March 2016 NCPA LTC Division Newsletter NCPA Offers FDA Additional Information on Repackaging Draft Guidance NCPA recently joined with the American Society of Consultant Pharmacists (ASCP) in a follow up response to FDA regarding the agency's draft guidance related to Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities and a listening session held last year at FDA. The draft guidance includes requirements of special concern to long term care pharmacies. Our response focuses on the content of a "typical" emergency kit (e kit), the scope of state oversight of e kits, availability of unit dose medications that are used in e kits, beyond use dating (BUD) for medications pre packaged by a long term care pharmacy (LTCP), and how to define an LTCP. Innovatix, the nation's leading non acute care group purchasing organization, is committed to providing unparalleled purchasing and supply chain solutions to our members nationwide. As an affiliate of Premier, we're able to leverage $44 billion in purchasing volume to negotiate a portfolio of contracted savings unmatched in today's marketplace. Recognizing the difficulties linked with obtaining maximum reimbursements on prescription claims, Innovatix recently launched a new Web based pharmacy claims support tool and data analytics service called Scriptmax. Scriptmax offers a comprehensive suite of pre edit, postedit, and reconciliation services. The goal: enable pharmacies to receive maximum reimbursement by minimizing errors on prescription claims. Senate Passes Opioid Abuse Bill, LTC Pharmacies Exempted from 'Lock in' Provision The Senate last week overwhelmingly passed the Comprehensive Addiction and Recovery Act (CARA), which is aimed at addressing the opioid crisis, with an amendment that would let Medicare Part D plans lock Medicare beneficiaries at risk of drug abuse into sole prescribers and pharmacies to fill Schedule II controlled substance prescriptions. The bill passed 94 1 and now goes to the House. In the midst of debate on CARA, Sen. Pat Toomey (R Pa.) offered his bill, the Stopping Medication Abuse and Protecting Seniors Act (S. 1913), as an amendment to CARA. The Proud sponsors of the NCPA LTC Division:
House has yet to schedule a hearing on companion legislation. As the next steps of the legislative process play out, NCPA will continue to educate Congress about the importance of supporting Medicare beneficiary access to essential medication and the community pharmacist they know and trust. NCPA was successful in ensuring the measure exempts LTC patients and that community pharmacists be included in the stakeholder group that will work with CMS and Part D plans to determine lock in patient criteria. CMS Publishes Long Awaited AMP Final Rule The long awaited final rule on the Medicaid Drug Rebate Program (MDRP) was finally published in the Federal Register on Feb. 1. The final rule implements various statutory amendments, revises the calculation of Average Manufacturer Price (AMP), makes certain changes to the determination of Best Price, and addresses other issues relating to Medicaid price reporting and reimbursement. The final rule takes effect April 1, 2016, and CMS is accepting public comments on a number of provisions in the rule. Of particular note, CMS finalized its definition of a retail community pharmacy to mean an independent pharmacy, a chain pharmacy, a supermarket pharmacy, or a mass merchandiser pharmacy that is licensed as a pharmacy by the state and that dispenses medications to the general public at retail prices. It excludes from this definition: pharmacies that dispense prescription medications to patients primarily through the mail, nursing home pharmacies, long term care facility pharmacies, hospital pharmacies, clinics, charitable or not for profit pharmacies, government pharmacies, or pharmacy benefit managers. The definition of retail community pharmacy is critical in determining how to calculate AMP, as AMP is defined as the average price paid by (1) wholesalers for drugs distributed to retail community pharmacies; and (2) retail community pharmacies for drugs purchased directly from the manufacturer. A key issue with this definition is the extent to which specialty pharmacies, home infusion pharmacies, and home health care providers are considered retail community
pharmacies. In the proposed rule, however, CMS sought comments on a proposal that would include "entities that conduct business as a wholesaler or retail community pharmacy," in the definition of retail community pharmacy. CMS' intent was to specifically capture specialty and home infusion pharmacies and home health care providers, and it indicated in the proposed rule that this proposed addition is consistent with the statutory language. CMS did not finalize this proposal, stating that these entities fall within the existing definition so the expansion is not required. CMS' decision not to expand the definition could be seen as backing away from the requirement that all specialty pharmacies, home infusion pharmacies, and home health care providers be included in the definition of "retail community pharmacies." Under the finalized definition, a pharmacy is only considered to fall into this group to the extent that it is an independent pharmacy, a chain pharmacy, a supermarket pharmacy, or a mass merchandiser pharmacy that dispenses medications to the general public at retail prices and is not otherwise excluded from the definition. On March 4, NCPA joined eight other organizations in writing CMS asking the agency to extend the effective date of the final AMP rule through Oct. 1, 2016. While the organizations greatly appreciate the increased clarity on Medicaid AMP calculations, the agency should consider giving stakeholders additional time to ensure successful implementation. Due to the sheer number of topics addressed many with complex operational implications stakeholders from across the supply chain are facing a multitude of challenges in their efforts to implement and comply with the Final Rule. Rushing this process could increase of the risk of errors, which could create legal risk for manufacturers that must certify to comply with the new rules as of April 1 and impose increased burdens on downstream entities that rely on these AMP calculations, including pharmacies. Not allowing manufacturers time to "get it right" may result in inaccurate AMP based federal upper limits (FULs), and impose a significant workload on states due to the increase in rebate restatements that may need to be submitted and reprocessed.
CMS Releases Annual Draft Call Letter On Feb. 19, CMS released its 2017 draft Call Letter for Medicare Advantage (MA) and Part D plans, which includes requirements and benefit parameters for plan year 2017. Of particular interest to pharmacy: Opioid overutilization edit requirements will expand to all plans: All Part D plans will be expected to implement both soft and hard formulary level cumulative morphine equivalent dose (MED) POS edits. Soft edits are to occur when a patient exceeds a daily cumulative MED between 90 120 mg. Hard edits are to occur for daily cumulative MED of 200 mg or higher. Beneficiaries with certain conditions such as cancer or those in hospice are to be exempted. Specialty drug cost threshold to increase: Since the program inception, CMS has used a cost threshold of $600 per month to identify "specialty" drugs. CMS is proposing to increase the threshold to $670 per month for 2017. CMS will allow a new "nonpreferred" drug tier: CMS will allow plan sponsors to incorporate a "nonpreferred" tier option in 2017 that allows for a combination of both branded and generic drugs. CMS is encouraging plans to use coinsurance for the non preferred tier to protect beneficiaries taking lower cost generic products. Sponsors will not be allowed to have both a "nonpreferred" tier and a "non preferred brand" tier. Plan sponsors can designate drugs for partial extended supply fill for new patients: sponsors will have the option to designate specific drugs where only a one month supply will be covered for the initial fill, rather
than a two or three month extended supply. Patients will not be required to obtain a new prescription to convert into an extended days' supply. MTM changes: The 2017 MTM program annual cost threshold will be adjusted based on the annual percentage and finalized in the 2017 Call Letter. The current MTM requirements are waived for plans approved to participate in the Enhanced MTM Model that begins in 2017. Establishing mail order protocols for urgent need fills to prevent gaps in therapy: CMS has received beneficiary complaints about mail order pharmacies indicating that they will rush ship an urgently needed order, but the order does not arrive when promised or at all, potentially resulting in gaps in therapy. To protect beneficiaries from inconsistent or unreliable practices that may jeopardize timely access to medications, CMS expects Part D sponsors to work with their mail order pharmacies to develop and implement protocols for providing access to urgently needed medications. Changes to the 2017 Star Ratings and beyond: CMS will implement additional data integrity checks to safeguard against inappropriate attempts to bias data used for the Medication Therapy Management (MTM) Program Completion Rate for Comprehensive Medication Reviews measure (Part D). The High Risk Medication (Part D) measure will be removed and moved to the display measures for 2017. Added to the 2017 Display Measures will be Medication Reconciliation Post Discharge (Part C) and Statin Use in Persons with Diabetes (SUPD) (Part D). CMS is considering Use of Opioids from Multiple Providers or at High Dosage in Persons without Cancer
(Part D) and Antipsychotic Use in Persons with Dementia (APD) (Part D) for the Star Ratings or display measures for 2018 and beyond. On March 4, NCPA submitted comments requesting that CMS address abusive DIR practices by examining the bid process and include information related to access to preferred costsharing pharmacies on Plan Finder. In addition, NCPA recommends that Part D preferred network plans should incur a financial penalty or other sanction in the event drugs are more expensive at preferred pharmacies after considering DIR. Also, NCPA expressed general support for a change to the definition of specialty drugs by amending the cost threshold to $670 per month, but also urged CMS to maintain the guidance that Part D plans cannot restrict access to specialty pharmacies that would go against convenient access standards. Lastly, regarding proposed soft and hard opioid edits, NCPA asks that LTC patients are accounted for in exception processes, pharmacists not be held financially responsible if a prescription is recouped based on edits, and that plans are not deviating from the daily cumulative MED thresholds to any great extent. NCPA supports the current drug utilization review controls in the Medicare Part D program, rather than taking steps to move to a more restricted access program such as a prescriber and/or pharmacy "lock in" program. NCPA Meets with DEA on Abuse, Diversion Issues NCPA and other representatives of the pharmaceutical supply chain participated in a Drug Enforcement Administration forum on Feb. 29 with a number of DEA officials, including Acting Administrator Chuck Rosenberg and Chief of the Office of Diversion Control Lou Milione. The forum "helps us all to find the right balance between providing patients with important prescription medications and reducing the addictions, overdoses, and crimes that too often result from these substances falling into the wrong hands," Rosenberg said. There were breakout sessions with DEA section chiefs where NCPA raised member concerns about shutoffs of needed medications, long term care issues, and constructive transfer. DEA disclosed that a proposed rule would be released in the next few weeks on suspicious orders, hoping to provide
clear guidance in what has seemed to be an arbitrary decision making process. Track and Trace Requirements for Dispensers Start March 1 In October, the FDA announced that it would exercise its discretion not to enforce the product tracing requirements of the DSCSA until March 1, 2016. The DSCSA originally required dispensers to collect transaction information starting on July 1, 2015, but FDA has twice delayed this requirement for dispensers. The FDA declined to delay the requirements a third time, so dispensers will have to receive and store transaction information when taking ownership of a drug, in addition to the other requirements in the DSCSA that took effect on Jan. 1, such as trading partners having systems in place to verify suspect and illegitimate products and entering into transactions only with authorized trading partners. FDA issued new guidance on March 1, indicating that it will not take action against "a dispenser who transfers ownership of product directly to a first responder where the dispenser does not provide the first responder with product tracing information." This new compliance policy does not extend to the requirements that manufacturers, wholesale distributors, and repackagers provide product tracing information to dispensers. In addition, this compliance policy does not extend to transactions in which dispensers must provide the subsequent owner with product tracing information, including transaction history. According to the FDA guidance document, "if a dispenser has not received product tracing information prior to or at the time it takes ownership of a product, FDA recommends that the dispenser work with the previous owner to receive this information." The new compliance policy is in effect until further notice by FDA. Grow Your LTC Business If you're looking to expand your current LTC offerings, you won't want to miss NCPA's High Performance Strategies for LTC Pharmacies program Oct. 13 14 in New Orleans. Our program will show you the trends in transitional care for the patient centric pharmacy market and help you use quality measures data to achieve a five star quality rating for your LTC pharmacy. The program will also cover issues such as soliciting new business, managing interactions between your pharmacy
and client facilities, and the impact of various pricing formulas. Whether you're new to LTC or have attended our Business Fundamentals Program before, you're guaranteed to learn new ideas at this intensive two day workshop! Only a limited number of seats are available, so register now online or by calling 1 800 544 7447. To unsubscribe from promotional emails and surveys but continue to receive important updates about community pharmacy issues, click here to manage your subscription preferences. To unsubscribe from all NCPA emails, including alerts on developments impacting community pharmacies, click here. [[tracking_beacon]] The NCPA LTC Newsletter is sent by NCPA, located at 100 Daingerfield Rd, Alexandria, VA 22314.