Prescription Drug Abuse - Susan Awad
•Télécharger en tant que PPTX, PDF•
2 j'aime•582 vues
State Legislative Conference 2016
Recommandé
Contenu connexe
Tendances
Tendances (20)
En vedette
Similaire à Prescription Drug Abuse - Susan Awad
Similaire à Prescription Drug Abuse - Susan Awad (20)
Plus de American Academy of Family Physicians
Plus de American Academy of Family Physicians (20)
Dernier
Dernier (20)
Prescription Drug Abuse - Susan Awad
- 1. SusanAwad American Society of Addiction Medicine
- 3. Source: Park H and Bloch M. How the Epidemic of Drug Overdose Deaths Ripples Across America. The New York Times. Jan 19, 2016. http://www.nytimes.com/interactive/2016/01/07/us/drug- overdose-deaths-in-the-us.html Accessed October 3, 2016.
- 4. POLICYTRENDS FEDERAL STATETREATMENT Medication-Assisted Treatment (MAT) • Increase patient limit • CARA Sec. 303 • Funding • Clinic regulations • Diversion control Naloxone • Co-prescribing & standing orders • Pricing • Access laws • Good Samaritan laws Parity • WHTask Force • New legislation • Implementation & enforcement PREVENTION PDMPs • NASPER reauthorization • Expanded access • Mandatory enrollment/ use Prescriber Education • ER/LA REMS update • CDC Guideline • Mandatory CME Quantity Limits • Partial fills • Medicare lock-in • Partial fills • Prescribing limits
- 5. ComprehensiveAddiction and RecoveryAct (CARA) Expands DATA 2000 prescribing privileges to NPs and PAs Requires updates to 8-hour course andTIP 40 Allows states to add training requirements and lower patient limit Administrative rule increases patient limit to 275 Qualify via board certification or practice setting Annual reporting requirements & 3-year renewal Grants to fund treatment
- 7. CARA Sec. 107:Grants to FQHCs,OTPs, DATA 2000-waived practitioners to support naloxone co-prescribing to patient or caregiver ($5m through 2021) Sec. 110:Grants to states to implement standing orders & encourage pharmacies to dispense naloxone, develop training materials & education public ($5m through 2019) House JudiciaryCommittee Hearing: Treating the Opioid Epidemic: The State of Competition in the Markets for Addiction Medicine (Sept. 2016) FDA AdvisoryCommittee (Oct. 2016)
- 8. Source: National Conference of State Legislatures. Drug Overdose Immunity and Good Samaritan Laws. August 1, 2016. http://www.ncsl.org/research/civil-and-criminal-justice/drug-overdose- immunity-good-samaritan-laws.aspx Accessed October 3, 2016. NaloxoneAccess laws may give immunity to prescribers, dispensers and/or lay administrators acting in good faith; allow for layperson distribution and possession w/o Rx; and/or allow for third-party prescribing or standing orders. Good Samaritan laws may give immunity for bystanders from possession of a controlled substance and/or drug paraphernalia, as well as other offenses such as probation or parole violations.
- 9. Mental Health Parity andAddiction EquityAct (2008) White HouseTask Force Recommendations due Oct. 31 Legislation Mental Health Reform (H.R. 2646/S. 2680) Behavioral HealthTransparencyAct (H.R. 4276/S. 2647)
- 10. Source: ParityTrack. Parity Implementation National Survey. Available at: https://www.paritytrack.org/reports Accessed: October 18, 2016.
- 11. CARA Sec. 109: NASPER Reauthorization allows funds to be used to maintain existing PDMP, improve integration with prescriber workflow; requires plan for achieving interoperability with HIT systems, facilitation of prescriber use ($10m/year through 2021)
- 13. CDC Guideline Surgeon General “Turn theTide” Campaign & Report FDA Opioids Action Plan • “Black Box” warning on opioids, benzodiazepines • ER/LA REMS Update • CARA Sec. 106: Requires HHS Secretary to develop recommendations regarding prescriber education on opioids VA/DOD Guideline update
- 14. Source: Federation of State Medical Boards. Continuing Medical Education Board-by-Board Overview. Available at: https://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/GRPOL_CME_Overview_by_State.pdf State Details CA 12 hrs before second license renewal or w/in 4 years FL Pain mgmt. clinics only IA 2 hrs every 5 years (primary care only) KY 4.5 hrs every 3 years on PDMP, pain mgmt. or addiction MD 1 hr on opioid prescribing MA 3 hrs every 2 years NC 1 hr NH 3 hrs for initial licensure + every 2 years State Details NV 2 hrs every other 2 yr cycle NM 5 hrs every 3 years OH Pain mgmt. clinics only OK 1 hr every 2 years RI 2 hrs – topic optional SC 2 hrs every 2 years TN 1 hr every 2 years TX Pain mgmt. clinics only VT 1 hr on pain mgmt. + 1 hr on controlled substances prescribing WV 3 hrs every 3 years
- 15. CARA Sec. 702: Partial Fills of Schedule II Controlled Substances.Allows for partial fills if requested by patient or prescriber. Remaining portions can be filled within 30 days. Sec. 704: Medicare Part D Drug Management Program. Allows Prescription Drug Plans (PDPs) to establish patient review and restriction programs (“lock-in” programs) for beneficiaries considered at risk of prescription drug misuse.
- 16. Source: K.Murphy, M.Becker, J.Locke, C.Kelleher, J.McLeod, and F.Isasi, Finding Solutions to the Prescription Opioid and Heroin Crisis: A Road Map for States (Washington, D.C.: National Governors Association Center for Best Practices, July 2016). State Type Prescription Limits Connecticut Statute 7-day limit for new opioid prescriptions for adults and all opioid prescriptions for minors. Exceptions for chronic and cancer pain, palliative care and clinical judgment. Illinois Statute Schedule II prescriptions limited to 30-day supply, with exceptions. Permits multiple prescriptions up to a 90-day supply if the prescriber meets specified conditions. Kentucky Board rules required by statute 48-hour limit on dispensing of Schedule II and III controlled substances by physicians. No limit on opioid prescriptions. Massachusetts Statute 7-day limit for new opioid prescriptions for adults and all opioid prescriptions for minors. Exceptions for chronic and cancer pain, palliative care and clinical judgment. Washington Guideline and board rules required by statute Pain specialist consultation required prior to prescribing daily morphine equivalent doses of 120 mg or greater, with exceptions.
Notes de l'éditeur
- 4,200 members Founded 1954 Membership composed of a mix of specialties: 1/3 psychiatry, 1/3 primary care, 1/3 other specialties (OB/GYN, pediatrics, emergency medicine, etc) Addiction medicine recently recognized as a multispecialty subspecialty under ABPM. We hope and are planning for the first ABMS exam to be held next year, although it hasn’t been announced There will be a 5-year period following the first exam when ABMS-boarded physicians can sit for the exam without going through a fellowship first
- 2014 More than 28,000 opioid-related overdose deaths (Rx 18,893 and heroin 10, 574). Treatment gap: In 2015, 2.0 million people reported having a pain reliever use disorder and 822,000 people received treatment for the misuse of pain relievers Over half of the nation’s counties did not have a health provider with the ability to prescribe the medication. Letter last month in JAMA Psychiatry found: Medicare beneficiaries had the highest and most rapidly growing rate of “opioid use disorder.” The data showed the number of doctors who prescribed buprenorphine-naloxone equaled less than 2 percent of the 381,575 prescribers responsible for 56,516,854 Schedule II opioid claims. For instance, the researchers found that for every 40 family physicians prescribing pain killers, only one family physician prescribed the addiction management drug.
- Overview of policy trends at federal and state level Policies can be categorized in two buckets: treatment (demand reduction) and prevention (supply reduction)
- Both Congress and the Obama Administration have made efforts to increase access to medication-assisted treatment. This summer, Congress passed CARA (P.L. 114-198): signed July 2016 First addiction-related bill to receive Senate floor time in decades MAT-related provisions include: Expansion of prescribing privileges to NPs and PAs – requires 24 hours of training. SAMSHA working on implementation. Update to 8-hour buprenorphine waiver course and TIP 40 Allows state to add training requirements and lower the patient limit For its part, the Administration included MAT as one of its three priorities to combat the opioid epidemic. (We’ll talk about the other two – naloxone access and prescriber education – shortly) In June, HHS issued a final rule to raise the buprenorphine patient limit to 275 Physicians must be board-certified or work in a qualified practice setting Requires annual reporting and renewal of waiver every three years At least 1200 physicians have received waivers to treat up to 275 patients HHS is also using its funding authority to increase treatment access March 2016: $94 million to 271 health centers in 45 states; administered by HRSA; expected to help awardees hire approximately 800 providers to treat nearly 124,000 new patients Aug 2016: $53 million in funding to 44 States, four tribes and DC; administered by SAMHSA and CDC; support 6 programs, including Medication-Assisted Treatment Prescription Drug Opioid Addiction Grants to provide up to $11 million to 11 states to expand access to MAT services. Awardees are Alaska, Arizona, Colorado, Connecticut, Illinois, Louisiana, New Hampshire, North Carolina, Oklahoma, Oregon, and Rhode Island. (SAMHSA).
- Laws/regulations to address treatment quality and diversion MA (2014) Chapter 258 of the Acts of 2014, “An Act to Increase Opportunities for Long Term Substance Abuse Recovery” - requires that all corporate entities treating more than 300 patients for opioid dependency in the form of agonist therapy obtain a license from the Department of Public Health WV SB 454 (March 2016) – establishes licensing requirements for medication-assisted treatment facilities TN SB 829 (April 2016) - requires all nonresidential substitution-based treatment centers for opiate addiction to obtain a certificate of need by July 1, 2016, including those on the premises of a physician's office GA SB 402 (April 2016) - provides for a moratorium on the issuance of new licenses to opioid treatment programs PA HB 2330 (introduced Sept 2016) – restricts buprenorphine access to opioid treatment programs
- CARA Sec. 107: Grant funds could be used to: (1) establish a program for prescribing a drug or device for overdose reversal; (2) train and provide resources for health care providers and pharmacists on the prescribing of overdose reversal drugs or devices; (3) purchase overdose reversal drugs or devices for distribution; (4) offset the co-payments and other cost sharing associated with overdose reversal drugs or devices; and (5) establish protocols to connect patients who have experienced a drug overdose with appropriate treatment, including medication-assisted treatment and appropriate counseling and behavioral therapies. CARA Sec 110: In this grant program, the Secretary of HHS would award grants to States to: (1) implement strategies for pharmacists to dispense an opioid overdose reversal drug or device pursuant to a standing order; (2) encourage pharmacies to dispense opioid overdose reversal medication pursuant to a standing order; (3) develop or provide training materials on the administration of an opioid overdose reversal drug or device; and (4) educate the public concerning the availability of overdose reversal drugs or devices. A grant may be awarded only if the State involved has authorized standing orders to be issued for overdose reversal drugs or devices. Aug 2016: The Prescription Drug Opioid Overdose Prevention Grants will provide up to $11 million to 12 states to reduce opioid overdose-related deaths. Funding will support training on prevention of opioid overdose-related deaths as well as the purchase and distribution of naloxone to first responders. Awardees are Alaska, Arkansas, Illinois, Missouri, New Jersey, New Mexico, Oklahoma, South Carolina, Washington, West Virginia, Wisconsin, and Wyoming. (SAMHSA)
- Naloxone access laws may give immunity to prescribers, dispensers and/or lay administrators acting in good faith; allow for layperson distribution and possession without a prescription; and/or allow for third-party prescribing or standing orders. Good Samaritan laws may give immunity for bystanders from possession of a controlled substance and/or drug paraphernalia as well as other offenses such as probation or parole violations. New Mexico became the first state to enact legislation to increase access to Naloxone in 2001. By June 22, 2016, all but three states (KS, MT, WY) had passed legislation designed to improve layperson naloxone access. Also as of June 22, 2016, 37 states and the District of Columbia have enacted some form of a Good Samaritan or 911 drug immunity law. These laws generally provide immunity from supervision violations and low level drug possession and use offenses when a person who is either experiencing or observing an opiate-related overdose calls 911 for assistance or otherwise seeks medical attention for themselves or another. Network for Public Health Law is good resource for various laws: https://www.networkforphl.org/_asset/qz5pvn/network-naloxone-10-4.pdf
- Mental Health Reform The House voted overwhelmingly (422-2) to pass H.R. 2646, the Helping Families in Mental Health Crisis Act of 2016 on July 6, 2016. Requires federal agencies to collaborate to improve compliance with the mental health parity law, to report on federal parity investigations and to create a plan to improve federal parity enforcement. Requires a Government Accountability Office (GAO) study on mental health insurance parity. S. 2680 - Requires audits of plans that have five or more parity violations and reports to Congress on the result of completed federal parity investigations. Requires additional federal guidance to help plans comply with the parity law. Requires a federal action plan to enhance parity enforcement and a GAO parity study Behavioral Health Coverage Transparency Act of 2015 This bill amends the Public Health Service Act, Employee Retirement Income Security Act of 1974 (ERISA), and Internal Revenue Code to direct the Departments of Health and Human Services (HHS), Labor, and the Treasury to require group health plans and health insurers to disclose the analyses performed to ensure compliance of plans or coverage with the law and regulations. Disclosures must include findings and conclusions regarding whether non-quantitative treatment limitations (e.g., tiered benefits, step therapy, or preauthorization) applied to mental health or substance use disorder benefits are comparable to, and applied no more stringently than, such limitations on medical and surgical benefits. HHS, Labor, and Treasury must: (1) issue guidance on the process for current and potential participants and beneficiaries to file formal complaints of plans or insurers being in violation of the requirement for parity between mental health and substance use disorder benefits and medical and surgical benefits, (2) conduct audits of plans and insurers to determine compliance with parity requirements and publish information from those audits, and (House bill) (3) publish information on denials of claims by plans and insurers for mental health and substance use disorder services compared to denials of claims for medical and surgical services. HHS must establish a consumer parity portal website that allows for submission of complaints and provides information to consumers on parity. The Government Accountability Office must report on HHS, Labor, and Treasury efforts to enforce parity. (Senate bill) State health insurance commissioners must report on compliance of plans and insurers with parity requirements and include a comparison of benefits.
- ParityTrack has: Analysis of current legislation, regulatory actions and litigation by state A model bill that addresses some of the most critical issues in parity at basic levels, including regulatory agency accountability, health benefit plan transparency, definitional clarity for mental health conditions and substance use disorders, consumer and provider education, and coverage for medications that address the opioid crisis. (http://scattergoodfoundation.org/sites/default/files/StateParityLegislation.pdf) Coalitions working on legislation in: Pennsylvania, Ohio, Tennessee, NJ, Connecticut Examples: Illinois: HB1 became law in Sept. 2015 (after a veto override by the General Assembly). It has several sections related to parity: Makes clear that medical necessity reviews for substance use disorder services cannot use any other criteria besides those put forth by the American Society of Addiction Medicine (ASAM). Requires plans to make medical necessity criteria for behavioral health treatment available to enrollees and provide a reason for coverage denials within a reasonable amount of time. Extends the state parity law so that it applies to individual plans. Requires plans to cover opioid antagonists (like naloxone), if a plan covers prescription medications. Requires plans to make their prescription medication formularies for substance use disorder medications “no less favorable” than those in place for other medications. Requires all Illinois Medicaid plans to cover opioid antagonists and other prescription FDA-approved medications for treating substance use disorders. Requires the Illinois Department of Insurance to enforce the state parity law and the Federal Parity Law by: Proactively looking for parity violations Actively responding to consumer and provider complaints Taking appropriate regulatory action when parity violations are found Requires the Illinois Department of Insurance to develop a consumer and provider education program about parity that will include live trainings and webinars. Requires the Illinois Department of Insurance to develop a parity hotline for consumers. Requires Illinois Medicaid plans to cover any prescription medications for substance use disorders and that there cannot be any prior authorization required for these medications and that any utilization management has to follow ASAM criteria. It also requires Medicaid coverage for opioid antagonists and requires Medicaid plans to comply with the state parity law Pennsylvania: Among many other things, HB 2173 from the current legislative session will do the following: Requires insurers to submit annual reports detailing their compliance with the Federal Parity Law , especially their compliance regarding the use of non-quantitative treatment limitations (NQTLs) Provides specific detail for how the Insurance Department can implement the Federal Parity Law Defines behavioral health conditions as they are defined in the most recent versions of the DSM or the ICD
- 22 of the 49 states with PDMPs now legally mandate prescribers to query the system before writing for controlled substances with recognized potential for abuse or dependence. In Sept. California Gov. Jerry Brown signed a law requiring prescribers to check the CURES database when prescribing Schedule II-IV medications and every 4 months thereafter. Delayed implementation until 6 months after the database is certified operational. Policymakers should seriously explore and evaluate more positive approaches, including pay-for-performance, malpractice discounts, or immunity from liability for prescribers who diligently use the systems. (Haffajee RL et al JAMA Mandatory Use of Prescription Drug Monitoring Programs 2015) NGA Opioid Road Map includes recommendations to: Require providers to check the PDMP before prescribing Schedule II, III and IV controlled substances. Require pharmacists to report to the PDMP within 24 hours. Examples: New Hampshire: Prescribers are required to query the PDMP when prescribing Schedule II-IV opioids for a patient’s initial prescription for the management or treatment of pain and at least twice a year thereafter; except when 1) controlled medications are being administered to patients in a health care setting; 2) treating acute pain associated with serious traumatic injury, post-operatively, or with an acute medical condition, with clear objective findings by the practitioner, for no more than 30 days. (Effective September 1, 2016) New Mexico: Requires practitioners other than veterinarians and pharmacists to obtain and review a PDMP report prior to prescribing or dispensing an opioid for the first time to a patient. It further requires practitioners who continuously prescribes or dispenses a controlled substance, to review a PDMP report and a report form an adjacent state, if the practitioner has access to such a system, no less than once every three months for these patients. (Effective January 1, 2017) In March, Virginia passed several PDMP-related bills: Allows prescribers and dispensers to delegate PDMP access authority Requires prescribers or their delegate to request PDMP information on a patient at the time a new course of treatment is being initiated that includes the prescribing of opioids for more than 14 days. Requires dispensing information be submitted within 24 hours or the dispenser’s next business day. (effective Jan 2017)
- CDC Guideline – webinar series 11/29:Assessment for Opioid Use Disorder and Referral to Evidence-Based Treatment 12/6: Risk Mitigation Strategies: PDMPs, UDT, and Naloxone 12/13: Effective Communication with Patients About Opioid Therapy Surgeon General is promoting CDC prescribing guidelines through the “Turn the Tide” campaign. Pocket guide pictured here. Report to be issued on November 17. Aug 2016 - FDA is requiring boxed warnings – the FDA’s strongest warning – and patient-focused Medication Guides for prescription opioid analgesics, opioid-containing cough products, and benzodiazepines – nearly 400 products in total Prescriber education recommendations must include recommendations on: Which prescribers should participate in such programs; and How often participation is necessary VA/DOD updating its Clinical Practice Guideline on the Management of Opioid Therapy for Chronic pain (issued in 2010)
- State CME requirements – updated May 19, 2016 CA – 12 hours before second license renewal or within four years, whichever comes first FL – limited to pain management clinics IA – for primary care physicians who treat chronic pain, two hours every five years KY – 4.5 hours every three year licensing cycle as of 2015. Requirement passed in 2012. MD – one credit – within current renewal cycle MA – three hours every two-year licensing cycle NC – one hour every licensing cycle. NH – three hours in the area of pain management and addiction disorder or a combination, as a condition for initial licensure and license renewal – every two years. NV – two hours every other two-year licensing cycle NM – Between November 1, 2012 and no later than June 30, 2014, all NM medical board licensees who hold a federal drug enforcement administration registration and licensure to prescribe opioids, shall complete no less than five hours OH – limited to pain management clinics OK – 1 hour every other year on prescribing, dispensing, and administering of controlled substances RI - 2 hours on universal precautions, infection control, modes of transmission, bioterrorism, end of life education, palliative care, OHSA, ethics, or pain management SC - at least two (2) hours must be related to approved procedures for prescribing and monitoring schedules II, III, and IV controlled substances. TN - at least 1 of 40 on prescribing practices; providers of intractable pain treatment must have specialized CME in pain management TX – limited to pain management clinics VT - 1 hour must be on hospice, palliative care, and/or pain management services. For each licensee who holds or has applied for a DEA number, at least 1 CME hour must be on safe and effective prescribing of controlled substances. WV - Beginning May 1, 2014, unless a physician certifies that he or she has not prescribed, administered, or dispensed a controlled substance during the entire previous reporting period, every physician must complete a minimum of three (3) hours of drug diversion training and best practice prescribing of controlled substances training as a condition of licensure renewal
- As of June 23, 2016, four states (Connecticut, Massachusetts, Maine and New York) have established seven-day statutory limitations on opioid prescriptions in certain circumstances, with exceptions. Other states have less restrictive statutory limits on prescribing, or promote safe opioid prescribing and dispensing through regulations and guidelines. The following chart provides examples of several state approaches. Maine – no patient can be on more than 100 MME Rhode Island – 30 MME limit