House E&C Committee Holds Hearing on Opioid Crisis: The Energy and Commerce Committee held a hearing this week on federal efforts to combat the opioid crisis. The committee heard from witnesses from the FDA, DEA, SAMHSA, CDC, and NIH on agency efforts to address the crisis and to implement the Comprehensive Addiction and Recovery Act (CARA) and the 21st Century Cures Act. Chairman Greg Walden (R-OR) detailed the committee’s ongoing bipartisan investigation into alleged pill dumping in West Virginia and chided the DEA for their lack of cooperation in providing documents and answers to the committee on shipments from distributers. Members of the committee focused on a range of problems contributing to and possible solutions for the crisis and of note, Rep. Buddy Carter (R-GA) raised the need for non-opioid alternatives to pain treatment and the perverse incentive that PBMs have created through greater reimbursement for opioids over non-addictive alternatives. NCPA joined the American Pharmacists Association (APhA), Academy of Managed Care Pharmacy (AMCP), American Society of Consultant Pharmacists (ASCP), American Society of Health-System Pharmacists (ASHP), College of Psychiatric and Neurologic Pharmacists (CPNP) and the National Alliance of State Pharmacy Associations (NASPA) in submitting a statement for the record (see attached) at the hearing encouraging the committee to pass H.R. 3991, the Expanded Access to Opioid Abuse Treatment Act of 2017, a bill that would enable pharmacists to obtain a Drug Addiction Treatment Act (DATA) waiver in the same manner as physician assistants and nurse practitioners.
President Declares Opioid Crisis a Health Emergency: On Thursday President Trump directed the Department of Health and Human Services (“HHS”) to declare the opioid crisis a public health emergency. Specifically, this declaration directs executive departments and agencies to “exercise all appropriate emergency authorities, as well as other relevant authorities, to reduce the number of deaths and minimize the devastation the drug demand and opioid crisis inflicts upon American communities.” The declaration allows expanded access to telemedicine services, including remote prescribing of medicine used for substance abuse or mental health treatment, and allows HHS to “more quickly make temporary appointments of specialists with the tools and talent needed to respond effectively” to the emergency. In addition, the White House indicates the declaration “allows for shifting of resources within HIV/AIDS programs to help people eligible for those programs receive substance abuse treatment, which is important given the connection between HIV transmission and substance abuse.” NCPA has addressed a number of actions pharmacists may take to help combat the opioid crisis with Congress, HHS, and the President, including support for the utilization of medication-assisted treatment programs. As the implementation of this declaration takes form, NCPA will continue to look for opportunities to promote pharmacists services to combat this important issue.
NCPA Spearheads Effort Recommending Rep. Buddy Carter Appointment to Drug Pricing Task Force: Recent media reports have indicated that President Trump is considering launching a bipartisan task force to investigate the rising cost of prescription drugs. In response to those reports, NCPA spearheaded an effort and was joined by the American Association of Colleges of Pharmacy (AACP), American Pharmacists Association (APhA), American Society of Consultant Pharmacists (ASCP), American Society of Health-System Pharmacists (ASHP), Community Oncology Alliance (COA), Community Oncology Pharmacy Association (COPA), Food Marketing Institute (FMI), Hematology/Oncology Pharmacy Association (HOPA), International Academy of Compounding Pharmacists (IACP), National Alliance of State Pharmacy Associations (NASPA), National Association of Chain Drug Stores (NACDS), National Association of Specialty Pharmacy (NASP), and the National Grocers Association (NGA) in sending a letter to President Trump recommending Rep. Buddy Carter (R-GA) as an appointee to any Commission created by his administration to address the cost of prescription medications. See letter attached.
Register Now: Nov. 1 Webinar on Medicaid Reimbursement Rule: Is Medicaid a large part of your pharmacy business? Don’t miss the NCPA Innovation Center’s Nov. 1 CE webinar updating pharmacists on the status of the Covered Outpatient Drug Rule or “AMP” rule. All state Medicaid fee-for-service pharmacy programs should have switched to the new acquisition-based model of pharmacy reimbursement to include a commensurate dispensing fee. John Coster, PhD, RPh, with CMS will tell you what this means for your pharmacy. The webinar is FREE and open to all pharmacists and technicians. (CE credit available only to those participating in the entire live webinar.)
NCPA Comments on HHS’ Strategic Plan for 2018-2022: Every four years the Department of Health and Human Services (“HHS”) solicits comments on their strategy to accomplish HHS’ goals and objectives in health care. HHS’ recently released its Strategic Plan for 2018-2022, which focused on strategies to promote price transparency, create a more integrated and team-based health care system, and how to combat the current opioid crisis. On Friday NCPA submitted comments in response the HHS’ Strategic Plan, highlighting NCPA’s legislative and regulatory priorities which would support HHS’ Strategic Plan. Specifically, NCPA highlighted the importance of price transparency through exposing PBMs, DIR fees, and MAC pricing issues. NCPA emphasized pharmacists’ role in a health care system with a team-based approach, including the opportunity for pharmacists to bill Medicare Part B and the issue of access for patients when independent pharmacies are left out of closed provider networks in Medicare Part D. Finally, NCPA highlighted policies that independent pharmacists support to combat the current opioid crisis.
FDA Announces Next PCAC Meeting: FDA has formally announced the next Pharmacy Compounding Advisory Committee (PCAC) Meeting. The meeting will occur November 20- 21. The substances that NCPA nominated that will be up for vote include:
- 7-Keto Dehydroepiandrosterone
- L-Citrulline
- Pregnenolone
- Resveratrol
Please let Ronna Hauser know if you compound with either 7-Keto DHEA or Resveratrol. Also please let Ronna Hauser know if you have patients or physicians who will publicly comment as to the need/importance of any of these substances.
NCPA Weighs in on FDA Guidelines on the Drug Supply Chain Security Act (“DSCSA”): NCPA recently submitted comments to the FDA on the draft guidelines on the DSCSA. By way of background, the DSCSA outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. NCPA submitted comments on dispenser to dispenser transactions, asking the FDA to clarify with state entities that a dispenser is not required under the law to obtain a wholesaler license when transactions between dispensers are for a specific patient need. NCPA is actively engaged with other industry actors to monitor the FDA’s implementation of the DSCSA and ensure that dispensers can continue to provide care for their patients and safeguard patients’ access to medication.
NCPA Attends MACPAC Meeting: On Thursday the Medicaid and CHIP Payment and Access Commission (“MACPAC”) held its monthly meeting. An NCPA representative was present at a number of MACPAC’s sessions on the opioid crisis, an overview of state Medicaid waivers, and any potential changes to pilot programs facilitated by the Center for Medicare and Medicaid Innovation (“CMMI”) . MACPAC expressed concern with any major changes to CMMI and is strongly considering sending a letter to support continuing funding under CMMI as these programs have successfully supported CMS’ goals to improve health care. NCPA will also be submitting comments on CMMI expressing similar concerns.
NCPA Attends USP Opioid Roundtable: There were approximately 50 attendees including representatives from government, other stakeholders across the health care spectrum, and USP. Pharmacy organizations included NABP, NCPA, APhA, NACDS, Rite Aid, and several health systems. The stated goal of the Roundtable was to collect input from stakeholders and implementers of USP standards on four concepts that USP is considering developing that are intended to help address the opioid abuse crisis prior to posting standards for public comment. The four concepts include: Consumer-directed labeling for naloxone, Storage and disposal of opioids, Prescription container labeling, and Patient counseling by health care providers. NCPA will remain engaged throughout the process.
Employers Say PBM Contracts Too Complicated, Lack Transparency: Many employers harbor serious concerns about PBM practices and yearn for a simpler, transparent model, according to a survey of 88 “jumbo” employers commissioned by the National Pharmaceutical Council. Barely one-third of employers rated their PBM as trustworthy and many questioned PBMs’ alignment with employers’ best interests, citing rebates as an example. “Supposedly, PBMs make their profit by charging employers administrative fees,” one observed. “If that was the case, theoretically, PBMs would be making nothing. But PBMs’ reported profits are so high. It shows that they are making money in ways that are not disclosed.” “The next-generation PBM model I would like to see is a simpler model with claim adjudication,” another executive stated. “There would be no rebates. Just drugs that are priced appropriately.” NCPA has previously shared its concerns about PBMs with NPC officials and will continue to raise awareness of how practices of PBMs contribute to rising prescription drug costs.
In the States:
- MassLive reports that a bill pending before the Massachusetts Legislature would require pharmacists to tell customers if the cost for paying in cash would be less than their insurance copay. Todd Brown, executive director of the Massachusetts Independent Pharmacists Association, is quoted in the story.
- NCPA recently presented the community pharmacy perspective in regards to drug pricing at the NALEO Legislative Health Summit. NCPA was invited to present to over 40 Latino state legislators who were very interested in the role of PBMs in the drug supply chain. Several of the legislators were strong advocates in their states for greater transparency and patient protections.
- NCPA Files Brief in Washington Medicaid Lawsuit: NCPA, along with the National Association of Chain Drug Store and the Washington State Pharmacy Association have filed a legal brief in a case that involves changes to the way that state reimburses community pharmacies that serve Medicaid patients. The suit alleges that the state rule does not make required adjustments for prescriptions to Medicaid patients and threatens patient access. In addition, the brief argues that the state is violating federal and state laws by hindering Medicaid patient access to care.
