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ASHP Submits Comments to CMS on the Proposed Physician Fee Schedule CY 2021

Centers for Medicare & Medicaid Services

October 5, 2020

[Submitted electronically to www.regulations.gov]

Seema Verma, Administrator
Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD21244-1850

 

Re: Docket CMS-1734-P for “Medicare Program; CY 2021 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Quality Payment Program; Coverage of Opioid Use Disorder Services Furnished by Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment Programs; Electronic Prescribing for Controlled Substances for a Covered Part D Drug Under a Prescription Drug Plan or an MA-PD Plan; Payment for Office/Outpatient Evaluation and Management Services; Hospital IQR Program; Establish New Code Categories; and Medicare Diabetes Prevention Program (MDPP) Expanded Model Emergency Policy.”

 

Dear Administrator Verma:

ASHP (American Society of Health-System Pharmacists) is pleased to submit comments to the Centers for Medicare & Medicaid Services (CMS) regarding the proposed changes to the Physician Fee Schedule (PFS) for calendar year 2021. ASHP represents pharmacists who serve as patient care providers in acute and ambulatory settings, including hospitals, health systems, and clinics. The organization’s nearly 55,000 members include pharmacists, student pharmacists, and pharmacy technicians. For more than 75 years, ASHP has been at the forefront of efforts to improve medication use and enhance patient safety.

ASHP thanks CMS for the opportunity to comment on the proposed rule. We hope that our feedback will assist CMS in refining the PFS to meet our shared patient care and quality goals.

A. Coding, Reimbursement, and Supervision

1. Ensure Appropriate Coding of Evaluation & Management (E/M) Visits

ASHP applauds CMS for again clarifying that pharmacists can provide services incident to a physician, including medication management services under Part B. We also appreciate CMS’s statement that it hopes this clarification “encourage[s] pharmacists to work with physicians and NPPs in new ways where pharmacists are working at the top of their training, licensure, and scope of practice.” We share CMS’s belief that fully engaging pharmacists is vital to healthcare quality and patient access. To ensure patients have access to critical services, whether provided in-person or via telehealth, CMS must ensure that physicians or non-physician practitioners (NPPs) can bill for pharmacists’ services using billing codes reflective of the complexity, duration, and intensity of the services.

At present, confusion remains regarding which codes can be billed for services provided by pharmacists (as auxiliary personnel) incident to a physician or NPP. In 2016, the PFS Final Rule stated that eligible providers could bill incident-to services performed by auxiliary personnel “…as if they personally furnished the service.”1 However, CMS’s adoption the AMA CPT E/M Office or Other Outpatient and Prolonged Services Code and Guideline Changes (the “AMA CPT Guideline” or “Guideline”) in the 2020 PFS Final Rule2 resulted in new confusion around incident-to services. The AMA CPT Guideline notes that “[t]he E/M services for which these guidelines apply require a face-to-face encounter with the physician or other qualified health care professional...if the physician’s or other qualified health care professional’s time is spent in the supervision of clinical staff who perform the face-to-face services of the encounter, use 99211.”3 The Guideline further notes that “[f]or E/M services that require prolonged clinical staff time and may include face-to-face services by the physician or other qualified health care professional, use 99415, 99416. Do not report 99354, 99355 with 99415, 99416, 99XXX.”4 Additionally, the Guideline’s definition of the term “medical decision making,” differs from the current CMS definition, which could potentially limit the ability of auxiliary staff to participate in patient care.5 Read together, these statements suggest that incident-to billing is limited only to codes 99211, 99415 and 99416, which is a total departure from CMS’ policy as outlined in the CY 2016 PFS. Further adding to the confusion, AMA’s definition of “auxiliary staff” may not mirror CMS’s. During a recent discussion, members of the AMA CPT panel indicated that they do not view pharmacists as auxiliary staff because pharmacists can bill some payers directly for services. If that is the case, the AMA CPT Guidelines should not be read to hinder physicians and NPPs from billing for pharmacists’ services at the level commensurate with the care provided.

Limiting coding for incident-to services ignores the essential role pharmacists play in treating patients in the ambulatory care space and the value and expertise they provide to their healthcare teams. Given the resource constraints of many providers, CMS should encourage and incentivize use of care delivery models that fully engage and utilize all clinicians on the healthcare team rather than instituting arbitrary limitations on E/M incident-to billing and coding that could force providers to jettison some of these highly efficient care models in favor of outdated models that add to physician and practitioner burden. Thus, as we did in our comments on the PFS CY 2020 proposed rule and in an August 2020 letter to the agency, we respectfully request that CMS clarify that physicians and NPPs can bill the highest level (E/M) codes for services provided by pharmacists if all incident-to requirements are met.

2. Reconsider the Term “Auxiliary Staff” for Pharmacists

Given the apparent conflict between the AMA CPT panel’s definition of auxiliary staff and CMS’s definition of the term, we suggest that CMS revisit the use of the term “auxiliary staff” as it applies to pharmacists to ensure that providers are able to utilize skilled clinicians to the greatest extent possible. Although pharmacists are not yet Medicare-eligible clinicians, their expertise is critical to quality patient care. Medications are the first line of therapy to treat patients with chronic diseases and acute complex diseases such as cancer and heart disease. Nearly 70 percent of Medicare beneficiaries have one or more chronic conditions6 , and many of these beneficiaries take multiple medications. Lack of proper medication oversight and management can result in suboptimal therapeutic outcomes and patient harm. It also costs the healthcare system hundreds of billions of dollars annually.7 Pharmacists are uniquely qualified to provide the type of medication and disease management (including behavioral health conditions) needed to not only stem the waste on ADEs and nonadherence, but also to enhance patient outcomes through improved medication use. Pharmacists offer an in-depth knowledge of medications that is unmatched in the healthcare arena. Pharmacists today receive clinically-based doctor of pharmacy degrees (Pharm.D.), and many also complete postgraduate residencies and become board certified in a variety of specialties. Advancements in medical science and evolution in care delivery models have made postgraduate residencies essential to performing certain patient care services, and they are now prerequisites for positions within specialties such as solid organ transplantation pharmacology, psychiatry, infectious diseases, critical care, cardiology, oncology, and neonatology, among others.8

Pharmacists in hospitals and ambulatory clinics work with physicians, nurses, and other providers on interprofessional teams to manage patients’ medications and ensure appropriate care transitions. These pharmacists often provide intensive patient care services including, but not limited to, comprehensive medication management, transition of care services, chronic disease management, anticoagulation services, and wellness visits. For instance, for medically complex new patients with multiple comorbidities and complicated medication regimens, pharmacists may take 45 – 60 minutes with the patient. Delegating such services to pharmacists reduces physician workload, ensures that pharmacist training and education is fully utilized, and increases care quality. Studies indicate that the inclusion of pharmacists on the patient care team demonstrates a significant return on investment in both patient outcomes and real dollars.9 For every dollar invested in clinical pharmacy services in all types of practice settings (hospital, clinics, government, etc.), health systems realize an average savings of $4.10 Thus, if the goal is to maximize the value of all clinical resources in our healthcare system while providing quality care, pharmacists should be integrated into healthcare teams across the full continuum of care.

Classifying pharmacists as auxiliary staff does not accurately reflect their value to our healthcare system. Despite ample evidence of pharmacists’ contributions, due to statutory and regulatory barriers it can still be a struggle to ensure they are effectively integrated into clinical practice. As noted above, CMS should be incentivizing full utilization of all clinical resources. Thus, we suggest that CMS classify pharmacists separately at a higher level than auxiliary staff and explicitly state that pharmacists can and should be fully integrated into patient care teams in all care settings.
 
3. Allow Permanent Virtual Supervision of Telehealth Services
 
ASHP appreciates CMS’s efforts to quickly expand access to telehealth during COVID-19, including its regular updates to the list of telehealth-eligible codes. While we were pleased that CMS will extend virtual supervision of services through the end of the public health emergency or until December 2021, we strongly urge that the agency make this flexibility permanent. During the pandemic, allowing physicians and pharmacists (as auxiliary personnel) to provide services from two separate locations has helped support the expansion of telehealth services and has protected frontline workers by allowing appropriate social distancing.
 
Many providers are currently evaluating further financial and operational investments in telehealth, and virtual supervision has allowed creative care delivery models to flourish without sacrificing any clinical oversight. Removing virtual supervision will unnecessarily limit clinician flexibility and undercut care innovation, making it less likely for providers to offer these services and more difficult to maintain and build on the telehealth expansion after the public health emergency ends.
 
4. Make COVID-19 Diagnostic Flexibilities Permanent
 
ASHP urges CMS to make the reimbursement for specimen collection permanent for COVID-19. Scientists have suggested that, much like influenza, COVID-19 may become a seasonal ailment. Until we have a better grasp of how the virus responds to a vaccine and how long it will be with us, it is short-sighted to limit reimbursement in a way that might de-incentivize the provision of testing, particularly for those providers who invested in creating new testing models during the pandemic.
 
In a similar vein, CMS should also make permanent the flexibility that allows pharmacists to order and administer COVID-19 tests, as well as influenza and respiratory syncytial virus (RSV) diagnostic tests because those viruses can present the same way as COVID-19. These new diagnostic testing models removed needless regulatory hurdles to greatly increase patient access. Logically, these mechanisms should be maintained to ensure that a similar quick response can be mounted in response to any viral threat, rather than forcing providers to recreate the wheel during the next outbreak. Recognizing that some state scope of practice laws would have to change to accommodate this authority after the public health emergency ends, ASHP would work with members to ameliorate any state barriers to pharmacist ordering and administration of these diagnostic tests.
 
5. Other Coding Issues
 
a. Transitional Care Management (TCM)
 
ASHP appreciates CMS’s ongoing refinement of the TCM code. We thank CMS for identifying additional codes, including the chronic care management (CCM) code, that can be billed concurrently with TCM.
 
b. Remote Physiological Monitoring (RPM)
 
ASHP thanks CMS for clarifying that physicians can bill for RPM services provided incident-to by pharmacists (as clinical staff) up to level 99458. We also appreciate CMS’s clarification that RPM services can be provided for both chronic and acute conditions. ASHP supports CMS’s proposal to permanently allow patient consent to be obtained at the time services are furnished. Additionally, we encourage CMS to move forward with new RPM codes that allow for a shorter period of monitoring and to consider allowing these services to provided under general, rather than direct, supervision. We suggest that CMS consider a separate RFI to obtain RPM-related input from clinicians.
 
B. Opioid Treatment Programs
 
ASHP continues to be strongly supportive of OTP framework and the consequent expansion of access to medication-assisted treatment (MAT) for Medicare beneficiaries. As a general matter, given the centrality of medication use for MAT, it is imperative that pharmacists, the healthcare team’s medication expert, be fully engaged in OTPs. We remain committed in our advocacy to Congress that either the X-waiver requirement should be removed or pharmacists should be added as eligible providers, consistent with state scope of practice laws. We believe that this would sharply increase the number of providers available to offer MAT and opioid use disorder (OUD) treatment services. Should legislation pass removing the X-waiver, we urge CMS to implement any corresponding regulatory changes for OTPs as soon as possible.
 
ASHP supports the addition of naloxone to the definition of OUD treatment services. We also support the creation of an add-on payment for both the nasal and auto-injector forms. This change will align coverage with Part D and should serve to further enhance treatment access for Medicare beneficiaries. Additionally, we encourage CMS to include overdose education for patients and/or the patient’s family and to provide reimbursement for that service. While naloxone can save lives, education is vital to ensuring that it is not treated as a replacement for MAT or other intensive treatment. We also support giving OTPs the flexibility to bill using institutional, rather than professional, claims.
 
Finally, we remain concerned that roles are still not clearly delineated in instances when OUD treatment intersects with treatment for other chronic conditions, particularly those that require intensive medication therapy. For instance, if a patient is receiving MAT and OUD treatment services, but also requires care for another chronic condition, does CMS anticipate that the primary provider will retain oversight of the patient and coordinate care with the OTP? Because MAT and OUD treatment services do not occur in a vacuum, to avoid confusion or duplicative services, we urge CMS to clearly and fully delineate responsibility for patient care in these situations.
 
C. Medicare Diabetes Prevention Program (DPP)
 
ASHP does not object to the DPP regulatory flexibilities outlined in the proposed rule. However, CMS notes several times that providers “must remain prepared to restart in-person services” when the public health emergency ends. While we acknowledge the need to reinstate in-person services, we urge CMS to provide a reasonable ramp-up period for restarting these services. Specifically, we suggest that this period should be no less than 60 days following the declared end of the public health emergency. Additionally, we urge CMS to consider retaining some virtual flexibilities after the public health emergency ends. Given the agency’s focus on telehealth more broadly, it may make sense to retain certain elements, such as remote weigh-ins, over the long-term. ASHP is committed to the success of the DPP and we believe that offering access to DPP through multiple modalities (e.g., in-person and through telehealth services) may extend the reach and impact of the program.
 
D. Electronic Prescribing of Controlled Substances (CIIs) in Medicare Part D
 
ASHP’s appreciates CMS’s clear timeline for implementing the CII e-prescribing mandate in Part D, as well its explanations of the various mandate exemptions. Although CMS indicates that it will not enforce the mandate until January 1, 2022, given the ongoing public health emergency, even that deadline may be a stretch for under-resourced providers. CMS should consider allowing longer compliance waivers beginning in 2021. The agency may also need to revisit its timeline should the public health emergency extend longer than is currently anticipated. ASHP has submitted additional feedback on this issue to CMS’s e-prescribing Request for Information.

E. Quality Metrics

ASHP appreciates CMS’s commitment to continue to streamline their quality reporting programs to allow more interaction with patients while easing burdens of reporting through meaningful measurement. We applaud efforts that continue to support the use of electronic clinical and digital quality measures. However, we urge CMS to reconsider some of its proposed changes for 2021, including the sunsetting of the CMS Web Interface, as well as the wholesale changes to how accountable care organization quality is assessed and evaluated. COVID-19 has already created tremendous challenges for providers – it seems like an inopportune time to change reporting systems, to replace one scoring system with another, and to overhaul the Alternative Payment Model Performance Pathway quality metrics. We urge CMS to delay these changes until 2022 at the earliest. Additionally, given the breadth of the proposed changes, CMS should consider decoupling these proposals from the PFS and instead seek specific stakeholder feedback over a longer term (e.g., through a Request for Information).

In addition, as CMS continues to reform MIPS through implementation of the MIPS Value Pathway (MVP), we urge CMS to include pharmacists as an eligible clinician for the purpose of contributing to quality measures, improvement activities, and the specialty measure sets included in the proposed rule. A number of the measures are being specified to include telehealth encounters and pharmacists are increasingly supporting patient chronic care needs through telehealth services. A significant percentage of these measures are related to medication use and therefore benefit from pharmacist engagement and influence.

ASHP appreciates the opportunity to offer our input and suggestions on the proposed rule. Please do not hesitate to contact me at 301-664-8698 or [email protected] if ASHP can provide any further information or assist the agency in any way.

Sincerely,

 

Jillanne Schulte Wall, J.D.
Senior Director, Health & Regulatory Policy

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1 CMS, Medicare program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to part B for CY2016. 80 Fed. Reg. 71066 (Nov. 16, 2015), available at https://www.federalregister.gov/d/2015-28005/p-1578 .

2 CMS, Medicare Program; CY 2020 Revisions to Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies, 84 Fed. Reg. 62568 (November 15, 2019), available at https://www.federalregister.gov/documents/2019/11/15/2019-24086/medicare-program-cy-2020-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other .

3 AMA CPT Editorial Panel (2019) at 1-2.

4 AMA CPT Codebook, p. 14.

5  Id. At 6; CMS definition in MLN matters.

6 See Centers for Medicare & Medicaid Services. Chronic Conditions Among Medicare Beneficiaries Chartbook (2012), available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Chronic-Conditions/Downloads/2012Chartbook.pdf .

7 See New England Healthcare Institute , Thinking Outside the Pillbox: A System-wide Approach to Improving Patient Medication Adherence for Chronic Disease (2009), available at https://www.nehi.net/publications/17-thinking-outside-the-pillbox-a-system-wide-approach-to-improving-patient-medication-adherence-for-chronic-disease/view .

8 Id.

9 C.A. Bond and C.L. Raehl, Clinical Pharmacy Services, Pharmacy Staffing, and Hospital Mortality Rates, 27 Pharmacotherapy 482-93 (2007).

10 G.T. Schumock et al ., Evidence of the Economic Benefit of Clinical Pharmacy Services: 1996–2000, 23 Pharmacotherapy 113–32 (2003).

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