater access to health care services provided remotely through telehealth or “telehealth-like” methods and to implement telehealth provisions included in the Bipartisan Budget Act of 2018 (BBA). The recently posted Medicare physician fee schedule (PFS) and home health prospective payment system (HH PPS) final rules and the Medicare Advantage and Prescription Drug Benefit proposed rule all included provisions that establish or would establish new rules concerning telehealth or related services. Viewed together, this demonstrates CMS’ belief that telehealth and related communication technology-based services can provide expanded access to high-quality and cost-effective health services and that CMS will be providing more flexibility to encourage the use of these services. These changes recognize growing beneficiary and health care professional comfort with the use of communication technology in the provision of health services. The changes also implicitly acknowledge the growing demand for the convenience of telehealth services. It remains to be seen whether these Medicare program developments will result in expanded coverage of telehealth services under any state Medicaid programs.

Medicare physician fee schedule final rule

On November 1, CMS posted the Medicare physician fee schedule final rule. Because the Medicare statute limits payment for telehealth services to beneficiaries in certain geographic  areas (primarily rural) and limits the “originating sites” where beneficiaries can get access to telehealth services, CMS has used its rule-making authority to bypass these restrictions by identifying and paying for certain telehealth-like services described below as “communication technology-based services” outside the telehealth benefit. CMS also is paying for new remote monitoring services, as described below. Medicare will begin paying separately for all of these new services in January 2019. CMS has expressed interest in recognizing innovations in the use of new communication technologies. CMS also noted that several of these new services are aimed at avoiding the scheduling of office visits that may not be necessary by providing a lower level payment for a separate service. The rates for these new services are provided in a chart below.

Virtual check-in (HCPCS code G2012)

Under Healthcare Common Procedure Coding System (HCPCS) code G2012, Medicare will pay separately for “brief communication technology-based services,” also referred to as a “virtual check-in,” provided certain conditions are met. This five to 10-minute non-face-to-face telephone or computer-based interaction can be provided only to established patients in order to assess whether the patient’s condition warrants an office visit. If the visit is in follow-up to a related evaluation and management (E/M) service provided within the past seven days, or if it results in an office visit within the next 24 hours or the soonest available appointment, then CMS will consider it to be bundled into those visits and it will not be separately reimbursed. The payment will be lower than the rate for the lowest level E/M in-person service, and because these “visits” will be subject to Medicare coinsurance, the patient’s verbal consent (oral consent, as opposed to written or electronic consent) must be obtained and noted in the medical record. CMS has said it will monitor utilization of this code to determine whether frequency limits are warranted.

Remote evaluation of prerecorded patient information (HCPCS code G2010)

Similar to the virtual check-in, Medicare also will pay separately for professional evaluation of prerecorded images or video transmitted by established patients for the purpose of determining whether an office visit is warranted. After reviewing the images or video sent by patients, the clinician must follow up with the patient within 24 business hours by phone, email, text message, or other mode of communication. As with the virtual check-in, if this remote evaluation originates from a related E/M service within the past seven days or results in an office visit within the next 24 hours or the next available appointment, the service will be considered bundled and not separately payable. Beneficiary consent (oral, written, or electronic) to the service must be documented because the service would be subject to coinsurance.

Interprofessional internet consultation (CPT®1 codes 99446-49 and 99451-52)

CMS also finalized its proposal to pay separately for four existing and two new Current Procedural Terminology (CPT®) codes describing consultations between physicians or other qualified health professionals when they are for the benefit of a specific patient. These consultations occur when a treating physician seeks the opinion and/or treatment advice of a consulting physician or other health professional with specific expertise, and CMS noted that the current lack of reimbursement for these interactions often leads to the scheduling of an office visit for the patient even though the patient’s presence is not necessary and a telephone or internet consultation between health care professionals would be sufficient. CMS views its recognition of these services as part of the movement away from a strictly fee-for-service-based system and toward a more care management-based approach to providing quality care to beneficiaries with multiple complex conditions. CMS is requiring documentation of beneficiary consent to receive these services because they will be subject to coinsurance, and it will monitor use of the consultations and consider refinements in documentation and billing policies if warranted.

Remote patient monitoring (HCPCS codes 99453, 99454, and 99457)

Having already established payment for chronic care management services in 2016, which are non-face-to-face, in 2019 CMS will establish payment for three codes to report “Chronic Care Remote Physiologic Monitoring.” These include a code for the initial setup and patient education regarding use of remote monitoring of physiologic parameters such as weight, blood pressure, pulse oximetry, and respiratory flow rate, and another code that can be billed monthly for the costs associated with the supplies and transmission of data. A separate code can be reported for 20 minutes or more of a physician or other health care professional’s time on treatment management during the month, but this service cannot be provided by auxiliary personnel and billed “incident to” a professional’s service. CMS will be issuing further guidance on the specific kinds of technology and scope of services covered under these codes.

Medicare telehealth services (HCPCS codes G0513 and G0514)

In addition to the new types of services described above, CMS annually updates the list of approved Medicare telehealth services, and this year added two codes for reporting “prolonged preventive services.” These codes, which are similar to existing E/M codes, are for reporting preventive services that require direct patient contact beyond the typical service time.

1 CPT Copyright 2018 American Medical Association. All rights reserved. CPT® is a registered trademark of the American Medical Association.

Use of telehealth in treatment of substance use disorders

The physician fee schedule final rule also implements provisions in the recently passed Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, which is focused on addressing the opioid crisis, expanding the use of telehealth for treatment of substance use. Effective July 1, 2019, the geographic restrictions applicable to most telehealth services will not apply to use of telehealth for the treatment of diagnosed substance use disorders or co-occurring mental health disorders. The patient’s home will also be an acceptable originating site, although no facility fee will be paid. Implementation of this SUPPORT for Patients and Communities Act provision was issued as an interim final rule with a 60-day comment period, and CMS solicits comments on this provision.

Medicare home health prospective payment system final rule

On October 31, CMS posted the HH PPS final rule, which will allow home health agencies to include the costs of remote patient monitoring as an allowable administrative cost (e.g., operating expense) on their cost report if the remote monitoring is used to assist in the care planning process. This will allow such expenses to be factored into the costs per visit. Commenters on the proposed rule suggested that CMS should take an even broader approach to telehealth and include payment for virtual visits. CMS declined to do so, but described the inclusion on the cost report of costs associated with remote patient monitoring as a necessary first step in determining whether the use of such technology improves outcomes for home health patients.  This suggests CMS may further expand payment for the use of telehealth in home health in the future.

Expanded coverage of telehealth by Medicare Advantage plans

In implementing the Bipartisan Budget Act of 2018, CMS also is proposing to allow Medicare Advantage (MA) plans to offer expanded coverage for “clinically appropriate additional telehealth benefits” beginning in plan year 2020. CMS would allow the plans to treat them as “basic benefits” for purposes of bid submission and payment, making it more likely that plans will offer them. Under the proposal, MA plans could offer Part B covered services as “additional telehealth benefits” outside the scope of services currently allowed under the Medicare telehealth benefit and not subject to the location restrictions applicable to telehealth services. To preserve beneficiary choice, any Part B service covered by plans as an “additional telehealth benefit” must also be available through an in-person visit and not only via telehealth. In addition, CMS is proposing to continue allowing plans to offer supplemental benefits (e.g., benefits not covered by original Medicare) via remote technologies or telemonitoring services that do not qualify as “additional telehealth benefits.”

CMS is not proposing to define which services are “clinically appropriate” to be offered as “additional telehealth benefits,” but would instead allow MA plans the flexibility to make that determination for themselves each year, consistent with professionally recognized standards of care. The MA plan would have to use contracted providers to provide these additional telehealth benefits and other MA regulations, including those regarding provider credentialing and selection would apply. Plans would be responsible for ensuring that the telehealth provider was in compliance with applicable licensing requirements and other state laws for the state in which the enrollee is located. CMS has solicited comments on its proposed approach and on the impact such telehealth providers should have on determinations of MA network adequacy.

Taken together, these recent changes by Congress and CMS indicate significant interest in making more health services available to Medicare beneficiaries via telehealth and similar technologies and to continue testing whether and when such services can be used to expand access to high-quality, cost-effective care, and to improve care coordination.

Appendix: Remote monitoring services payment rates

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Mandy Roth is the innovations editor at HealthLeaders.

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On November 1, 2018, the Centers for Medicare and Medicaid Services (CMS) released in pre-publication form the Medicare Physician Fee Schedule (PFS) Final Rule for Calendar Year (CY) 2019 (PFS Final Rule) [1]. The PFS Final Rule contains a number of significant changes, including:

• providing for reimbursement for communication technology-based services and expanding access to telehealth services by allowing for reimbursement for acute stroke telehealth services;
• streamlining requirements for evaluation and management (E/M) visits to reduce administrative and regulatory burden associated with documentation of the visits and changing payment guidelines to create a single payment rate for levels 2 through 4 visits;
• establishing a payment methodology for the general care management services for Rural Health Centers (RHCs) and Federally Qualified Health Centers (FQHCs);
• aligning the electronic clinical quality measures (eCQMs) available for Medicaid Eligible Professionals (EPs) in 2019 with those available for Merit-Based Incentive Payment System (MIPS) eligible clinicians for the CY 2019 performance period;
• implementing amendments to the Stark Law regulations consistent with statutory changes related to the writing and signature requirements;
• updating the CMS Quality Payment Program (QPP); and
changing the definition of “applicable laboratories” for purposes of the rules requiring reporting of private payor rates.

We provide below a full summary of each of the key changes noted above and provide other highlights from the PFS Final Rule. The PFS Final Rule is scheduled to be published in the Federal Register on November 23, 2018. A link to our prior alert on the PFS Proposed Rule is provided here.

Modernizing Medicare Physician Payment by Recognizing Communication Technology-Based Services
CMS finalized its proposals to establish new payment codes to reimburse clinicians for certain technology-based services under specified conditions, including:

• Healthcare Common Procedure Coding System (HCPCS) code G2012, for brief communication technology-based services, such as brief non-face-to-face virtual check-ins that occur via telecommunications technology (including audio-only communications) if certain requirements are met;
• HCPCS code G2010 to make separate payment for remote evaluation of recorded video and/or images submitted by an established patient; and
• separate payment for interprofessional consultation CPT codes 99451, 99452, 99446, 99447, 99448, and 99449, which describe assessment and management services conducted through telephone, internet, or electronic health record consultations furnished when a patient’s treating physician or other qualified health care professional requests the opinion and/or treatment advice of a consulting physician or qualified health care professional with specific specialty expertise to assist with the diagnosis and/or management of the patient’s problem without the need for the patient’s face-to-face contact with the consulting physician or qualified health care professional.

CMS specifically emphasized the importance of notifying patients of their cost-sharing obligations related to these remote services (which CMS stated it does not have the authority to waive), despite any potential burden on clinicians. Accordingly, clinicians must obtain patient consent, which must be documented in the medical record, each time such remote services are provided.

In addition, in order to implement the requirements of section 50325 of the Bipartisan Budget Act of 2018, CMS finalized a new modifier to identify acute stroke telehealth services and revisions to 42 C.F.R. § 410.78 and § 414.65 to allow for reimbursement for acute stroke telehealth services, including a definition of “mobile stroke unit” and the addition of a mobile stroke unit as a permissible originating site for such acute stroke telehealth services [2].

Interim Final Rule Expanding the Use of Telehealth Services for the Treatment of Opioid Use Disorder and Other Substance Use Disorders Under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act
Section 2001(a) of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act [3] (SUPPORT Act) amended Section 1834(m) of the Social Security Act to remove the originating site geographic requirements for telehealth services furnished on or after July 1, 2019, for the purpose of treating individuals diagnosed with a substance use disorder or a co-occurring mental health disorder (with the exception of a renal dialysis facility), add an individual’s home as a permissible originating site for these telehealth services, and require that no originating site facility fee be paid in instances when the individual’s home is the originating site. In addition, Section 2005 of the SUPPORT Act establishes a new Medicare benefit category for opioid use disorder treatment services furnished by Opioid Treatment Programs (OTPs) under Medicare Part B, beginning on or after January 1, 2020, which requires that opioid use disorder treatment services include Food and Drug Administration (FDA) approved opioid agonist and antagonist treatment medications, the dispensing and administration of such medications (if applicable), substance use disorder counseling, individual and group therapy, toxicology testing, and other services determined appropriate (but not meals and transportation). Section 2005 defines OTPs as those that enroll in Medicare and are certified by the Substance Abuse and Mental Health Services Administration (SAMHSA), accredited by a SAMHSA-approved entity, and meeting additional conditions as the Secretary finds necessary to ensure the health and safety of individuals being furnished services under these programs and the effective and efficient furnishing of such services. [4]

In order to implement the requirements of Section 2001(a) of the SUPPORT Act, CMS has issued an interim final rule with comment period revising several Medicare telehealth regulations. There is a 60-day period following publication of the interim final rule for the public to comment on these interim final amendments to the regulations and to respond to CMS’s request for information regarding services furnished by OTPs, payments for these services, and additional conditions for Medicare participation for OTPs that stakeholders believe may be useful to consider for future rulemaking to implement this new Medicare benefit category. In addition, CMS is requesting as part of this interim final rule additional information from stakeholders and the public that might be considered for future rulemaking regarding payment structure and amounts for substance abuse disorder (SUD) treatment that account for ongoing treatment and wide variability in patient needs for treatment of SUDs while improving access to necessary care. [5]

Payment Rates under the Medicare PFS for Nonexcepted Items and Services Furnished by Nonexcepted Off-Campus Provider-Based Departments of a Hospital
In the PFS Final Rule, CMS finalized its proposal to continue the CY 2018 payment mechanism and reimbursement amounts for nonexcepted off-campus hospital outpatient provider-based departments (PBDs). In particular, CMS will continue to allow nonexcepted off-campus PBDs to bill for nonexcepted items and services on institutional claims with a “PN” modifier, which will be used “until we identify a workable alternative mechanism to improve payment accuracy.” [6] CMS will also continue to pay with the PFS reimbursement amount for such services set at 40% of OPPS — i.e., the PFS Relativity Adjuster. In calculating this PFS Relativity Adjuster, CMS stated that its analysis supports maintaining an adjustment of 40% for CY 2019 and beyond “until there is an appropriate reason and process for implementing an alternative to our policy.” [7] In setting the rate, CMS rejected the arguments of commenters who wrote that a rate of 65–70% would be more appropriate. [8]

Evaluation and Management Visits
CMS finalized several changes to E/M visit documentation and payment guidelines, which will apply primarily to office-based and outpatient visit codes. [9] These changes are part of CMS’s ongoing effort to reduce the regulatory burden associated with E/M coding and payment. [10]

Documentation
CMS’s E/M Documentation Guidelines set forth the medical information required to support an E/M visit in three categories: history of present illness, physical examination, and medical decision-making. [11] Practitioners currently may choose to use one of two versions of the E/M Documentation Guidelines, the “1995” or the “1997” guidelines, to support a level 1 through 5 E/M visit. [12] In an effort to reduce administrative burden, CMS finalized new documentation options to promote flexibility regarding the documentation required for E/M visits. [13] Effective January 1, 2021, practitioners will be able to choose among the following documentation methodologies to support E/M level 2 through 4 visits:

1) the current “1995” or “1997” E/M Documentation Guidelines, sufficient to support a level 2 E/M visit;
2) the medical decision-making component of an E/M visit alone, sufficient to support a level 2 E/M visit under the 1995 or 1997 E/M Documentation Guidelines; or
3) the total amount of face-to-face time or duration of an E/M visit alone, documenting that the practitioner personally spent the current typical time associated with the CPT code reported on the claim. [14]

Simplified Payment Amounts
In the PFS Proposed Rule, [15] CMS proposed to pay a single rate for level 2 through level 5 E/M visits by developing sets of relative value units (RVUs) under the PFS for new patients and existing patients. [16] CMS received comments that the proposed single payment rate would not adequately account for the amount of resources required to treat the most complex patients. [17] In response, CMS instead finalized a single payment rate for E/M visit levels 2 through 4, developing a set of RVUs under the PFS for E/M visit levels 2 through 4 for new patients (CPT codes 99202 through 99204) and a set of RVUs for E/M visit levels 2 through 4 for existing patients (CPT codes 99212 through 99214). [18] CMS will maintain separate payment rates for new and established patients for E/M levels 1 and 5 visits. [19] In addition, in response to commenters’ concerns regarding the timing of such change, CMS delayed the effective date of the single payment rate for levels 2 through 4 E/M visits, which will not become effective until January 1, 2021. [20]

Corresponding Payment Adjustments
In addition to finalizing a single payment rate for visit levels 2 through 4, CMS also accounted for resource costs associated with certain E/M level 2 through 4 visits requiring different types of care by finalizing two corresponding payment policies and adjustments:

• HCPCS codes GCG0X and GPC1X, for visit complexity inherent to E/M services associated with primary care and non-procedural specialty care (e.g., endocrinology, rheumatology, etc.), respectively. [21]
• HCPCS code GPRO1, for extended time for E/M services, when the visit requires direct patient contact of 34-69 face-to-face minutes overall for existing patients or 38-89 face-to-face minutes overall for new patients. [22]

These payment adjustments will also become effective January 1, 2021. [23]

Teaching Physician Documentation Requirements for Evaluation and Management Services
CMS finalized changes to the documentation required for payment for teaching physician services under the PFS. [24] Currently, a teaching physician’s participation in the review and direction of E/M services performed by a resident must be personally documented by the teaching physician. In an effort to reduce burden and duplication of effort for teaching physicians, [25] CMS finalized changes such that the participation of the teaching physician during E/M services need not be separately documented by the teaching physician, but may be demonstrated by the notes in the medical records made by a physician, resident, or nurse. [26] This documentation requirement will become effective January 1, 2019. [27]

Therapy Services
Outpatient therapy services (physical therapy and occupational therapy) furnished in whole or in part by a therapy assistant will be reimbursed at a rate of 85% of the otherwise applicable Part B payment amount for the service. This reduced payment amount for outpatient therapy services is applicable when payment is made directly under the PFS. [28] To implement this provision, CMS proposed to establish two new modifiers to identify separate physical therapy and occupational therapy services that are furnished in whole or in part by a therapy assistant. [29] Rather than establishing these modifiers as new therapy modifiers, as proposed, CMS opted to establish the two new modifiers as payment modifiers to be used in conjunction with existing therapy modifiers in order to reduce the administrative burden on physical therapy and occupational therapy professionals associated with the addition of new therapy modifiers. [30] In the PFS Final Rule, CMS also changed its proposed definition of a service that is furnished in whole or in part by a therapy assistant to create a de minimis standard under which a service is furnished in whole or in part by a therapy assistant when more than 10% of the service is furnished by a therapy assistant. [31]

In addition, CMS indicated that the general consensus of commenters who responded to CMS’s Request for Information on burden reductions was that the functional reporting requirements for outpatient therapy services are overly complex and burdensome. [32] In response to the comments, CMS finalized its proposal to discontinue the functional reporting requirements for outpatient therapy services furnished on or after January 1, 2019. [33]

Part B Drugs: Application of an Add-on Percentage for Certain Wholesale Acquisition Cost (WAC)-based Payments
CMS finalized its proposal to use a 3% add-on in place of the current 6% add-on for payments for Part B drugs based on wholesale acquisition cost (WAC) made under Section 1847A(c)(4) of the Social Security Act. In so doing, CMS indicated that the change would reduce the financial incentive under the current system to over utilize new drugs and would not significantly affect providers through reduced margins for Part B drugs. [34]

Potential Model for Radiation Therapy
The Patient Access and Medicare Protection Act, [35] enacted December 28, 2015 (PAMPA), required CMS, in 2017 and 2018, to apply the same code definitions and work RVUs for the fee schedule established under Section 1848(b) of the Act and Section 1848(c)(2)(C)(ii) of the Act, and to apply the same direct inputs for the PE RVUs for radiation treatment delivery and related imaging services under Section 1848(c)(2)(C)(ii) of the Act as those definitions, units, and inputs for such services for the fee schedule established for services furnished in 2016. PAMPA also required the Secretary of Health and Human Services (HHS) to submit a report to Congress on the development of an episodic advanced payment model for Medicare payment for radiation therapy services furnished in non-facility settings. HHS delivered this report to Congress in November 2017. CMS noted that “episode payment models can be a tool for improving care and reducing expenditures” and further indicated that CMS believes that “radiation oncology is a promising area of health care for bundled payments.” The PFS Final Rule states that the CMS Innovation Center will continue to use stakeholder feedback and public information regarding commercial initiatives to help inform the development, implementation, and refinement of design and testing of a potential model that tests payment for radiation therapy services. [36]

Clinical Laboratory Fee Schedule
CMS implemented revisions to the Clinical Laboratory Fee Schedule (CLFS) in response to Section 216 of the Protecting Access to Medicare Act of 2014 (PAMA), which required that the payment amount for most clinical diagnostic laboratory tests (CDLTs) be equal to the weighted median of private payor rates. [37] Pursuant to regulations promulgated by CMS at 42 C.F.R. § 414.500 et seq., an entity must report private payor rates, volume data, and other “applicable information” for each CDLT furnished by each of its components that meets the definition of an “applicable laboratory” every three years. [38] The first round of reporting was required in the first part of 2017, and was used by CMS to set rates under the CLFS beginning January 1, 2018. [39]

As currently defined, the term “applicable laboratory” means an entity that is a laboratory, as defined in the Clinical Laboratory Improvement Amendments (CLIA) regulations; bills Medicare Part B under its own National Provider Identifier (NPI); and, in the applicable six-month data collection period, meets both the “majority of Medicare revenues threshold” and the “low expenditure threshold.”  [40] The majority of Medicare revenues threshold is met if the entity receives, under its NPI, more than 50% of its Medicare revenues through payment under the CLFS (42 C.F.R. part 414, subpart G) and/or the PFS (42 C.F.R. part 414, subpart B). [41] The low expenditure threshold is met if the entity receives, under its NPI, at least $12,500 of its Medicare revenues from the CLFS for CDLTs that are not advanced diagnostic laboratory tests. [42]

In response to stakeholder feedback noting that the 2018 CLFS payment rates were based on data collected from a relatively small number of applicable laboratories and, therefore, arguing that the rates were inaccurate, CMS finalized its proposal to change the calculation of the majority of Medicare revenues threshold by excluding payments made by Medicare Advantage (MA) plans under Medicare Part C from the denominator.  [43] CMS maintains that this change will permit laboratories that have significant revenues from MA payments to qualify as applicable laboratories, thereby increasing the amount of reported data used to determine CLFS payment rates. [44]

As noted above, an applicable laboratory is currently defined, in part, as an entity that bills under its own NPI. However, many hospital outreach laboratories bill under the NPI of the hospital, rather than their own NPI. [45] Accordingly, in an effort to include a greater number of hospital outreach laboratories under the definition of an applicable laboratory, CMS finalized an approach, whereby hospital outreach laboratories will determine whether they meet the requirements to be considered an “applicable laboratory” using only revenues for services reported under bill type 14x on the Form CMS-1450, which is used for hospital laboratory services provided to non-patients, rather than using all Medicare revenues reported under the NPI used on the bills. [46] In the proposed rule, CMS expressed its concerns that this approach would present operational issues for hospitals as well as potentially be inconsistent with statutory authority, based in part on CMS’s view that this change would result in all hospital outreach laboratories meeting the definition of applicable laboratories. [47] However, after receiving stakeholder commentary on the issue, CMS reasoned that this change will not impermissibly cause all hospital outreach laboratories to meet the definition of applicable laboratories because, in order to meet that definition, the $12,500.00 low expenditure threshold still must be met. [48]

Finally, as discussed in greater detail in our prior alert, in the Proposed Rule, CMS requested comments on a proposal to change the low expenditure threshold, and a proposal to use CLIA certificates to define applicable laboratories. In the Final Rule, CMS acknowledged stakeholder comments, but declined to finalize changes implementing either proposal. [49]

Payment for Care Management Services and Communication Technology-Based Services in Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)
For Rural Health Centers (RHCs) and Federally Qualified Health Centers (FQHCs), CMS finalized the proposed payment methodology for the general care management services HCPCS code G0511, as the average of the national non-facility PFS payment rate for certain CPT codes. CMS also finalized its proposal to establish a separate payment to RHCs and FQHCs for HCPCS code G0071 (Virtual Communication Services), which represents at least five minutes of communication technology-based services or remote evaluation services not currently captured in the RHC all-inclusive rate or the FQHC prospective payment systems when the requirements for such services are met. [50]

Appropriate Use Criteria for Advanced Diagnostic Imaging Services
CMS finalized many of its proposals regarding appropriate use criteria (AUC) for advanced diagnostic imaging services as initially proposed. Originally established in the CY 2016 final rule, practitioners will be required to consult evidence‐based AUC when ordering and furnishing applicable imaging services to make the most appropriate treatment decisions for specific clinical conditions beginning in 2020. These proposals seek to provide additional clarification to AUC requirements that, while currently voluntary, will be required for providers effective January 1, 2020. The PFS Final Rule clarifies the following:

• independent diagnostic testing facilities are applicable settings which require AUC consultation and reporting, as initially proposed; [51]
• when not personally performed by the ordering professional, AUC consultation may be delegated to and performed by clinical staff working under the direction of the ordering professional, as modified from the initial proposal that “auxiliary personnel” may perform the AUC consultation “incident to” the ordering professional’s services; [52]
• AUC consultation must be reported on all claims for applicable imaging services, including both the professional and facility claims, as initially proposed; [53]
• providers may report AUC information on claims using established coding methods, including certain G-codes and modifiers, as initially proposed; however, CMS acknowledged potential technical issues regarding this approach and stated that it will continue to address such issues during implementation; [54] and
• changes to the significant hardship exception that include insufficient internet access, electronic health record (EHR) or clinical decision support mechanism vendor issues, or extreme and uncontrollable circumstances, as initially proposed. [55]

Finally, CMS stated its intention to address outlier identification and prior authorization more fully in future CY 2022 or 2023 rulemaking. [56]

Medicaid Promoting Interoperability Program Requirements for Eligible Professionals
CMS finalized without change its proposal to amend the list of available eCQMs for the CY 2019 performance period. [57] Through these changes, CMS aligns the eCQMs available for Medicaid Eligible Professionals (EPs) in 2019 with those available for Merit-Based Incentive Payment System (MIPS) eligible clinicians for the CY 2019 performance period, so that the eCQMs available for Medicaid EPs in 2019 consist of the quality measures available under the eCQM collection type on the final list of quality measures established under MIPS for the CY 2019 performance period. [58]

CMS also finalized its proposal for CY 2019 that requires Medicaid EPs to report on any six eCQMs that are relevant to the EP’s scope of practice, either via attestation or electronically. [59] Additionally, CMS finalized its proposal that EPs report on at least one outcome measure (or, if an applicable outcome measure is not available or relevant, one other high-priority measure). [60] CMS explains in the PFS Final Rule that, if no outcome or high-priority measure is relevant to a Medicaid EP’s scope of practice, the EP may report on any six eCQMs relevant to his or her practice. [61]

Furthermore, CMS finalized its proposal to allow states to indicate which eCQMs are high-priority measures for that state’s Medicaid agency. [62] CMS reiterates that, if no outcome or priority measure is relevant to the Medicaid EP’s scope of practice, he or she may report on six relevant measures. [63]

CMS finalized its proposal that the eCQM reporting period for EPs in the Medicaid Promoting Interoperability Program will be a full CY in 2019 for EPs that have demonstrated meaningful use in a prior year, in order to align with the corresponding performance period in MIPS for the quality performance category. [64] CMS also finalized the EHR reporting period in 2021 for all EPs in the Medicaid Promoting Interoperability Program as a minimum of any continuous 90-day period within CY 2021, provided that the end date for this period falls before October 31, 2021. [65]

Finally, for Measure 1 (View, Download, or Transmit) and Measure 2 (Secure Electronic Messaging) of Meaningful Use Stage 3 EP Objective 6 (Coordination of Care through Patient Engagement), CMS finalized its change to the thresholds so that they will remain at 5% for 2019 and subsequent years. [66]

Physician Self-Referral Law & Annual Update to the List of CPT/HCPCS Codes
In order to align the Stark Law regulations with Stark Law statutory amendments enacted as part of the Bipartisan Budget Act of 2018, CMS had proposed amendments to existing requirements for a written agreement and signature requirements.

• Written Agreement: CMS proposed a new special rule on compensation arrangements at 42 C.F.R. § 411.354(e) to explicitly permit that, for any compensation arrangement that is required to be in writing, the writing requirement may be satisfied by a collection of documents, including contemporaneous documents evidencing the course of conduct between the parties. CMS received a few comments in support of its proposal to codify its existing policy on the writing requirement, and received no comments opposing its proposal. CMS finalized the proposed § 411.354(e) without modification. [67]
• Signature Requirements: CMS also proposed modifications to the regulatory provision regarding temporary noncompliance with signature requirements at 42 C.F.R. § 411.353(g)(1) to provide that parties have 90 days to obtain signatures whether the lack of a timely signature was advertent or inadvertent, and deletion of the current restriction that the temporary compliance rule could only be used once every three years for a particular physician or physician group. In the alternative, CMS proposed deleting the regulatory section 42 C.F.R. § 411.353(g) in its entirety, which set out the special rules for arrangements involving temporary noncompliance with the signature requirement, and instead codifying the statutory language setting forth the special rule for signature requirements. CMS received a few comments expressing general support for the special rule on temporary noncompliance with signature requirements, and no comments opposing the proposal. [68] CMS noted that it will be less disruptive to amend the existing regulation at § 411.353(g), rather than delete the section in its entirety and codify the statutory language in a new regulatory section. [69]
As such, CMS finalized its proposal to revise the special rule for temporary noncompliance with signature requirements at § 411.353(g), thus aligning § 411.353(g) with the newly added statutory provision. Finally, CMS notes that the effective date of the applicable Bipartisan Budget Act section was February 9, 2018, and as such, beginning on that date, parties who met the requirements of the statutory provision regarding noncompliance with signature requirements, but otherwise would have been barred from relying on the special rule for certain arrangements involving temporary noncompliance with signature requirements because of the three-year limitation, may avail themselves of the new statutory provision of that date. [70]
• Annual Update to the Code List: CMS also published the annual list of the additions and deletions to the comprehensive list of CPT codes considered DHS for purposes of four categories of DHS: (1) clinical laboratory services; (2) physical therapy, occupational therapy, and outpatient speech-language pathology services; (3) radiology and certain other imaging services; and (4) radiation therapy services and supplies. The updated Code List becomes effective January 1, 2019. [71]

CY 2019 Updates to the Quality Payment Program
The PFS Final Rule makes a significant number of operational changes to the Quality Payment Program (QPP), as QPP enters its third transitional year. These changes cover a wide variety of issues impacting both the Merit-Based Incentive Payment System (MIPS) and the Advanced Alternative Payment Model program (Advanced APM). The majority of the updates introduced in the Proposed Rule were finalized without change.

A future client alert will discuss these QPP changes in-depth. However, some key finalized provisions include the following:

• expanding the definition of a “MIPS eligible clinician” to add a number of additional clinician-types, such as physical and occupational therapists; [72]
• revising the MIPS final score performance category weights; [73]
• altering the methodology for calculating the small practice performance bonus under MIPS; [74]
• several modifications to the recently introduced facility-based measurement option under MIPS, including adding on-campus outpatient hospitals (POS-code 22) to the list of site of services that CMS will use to determine eligibility for facility-based measurement; [75]
• increasing the “performance threshold” (the point at which a clinician will not incur a payment reduction under MIPS) from 15 to 30 points out of a total of 100 for MIPS payment year 2021. [76] In addition, CMS is setting the “additional performance threshold” (the point at which a clinician is eligible for sharing in $500,000,000 of additional incentive funding) at 75 points for MIPS payment year 2021, slightly less than the 80 points initially proposed; [77] and
• increasing the certified EHR technology (CEHRT) threshold for an APM to qualify as an Advanced APM, by requiring at least 75% of eligible clinicians participating in an Advanced APM to use CEHRT starting in calendar year 2019, up from the current threshold of 50%. [78]

Medicare Shared Savings Program; Accountable Care Organizations—Pathways to Success
The PFS Final Rule also contains several provisions related to updating Medicare Shared Savings Program (MSSP) rules. [79] These changes include finalizing proposals introduced in the PFS Proposed Rule, as well as finalizing some of the proposals introduced in the recent “Pathway to Success” proposed rule related to MSSP. A number of the proposed changes from the Pathway to Success proposed rule are not addressed in the PFS Final Rule, however, and will be addressed in future rulemaking, including the proposed restructuring of MSSP program design. A summary of the MSSP changes contained in the PFS Final Rule will be the subject of a future client alert.

Radiologist Assistants
In accordance with 42 C.F.R. § 410.32(b), unless an exception applies, all diagnostic X-ray and other diagnostic tests are required to be provided under the level of physician supervision specified by CMS, either general, direct, or personal, as those terms are defined in the regulation. For most diagnostic imaging procedures, the required physician supervision level applies only to the technical component of the procedure. CMS finalized its proposal to amend § 410.32(b) such that any diagnostic tests that would otherwise require personal supervision will now only require direct supervision when performed by a registered radiologist assistant (RRA) who is certified and registered by the American Registry of Radiologic Technologists or a radiology practitioner assistant (RPA) who is certified by the Certification Board for Radiology Practitioner Assistants, as permitted by state law and state scope of practice regulations. [81] Diagnostic imaging tests requiring a general level of physician supervision still only require general supervision. [82]

Conclusion
As underscored in this alert, the changes implemented in the PFS Final Rule are significant and wide ranging in their scope.

Providers will need to quickly assess both the practical compliance elements of implementing the changes identified in the PFS Final Rule and the financial impact of those changes on their budgets. K&L Gates’ Health Care Practice can assist health care providers in conducting this analysis and will continue to closely monitor further developments as these changes are applied and further subregulatory guidance is issued.

NOTES:

[1] Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; Medicaid Promoting Interoperability Program; Quality Payment Program–Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS Payment Year; Provisions from the Medicare Shared Savings Program–Accountable Care Organizations–Pathways to Success; and Expanding the Use of Telehealth Services for the Treatment of Opioid Use Disorder under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, available at https://federalregister.gov/d/2018-24170 (unpublished November 1, 2018).
[2] Id. at 104–56.
[3] Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, Pub. L. 15-271, __ Stat. __ (October 24, 2018).
[4] PFS Final Rule at 156–58.
[5] Id. at 158–63.
[6] Id. at 197.
[7] Id. at 213.
[8] Id. at 208.
[9] Id. at 537.
[10] Id. at 539.
[11] Id. at 537.
[12] Id. at 536.
[13] Id. at 565.
[14] Id. at 565–66. Regarding time, CMS notes that “[f]or administrative simplicity, it may be most straight forward to track to the typical time for the CPT code.” Id. at 566. For the 1995 or 1997 E/M Documentation Guidelines, see: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/eval-mgmt-serv-guide-ICN006764.pdf.
[15] Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; and Medicaid Promoting Interoperability Program, 83 Fed. Reg. 35,704 (proposed July 27, 2018).
[16] 83 Fed. Reg. 35,839.
[17] PFS Final Rule at 578.
[18] Id. at 581.
[19] Id.
[20] Id.
[21] Id. at 606.
[22] Id. at 620.
[23] Id.
[24] Id. at 633.
[25] Id.
[26] Id. at 634.
[27] Id. at 635.
[28] Id. at 640.
[29] Id. at 650.
[30] Id. at 651.
[31] Id. at 660.
[32] Id. at 664.
[33] Id.
[34] Id. at 677.
[35] Pub. L. 114–15, 129 Stat. 3131 (December 28, 2015).
[36] PFS Final Rule at 686.
[37] Id. at 687–88.
[38] Id. at 689.
[39] Id. at 688.
[40] Id.
[41] Id. at 691.
[42] Id. at 688.
[43] Id. at 701.
[44] Id.
[45] Id. at 706-07.
[46] Id. at 718.
[47] Id. at 710.
[48] Id. at 719.
[49] Id. at 723–25, 729, 732.
[50] Id. at 746–65.
[51] Id. at 777.
[52] Id. at 785-86.
[53] Id. at 788–89.
[54] Id. at 798.
[55] Id. at 812.
[56] Id.
[57] Id. at 815, 821.
[58] Id. at 821–22.
[59] Id. at 824.
[60] Id.
[61] Id.
[62] Id. at 825.
[63] Id.
[64] Id. at 826–27.
[65] Id. at 830.
[66] Id. at 832, 839.
[67] Id. at 862–63.
[68] Id. at 863–64.
[69] Id. at 865.
[70] Id. at 866.
[71] Id. at 867-69.
[72] Id. at 906.
[73] Id. at 1003.
[74] Id. at 1305–06.
[75] Id. at 1338.
[76] Id. at 1419.
[77] Id. at 1428.
[78] Id. at 1550.
[79] Id. at 837–63, 1621–1805.
[80] http://healthcare-triage.klgates-media.libsynpro.com/category/Accountable+Care+Organizations+%28ACO%29%2C+Clinically+Integrated+Networks+%28CIN%29+%26amp%3B+Bundled+Payments
[81] PFS Final Rule at 190.
[82] Id. at 188.

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November 02, 2018 – The Centers for Medicare & Medicaid Services has finalized plans to reimburse healthcare providers for certain remote patient monitoring and telehealth services.

CMS this week issued its final 2019 Physician Fee Schedule and Quality Payment Program, opening the door to reimbursement for connected care services that enable providers to manage and coordinate care at home. The changes are focused on three new CPT codes that separate RPM services from telehealth, which is more restricted.

“This provides opportunities for patients around communicating with providers remotely,” CMS Administrator Seema Verma said during a Thursday afternoon conference call with reporters. “We’ve never had this in the program at large. There has been a telehealth benefit mostly for rural providers, but access to care is not just a rural issue, it’s something that patients struggle with across the country.”

“This is an historic change in terms of increasing access and it’s also a great example of some of the efforts that we’re trying to make around supporting innovation,” she added. “This has been happening in the private market and I think the opportunities and the impact could be tremendous. We’re excited to be able to harness this innovation for Medicare beneficiaries.”

Alongside the 2,378-page rule, CMS also issued a fact sheet breaking down the changes.

When the changes were proposed this past July, Nathaniel Lacktman, a partner and healthcare lawyer with Foley & Lardner who chairs the firm’s Telemedicine Industry Team and co-chairs its Digital Health Work Group, said they represent a “landmark change” in government efforts to embrace telehealth and mHealth.

He made that point again in a blog released today.

“With the new CPT codes for Chronic Care Remote Physiologic Monitoring, RPM will become an area of significant upside potential over the coming years,” Lacktman said. “Hospitals and providers using RPM and non-face-to-face technologies to develop patient population health and care coordination services should take a serious look at these new codes, and keep abreast of developments that can drive recurring revenue and improve the patient care experience.”

The new CPT codes are:

• CPT code 99453: “Remote monitoring of physiologic parameter(s) (eg, weight, blood pressure, pulse oximetry, respiratory flow rate), initial; set-up and patient education on use of equipment.”
• CPT code 99454: “Remote monitoring of physiologic parameter(s) (eg, weight, blood pressure, pulse oximetry, respiratory flow rate), initial; device(s) supply with daily recording(s) or programmed alert(s) transmission, each 30 days.”
• CPT code 99457: “Remote physiologic monitoring treatment management services, 20 minutes or more of clinical staff/physician/other qualified healthcare professional time in a calendar month requiring interactive communication with the patient/caregiver during the month.”

Among the significant changes highlighted by Lacktman, CPT 99457 allows RPM services to be performed not only by the physician or qualified healthcare professional, but also by “clinical staff,” such as RNs and medical assistants. This could make it easier for healthcare providers to figure RPM programs into their workflow.

Lacktman also noted the new guidelines aren’t specific about the technology that would qualify for reimbursement.

“Many advocates asked CMS to clarify the kinds of technology covered under CPT codes 99453, 99454, and 99457,” he wrote in his blog. “Some groups gave examples of the kinds of technology they believe these codes should cover, such as software applications that could be integrated into a beneficiary’s smartphone, Holter-Monitors, Fitbits, or artificial intelligence messaging. Other examples included behavioral health data and data from wellness applications, or results of patients’ self-care tasks. Unfortunately, CMS did not offer any specifics in the final rule on what technology qualifies, but CMS does plan to issue forthcoming guidance to help inform practitioners and stakeholders on these issues.  This may likely be in the form of a CMS MLN article or Q&A.”

Aside from the new CPT codes, CMS has issued an interim final rule to eliminate geographic restrictions for telehealth services furnished for purposes of treatment of a substance use disorder or a co-occurring mental health disorder for services furnished on or after July 1, 2019. That ruling – a provision from the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act – would also make the home an originating site, enabling consumers to receive treatment through telehealth at home.

Also this week, CMS released final calendar year 2019 and 2020 payment and policy changes for Home Health Agencies and Home Infusion Therapy Suppliers. Among the changes listed, CMS will no longer require the home health agency to prove medical necessity for a home visit in place of an office visit, giving HHAs more leeway to use RPM and telehealth.

“CMS is finalizing its proposal to define remote patient monitoring in regulation for the Medicare home health benefit and to include the cost of remote patient monitoring as an allowable cost on the HHA cost report,” the agency said. “Studies note that remote patient monitoring has a positive impact on patients as it allows patients to share more live-time data with their providers and caregivers, which will lead to more tailored care and better health outcomes. CMS believes that defining remote patient monitoring and including such costs as allowable costs on the HHA cost report could encourage more HHAs to adopt the technology.”

These announcements follow by one week a CMS proposal to expand the use of telehealth and telemedicine in Medicare Advantage plans.

As part of a 362-page proposal issued on October 26, the Centers for Medicare & Medicaid Services (CMS) is proposing to eliminate geographical restrictions on telehealth access in MA plans by 2020, enabling those in urban areas to use connected health technology. The proposal would also give members more locations to access care, including their own home.

“The Original Medicare telehealth benefit is narrowly defined and includes restrictions on where beneficiaries receiving care via telehealth can be located,” the agency wrote in an accompanying fact sheet. “CMS believes that the additional telehealth benefits in MA will increase access to patient-centered care by giving enrollees more control to determine when, where, and how they access benefits.”

“The proposed rule would give MA plans more flexibility to offer telehealth benefits to all their enrollees, whether they live in rural or urban areas,” the agency stated. “It would also allow greater ability for Medicare Advantage enrollees to receive telehealth from places including their homes, rather than requiring them to go to a health care facility to receive telehealth services. Plans would also have greater flexibility to offer clinically-appropriate telehealth benefits that are not otherwise available to Medicare beneficiaries.”

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Despite industry concerns, the Centers for Medicare & Medicaid Services (CMS) has finalized the Patient-Driven Groupings Model (PDGM) planned to start in 2020. The agency has also finalized several other changes to how home health providers are reimbursed for their services starting in 2019, tweaking remote patient monitoring rules and refining the Value-Based Purchasing Model (VBPM).

CMS projects that Medicare payments to home health agencies in calendar year 2019 will be increased by 2.2% — or $420 million — based on its finalized policies, announced Wednesday.

The reimbursement rate increase is the first the home health industry has received in a decade — and slightly more than what CMS initially suggested in July’s proposed payment rule. The agency originally projected that home health payment changes would increase Medicare payments to home health agencies by $400 million.

Among its provisions, PDGM is designed to remove current incentives to over-provide therapy services by more strongly weighting clinical characteristics and other patient information, according to CMS. PDGM would also mean that the traditional 60-day unit of payment would be halved to 30 days.

PDGM — mandated to be budget neutral by the Bipartisan Budget Act of 2018 — takes into account certain behavioral changes that policymakers expect home health providers to make after the model is implemented. In particular, they include assumed changes to clinical and co-morbidity coding behavior, along with how Low Utilization Payment Adjustment (LUPA) claims are handled.

If no behavioral assumptions are made, CMS estimates that the 30-day payment amount needed to achieve budget neutrality would be $1,873.91. With the behavioral assumptions, that amount drops to $1,753.68 — a 6.42% decrease.

Home health stakeholders have widely criticized the behavioral assumptions, even teaming up with several members of Congress to get them changed or removed in PDGM via multiple pieces of legislation — S. 3545, S. 3458 and H.R. 6932.

“While we had hoped CMS would consider modifications outlined by the home health provider sector when finalizing this rule, this announcement reinforces the need for the industry to continue our advocacy to get the new home health payment system right,” LHC Group (Nasdaq: LHCG) CEO and Chairman of the Partnership for Quality Home Healthcare Keith Myers said in a statement. “We will continue to work collaboratively with CMS and lawmakers in Congress to refine this new payment system to ensure it is based on a data-driven approach and will support the delivery of uninterrupted, high quality home healthcare to older Americans.”

Although language for PDGM is included in CMS’ final home health payment rule for 2019, that does not mean the payment model is set in stone, Amedisys, Inc. (Nasdaq: AMED) CEO Paul Kusserow told investors during a conference call Tuesday. Stakeholders will likely have until Jan. 1 2020 to secure modifications on the model, he said.

The final rule’s implementation language differs than the proposal’s, Joy Cameron, vice president of policy and innovation for ElevatingHOME, told Home Health Care News via email. The proposed rule stated PDGM will be implemented on Jan. 1, 2020, while the final rule states “on or after” Jan. 1, 2020.

“Time to make sure we have it right and necessary vendors and CMS are fully online,” Cameron said.

The final rule’s PDGM language includes 216 more Home Health Resource Groups (HHRGs) than originally proposed because of a Medication Management Teaching and Assessment (MMTA) split, she said.

In addition to the rate increase and finalization of PDGM, the home health final rule also solidifies CMS’ proposal to define remote patient monitoring in regulation for the Medicare home health benefit and to include the cost of remote patient monitoring as an allowable cost on agencies cost reports.

“This home health final rule focuses on patient needs and not on the volume of care,” CMS Administrator Seema Verma said in a statement. “This rule also innovates and modernizes home health care by allowing remote patient monitoring.”

The Partnership for Quality Home Healthcare supports the final rule’s move to include costs associated with tele-monitoring. The Washington, D.C.-based organization also supports changes in the final rule aimed at better payment accuracy related to the MMTA clinical group.

The home health final rule also solidifies substantial changes to rural add-on payments, namely by categorizing counties and equivalent areas into one of three new buckets with varying add-on levels.

The full rule can be accessed here.

Written by Robert Holly

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[pdf-embedder url=”https://drmiltie.com/wp-content/uploads/2018/07/2019-Medicare-Physician-Fee-Schedule-and-Quality-Payment-Program-CMS-Proposed-Rule-CPT-Codes-990X0-990X1-and-994X9-2018-07-12.pdf” title=”2019 Medicare Physician Fee Schedule and Quality Payment Program – CMS Proposed Rule – CPT Codes 990X0, 990X1, and 994X9 – 2018-07-12″]

CMS’ explanation for its bold, new proposal: “We now recognize that advances in communication technology have changed patients’ and practitioners’ expectations regarding the quantity and quality of information that can be conveyed via communication technology. From the ubiquity of synchronous, audio/video applications to the increased use of patient-facing health portals, a broader range of services can be furnished by health care professionals via communication technology as compared to 20 years ago.”

The biggest takeaways from the proposed 2019 Medicare Physician Fee Schedule and Quality Payment Program with regard to remote patient monitoring (Chronic Care Remote Physiologic Monitoring):

CMS introduced three new RPM codes, retitled “Chronic Care Remote Physiologic Monitoring,” which largely adopt the new codes created by the American Medical Association in 2017.  The codes (CPT 990X0, 990X1, and 994X9) are intended to better reflect how RPM services can be delivered to patients.

Even before these new codes were proposed, separate billing Medicare for RPM has been allowed using CPT 99091, defined as:  “Collection and interpretation of physiologic data (e.g., ECG, blood pressure, glucose monitoring) digitally stored and/or transmitted by the patient and/or caregiver to the physician or other qualified health care professional, qualified by education, training, licensure/regulation (where applicable) requiring a minimum of 30 minutes of time.”

The three biggest takeaways from the new RPM codes that differ from the current CPT 99091 are as follows:

1. Less treatment time required to qualify for reimbursement. CPT 99091 requires at least 30 minutes per 30-day period, whereas CPT 994X9 requires only 20 minutes per calendar month.  The new code is much easier to track on a monthly basis, and requires 33 percent less time.

2. Separate payment for initial set-up and patient education. CPT 99091 does not offer additional reimbursement for the time spent setting up the RPM equipment or educating the patient on its use.  The new codes offer separate reimbursement for the work associated with onboarding a new patient, setting up the RPM equipment and training the patient on same. This is a very helpful move to further incentivize providers to start using these technologies with their patients. In addition, this separate payment is different from how Medicare reimburses Durable Medical Equipment (DME) suppliers (e.g., CPAP, oxygen, etc.). CMS requires the DME supplier to set up the equipment at the patient’s home and educate the patient on how to use the equipment, but does not offer separate payment for that work.
3. Clinical staff allowed. CPT 99091 is limited only to “physicians and qualified health care professionals” and does not expressly allow the RPM service to be delivered by clinical staff (e.g., RNs, medical assistants, etc.). This means the physician or qualified health care professional must perform the full 30 minutes per 30-day period, which is a lot of time for these highly trained professionals. For some providers, this is too resource-intensive to justify the $58.68 per month reimbursement rate.  The new code allows RPM services to be performed by clinical staff.

The only manner in which a Medicare provider could potentially use clinical staff for CPT 99091 is by complying with all the requirements for “incident to” billing, which – among other things – requires that auxiliary personnel be under the direct supervision of the physician. Under Medicare rules, direct supervision means the physician must be present in the office suite and immediately available to provide assistance and direction throughout the time the auxiliary personnel is performing services.

Most RPM services are best provided via general supervision, which does not require the physician and auxiliary personnel to be in the same building at the same time, and the physician could instead exert general supervision via telemedicine. This is a huge difference in operations and business models, but in order for CMS to make these new RPM codes work in the real world, it is near-essential that CMS allow RPM to be delivered “incident to” under general supervision.

Healthcare providers should begin launching RPM programs:

Healthcare providers service Medicare patients should consult with companies, such as Dr. Miltie, to deliver RPM services to patients, similar to what we have seen with Chronic Care Management (CCM) companies. This is because the new codes expressly allow the use of “clinical staff” to help fulfill part of the 20 minutes per month. Current CMS guidance on CCM services expressly contemplates and allows third-party companies to contract with Medicare providers to help deliver CCM services. In order to further enable that, CMS created an exception allowing a Medicare provider to bill CCM services as “incident to” under general supervision. Normally, most services billed incident to must be provided under the direct supervision of the provider.  

Healthcare providers should prepare for these new opportunities:

The first thing is to take the time to truly understand, with precision, the billing and supervision rules fundamental to a compliant RPM service model. Providers should not focus too much on the technology and business development until they are confident the model they are “selling” or delivering does, in fact, comply with Medicare billing requirements.

Second, providers should take time to develop a model business-to-business RPM contract with Dr. Miltie, whether this is technology-only, support services-only or a combination of both.

The post 2019 Medicare Physician Fee Schedule and Quality Payment Program – CMS Proposed Rule CPT Codes 990X0, 990X1, and 994X9 appeared first on Dr. Miltie.

July 20, 2018 – Earlier this month, the Centers for Medicare & Medicaid Services unveiled its proposed 2019 Medicare Physician Fee Schedule and Quality Payment Program, with several amendments designed to boost remote patient monitoring and telehealth programs through improved reimbursements.

Reaction so far – public comments are due back to CMS by September 10 and a final ruling is expected in November – has been positive from connected health advocates. They include Nathaniel Lacktman, a partner and healthcare lawyer with Foley & Lardner LLP, who chairs the firm’s Telemedicine Industry Team and co-chairs its Digital Health Work Group.

mHealthIntelligence recently sat down with Lacktman (virtually, of course) to discuss how these proposals would make telehealth and mHealth more enticing.

Q. What are the biggest takeaways from the proposed 2019 Medicare Physician Fee Schedule and Quality Payment Program with regard to remote patient monitoring (Chronic Care Remote Physiologic Monitoring)?

A. CMS introduced three new RPM codes, retitled “Chronic Care Remote Physiologic Monitoring,” which largely adopt the new codes created by the American Medical Association in 2017.  The codes (CPT 990X0, 990X1, and 994X9) are intended to better reflect how RPM services can be delivered to patients.

Even before these new codes were proposed, separate billing Medicare for RPM has been allowed using CPT 99091, defined as:  “Collection and interpretation of physiologic data (e.g., ECG, blood pressure, glucose monitoring) digitally stored and/or transmitted by the patient and/or caregiver to the physician or other qualified health care professional, qualified by education, training, licensure/regulation (where applicable) requiring a minimum of 30 minutes of time.”

The three biggest takeaways from the new RPM codes that differ from the current CPT 99091 are as follows:

1. Less treatment time required to qualify for reimbursement. CPT 99091 requires at least 30 minutes per 30-day period, whereas CPT 994X9 requires only 20 minutes per calendar month.  The new code is much easier to track on a monthly basis, and requires 33 percent less time.
2. Separate payment for initial set-up and patient education. CPT 99091 does not offer additional reimbursement for the time spent setting up the RPM equipment or educating the patient on its use.  The new codes offer separate reimbursement for the work associated with onboarding a new patient, setting up the RPM equipment and training the patient on same. This is a very helpful move to further incentivize providers to start using these technologies with their patients. In addition, this separate payment is different from how Medicare reimburses Durable Medical Equipment (DME) suppliers (e.g., CPAP, oxygen, etc.). CMS requires the DME supplier to set up the equipment at the patient’s home and educate the patient on how to use the equipment, but does not offer separate payment for that work.
3. Clinical staff allowed. CPT 99091 is limited only to “physicians and qualified health care professionals” and does not expressly allow the RPM service to be delivered by clinical staff (e.g., RNs, medical assistants, etc.). This means the physician or qualified health care professional must perform the full 30 minutes per 30-day period, which is a lot of time for these highly trained professionals. For some providers, this is too resource-intensive to justify the $58.68 per month reimbursement rate.  The new code allows RPM services to be performed by clinical staff.

The only manner in which a Medicare provider could potentially use clinical staff for CPT 99091 is by complying with all the requirements for “incident to” billing, which – among other things – requires that auxiliary personnel be under the direct supervision of the physician. Under Medicare rules, direct supervision means the physician must be present in the office suite and immediately available to provide assistance and direction throughout the time the auxiliary personnel is performing services.

Most RPM services are best provided via general supervision, which does not require the physician and auxiliary personnel to be in the same building at the same time, and the physician could instead exert general supervision via telemedicine. This is a huge difference in operations and business models, but in order for CMS to make these new RPM codes work in the real world, it is near-essential that CMS allow RPM to be delivered “incident to” under general supervision.

Q. Will this be enough to prompt healthcare providers to launch RPM programs?

A. I believe it will. This is particularly so for entrepreneurs and start-ups who would like to create companies helping Medicare providers deliver RPM services to patients, just like we have seen with Chronic Care Management (CCM) companies. This is because the new codes expressly allow the use of “clinical staff” to help fulfill part of the 20 minutes per month. Current CMS guidance on CCM services expressly contemplates and allows third party companies to contract with Medicare providers to help deliver CCM services. In order to further enable that, CMS created an exception allowing a Medicare provider to bill CCM services as “incident to” under general supervision. Normally, most services billed incident to must be provided under the direct supervision of the provider.

Q. What should healthcare providers be doing now to prepare for these new opportunities?

A. The first thing is to take the time to truly understand, with precision, the billing and supervision rules fundamental to a compliant RPM service model. They should not focus too much on the technology and business development until they are confident the model they are “selling” or delivering does, in fact, comply with Medicare billing requirements. Otherwise, they could face significant overpayment liability if the Medicare contractor conducts a post-payment audit.

Second, they should take time to develop a model business-to-business RPM contract, whether this is technology-only, support services-only or a combination of both.

Third, companies interested in RPM should read the proposed rule and consider submitting comments to CMS during this current open period, asking CMS to allow the new RPM codes to be delivered incident to under general supervision, just like CMS did for Chronic Care Management. Do not wait until after the final rule is published, only to complain that CMS didn’t consider something important – you need to help CMS by informing them through the public comment process.

Fourth, companies currently offering CCM services should be particularly focused on expanding their business lines into RPM. Not only do CCM companies have current customers who can benefit from RPM services, the non-face-to-face technology is fairly similar. Moreover, CCM and RPM can both be separately billed for the same patient in the same month, allowing additional revenue. (Note: You cannot double count the minutes for CCM and RPM, so billing both would require at least 40 minutes – 20 minutes of CCM and 20 minutes of RPM – per month).

Q. With regard to new Virtual Care codes introduced by CMS, how will these new codes help providers?

A. CMS has proposed three new code sets for services to be covered under specific conditions:

1. Virtual Check-Ins, officially titled “Brief Communication Technology-Based Service;”
2. Asynchronous Images and Video, officially titled “Remote Evaluation of Pre-Recorded Patient Information;” and
3. Peer-to-Peer Internet Consults, officially titled “Interprofessional Internet Consultation.”

None of these codes require the use of interactive audio-video technology, nor do they require the patient be located in a rural area or a specific qualifying originating site. Moreover, CMS’ proposal to cover asynchronous telemedicine and non-face-to-face services is a major recognition of the validity of asynchronous telemedicine (also known as store-and-forward medical care without the use of interactive audio-video or a face-to-face exam).

Asynchronous telemedicine is efficient and patient-centered and aligns with how many service providers deliver non-healthcare and online services today. CMS’ coverage of these services sends a strong message, both to medical boards and commercial health plans, that asynchronous telemedicine is an important and clinically-valid tool through which providers can deliver healthcare services.

Q. Does this mean we’ll see providers embracing more asynchronous technology, as opposed to real-time audio-visual services?

A. Yes. I am a firm believer that asynchronous telemedicine is the future, both from a convenience/satisfaction perspective and from a cost-savings perspective.

Consumers and providers alike have become increasingly comfortable using telemedicine technology to deliver health care services. Ten to 15 years ago, the debate focused on the need for an in-person exam vs. interactive audio-video. Five to 10 years ago, the debate shifted to audio-video vs. “interactive audio with store-and-forward.” Now, asynchronous telemedicine is simply the natural evolution of this growing comfort with delivering quality health care services through low cost, highly-convenient technology.

A growing number of states allow a valid doctor-patient relationship to be created via asynchronous telemedicine in a clinically-appropriate manner. We are seeing notable use of this technology not only in direct-to-consumer telemedicine, but also among hospitals and academic medical centers, who often refer to them as “eConsults” and have realized astonishingly high satisfaction ratings from patients and providers alike who use this technology.

With regard to cost savings and resource conservation, the sheer amount of time saved in scheduling, administrative management and physician minutes associated with asynchronous telemedicine outstrips not only in-person services but even interactive audio-video telemedicine services.

Q. What should providers do now to be ready to adopt this technology next year?

A. Providers should read the proposed rule and understand what these new virtual care codes will and will not accomplish. Then consider submitting comments to CMS during this current open period to make their voice heard.

Similarly, those providers who currently offer any asynchronous telemedicine services as a patient-pay, non-covered service (i.e., patient-liable) should carefully review their services and these new codes to determine whether they can continue to bill patients out-of-pocket, or if the services are covered by Medicare (i.e., provider-liable or separately reimburseable).

Q. Are there any concerns or potential missteps that providers should be wary of in embracing these new guidelines?

A. Some of the proposed codes can only be used with established patients, not new patients. But that might not be a bad thing for reimbursement purposes, as the low reimbursement rate for virtual check-ins reflects that it is not a substitute for a more thorough patient evaluation (via telemedicine or otherwise). Due to the code’s definition and low reimbursement rate, some practitioners may not even want this code to be used for more robust and time-intensive initial patient evaluations.

Moreover, there is no language in the code mandating that the requisite doctor-patient relationship be created via an in-person exam, rather than via telemedicine. That said, commenters should consider whether they agree with this limitation or if they want to suggest that CMS remove the restriction and allow providers to use this code for new patients. Asynchronous telemedicine providers, in particular, might want the flexibility to have this count as a covered service even for new patients, as more and more states allow the creation of a doctor-patient relationship via asynchronous telemedicine.

Some of the codes have frequency limitations unrelated to medical necessity. Providers have seen the frustration such frequency limits create (e.g., inpatient telehealth E/M covered only once every three days) and might not want CMS to impose any such arbitrary limits here.

Q. We also have two new telehealth codes for prolonged preventive services in the office or other outpatient setting – how will providers benefit from these codes?

A. These are a modest expansion of the current set of covered telehealth services, simply to account for those situations where the provider needs more time to deliver the care. These are helpful, but don’t represent a landmark change or expansion to telehealth services under Medicare.

More notable are the changes CMS declined to make this year, including declining (again) to cover initial inpatient hospital E/M services and declining to remove the frequency limitations on subsequent inpatient E/M services).

Q. We’re looking here at three specific sections within the proposed rule that ostensibly support the advancement of mHealth and telehealth. Are there are aspects of this rule that also address this industry?

A. A little “inside baseball” is how CMS will pay for these new codes. In order to remain budget neutral, CMS will slightly reduce the reimbursement rates associated with other in-person services. This reallocation of funds not only supports the virtual care services, but reflects the shifting policy priorities and recognition of value for the next generation of technology-enabled healthcare.

Q. Overall, is this what you’d expected from CMS, or has this surprised you in any way?

A. I was overjoyed to read the proposed rule. Providers seeking further validation of the administration’s attitude on telemedicine and virtual care need only read CMS’ explanation for its bold, new proposal: “We now recognize that advances in communication technology have changed patients’ and practitioners’ expectations regarding the quantity and quality of information that can be conveyed via communication technology. From the ubiquity of synchronous, audio/video applications to the increased use of patient-facing health portals, a broader range of services can be furnished by health care professionals via communication technology as compared to 20 years ago.”

Q. Based on this proposal, could we expect CMS to be more accepting of telehealth and mHealth in the future?

A. It saddens me when I hear telehealth advocates blame CMS for the scant coverage of telehealth services under Medicare. In my opinion, CMS has done everything within its authority to encourage providers to use these new technologies, and the only notable limitations remaining are statutory in nature. This means that only Congress has the power to significantly expand Medicare coverage of telehealth services (e.g., eliminating the rural geographic or originating site limitations) and would do so by amending the Social Security Act. Congress did just that earlier this year with regard to stroke and ESRD services.

We may see more from Congress, but in the interim, CMS’ proposed rule is a landmark change allowing providers to much more meaningfully use new technologies when delivering medical care. By including new payment codes for remote patient monitoring, virtual check-ins, asynchronous image and video review and peer-to-peer consultations, the proposed rule exemplifies CMS’ renewed vision and desire to bring the Medicare program into the future of clinically-valid telemedicine services.

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