APhA Advocacy Issues

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Final Part D Rule Released - Key Provisions Not Finalized

On May 19, 2014, Centers for Medicare & Medicaid Services (CMS) released the Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs Final Rule (Final Rule).  The Proposed Rule contained many important Part D reforms, including greatly expanded medication therapy management (MTM) eligibility, an “any willing pharmacy” provision designed to allow pharmacies willing to accept a plan’s terms and conditions to participate in currently restrictive networks, and changes that place mail-service pharmacies and community pharmacies on an even playing field.  However, on March 10th, prior to the end of the comment period, CMS indicated that four key provisions of rule would be held--the protected drug classes provision, the “any willing pharmacy”/preferred cost-sharing provisions, the changes to the number of plans sponsors may offer, and the non-interference provisions.  CMS explained that it would "engage in further stakeholder input before advancing some or all of the changes in these areas in future years.”  

In the Final Rule, CMS also opted not to finalize the proposed expansion of medication therapy management (MTM) services or the proposed changes to mail-service preferred cost-sharing.  Instead, CMS announced that it will continue to study these proposals and “will engage in new notice and comment rulemaking on [the issues] as warranted in the future.”  APhA continues to work with CMS, Congress, and other stakeholders to instiute these important reforms. Provisions that were finalized in the Final Rule include the following (this is not an exhaustive list):

  • Publication of Maximum Allowable Cost (MAC) prices: Part D plans and pharmacy benefit managers must make the reimbursement rates for drugs under Maximum Allowable Cost pricing standards available to contracted pharmacies effective contract year 2016.

  • Abusive Prescribing Prevention:  The Final Rule allows CMS to revoke a physician’s or eligible professional’s Medicare enrollment if CMS determines that the individual engages or has engaged in abusive prescribing practices and patterns.

  •  Medicare Prescriber Enrollment:  The Final Rule requires that, effective June 1, 2015, physicians and eligible professionals who write prescriptions for covered Part D drugs must be enrolled in Medicare, or have a valid record of opting out of Medicare for their prescriptions to be covered under Part D.

  • Information Collection Changes :The Final Rule allows CMS, its antifraud contractors, and other oversight agencies the ability to request and collect information (e.g., invoices and prescriptions) directly from pharmacy benefit managers, pharmacies and other entities that contract or subcontract with Part D Sponsors to administer the Medicare prescription drug benefit.

  • Expanded Part D data sharing: The Final Rule increases access for researchers and other external entities to unencrypted prescriber, plan and pharmacy identifiers contained in prescription drug event (PDE) records.

  • OverpaymentsThe Final Rule sets forth requirements for the returning and reporting of overpayments by plan sponsors.  Plans are allowed to submit data to correct overpayments but will be prohibited from submitting diagnosis codes for additional payment 

Health Care Reform - Implementation of the Affordable Care Act<

In March 2010, President Obama signed into law the Affordable Care Act (P.L. 111-148; ACA), also referred to as health care reform. Beyond provisions impacting patients and insurance companies, numerous provisions within the final law either impact directly or could impact pharmacists. ACA issues of importance to APhA, pharmacists, and the pharmacy profession include:

Revisions to FDA Drug Paradigm (OTC+)

In 2012, FDA announced it is looking at ways to make the distinction between prescription and over-the-counter (OTC) drugs more flexible through "conditions of safe use" including interventions by a pharmacist or innovative technologies (OTC+).
APhA supports the concept and believes that this is an exciting opportunity for pharmacists to help improve public health, much like what pharmacists have done with immunizations.

Read more about the revisions to the FDA Drug Paradigm (OTC+).

Fraud, Waste, and Abuse

The Centers for Medicare & Medicaid Services (CMS) established the Center for Program Integrity (CPI) to ensure the integrity of Medicare and Medicaid. Within CPI, the Division of Plan Oversight and Accountability (DPOA) safeguards Medicare Advantage (Part C) and Medicare Part D (Prescription Drug Program).  DPOA carries out its mission with an experienced anti-fraud team, of which the Medicare Drug Integrity Contractors (MEDICs) are members.   The MEDICs are comprised of the CMS National Benefit Integrity (NBI) MEDIC and the CMS Outreach and Education (O&E) MEDIC.  

Learn more about the CMS Outreach and Education (O&E) MEDIC.


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