President’s Commission on Combating Drug Addiction Interim Report Released: The report, attached, includes recommendations for action by the President. The Commission recommended that the President “declare a national emergency” that would empower Cabinet members “to take bold steps” and “force Congress to focus on funding and empowering the Executive Branch even further” to deal with the loss of life associated with opioids and drug addiction. Other policy recommendations of interest to pharmacy include the following: (1) mandate prescriber education assistance with the assistance of medical and dental schools, and amend the Controlled Substances Act to require Drug Enforcement Administration registrants to take a course in proper pain management; (2) provide federal funding to enhance access to Medication Assisted Treatment (MAT); (3) provide states with model legislation to enhance access to naloxone; and (4) provide states with federal funding and support to enhance data sharing among Prescription Drug Monitoring Programs. The Commission will issue further recommendations this Fall. NCPA is reviewing the report and will respond and will be offering further suggestion on the role of the pharmacist.
NCPA Federal Pharmacy Priority Legislation Cheat Sheet: Attached and current as of July 28th the chart is a helpful NCPA member resource.
HIPAA Cyber Security Checklist and Infographic Available From HHS: The guide and graphic explains, in brief, the steps for a HIPAA covered entity or its business associate to take in response to a cyber-related security incident. Here is a link to the guide and infographic: https://www.hhs.gov/hipaa/for-professionals/security/guidance/cybersecurity/index.html. Also, here is information on a community pharmacy resource: COMPLIANCETrack (http://www.prsrx.com/compliance/)
NCPA Participates in Federal Meeting to Discuss the Role of Pharmacists in Mental Health and Substance Use Disorders: The meeting was hosted by the Substance Abuse and Mental Health Services Administration (SAMHSA) and discussion centered on how to best incorporate the pharmacist in care for these patients. Much of the meeting focused on the role of community pharmacy. NCPA will continue to participate in future work of the group and has provided input on a white paper on the topic.
CMS Projects Medicare Part D 2018 Premium Decline: The Centers for Medicare & Medicaid Services (CMS) announced that the Medicare Part D prescription drug plan average basic premium for 2018 “is projected to decline to an estimated $33.50 per month.” CMS notes that the decline is “approximately $1.20 below the actual average premium of $34.70 in 2017.” The agency expects to release premiums and costs for Medicare health and drug plans for 2018 “in mid-September.” The agency also notes that Medicare Part D spending “continues to increase faster than spending for other parts of Medicare, largely driven by spending on high-cost specialty drugs.” Additional information can be found at: https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Ratebooks-and-Supporting-Data.html.
Medicare Diabetes Prevention Program Call Announced: This week the Center for Medicare and Medicaid Innovation (CMMI) announced it will hold an August 16, 2017 listening session on the Medicare Diabetes Prevention Program (MDPP) expanded model, focusing on the MDPP proposals included in the 2018 Medicare Physician Fee Schedule (PFS) proposed rule. The 2018 PFS proposed rule addressed issues including the MDPP payment structure, as well as additional supplier enrollment requirements and supplier compliance standards to ensure program integrity. During this call, CMS experts will provide a high-level overview of the proposed MDPP policies and the call will run from 1:30pm-3:00pm EST. Additional information can be found here<https://innovation.cms.gov/resources/dpp-listeningsession.html>, and interested participants can register here<https://blh.ier.intercall.com/>. NCPA is reviewing the proposed 2018 physician fee schedule rule as it applies to community pharmacy and will be providing comments by the September deadline.
Pharmacy HIT Collaborative Weighs in With Office of the National Coordinator: On July 31, 2017, PHIT Collaborative submitted comments regarding the proposed Interoperability Standards Measurement Framework. The Collaborative has been involved with the federal agencies, including the Office of the National Coordinator (ONC), developing the national health information technology (HIT) framework since 2010. Pharmacists are users of health IT and are especially supportive of interoperability standards incorporating Health Level Seven (HL7), SNOMED CT, RxNorm (National Library of Medicine), NCPDP SCRIPT (National Council of Prescription Drug Programs), and NCPDP Real Time Formulary and Benefits (currently under development). The Collaborative supports the use of these particular standards which are not only important to pharmacists for use in providing specific person-centered care and services to patients, but these particular standards would help in reaching the proposed framework’s goal of measuring nationwide interoperability progress.
FDA User Fee Legislation Heads to President’s Desk: The Senate cleared, 94-1, a five-year reauthorization of FDA user fee programs that fund the agency’s drug and medical device reviews. The FDA Reauthorization Act of 2017 now heads to President Donald Trump. The administration put out a mixed statement on the bill in July following House passage. The user fee programs account for about half of FDA’s yearly budget. The current program expires on Sept. 30. The new five-year agreement runs from fiscal 2018 to 2022 and enables FDA’s prescription drug program to collect nearly $880 million in user fees from the industry next year. In addition, FDA would take in $494 million in generic drug fees, $183 million in medical device fees and $45 million in biosimilar fees. The package also addresses FDA’s digital health work and expanded use of electronic health records for oversight of drugs and devices.
In the States:
- 2017 Key Legislation Passed in the States: NCPA has compiled the attached report on key pharmacy legislation passed in states thus far this year. Please note this is not a comprehensive listing; rather, it’s geared mostly to PBM-related issues with a few exceptions.
- Texas: NCPA State Government Affairs submitted a letter to the Texas State Board of Pharmacy supporting the recommendations their Task Force identified regarding the new General Chapter <800> implementation. NCPA fully supports the comprehensive and thoughtful work of the Task Force and is happy to report that the TSBP recognized the current requirements in rules regarding “hazardous drugs” as sufficient safety precautions and aligned with USP Chapter 800 requirements.
