ASHP Submits Comments to CMS Regarding Regulatory Flexibilities During the COVID-19 Public Health Emergency

[Submitted electronically to www.regulations.gov]

Seema Verma
Administrator
Centers for Medicare & Medicaid Services
Attention: CMS-5531-IFC
P.O. Box 8013
Baltimore, MD 21244-1850

Re: Docket CMS-5531-IFC for “Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID–19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program.”

Dear Administrator Verma:

ASHP is pleased to submit comments to the Centers for Medicare & Medicaid Services (CMS) regarding the interim final rule’s (IFR) proposed regulatory flexibilities during the COVID-19 public health emergency (PHE). ASHP represents pharmacists who serve as patient care providers in acute and ambulatory settings. 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.¹

ASHP applauds CMS for its responsiveness in the face of COVID-19 and urges the agency to continue to maintain focus on combatting the pandemic until a vaccine is available. Specifically, to safeguard patient access and to assist frontline providers, we request the following:

• Maintain All Current Flexibilities Through, At Minimum, January 2021: Although the hope is that there will be no second wave in the fall, the current steep increase in case count begs the question of whether the first wave will have ended by fall. Add the onset of seasonal influenza to COVID-19 cases, and there is a high likelihood that healthcare systems across the country will be under tremendous stress in late 2020. Rather than rolling back flexibility piecemeal and then losing valuable time having to re-promulgate the same flexibilities, ASHP urges CMS to extend all current COVID-19 related regulatory flexibilities through at least January 2021.

• Permanently Maintain and Enhance Telehealth Flexibility: In addition to maintaining all current flexibilities, we recommend that CMS make telehealth flexibilities permanent. The rapid shift to telehealth services during COVID-19 has illustrated the value of telehealth long-term, particularly for patients with mobility issues and those in rural and/or medically underserved areas. In order to assure the broadest possible patient access and the highest quality services, we further recommend that CMS take the following steps:

• Permanently Allow Direct Supervision To Be Provided Virtually: During the COVID-19 public health emergency, in order to accommodate provision of telehealth services, CMS has relaxed its rule requiring physicians to provide “direct supervision” of auxiliary personnel. Pursuant to the temporary regulatory flexibility, physicians may provide “virtual supervision” of auxiliary personnel. Physicians should be empowered to supervise clinical staff virtually, at their discretion, regardless of whether there is a declared public health emergency.  By allowing physicians and auxiliary personnel to provide services from two separate locations, this flexibility supports the expansion of telehealth services and protects frontline workers by allowing appropriate social distancing. Therefore, we ask that CMS permanently allow direct supervision to be provided virtually in order to meet the growing demand for telehealth services, which will likely extend beyond the COVID-19 pandemic.
  
  
• Clarify Coding for Services Provided Incident To a Physicians’ Services, Including Telehealth: To ensure patients have access to critical services, whether provided in-person or via telehealth, CMS must ensure that billing codes reflect the value, duration, and intensity of the services. However, at present, confusion remains regarding which codes can be billed for services provided by auxiliary personnel incident to a physician or NPP. As a result, it is unclear whether incident-to services provided by a pharmacist² could be billed at anything beyond the lowest level of evaluation and management codes (e.g., 99211 in person or 99441 for telehealth). If, this is the case, it will be financially infeasible for pharmacists to provide many of the medication and chronic disease services they currently provide in concert with physicians and other NPPs.

In 2016, the Physician Fee Schedule (PFS) Final Rule stated that eligible providers could bill for auxiliary personnel provided incident-to services “…as if they personally furnished the service.”³ However, CMS’s plan to adopt the AMA CPT Codebook for determining billing levels created new confusion around incident-to services. The codebook’s preamble 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.”⁴ The codebook further notes that “For 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.”⁵ Additionally, the codebook’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.⁶ 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’s policy as outlined in the FY 2016 PFS. 

These contradictory statements have generated uncertainty among provider compliance officers and Medicare Administrative Contractors (MACs). Some MACs have indicated that medication management service provided by pharmacists cannot be billed higher than 99211, even when a physician is involved, despite the complexity, decision making and time necessary to provide certain services. Limiting providers to billing the lowest E/M codes will limit the provision of high-quality, accessible care and shift additional burden to already overtaxed physicians. Studies have shown that without the ability to utilize incident-to services provided by pharmacists and other clinical staff, the average physician would need to see patients for 18 hours each day, every day of the year just to meet the minimum recommended preventative services and chronic care requirements.⁷ Physicians are suffering burn out with current caseloads – removing vital clinician support will only exacerbate the problem.

To ensure that patients can assess appropriate medication management services, we respectfully request that CMS confirm that physicians can bill the following codes, including when provided by a pharmacist, if the incident-to requirements are met:

• Evaluation and management (E/M) codes for established patients
  • 99211-99215
• Telehealth codes (telephonic equivalent to E/M codes)
  • 99441- 99443 

• Define “Medication Management” Services in Part B to mean Comprehensive Medication Management: We were extremely pleased that the IFC clarified that “medication management is covered under both Medicare Part B and Part D.” We also thank CMS for clarifying that pharmacists, as auxiliary personnel, can provide such services incident to a physician or non-physician practitioner (NPP).⁸ While we applaud CMS’s recognition of medication management services, we want to ensure that patients have access to the most effective interventions. To accomplish this, we recommend that CMS clarify the definition of “medication management” in Part B.

Specifically, we urge CMS to specifically define the term “medication management” as used in the IFC to mean “comprehensive medication management” (CMM). CMM is more rigorous in process and purpose, team-based, information-focused, and patient-centric than Medication Therapy Management (MTM), which is typically provided under Part D. CMM services require the clinical pharmacist to work in concert with other physicians and other non-physician practitioners (NPP) to improve overall patient outcomes.

CMM focuses on patients who have not achieved clinical goals of therapy. It is a patient-centered approach to optimizing medication use and improving patient health outcomes that individually assesses each patient’s medications (prescription, nonprescription, alternative, vitamins, or nutritional supplements) to determine that each medication has an appropriate indication, is effective for the medical condition and achieving defined patient and/or clinical goals, is safe given the patient’s comorbidities and other mediations, and that the patient is engaged with the therapy plan and can take the medication as intended with proper adherence. Care is coordinated with the other team members, and patients actively participate in the process. Pharmacists provide high-level services for both acute and chronic issues that are supported by documentation.⁹ CMM is a well-defined strategy for optimizing medication use, ensuring that it is consistently replicable across care settings, yields positive outcomes, and is readily scalable.¹⁰

Data shows that CMM benefits the healthcare system through lower hospital readmission rates, increase in adherence, and improved clinical outcomes.¹¹ A 2018 study including more than 43,000 patients found that patients who had received a CMM visit within 30 days post discharge had a significantly lower rate of readmissions compared to the comparator cohort. The 60 day readmission rate was also lower.¹²

CMM also provides significant benefit for chronic disease patients through improved medication adherence. Given that the vast majority of Medicare beneficiaries has one or more chronic conditions, medication adherence across multiple chronic disease medication classes would provide significant clinical and financial systemic benefits. Improved adherence among patients with diabetes, hypertension, hypercholesterolemia, and congestive heart failure reduces hospitalization rates, thereby reducing total health care costs.^{13 14}

Access to CMM is particularly important for COVID-19 patients, who require a coordinated, synchronous healthcare team, with input from the pharmacist as the medication expert. Many patients with severe COVID complications have multiple comorbidities that require expert medication management, and they may need additional treatment with antithrombotic, anticoagulant, or antiplatelet agents to combat potentially deadly inflammation and thrombosis.

Because CMM follows a proven model and utilizes the entire healthcare team, it is a far superior approach to ad hoc or scattershot medication interventions. At present, “medication management” is undefined, meaning that numerous less effective and comprehensive interventions could fall under its auspices. To realize the clinical and financial benefits of CMM, CMS must explicitly define medication management to mean CMM.

• Work with Drug Enforcement Administration (DEA) to Remove Telehealth Barriers: ASHP appreciates CMS’s efforts to reduce barriers to telehealth provision. However, we wanted to ensure that CMS is aware of a DEA provisions that impacts the ability of pharmacists to provide telehealth services, particularly in the context of Opioid Treatment Programs (OTPs). Specifically, DEA defines telemedicine at 21 U.S.C. § 802(54) as follows: “The term ‘practice of telemedicine’ means, for purposes of this title, the practice of medicine in accordance with applicable Federal and State laws by a practitioner (other than a pharmacist) who is at a location remote from the patient and is communicating with the patient, or health care professional who is treating the patient…”. We believe that this definition is based on outdated understanding of clinical and ambulatory pharmacy practice, and that it will significantly impede patient access to services. DEA has indicated a willingness to revisit its telemedicine definition — we urge CMS to support a change to remove the definition’s pharmacist exclusion.
  
  
• Work Directly with States on Implementation of Pharmacist Ordering and Administration of COVID-19 Diagnostic Testing as well as Vaccination and Other Medical Countermeasures: ASHP appreciates CMS’s clarification of rules governing pharmacist ordering and administration of COVID-19 diagnostic tests. However, many of our members have reported that their states continue to struggle with implementing the rule. Despite the Office of the Assistant Secretary of Health (OASH) advisory opinion confirming that the Public Readiness and Emergency Preparedness (PREP) Act preempts state law that would prevent pharmacists from ordering and administering tests, certain states, including Pennsylvania, are not removing barriers. We urge CMS to intervene with states directly to ensure that lingering state-level confusion does not impede testing availability.  

Additionally, the rule notes that pharmacists should also be able to order influenza and respiratory syncytial virus (RSV) diagnostic tests because those viruses can present the same way as COVID-19. However, the OASH advisory opinion makes no mention of influenza or RSV. We urge CMS to clarify that the PREP Act also preempts state laws that prevent pharmacists from ordering and administering these tests, and encourage HHS to expand the PREP Act authorization to include vaccination and other medical counter measures that could be administered by pharmacists. 

• Continue to Share Information with Other Agencies: ASHP urges CMS to maintain strong information-sharing practices with other agencies, particularly the DEA and the Food & Drug Administration (FDA). Although the risk of major shortages of sedatives and paralytics necessary for mechanical ventilation abated somewhat with the reduction in cases, as the case count climbs, so do the shortage risks. CMS coordination with FDA and DEA was highly beneficial in addressing shortages early on – continued coordination may help mitigate the impact of future shortages by ensuring concerted action. 
  
  
• Continue to Share Information with Stakeholders: CMS’s outreach to stakeholders, including its regular Office Hours calls, has been very helpful. We strongly encourage the agency to continue these communications until the public health emergency ends.

ASHP thanks CMS for its consideration of our comments. We look forward to continuing to work with CMS to fight COVID-19. If you have questions or if ASHP can assist the agency in any way, please contact me at 301-664-8698 or jschulte@ashp.org .  

Sincerely, 

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

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¹ For more information about the wide array of ASHP activities and the many ways in which pharmacists advance healthcare, visit ASHP’s website,  www.ashp.org , or its consumer website,  www.SafeMedication.com .

² Note that as members of the healthcare team, clinical pharmacists practice under formally granted clinical privileges from the medical staff or credentialing system of the organization in which they practice or under written collaborative practice agreements (CPA) with individual physicians or medical groups. CDC has found “strong evidence that when pharmacists are part of the health care team, outcomes related to preventing or managing chronic diseases and adherence to medication improve.” These outcomes include clinical and behavioral health indicators including lowering blood pressure, HbA1c, and LDL cholesterol levels. (CDC Advancing Team Based Care)  

³ Medicare program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to part B for CY2016. (Final rule). Federal Registrar. 80: 220. (November 16, 2015) p. 71066 https://www.federalregister.gov/d/2015-28005/p-1578. Accessed June 22 2020.

⁴ AMA CPT Editorial Panel (2019) at 1-2.

⁵ AMA CPT Codebook, p. 14.

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

⁷ See Kimberley Yarnall et al., “Primary Care: Is There Enough Time for Prevention?” Am. J. Pub. Health (April 2003) (Finding that a primary care physician with a typical panel of 2,500 patients would need 7.4 hours every day to provide all recommended preventive services to patients); T. Ostbye et al., “Is there time for management of patients with chronic diseases in primary care?” Ann. Fam. Med. (May-June 2005) (Finding that a physician would need 10.6 hours each day, every day to provide all chronic care services for a typical patient panel).

⁸ Centers for Medicare & Medicaid Services, “Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID– 19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program: Pharmacists Providing Services Incident to A Physicians’ Service,” 85 Fed. Reg. 27550 (May 8, 2020).  

⁹ CMM visits are 30-60 minutes in duration. One example of a visit would entail a pharmacist meeting with an 80 year old patient referred by the physician with type 2 diabetes, hypertension, coronary artery disease, and chronic kidney disease taking over 10 medications. The pharmacist will take a comprehensive history of present illness, review of systems, home measurements like blood glucose, blood pressure, physical exam (if face-to-face visit) and then a medication review. Labs are reviewed, a treatment plan will be developed including modifying, discontinuing and initiating medications and comprehensive disease/medication education will be provided. 

¹⁰ McClurg, M., Sorensen, T., Carroll, J.The Patient Care Process for Delivering Comprehensive Medication Management (CMM): Optimizing Medication Use in Patient-Centered, Team-Based Care Settings. CMM in Primary Care Research Team. July 2018

¹¹ Sapp E., Francis S., Hincapie, A. The American Journal of Accountable Care. 2020;8(1):8-11 https://www.ajmc.com/journals/ajac/2020/2020-vol8-n1/implementation-of-pharmacistdriven-comprehensive-medication-management-as-part-of-an-interdisciplinary-team-in-primary-care-physicians-offices

¹² Budlong, H., Brummel, A., Rhodes., A., Nici, H. Impact of Comprehensive Medication Management on Hospital Readmission Rates. Population Health Management. 2018.

¹³ Brummel, A, Carlson, A. Comprehensive Medication Management and Medication Adherence for Chronic Conditions. Journal of Managed Care Pharmacy 2016; 22 (1); 56-62.

¹⁴ Clinical pharmacy services like CMM are cost-saving to the health care system, primarily through avoided hospitalization and emergency room (ER) visits. A 2017 study showed a 10:1 ROI when clinical pharmacists worked collaboratively with a multi-disciplinary care management team through targeted engagement with members and providers regarding opportunities to optimize drug regimens. (Khazraee et al 2017)