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Weighing in on Changes Affecting Medicare Advantage
Full title: Weighing in on Changes Affecting Medicare Advantage and Prescription Drug Benefits
On January 6, 2014, the Centers for Medicare & Medicaid Services (CMS) proposed making changes to the Medicare Advantage plans and the prescription drug benefit program that if approved, could go into effect as early as January 1, 2015. Among the major provisions proposed, the one causing the most commotion among patients and healthcare providers is the proposal to change the criteria defining protected drug classes. If approved, these new criteria could affect Part D beneficiaries’ access to some antipsychotic, antidepressant, and immunosuppressant medications.1 This article gives an overview of these major provisions and the impact they could have on geriatric care providers. CMS is accepting comments from the public on these proposed changes through March 7, 2014. At the end of this article, please follow the instructions for submitting a comment to Annals of Long-Term Care: Clinical Care and Aging®. All comments will be submitted online to the CMS before the deadline.
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Changes to Protected Drug Classes
In 2006—the first year of the Medicare prescription drug benefit—CMS implemented a policy that required all Part D plans to include on their formularies “all or substantially all” Part D drugs within six drug classes because of clinical concern: antineoplastics, anticonvulsants, antiretrovirals, antipsychotics, antidepressants, and immunosuppressants. CMS designated these as protected classes to ensure that beneficiaries who needed these life-saving therapies would not be discouraged from enrolling in certain Part D plans, as well as to mitigate any risks and complications associated with interrupting therapy.2 These six classes have commonly become referred to as protected classes. The Patient Protection and Affordable Care Act recently codified this existing policy, allowing CMS to outline criteria for identifying protected classes through notice and comment rulemaking. The criteria are outlined as follows3:
1. A typical beneficiary who is initiating therapy must be able to administer a drug within the category or class in less than 7 days, or failure to do so may lead to hospitalization, incapacity, disability, or death.
2. Other CMS formulary requirements are not sufficient to ensure the access to the appropriate range of therapies, either due to the diversity of disease or condition manifestations of the associated specificity or variability of drug therapies necessary for treatment.
If these criteria are accepted, CMS would continue to require formulary inclusion of all drugs within the antineoplastic, anticonvulsant, and antiretroviral drug classes (subject to proposed exceptions), but would no longer require all drugs from the antidepressant and immunosuppressant drug classes to be on all Part D formularies starting on January 1, 2015. Although antipsychotics do not meet the proposed criteria, according to CMS, they will remain protected at least through 2015 while CMS considers transitioning individuals already taking these medications and the need for any other formulary exceptions.1
These changes could create a significant barrier for Medicare beneficiaries who need access to previously available antidepressants, immunosuppressants, and antipsychotics. This would include individuals who had previously been maintained on a covered medication that is no longer available through a Part D plan as well as newly started medications for individuals who have failed treatment or haven’t been able to receive treatment with the Part D plan’s covered medications such that they require a non-covered Part D drug. While these drugs might still be available, obtaining them would require an appeals process and potentially higher out-of-pocket expenses.
Other Proposed Changes
While proposed changes to the protected classes are most critical to Medicare beneficiaries and their providers, CMS has proposed seven additional changes that patients and providers should be aware of. If finalized, the changes described below are projected to save $1.3 billion between 2015 and 2019 and improve healthcare quality, according to CMS1:
Create market competition: CMS proposes to revise the regulatory definition of negotiated prices to require all price concessions from pharmacies to be reflected in negotiated prices, such that a plan sponsor could not incentivize the use of selected pharmacies that charge higher rates than their competitors.
Reduce plan offerings: CMS proposes that prescription drug plan sponsors offer no more than two Part D plans in the same service area. Additionally, CMS would prohibit Medicare Advantage plans from offering new plans that simply replace plans CMS has required to be terminated or consolidated because of low enrollment.
Return Medicare overpayments: CMS proposes to implement a requirement for Medicare Advantage plans and Part D sponsors to report and return identified Medicare overpayments, as stipulated in the Affordable Care Act.
Assure appropriate Medicare Advantage plan payment: CMS proposes to strengthen and organize the risk-adjustment data validation audit process. The processes of error rate calculation appeals and medical record review-determination appeals would be one combined process.
Expand Part D data-sharing to researchers for value-based purchasing: CMS proposes to expand the release of unencrypted prescriber, plan, and pharmacy identifiers contained in prescription drug event records to give researchers broader access to healthcare data.
Expand incentives for wellness and prevention: CMS proposes to expand rewards and incentives programs that do not discriminate against any Medicare Advantage plan beneficiaries. These programs would help encourage beneficiaries to participate in activities for improving their health and to make use of available healthcare resources as a means of preventing injuries and illness.
Restrict Part D orders to Medicare-enrolled prescribers: CMS proposes that all physicians and non-physicians who write prescriptions for Part D drugs must be enrolled in Medicare for their prescriptions to be covered under Part D.
CMS is accepting the public’s comments on these proposed changes until March 7. Annals of Long-Term Care® wants your opinions to be your heard. All readers’ comments received before the deadline will be submitted to the CMS. You can weigh in by casting your vote in a simple 3-question survey online at www.annalsoflongtermcare.com/news/cms-partD-antipsychotics-antidepressants. Or, send us your thoughts in a Letter to the Editor, which can be e-mailed to amusante@hmpcommunications.com.
References
1. Fact sheet: CMS proposes program changes for Medicare Advantage and Prescription Drug Benefit programs for contract year 2015 (CMS-4159-P) [news release]. Baltimore, MD: Centers for Medicare & Medicaid Services; January 6, 2014. www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-Sheets/2014-Fact-sheets-items/2014-01-06.html. Accessed February 3, 2014.
2. 30.2.5 Protected classes. In: Medicare Prescription Drug Benefit Manual: Chapter 6: Part D Drugs and Formulary Requirements. www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/downloads/Chapter6.pdf. Accessed February 3, 2014.
3. Medicare program; contract year 2015 policy and technical changes to the Medicare Advantage and the Medicare Prescription Drug Benefit programs; proposed rule. Federal Register. 2014;79(4):1941. www.gpo.gov/fdsys/pkg/FR-2014-01-10/pdf/2013-31497.pdf. Accessed February 3, 2014.
Dr. Stefanacci served as a CMS Health Policy Scholar for 2003-2004, is an associate professor of health policy, University of the Sciences, and a Mercy LIFE physician, Philadelphia, PA; and is chief medical officer, The Access Group, Berkeley Heights, NJ
Dr. Spivack is the founder of the Connecticut Geriatrics Society, and is on the medical staff, Greenwich Hospital, Greenwich, CT.
