House Passes Defense Authorization Bill that includes TRICARE Mail Order Requirements: The House passed the National Defense Authorization Act (NDAA), H.R. 3979, on December 4th by a vote of 300-119. The vehicle for the defense authorization bill was originally a bill that was referred to the Ways and Means Committee and dealt with an entirely different issue. The House and Senate passed that bill and then the House added the enormous defense authorization bill to it. The Senate is expected to consider the large measure next week and it is expected to pass.

The bill reduces benefits for troops and their families; it would raise the copay by $3 for most prescriptions under Tricare and extends the current Tricare for Life pilot that requires certain brand-name maintenance medications be obtained via mail to ALL Tricare beneficiaries.

The NDAA is a $585 billion measure and is one of the few pieces of legislation that has always been renewed on time, with Congress passing it for 52 consecutive years. Of importance to community pharmacy, the bill reduces benefits for troops and their families. It would raise the copay by $3 for most prescriptions under Tricare. In addition, it extends the current Tricare for Life pilot that requires certain brand-name maintenance medications be obtained via mail to ALL Tricare beneficiaries, starting in October 2015. NCPA has serious concerns with this provision, as we believe the choice of where to obtain a prescription medication should be left to the patient alone, and is recommending that before implementing any new policies with such a broad impact, the results of the pilot program should be fully disclosed and its impact fully understood.

FDA Provides Initial Track and Trace Guidance: On November 26, FDA issued its "DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information." It is draft guidance in name only, because FDA intends to treat it as final. The guidance sets initial standards for product tracing, and the requirements for wholesale distributors, dispensers, and repackagers under the Drug Supply Chain Security Act. The law required FDA to provide initial guidance by November 27, so the document was relatively short and nonspecific. Given the difficulty of establishing true "interoperability" systems by January 1, 2015, FDA permits the use of "any system, process, or practice" to satisfy the law’s interoperability requirement, provided subsequent purchasers are "able to successfully capture and maintain the product tracing information, regardless of whether the information is provided in a paper or electronic format."

FDA provides a partial, non-exclusive list of acceptable formats:

• paper or electronic versions of invoices;
• paper versions of packing slips;
• Electronic Data Interchange (EDI) standards, such as 856 Advance Ship Notice (ASN)

With this draft guidance, FDA has made clear that compliance will not be delayed beyond January 15, 2015.

GAO Report Outlines CMS Practices to Address Prescription Fraud, Waste and Abuse: the Government Accountability Office (GAO) developed a list of practices based on interviews with 14 stakeholder groups (including NCPA) and identified 23 practices for addressing FWA that fall within three categories: prevention, detection/monitoring, and investigation/prosecution. The GAO found that CMS activities reflect 14 of the 23 identified practices, some which span multiple categories and the Agency intends to implement 3 additional practices, including use of PDMPs. And although not a current requirement, CMS noted it is still considering whether to require pharmacies that dispense covered Part D drugs to enroll in the Medicare program. See the report here: http://www.gao.gov/assets/670/666647.pdf

Legislation Introduced that would Require Part D Lock-in Programs: The Protecting Integrity of Medicare Act (PIMA) of 2014 was introduced by Ways and Means Health Subcommittee Chairman Kevin Brady (R-TX) and Ranking Jim McDermott. Several sections of interest to community pharmacy include:

Modification of face-to-face encounter documentation requirement for DME: expands eligible professionals who can document the face-to-face encounter required for DME prescriptions to include nurse practitioners and physician assistants, as allowed by state law.

Requiring valid prescriber NPI on pharmacy claims: requires CMS to use NPI as the only allowed prescriber identifier.

Programs to prevent prescription drug abuse under Medicare Part D: creates a drug management program for beneficiaries at risk of prescription drug abuse starting CY2017. Beneficiaries determined to be at-risk of prescription drug abuse can be limited to one or more physicians and one or more pharmacies for certain opioids and similar drugs. PDP sponsors must respect beneficiary requests regarding their preferred pharmacy (or pharmacies) to the extent feasible.

NCPA has repeatedly relayed our concerns with Part D lock in programs, including that such a system must be a level playing field for independent community pharmacies. Patients should not be locked against their will into a pharmacy they don’t want to use or into mail order pharmacies, most if not all of which are owned by the PBMs running Part D plans (a conflict-of-interest in itself), and which typically ship 90-day supplies that could be particularly inappropriate for controlled substances.

Register for NCPA Members Forum: Community Pharmacy 2015 Checklist with NCPA Advocacy Center Staff: There are several important changes in Medicare, Medicaid and at the state level that will take effect in 2015. NCPA staff will review hot topics, update you on what you need to know about new policies, and remind you of several important Medicare-related issues that affect your business, as well as changes to Medicaid populations that will occur as a result of the Affordable Care Act.

National Influenza Vaccination Week, Dec 7-13; CDC provides updates on 2014-2015 influenza season: the CDC recently reported that overall, influenza activity remains low, but is beginning to increase. Surveillance data indicate that influenza A (H3N2) viruses have predominated so far. About half of the H3N2s the CDC has analyzed since October are different from the H3N2 virus that is included in this season’s flu vaccine. Because of the detection of drifted H3N2 viruses, CDC is urging influenza vaccination of unvaccinated patients as the continued first line of defense, and reminding clinicians about the importance of the use of neuraminidase inhibitor antiviral medications when indicated for the treatment of influenza illness, as an adjunct to vaccination. This week is also National Influenza Vaccination Week, the national observance that was established to highlight the importance of continuing influenza vaccination.

CMS Issues Final Rule to Enhance Medicare Provider Oversight: On December 3, using new authorities created by the Affordable Care Act to clamp down on Medicare fraud, waste and abuse, CMS issued a final rule to strengthen oversight of Medicare providers. The final rule allows CMS to:

• Deny enrollment to providers, suppliers and owners affiliated with any entity that has unpaid Medicare debt to prevent individuals and entities that have incurred Medicare debts from exiting the program and then attempting to re-enroll as a new business to avoid repayment of the outstanding debt
• Deny or revoke the enrollment of a provider or supplier if a managing employee has been convicted of a felony offense.
• Revoke enrollments of providers and suppliers engaging in abuse of billing privileges by demonstrating a pattern or practice of billing for services that do not meet Medicare requirements.

In the States: