There have been plenty of surprises during this election cycle, including the presidential candidates that remain in the race and the prospect of divisive party politics between now and the November 8 general election. With all this uncertainty, division among the parties and political rancor, it would be easy to write off policymakers for the rest of the year and conclude nothing will happen with healthcare policy in Washington, DC. However, transformation and change are moving forward rapidly, and pharmacists and pharmacies are increasingly being viewed as major players to help improve patient care and lower costs.
President Obama’s signature domestic policy, the Affordable Care Act (ACA), was signed into law over six years ago, yet pharmacists and pharmacies are just beginning to feel the direct impact of the sweeping health reform law. Set against this backdrop of changing reimbursement incentives, a number of new policy initiatives are increasing the demand for pharmacist and pharmacy services. Some key developments to watch for the remainder of the year and into 2017 include the Medicare Part D Enhanced Medication Therapy Management (MTM) model, implementation of the Improving Medicare Post-Acute Care Transformation (IMPACT) Act for post-acute care settings and legislation to combat opioid abuse.
Enhanced MTM Model
The Centers for Medicare & Medicaid Services (CMS) is implementing a new Enhanced MTM model that will start January 1, 2017 with a five-year performance period. The Enhanced MTM model is an attempt to align the incentives of Part D sponsors and CMS to develop and optimize MTM resources and outcomes. Under the model, sponsors can obtain CMS approval to use different eligibility criteria based on cost thresholds, number of chronic conditions, number of current medications, drug adherence, patient safety, patient population and other demographic and clinical factors.
Traditionally, Part D has set specific criteria for MTM programs that all sponsors must follow. Sponsors have argued that the one-size-fits-all structure has limited the results of their MTM programs. The Enhanced MTM model will test whether sponsor flexibility can improve quality of care while also reducing costs. Sponsors will be allowed to use a wide variety of patient education and follow-up strategies in their MTM programs and are likely to collaborate with pharmacists and prescribers to identify and resolve medication therapy issues. The Enhanced MTM model puts financial incentives in place for participating sponsors; they receive a prospective per-member per-month payment plus a performance-based incentive payment of up to $2 per member per month.
How these financial incentives translate into opportunities for pharmacists and pharmacies to generate additional revenue will be watched closely. The model begins in 2017 in up to 11 states: Arizona, Florida, Iowa, Louisiana, Minnesota, Montana, Nebraska, North Dakota, South Dakota, Virginia and Wyoming.
Transforming Post-Acute Care
CMS is also moving forward with plans to implement provisions in the IMPACT Act, HR4994. In October 2014, Congress passed legislation and President Obama signed it into law to standardize quality measures and assessments across four post-acute care (PAC) settings: long-term care hospitals (LTCHs), inpatient-rehabilitation facilities (IRFs), skilled- nursing facilities (SNFs) and home-health agencies (HHAs). Standardized measurements and assessments are intended to enable CMS to compare quality across PAC settings and will likely lead to future changes that direct provider payments toward quality measures. Under the IMPACT Act, quality measures include: medication reconciliation, functional status and change in function, skin integrity, incidence of major falls and patient preference of treatment and discharge options. Under the IMPACT Act, CMS must specify a quality measure to address the domain of medication reconciliation by October 1, 2018 for IRFs, LTCHs and SNFs; and by January 1, 2017 for HHAs.
In April 2016, CMS proposed to adopt the quality measure Drug Regimen Review Conducted with Follow-Up, with data collection beginning October 1, 2018. CMS believes this proposed measure assesses whether PAC providers were responsive to potential or actual clinically-significant medication issue(s) when such issues were identified. If implemented, the proposed measure would emphasize the role of pharmacists and pharmacies to help ensure appropriate medication use in PAC settings.
Combating Opioid Abuse
Congress has been working for much of 2016 on legislation to support opioid abuse prevention, treatment and recovery as well as strengthening resources for law enforcement and first responders. The Senate was first to act by passing the Comprehensive Addiction and Recovery Act (CARA) in March 2016 on a 94-1 vote. The House followed by passing a package of 18 separate opioid-related bills by a vote of 400-5 in May 2016. While broad in scope, the legislation addresses areas that impact the dispensing of opioids and the role of pharmacists and pharmacies. Provisions in the legislation aim to address unused medications by allowing for partial-fills of opioid prescriptions and supporting the efficient disposal of medications no longer needed by patients. Legislation would also put a “pharmacy lock-in” policy in place, under which high-risk beneficiaries can be limited to a single pharmacy and prescriber. There is exemption language for the pharmacy lock-in provision for beneficiaries who reside in LTC facilities (including SNFs and intermediate-care facilities for individuals with intellectual disabilities) or other facilities that contract with a single pharmacy. The overwhelming bi-partisan support in both the House and Senate signals that passage of opioid legislation is highly likely this year. A Senate-House conference group is expected to complete work on compromise legislation, which Congress plans to send to President Obama to sign into law this summer.
The convergence of these policies - the Enhanced MTM model, the IMPACT Act for PAC settings and opioid legislation - creates opportunities for pharmacies and pharmacists to advance their scope of services. However, there are significant challenges on the horizon due to the uncertainty of the shifting health marketplace and whether these policies will translate into significant revenue to incentivize pharmacists and pharmacies to actively participate. With the general election around the corner, politicians will surely keep a narrow focus on policy maneuvers that keep them well positioned for the 2016 election. Beyond the opioid legislation, it is unlikely that Congress will move additional health legislation this year. On the regulatory side, CMS will continue to press forward with implementation of ACA programs, which continue to shift Medicare payment incentives toward quality measures and patient outcomes. This means we can expect incremental movement, rather than abrupt shifts, in the health policy landscape in the months leading up to the inauguration of the next president in January 2017. After that? There is an equal chance for tranquility or chaos.
Brad Kile is president of the Dumbarton Group, LLC, an advocacy and policy firm.