NCPA Advocacy Center Update – Week Ending January 21, 2017

NCPA Members List Top 2017 Political Priorities:   For the fourth consecutive year, NCPA has asked its members to rank their most important legislative and regulatory priorities. The top issue chosen by respondents is to end the retroactive nature of DIR fees by PBM corporations. The next most important issue is creating greater transparency in generic prescription drug reimbursements. Rounding out the top three priorities is the inclusion of an any willing pharmacy provision for Medicare Part D ‘preferred pharmacy’ prescription drug plans. Legislative remedies have previously generated bipartisan support, and NCPA will work to get them introduced and passed in the new Congress.  While not part of the survey questioning, NCPA also is equally focused on the changed political landscape and potentially dramatic changes in health care.

First of Two Hearings Held for HHS Nominee:  Rep. Tom Price (R-Ga.), President Trump’s nominee to lead the Department of Health and Human Services (HHS) testified this week before the Senate Health, Education, Labor and Pensions Committee where he offered vague commitments when asked for details on what types of policies could replace the Affordable Care Act.  He was also asked about Trump’s commitment to allow Medicare to negotiate drug prices (which Price has opposed in the past) where he indicated that he would follow the president’s intent. Next up for Price will be the official confirmation hearing set for this week before the Senate Finance Committee.

CMS Releases Part D DIR Analysis:  NCPA is pleased to report that CMS released an analysis related to Part D DIR fees and the impact of these fees on the Part D program.  The CMS analysis is an important step toward greater transparency and program integrity for Medicare Part D and we are pleased that CMS has heard our concerns over the past two years and is working to provide more clarity surrounding the #1 advocacy priority for NCPA members.  As CMS explains and contrary to what Part D plans and PBMs have previously asserted, DIR fees do not reduce the cost of drugs for beneficiaries at the point of sale and in fact push seniors into the ‘donut hole’ or catastrophic phase of the Part D benefit faster. CMS also details that Part D plans and PBMs favor the use of these post point-of-sale price adjustments because it shifts more liability to the Medicare program and the federal government and away from the Part D plan and PBM.

The CMS analysis is timely given the recent OIG report that documented a sharp increase in government spending on catastrophic coverage under Medicare Part D – a rise that has coincided with the steep jump in the prevalence and magnitude of DIR fees. OIG determined that these costs – borne completely by Medicare and the taxpayers who support it – have gone from $10 billion in 2010 to $33 billion in 2015.  Similarly, MedPAC has expressed concern with the apparently decreasing amount of risk sharing that Part D plan sponsors incur that is tied to this trend. Some important next steps could be for CMS to finalize the ‘negotiated price’ guidance as proposed to require fees be approximated at point-of-sale and for Congress to consider enacting bipartisan legislation to eliminate retroactive DIR fees.

NCPA will continue the fight against these egregious retroactive fees on behalf of independent community pharmacy. Here is a link to the CMS report:

https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2017-Fact-Sheet-items/2017-01-19-2.html

NCPA Asks Senate Aging Committee to Investigate PBM Practices:  The Senate Aging Committee released a report in December 2016 titled “Sudden Price Spikes in Off-Patent Prescription Drugs: The Monopoly Business Model that Harms Patients, Taxpayers, and the U.S. Health Care System.” Particularly noteworthy was the following passage from page 125 of the report, “another area worthy of further study is the role of PBMs. While some experts claim that PBMs function to keep down the price of drugs, other have suggested that PBMs may be contributing to part of the drug pricing problem. The Committee does not have visibility into this area from its investigation due to the fact that PBMs played a limited role in the drugs investigated by the Committee.”

NCPA is encouraging the Aging Committee to investigate the role that PBMs may be playing in increasing prescription drug prices. We believe it’s crucial for the Aging Committee to investigate PBM practices and how they may be contributing to rising drug costs. Such an investigation is necessary in providing committee members and Congress as a whole with a comprehensive view of the causes of higher drug prices and to develop policies that properly address them.

CMS Center for Medicaid Encourages States to Expand Access to Drug Therapy by Expanding Pharmacists Scope of Practice:  This week the Director of the Center for Medicaid and CHIP Services released guidance addressing flexibilities that states may have to facilitate timely access to specific drugs by expanding the scope of practice and services that can be provided by pharmacists. This includes dispensing of drugs based on independently initiated prescriptions, collaborative practice agreements with other licensed prescribers, standing orders issued by the states or other predetermined protocols.  The guidance mentions naloxone as an example in which states can used their authority to define the scope of practice for pharmacists to include the ability to dispense the drug for individuals, including Medicaid beneficiaries, prior to overdose emergencies.  Currently 40 states authorize pharmacists to dispense naloxone under standing orders.  The guidance also references nicotine replacement therapy and other tobacco cessation treatment as well as flu-shots and emergency contraception as options for states to consider expanding the ability of pharmacists to prescribe, modify, or monitor drug therapy in order  to address pressing public health issues.

New PBM Resources Added to NCPA WebsiteNCPA has updated its content on PBMs to spotlight how they are contributing to increased prescription drug costs. The new PBM Resources pages provide information tailored to specific stakeholders, including plan sponsors, patients, pharmacists, and the government. Additionally, there is a new PBM toolkit for NCPA members to utilize with policymakers and local employers, as well as information on alternatives to traditional PBMs that plan sponsors could consider when structuring their prescription drug benefit.

MedPAC Recommends Payment Cuts for Skilled Nursing Facilities:  The Medicare Payment Advisory Commission (MedPAC) has finalized its recommendations for the skilled nursing industry, keeping with its earlier proposal that calls for payment cuts and a revised prospective payment system.MedPAC hasn’t called for a payment increase for skilled nursing providers since 2008. The level of Medicare payments received by the sector have remained “too high,” according to the panel. The recommendations also include deletion of market basket updates for long-term care hospitals and hospice providers, as well as pay cuts for inpatient rehabilitation facilities. The recommendations will be published in a report to Congress that is typically released in March.

FDA Finalizes Biosimilar Naming Guidance:  FDA’s finalized naming convention, which includes a non-proprietary name combined with a four letter suffix, remains largely unchanged from the convention the agency laid out in a highly controversial August 2015 draft guidance. Under this naming convention, the nonproprietary name designated for each originator biological product, related biological product, and biosimilar product will be a proper name that is a combination of the core name and a distinguishing suffix that is devoid of meaning and composed of four lowercase letters.  FDA said it would use the same system of a core name and suffix for interchangeable biosimilars, but is still weighing options of what format the suffix will take. While Thursday’s final guidance allows applicants to suggest suffixes, the final guide says proposed suffixes should not “look similar to or otherwise connote the name of the license holder” nor “be too similar to any other FDA-designated nonproprietary name suffix.” NCPA previously recommended to FDA that biosimilar products maintain the same name as their reference biologic counterparts and not use suffixes.

NCPA Champions Pro-Pharmacy ACA, Medicaid Provisions:  Important pharmacy policies such as fair Medicaid reimbursement, PBM transparency and no mandatory mail order should be retained in any repeal and replace of the ACA/Obamacare, NCPA wrote in an article on MorningConsult.com: https://morningconsult.com/opinions/bipartisan-aca-provisions-worth-keeping/

In the States: 

Maine: NCPA submitted a letter in support of L.D. 6 which attempts to prohibit a health insurance carrier from retroactively reducing payment on a properly submitted claim by a pharmacy provider