In the final days of the Trump administration, the Centers for Medicare and Medicaid Services (CMS) have finalized a flurry of rules and made announcements that can impact both the profession of pharmacy and the patients of pharmacists. This week, we review these rules and what to look out for as the leadership of CMS switches hands.
Prescription Drug Card for Seniors
Earlier this fall, President Trump signed an executive order (EO) in which he promised to send $200 debit cards ($6.6 billion in total) to seniors to assist them in paying for prescription medications. He claimed under this plan that 33 million Medicare beneficiaries would qualify to receive the assistance, which means over 70% of total Medicare Part D enrollees were set to receive this benefit. In the midst of a pandemic that has had a dramatic economic impact, especially on seniors, the possibility of extra assistance was well received. However, questions quickly arose as to the true impact such a policy would make. For example, if a Medicare beneficiary was in the coverage gap (or donut hole), they have to spend around $2,500 to reach the point of catastrophic coverage.
Although an 8% discount provided by the $200 debit card would likely not be turned away, the burden our seniors face is hardly minimized. This EO brought to the conversation that policy instituting meager debit cards is not the way to help our seniors with the rising cost of medications. Widespread changes are needed in federal policy to lower the cost of medications and ensure unrealistic financial expectations are not passed on to the patient (read about plans from the incoming administration to address this here). In recent days, news sites have reported that the promised debit cards would not be sent out. Although challenging news for seniors that were anticipating the help, we can only hope that with the plan scrapped, the billions that would have gone to these seniors instead goes towards policy changes that may actually address the underlying issue of rising drug costs.
Prior Authorization – but not the one we hoped for
The Patients Over Paperwork Initiative is a Trump-era program launched by CMS Administrator Seema Verma to decrease regulatory burdens in order to increase the efficiency and quality of healthcare delivery. An example of these efforts may be the removal of certain documentation requirements from providers to allow them more time to deliver patient care rather than filling out electronic health records. One of the targets of the initiative has been prior authorization and attempting to find ways to decrease burden on both providers and patients.
On January 15, 2021, CMS announced a major rule that will impact patients, providers, and many health insurers, including Medicaid managed care organizations. This rule requires health insurers to include additional information in application programming interfaces (APIs) that will be used to increase efficiency of prior authorizations. This additional information includes, claims data, lab results, and information about prior authorizations and their statuses. There is hope that this information will facilitate more efficient prior authorizations and decrease repeat unnecessary submissions. Although not specifically mentioned in the press release, upon further examination of the rule, one learns that surprisingly “prescription drugs and/or covered outpatient drugs” are excluded.
Where there may have been hope from pharmacist providers of additional resources to increase efficiency of medication prior authorizations, this rule unfortunately does not move the needle on these efforts, despite creating a façade as if it does so. It was evident from many of the comments included in the rule that health care provider associations were frustrated with this exclusion. Although this rule will not address it, there is hope that change of the prior authorization process for services may result in reevaluation of the medication authorization process in the future. Additionally, many of the comments submitted on this rule were in regard to medication prior authorization, making it challenging for CMS to ignore calls from many of its providers to address issues with the process. The importance here is continuing to voice issues with the process both at the provider level and patient level. There can be hope that continued expressions of the burdens and gaps created in patient care will result in the changes needed to improve the system.
Changes to Medicare Advantage and Part D
One of the final actions taken by CMS leadership in their last days is the expansion of coverage for Medicare Advantage and Part D beneficiaries that hope to lower beneficiary costs, compare costs between different medications, and could save the federal government over $75 million over ten years. Additionally, included in this rule are CMS regulatory changes regarding The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act.
Regulations specific to the SUPPORT Act are focused on addressing the misuse of opioids. Relevant to pharmacists is that part of the provisions of implementing these rules will allow for the suspension of payments to pharmacies if there are credible allegations of fraud. Additionally, CMS, Medicare Advantage Programs, and Part D plans will be increasing data sharing to decrease risk of misuse and abuse of opioids. More information on these rules can be found here.
New Leadership for CMS
The work of CMS has changed over the past four years, with one of the primary focuses being on decreasing regulatory burdens. In the final days of this administration, large packages of rules are being finalized that have the potential to greatly impact both patients and providers, however, it is unclear at this time the true impact they will have. President-elect Joe Biden has chosen Xavier Becerra to be the incoming Secretary of Health and Human Services. It is unknown at the time of writing who will take the place of CMS Administrator. Given the campaign focus of President-elect Biden, and Mr. Becerra’s history as California’s Attorney General, it can be expected that a strong focus of HHS and CMS will be on strengthening and protecting the Affordable Care Act.
We will have to wait and see how they will work to accomplish this, and what else will be on the table. But if CMS continues the momentum seen in the past several years, we can expect to see continued rapid changes in the rules and regulations that oversee how millions of patients and providers deliver care across the country.