[Submitted electronically to www.regulations.gov]
Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244-1850
Re: Docket CMS-1693-P for “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.”
ASHP 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 2019. ASHP represents pharmacists who serve as patient care providers in acute and ambulatory settings. The organization’s 45,000 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 and Reimbursement
I. Evaluation & Management (E/M) Visits
ASHP supports CMS’s proposed changes to reduce the burden of documenting evaluation and management (E/M) codes. We support efforts to streamline coding and to reduce the unnecessary expenditure of clinician time on care documentation. We encourage CMS to continue working toward the creation of more efficient documentation frameworks throughout the care continuum.
II. Bundled Episode of Care for Management and Counseling Treatment for Substance Use Disorders
CMS proposes the creation of a bundled payment for the care management and treatment of substance use disorders (SUD), suggesting that such a change could enhance access to SUD treatment. ASHP strongly supports efforts to increase the availability of such services. Should CMS move forward with the creation of a separate bundled payment for SUD treatment, we urge the inclusion of providers beyond physicians – namely pharmacists – either directly or through incident-to billing. Medication-assisted treatment, in particular, should be overseen by pharmacists, the healthcare team’s medication expert.
Pharmacists are uniquely qualified to provide the type of medication and disease management (including management of behavioral health conditions) needed to address the opioid epidemic. Pharmacists today receive clinically based Doctor of Pharmacy (Pharm.D.) degrees, and many also complete postgraduate residencies and become board certified in a variety of specialties. In hospitals and ambulatory clinics, pharmacists regularly 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 a 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. Thus, if the goals are to ensure appropriate medication use as well as to manage pain and prevent and treat SUD effectively, pharmacists must play a more prominent role in medication selection and modification, patient education, follow-up and monitoring of medication use, and overall treatment.
Pharmacists work on the front lines of treatment, providing direct patient care in hospitals and clinics and collaborating with and carrying out the plan of each patient’s initial opioid prescriber. In addition, pharmacists have expertise and experience in managing opioids throughout the entire medication use cycle, from medication procurement and storage, patient and prescriber education, and dispensing to disposal. Thus, excluding pharmacists from SUD treatment would be a waste of clinical resources and a lost opportunity to greatly expand access to highly-skilled clinical care at a time when physician resources are under increasing strain.
Regarding CMS’s request for input related to the number of sessions and appropriate billing amounts for SUD services, we encourage payment sufficient to incentivize provision of SUD treatment and suggest that the number of sessions covered should be consistent with the number covered for the management of any other complex chronic disease state. Effectively incentivizing SUP treatment may necessitate higher payment amounts than are currently offered on a fee-for-service basis. As CMS considers potential designs for an SUD bundled payment, we urge the agency to seek regular stakeholder feedback before finalizing the policy.
III. Changes to WAC-Based Reimbursement for Part B Drugs
ASHP strongly objects to the proposed cuts in reimbursement for new drugs acquired at wholesale acquisition cost (WAC). CMS proposes to cut the current reimbursement of WAC plus 6 percent to WAC plus 3 percent. However, when the effect of the sequester is factored in, reimbursement for these drugs drops to WAC plus 1.35 percent. The percentage add-on for the WAC and Average Sales Price (ASP) formulas for Part B drugs is intended to cover the costs of acquisition, storage, handling, and preparation for administration associated with these drugs. The WAC drugs at issue are, in most cases, novel and complex specialty medications, many of which require specific storage and handling protocols that can be expensive to maintain. Further, many providers purchase these drugs at the WAC price, leaving little margin to cover the costs associated with storing and handling the drugs.
The reimbursement cut may make it financially infeasible for practices to purchase these drugs to provide to their patients. Furthermore, CMS’s assertion that cutting reimbursement for these drugs will reduce high-cost prescribing fundamentally misunderstands the calculus behind prescribing. Physicians, in conjunction with pharmacists, select the medication that best fulfills the patient’s clinical needs regardless of cost; unfortunately, all too often the requisite medication is extremely expensive. ASHP commends CMS for its efforts to reduce patient out-of-pocket costs, but in order to make real progress on this issue, we suggest that the agency focus on the actual list price of the drug rather than reimbursement for the drug, which also accounts for other services including storage, preparation for administration, etc.
B. Quality Metrics
ASHP supports the CMS Meaningful Measure Initiative announced by Administrator Verma in October 2017. This approach has great potential for incorporating the patient voice into measurement, identifying the most impactful measures, and minimizing measurement burden. We have been monitoring implementation of the new framework and we are pleased to see it being applied in the PFS via inclusion of patient experience and outcome-based measures, harmonization with the Medicare Quality Payment Program, and reduction of unnecessary and/or duplicative measures. ASHP has also been following the mapping of the Meaningful Measures areas and metrics to the six CMS Quality Priorities, and we support CMS’s approach thus far. For example, we are encouraged that the “Prevention and Treatment of Opioid and SUDs” is categorized under “Promote Effective Prevention and Treatment of Chronic Disease” measure and that opioid-related measures will be considered high priority. However, we encourage CMS to follow a robust measure development and endorsement process to ensure that any opioid-related measure truly bridges the gap between evidence-based decisions and quality measurement. In addition, opioid-related measures should be consistent with the definition of a high-priority measure (e.g., outcome, appropriate use, patient safety, efficiency, patient experience, or care coordination). With that emphasis, opioid-related measures should extend beyond opioid overuse and focus on improving outcomes, reducing harm, coordinating care, and enhancing the patient experience.
As noted above, ASHP commends CMS for its focus on addressing SUD. Thus, we were pleased to see two new opioid-related measures added to the e-prescribing objective for the Merit-Based Incentive Payment System (MIPS): query of prescription drug monitoring programs (PDMPs) and verification of opioid treatment agreements. Pharmacists regularly query PDMPs, but pharmacists alone cannot stem overprescribing. Active engagement with PDMPs by prescribers and their delegates will assist all clinicians in recognizing and preventing potential SUD. Similarly, verifying opioid treatment agreements at the physician level will facilitate coordination of care, improving outcomes and reducing systemic and societal costs associated with SUD. We strongly encourage CMS to provide stakeholders with additional details regarding the content of opioid treatment agreements and to solicit ongoing stakeholder feedback on their content and structure. We appreciate CMS consideration of state limitations and e-prescribing readiness by the prescriber and the receiving pharmacy when enforcing these new measures.
ASHP appreciates this 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 by telephone at 301-664-8696 or by email at [email protected].
Jillanne Schulte Wall, J.D.
Director, Federal Regulatory Affairs