[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, MD 21244-1850
Re: Docket CMS-1715-P for “Medicare Program; CY 2020 Revisions to 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; Establishment of an Ambulance Data Collection System; Updates to the Quality Payment Program; Medicare Enrollment of Opioid Treatment Programs and Enhancements to Provider Enrollment Regulations Concerning Improper Prescribing and Patient Harm; and Amendments to Physician Self-Referral Law Advisory Opinion Regulations.”
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 2020. ASHP represents pharmacists who serve as patient care providers in acute and ambulatory settings, including hospitals, health systems, and clinics. The organization’s nearly 50,000 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
I. Evaluation & Management (E/M) Visits
ASHP supports CMS’s decision to maintain the current E/M coding levels rather than collapsing the levels as proposed in the FY2019 PFS. However, we have serious concerns regarding CMS’s proposal to adopt the American Medical Association (AMA) CPT Editorial Panel’s (“AMA CPT codebook” or “codebook”) revised coding definitions beginning in 2021. Specifically, we are concerned that adopting the AMA CPT codebook as written could seriously disrupt established care delivery models, putting patients at risk and reducing care quality.
ASHP’s objections are not to the AMA CPT codebook’s coding definitions, but to apparent changes to terminology that would contradict current CMS guidance on incident-to billing. 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.”
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.” 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. Read together, these statements suggest that incident-to billing is limited only to codes 99211, 99415 and 99416. This would represent a total departure from current CMS policy on incident-to billing, as set forth in detail in the FY 2016 Physician Fee Schedule final rule. Per that rule, incident-to services provided by pharmacists and other auxiliary personnel who meet the incident-to criteria and documentation requirements are not limited to certain codes.
Limiting coding for incident-to services ignores the essential role pharmacists play in treating patients in the ambulatory care setting 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. 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, we request that CMS clarify that the AMA CPT codebook does not change incident-to billing rules and ask that CMS work with AMA to revise the codebook accordingly.
Further, to ensure that providers are able to utilize skilled clinicians to the greatest extent possible, we suggest that CMS revisit the use of the term “auxiliary staff” as it applies to pharmacists. 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 conditions, 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. 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 in specialties such as solid organ transplantation pharmacology, psychiatry, infectious diseases, critical care, cardiology, oncology, and neonatology, among others.
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. Patient care discussions often revolve around the pathophysiology of disease or chronic condition, but far too often patients receive little information regarding perhaps the most essential part of treatment — the medication prescribed to cure or manage the condition. In many cases, the prescribing clinician does not have the same medication expertise as a pharmacist. 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.  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. Thus, if the goal is to avoid overspending on drugs and to maximize the value of the drugs patients purchase, pharmacists must play a more prominent role in medication selection and modification, patient education, follow-up and monitoring of medication, and overall medication and chronic disease management.
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 either explore classifying pharmacists separately at a higher level than auxiliary staff, or, at minimum, explicitly state that pharmacists can and should be fully integrated into patient care teams in all care settings.
II. Opioid Treatment Programs and Bundled Payment
ASHP supports CMS’s efforts to expand access to medication-assisted treatment (MAT) for Medicare beneficiaries through the creation of opioid treatment programs (OTPs) and coverage of methadone. We applaud CMS for proposing a $0 copay for beneficiaries receiving MAT from an OTP.
Given the centrality of medication to MAT, it is imperative that pharmacists, the healthcare team’s medication expert, be fully engaged in OTPs. ASHP has joined other providers in advocating to Congress that the X-waiver requirement be removed or that pharmacist be added as eligible providers, as 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.
Regarding bundled payment for OUD treatment services, we were pleased that CMS opted not to impose a duration limit on coverage. Given that substance use disorder (SUD) treatment often requires ongoing care over years, we suggest that CMS also create a monthly episode of care to supplement the proposed weekly model. Further, we urge CMS to consider the intersection of SUD and 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, responsibility for patient care must be clearly and fully delineated.
III. Principal Care Management (PCM), Chronic Care Management (CCM), and Transitional Care Management (TCM)
a. PCM Code
ASHP supports the creation of a PCM code. CMS notes in the proposed rule that CCM and TCM codes are underutilized – in order to avoid this issue with the PCM code, CMS should value it accordingly. Considering that PCM is to be used for complex cases in specific specialties, we suggest that the code be valued at a significantly higher level than the complex CCM code. Further, CMS should create a supplementary add-on code to account for particularly time-intensive patient interactions. Effective management of a chronic condition can require multiple interactions per month. For example, a patient may need his or her medication titrated on a weekly basis. Thus, we suggest that CMS allow for the PCM code to be billed at least four times per month (e.g., weekly). We also encourage CMS to provide additional clarity on two aspects of PCM:
- How should providers determine whether to use complex CCM or PCM? Can CMS provide examples or other criteria to better differentiate when each code should be used?
- Can the PCM code also be used in federally qualified health centers and hospitals, as is the case with the CCM codes?
b. CCM and TCM Codes
ASHP appreciates CMS’s ongoing refinement of CCM and complex CCM codes. As CMS is aware, providers still struggle to determine when a chronic condition has escalated to the point where the provider should convert over to the chronic CCM codes. This judgment call may be further complicated with the addition of the PCM codes. As noted above, we encourage CMS to provide comprehensive guidance, including examples and criteria for when the agency believes each code should be used.
To offer providers maximum flexibility, we support allowing TCM, CCM, and PCM to be billed in the same month. We believe that duplication of services can be avoided if CMS implements parameters around billing. Specifically, we suggest that CCM and TCM should not be billable with fourteen days of hospitalization and that the National Provider Identifier (NPI) of the clinical staff providing CCM, TCM or PCM be included on the claim. Including a clinical staff member’s NPI on claims would also allow CMS to ensure that the clinical staff providing the services are acting within their scope of practice. We remain concerned that some practitioners are providing services, particularly complex medication management services, which are well beyond their training and scope of practice.
ASHP strongly objects to CMS’s proposed revision of the CCM care plan elements to change “medication management” to “medical management.” Treatment of chronic conditions almost always involves significant medication management. As CMS is aware, a large number of CCM interactions have a medication-related component. Although we recognize CMS’s intent is to allow flexibility, we are concerned that loosening terminology will also loosen the standards under which medication management is provided. Medication management should be provided by, or under the supervision of, a pharmacist. Removing the medication management requirement suggests that CMS does not believe medication management should be conducted under expert oversight. Considering the human and financial costs associated with adverse drug events and nonadherence, quality medication management provided by, or overseen by, a pharmacist offers a significant return on investment for patients and our healthcare system.
Finally, as noted in ASHP’s comments on the CY 2020 Hospital Outpatient Prospective Payment System proposed rule, we urge CMS to extend its proposal to allow general, rather than direct, supervision of all therapeutic services provided by hospitals and critical access hospitals (CAHs) to clinics and physicians’ offices. We believe this change will ensure consistency across practice settings and will significantly increase provider flexibility and improve patient access.
B. Quality Metrics
ASHP generally supports CMS’s vision for the Merit-Based Incentive Program System (MIPS) Value Pathways because we believe that it may help alleviate some MIPS issues, including program complexity, lack of robust performance information, and restrictions on differentiation of clinician specialties. However, ASHP remains concerned that pharmacists’ contributions to quality measures and improvement activities are not adequately captured in or reflected by MIPS. Thus, we urge CMS to create a medication-related MIPS Value Pathway (MVP). ASHP has specialized member groups prepared to advise CMS regarding selection of medication-related measures and improvement activities and to assist the agency in developing an effective MVP structure. For the MVP to succeed, pharmacists must be eligible clinicians for the purpose of measure performance.
In general, ASHP supports the remaining quality measure changes outlined in the proposed rule. As efforts to further strengthen and refine these measures continue, we encourage CMS to consider the following measure-specific feedback:
- RFI Potential Opioid Overuse Measure: Due to feasibility and usability issues identified during early testing of this measure concept, we caution CMS against advancing it at this time. We recommend that the measure undergo the same rigorous National Quality Forum (NQF) development and endorsement process as other opioid-related measures.
- NQF and Centers for Disease Control & Prevention (CDC) Opioid Measures: ASHP supports the opioid-related measures developed by the Pharmacy Quality Alliance (PQA) and endorsed by NQF. We strongly support inclusion of these measures in the Promoting Interoperability category and stand ready to assist CMS and PQA with this goal. Once they are available for use beyond the health plan level, members can utilize these measures to promote adherence to opioid prescribing guidelines in hospitals and health systems.
- Medication Reconciliation (NQF #0097): While we appreciate CMS’s rationale for removing this measure, we are concerned that wholesale deletion of the measure, which explicitly requires pharmacist engagement in medication reconciliation, will reduce care quality. Pharmacists are the medication experts on the healthcare team, and care quality will decrease if they are not fully and effectively engaged. To address this concern, the replacement measure’s language should be revised to explicitly name pharmacists.
- Documentation of Current Medications in the Medical Record (# Q130): Although ASHP recognizes the value of this measure, we feel that it would be greatly improved if it more closely mirrored NQF #2988, “Medication Reconciliation for Patients Receiving Care at Dialysis Facilities.” Specifically, we prefer NQF #2988’s approach to measure attribution, date of reconciliation, medication assessment process, and inclusion of allergy and adverse drug event documentation requirements.
ASHP appreciates the opportunity to offer our input and suggestions. Please contact me if you have any questions regarding ASHP’s comments on the proposed rule. I can be reached at 301-664-8698 or [email protected].
Jillanne Schulte Wall, J.D.
Director, Federal Regulatory Affairs