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#RXABUSE WASHINGTON, D.C. National Prescription Drug Abuse Prevention Policy Meeting Tuesday, December 2, 2014 COMMERCIAL.

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Presentation on theme: "#RXABUSE WASHINGTON, D.C. National Prescription Drug Abuse Prevention Policy Meeting Tuesday, December 2, 2014 COMMERCIAL."— Presentation transcript:

1 #RXABUSE WASHINGTON, D.C. National Prescription Drug Abuse Prevention Policy Meeting Tuesday, December 2, 2014 COMMERCIAL SUPPORTERS

2 #RXABUSE WASHINGTON, D.C. Objectives Information sharing –Unique perspectives –Contextual analysis Policy discussion and consensus (lowest common denominator) Planning –Maximize use of limited resources –Harmonize efforts

3 #RXABUSE WASHINGTON, D.C. Methods Participant presentations –Accomplishments –Policy priorities Presentations, Q&A Networking

4 #RXABUSE WASHINGTON, D.C. Themes Progress [2013] Evolution of the epidemic [2013] Evaluation of policy –Expand and enhance for greater impact –Refine to address unintended consequences Access to care Core values

5 #RXABUSE WASHINGTON, D.C. Federal Policy Activity Secure and Responsible Drug Disposal Act (effective 10/9/14) Abuse-deterrent opioids (guidance, approval, and labeling) FDA approved naloxone auto-injector New opioid labels (“severe enough”) and post-market study requirements DEA enforcement (distributors, pharmacies, prescribers, FedEx, and NFL) and prosecutions Hydrocodone rescheduling Grant support (PMPs and research) LA/ER opioid REMS (voluntary education)

6 #RXABUSE WASHINGTON, D.C. State Responses to Opioid Abuse Mandatory prescriber education – should cover all controlled substances, differential diagnosis, interventions/referrals, and fraud Mandatory PMP data checks Good Samaritan, naloxone laws – first responders, Rx Pain clinic registration and regulation Safer prescribing and abuse-prevention standards Prosecutions –Second-degree murder (knowing indifference to consequence) –Involuntary manslaughter (harmful activity w/o due caution)

7 #RXABUSE WASHINGTON, D.C. Progress CDC reported 5% decline in opioid-related overdose deaths between 2011 and 2012, the first decline since 1999 (10/15/14) Overdose deaths from opioids fall 27% in Washington (1/28/14) Prescription drug deaths falling across Florida (10/14/13) National survey shows reduced levels of Rx abuse among young adults (9/4/13) Kentucky sees decline in drug overdose deaths, including Rx overdose (8/8/13) Opioid medication abuse down in 10 states (KY, LA, MA, MS, NH, NY, OH, OK, RI, WV) (1/8/13)

8 #RXABUSE WASHINGTON, D.C. Evolution of the Epidemic Reduced supply of opioid medications available for abuse and inadequate reduction in demand contribute to increased use of heroin and misuse of buprenorphine Benzodiazepine and stimulant abuse Counterfeits, analogs, and new delivery systems and manufacturing processes Shifting tactics of dirty docs –From pill mills to black market biologics (created by biological processes) –Waste, fraud, and abuse in testing for substance use

9 #RXABUSE WASHINGTON, D.C. Building on Progress: Accomplishments and Priorities

10 #RXABUSE WASHINGTON, D.C. Brief Introductions Name Organization 2014 Accomplishments 2015 Priorities

11 #RXABUSE WASHINGTON, D.C. Updating the National Strategy National Strategy was endorsed by 30+ not-for-profit organizations 2015 update in draft form Themes and topics discussed at Policy Meeting Seeking feedback, endorsements, and quotes –Embargoed draft at claad.org/2015ns –January release

12 #RXABUSE WASHINGTON, D.C. National Strategy Topics Community coalitions and recovery communities Data collection and analysis Interventions and treatment Professional education New technologies Restrictions on coverage Safe storage and responsible disposal Waste, fraud, and abuse

13 #RXABUSE WASHINGTON, D.C. Break

14 #RXABUSE WASHINGTON, D.C. Evaluating Policy

15 #RXABUSE WASHINGTON, D.C. Women and Newborns: A More Therapeutic Approach Stacey Worthy, Esq. Associate Attorney DCBA Law & Policy

16 #RXABUSE WASHINGTON, D.C. Pregnant Women and Substance Use Rx drug abuse epidemic affects all ages and demographics Impacts health and safety of mother and child Low rates of use (5.4%), but consequences are severe

17 #RXABUSE WASHINGTON, D.C. Neonatal Abstinence Syndrome Definition: group of problems due to opioid exposure in the womb –Other substances: alcohol, barbiturates, amphetamines, cocaine, marijuana, etc. Symptoms: fever, irritability, poor feeding, rapid breathing, seizures, sleep problems, slow weight gain, tremors, etc.

18 #RXABUSE WASHINGTON, D.C. Statistics Significant increases in newborns with NAS Tripled over the past 10 years –>5 of every 1,000 –200,000 per year

19 #RXABUSE WASHINGTON, D.C. Barriers to Treatment Barriers: stigma, punitive laws & policies Detection and punishment policies: –Surveillance-oriented drug testing –Arrest –Prosecution –Incarceration –Loss of custody

20 #RXABUSE WASHINGTON, D.C. Theories of Prosecution Child abuse in 17 states Involuntary commitment in 3 states Mandatory reporting laws in 19 states Child protection laws apply to unborn fetuses in 2 states

21 #RXABUSE WASHINGTON, D.C. Tennessee Cases Criminalized substance use during pregnancy –Assault –“Narcotics” narrowly defined, broadly applied At least 4 arrests between July and November –Law may deter care: mother gave birth roadside and failed to take newborn to hospital

22 #RXABUSE WASHINGTON, D.C. Arguments Against Punitive Laws Not effective deterrent b/c SUD is an illness Cause distrust of health care providers Disincentive to seek prenatal care

23 #RXABUSE WASHINGTON, D.C. Treatment Comprehensive treatment and recovery services MAT is effective Retain mother-child relationship & custody

24 #RXABUSE WASHINGTON, D.C. States with Non-Punitive Laws 25 states give priority access to treatment Florida task force Ohio pilot program

25 #RXABUSE WASHINGTON, D.C. Conclusion For more information, see: – NAMSDL’s Commentary: State Responses to Increasing Rates of Neonatal Abstinence Syndrome: Alternatives to Prosecution and Incarceration CLAAD.org LinkedIn.com/in/staceyworthy DCBALaw.com Thank You Questions and Discussion

26 #RXABUSE WASHINGTON, D.C. Mitigating Unintended Consequences Part 1 Michael C. Barnes, Esq. Executive Director Center for Lawful Access and Abuse Deterrence

27 #RXABUSE WASHINGTON, D.C. Access to Care: Controlled Substance Regulation Regulatory role fulfilled using law enforcement tactics –Drug distributors –Pharmacies –Controlled substance prescribers –FedEx and NFL Fear of prescribing controlled substances Denials of medications – even for addiction – at pharmacies H.R and S would provide for corrective action plans

28 #RXABUSE WASHINGTON, D.C. Access to Care: Medication-assisted Treatment DATA 2000: 30/100 patient limit for buprenorphine treatment (opioid dependence) –Waiting lists –Prescribers compelled to abandon patients –Increasing demand on black market Petition to HHS to raise the limit Federal legislation –“Omnibus” coalition bill –S (Markey bill)

29 #RXABUSE WASHINGTON, D.C. Access to Care: Payer Policies Payer policies enable waste, fraud, and abuse in testing for substance use –Outmoded, inaccurate technology –Duplication of services Payer responses to waste, fraud, and abuse yield further limits on access –Restrictions on coverage –Labs forced to question professional discretion Medicare contractor: bundle 40+ for a flat fee

30 #RXABUSE WASHINGTON, D.C. Protecting Core Values: Compassion Jailing moms and seizing newborns in response to NAS Denials of medications –Pain –Anxiety, sleeplessness, ADHD –Addiction Waiting lists for treatment

31 #RXABUSE WASHINGTON, D.C. Federal Policy Update

32 Federal Update: “Ensuring Patient Access to Effective Drug Enforcement Act” (H.R. 4709/S. 2862) Kristen LaRose Freitas Senior Director, Federal Government Affairs HDMA

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34 Controlled Substances Act (CSA) of 1970 Manufacturers Distributors/Wholesalers Pharmacies Prescribers

35 Prescription Drug Abuse Numerous bills introduced to address various aspects of the issue – PDMPs, Education, etc. Specifically, patients challenges with filling prescriptions for opioids for the management of pain and treatment of addiction – “Making the Pharmacy Crawl” – Wall Street Journal (September 29, 2012) – “Prescription painkiller crackdown has gone ‘way too far,’ some doctors believe” – Tampa Bay Times (September 1, 2014)

36 H.R. 4709/S Clarifies existing authorities under the CSA – defines “imminent danger” Requires enforcement escalation process (Corrective Action Plan) Requires a Report to Congress on the impact of enforcement activities and opportunities for agency and stakeholder collaboration

37 H.R Introduced by Reps. Marino (R-Pa.), Blackburn (R-Tenn.), Welch (D-Vt.) and Chu (D-Calif.) Jointly Referred to: Energy and Commerce Committee Judiciary Committee Passed the House by voice vote on July 29, 2014

38 S Introduced by Sens. Hatch (R-Utah) and Whitehouse (D-R.I.) Referred to Senate Health, Education, Labor and Pensions Committee

39 Supporters American Academy of Pain Management American Pharmacists Association Center for Lawful Access and Abuse Deterrence The Center for Practical Bioethics and PAINS Compassion & Choices Healthcare Distribution Management Association Hospice and Palliative Nurses Association National Fibromyalgia & Chronic Pain Association National Association of Chain Drug Stores National Community Pharmacists Association Virginia Cancer Pain Initiative U.S. Pain Foundation

40 Outlook for 114 th Congress Legislation will need to be reintroducedTiming?Opposition?

41 Questions? Kristen LaRose Freitas Senior Director, Federal Government Affairs Healthcare Distribution Management Association

42 #RXABUSE WASHINGTON, D.C. “Omnibus” Draft Legislation Kyle Simon Director of Policy and Advocacy Center for Lawful Access and Abuse Deterrence

43 #RXABUSE WASHINGTON, D.C. “Omnibus” Draft Legislation (1/6) Bipartisan U.S. Senate HELP Committee Prescription Drug Abuse Working Group formed April 2014 Examine ways to reduce Rx abuse –Characteristics and challenges –Consider government, public health groups, providers, and law enforcement activities

44 #RXABUSE WASHINGTON, D.C. “Omnibus” Draft Legislation (2/6) Pain Care Forum of 60+ organizations rose to the occasion and drafted wish list 12 recommendations for federal government to impact prescription drug abuse epidemic Draft online at claad.org/omnibus Presented to HELP Committee staff in October; next steps with GOP control?

45 #RXABUSE WASHINGTON, D.C. “Omnibus” Draft Legislation (3/6) 1.Strengthen prescription monitoring programs –Interoperability –NASPER reauthorization 2.Regulate before raiding –Healthcare distribution supply chain raided by DEA without clear guidelines for compliance

46 #RXABUSE WASHINGTON, D.C. “Omnibus” Draft Legislation (4/6) 3.Specialty certification for opioid prescribers 4.Repeal Institution for Mental Diseases exclusion for substance use disorder treatment –Medicaid cannot cover institutional treatment in programs with more than 16 beds 5.Increase pain care education in medical curricula

47 #RXABUSE WASHINGTON, D.C. “Omnibus” Draft Legislation (5/6) 6.Pain management awareness campaign –Impact and magnitude: 100 million Americans in pain (IOM) –Risks, benefits, availability of treatment options –Danger of diversion and sharing prescriptions 7.Abuse-deterrent technology –FDA road map and incentives for manufacturers

48 #RXABUSE WASHINGTON, D.C. “Omnibus” Draft Legislation (6/6) 8.Expand access to opioid addiction treatment –Raise treatment limits from 30/100 to 250/500 9.Increase access to naloxone 10.Expand federal data collection on pain prevalence, barriers to care 11.Expand evidence-based data collection efforts around pain and pain management 12.Ensure coverage for quantitative urine drug testing for federal health program beneficiaries

49 #RXABUSE WASHINGTON, D.C. Networking Lunch

50 #RXABUSE WASHINGTON, D.C. State Policy Update

51 #RXABUSE WASHINGTON, D.C. Overdose Death Prevention Act Karen Perry Executive Director NOPE Task Force

52

53 Richard Perry Age 21

54 Florida Hospital Consent to Treatment

55 Hospital Release Orders

56 Facts  In 2012, there were 33,175 unintentional drug overdose deaths in the United States. (Source: Center for Disease Control)  2.5 million emergency department visits are attributed to drug misuse or overdose. (Source: Drug Abuse Warning Network (DAWN), 2011 National ED Estimates)  26.8% of the people who died from a drug overdose had experienced a prior drug overdose with a hospital visit. (Source: Palm Beach County Sheriff’s Office Overdose Suppression Project 2013)  82.3 % of the decedents had a known substance abuse history (Source: Palm Beach County Sheriff’s Office Overdose Suppression Project 2013)  51.3 % of the decedents were under the care of a physician (Source: Palm Beach County Sheriff’s Office Overdose Suppression Project 2013)

57 Heart Attack Victim Care The first 24 hours following a heart attack are usually spent in a coronary care unit (CCU) or an intensive care unit(ICU). Where skilled staff will:  Continuously monitor your heart rhythm  Administer a series of test and blood work  Administer medication as needed  Review patient’s history  Contact primary care and/or cardiac care physicians

58 Cardiac Care Day Two If you remain stable after 24 hours You may be transferred to the "telemetry" floor of the hospital  Continue to receive care by a cardiac care team.  Depending upon the severity of the heart attack and how quickly you received treatment, you may be able to go home within two to four days.

59 Overdose Patient Treat and Street

60 Intervention Point

61 Overdose Death Prevention Act (ODPA) A bill that requires specific rules that would apply to an emergency care practitioner when the patient suffers a non-fatal unintentional overdose.

62 ODPA Rules and Procedures  Proper medical stabilization (detox)  Substance Abuse Screening Brief Intervention and Referral to Treatment (SBIRT)

63 ODPA Rules and Procedures  Notify patient’s primary care physician.  Notify all patient’s prescribing doctors within last 12 months.

64 ODPA Rules and Procedures  Notify the patient’s emergency contact or next of kin.  Provide materials on addiction treatment, treatment facilities and practitioners.  Provide local involuntary treatment laws.

65 HIPAA The HIPAA law currently indicates that emergency room physicians may notify next of kin if they feel it important or necessary for survival of the patient. This linked-document (authored by the U.S. Department of Health and Human Services) provides a summary of the HIPAA Privacy Rule. dex.htmlhttp://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/in dex.html

66 HIPAA Federal Register-Volume 65. No. 250 ( ) Section (g) – Personal Representatives “We continue to allow covered entities to use their discretion to disclose certain protected health care information to family members, relatives, close friends, and other persons assisting in the care of an individual, in accordance with (b). We recognize that many health care decisions take place on an informal basis, and we permit disclosures in certain circumstance to permit this practice to continue. Health care providers may continue to use their discretion to address these informal situations” (p ).

67 Readmissions Because Centers for Medicare & Medicaid Services will penalize hospitals that see too many patients return within a month, now is the time to create strategies to avoid readmissions. The Centers for Medicare & Medicaid Services have been focusing on reducing acute care readmissions within 30 days of discharge through its Hospital Readmissions Reduction Program. Hospitals with higher than expected 30-day readmission rates incur penalties against their total Medicare payments as federal fiscal year Commercial payers likely will follow suit, as organizations such as the Joint Commission, Partnership for Patients and the National Quality Forum support this program.

68 Education and Advocacy  Be informed of local issues  Build Relationships  Educate Legislators and community partners  Create tool kit for community partners  Attend and provide testimonials at important legislative meetings

69 NOPE Task Force Mission To reduce the frequency and impact of drug overdose death through:  Community Education  Family Support  Purposeful Advocacy

70 Karen H. Perry Executive Director x201

71 Controlled Substance Enforcement Update With special thanks to: Lucy C. Gee, M.S., Director Florida Department of Health

72 Oxy

73

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77 Increased penalties for violations of controlled substance prescribing requirements Counterfeit-proof prescriptions pads Physicians and dentists to register on profile if prescribe controlled substances for pain Standards for controlled substance prescribing HB 7095 (2011) Overview 77

78 Pain management clinic registration - Physical examination - Designated physician - Exemptions from registration Prohibition on physician dispensing of CS II and III HB 7095 Overview (2011) 78

79 Public Health Emergency declared July 1, July 5 law enforcement and department investigators quarantined 105,579 drugs Pharmacies required to re-register with criminal background screening HB 7095 (2011) Overview 79

80 Days to report dispensing information to PDMP decreased from 15 days to 7 Changes to Chapter 499-Drug, Cosmetic and Household Products - Increased criminal acts - Wholesalers required to report distribution of controlled substances to database - Wholesalers required to credential physicians and pharmacies HB 7095 (2011) Overview 80

81 Senate Bill 462 Senate Bill 2272 House Bill Pain Management Clinics Registered 81

82 Pain Management Clinic Inspections 82

83 Prescribers Oxycodone Dosage Units Purchased by Florida Practitioners Source: ARCOS DEA Registration 83

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86 Prescribers Oxycodone Prescriptions Issued Source: Prescription Drug Monitoring Program 86

87 Dispensers Community Pharmacies 87

88 51% Decrease in Doctor Shopping Source: Prescription Drug Monitoring Program 88

89 Pain Management Clinic “Oxycontin Express” Derailed Figures are from Jan-June 2011 and required at that time only from Osteopatic Physicians 89

90 Discipline and Emergency Actions 90

91 41% Decrease in Oxycodone Deaths in Florida in 2012 Source: Drugs Identified in Deceased Persons by Florida Medical Examiners 2012 Report *The interim report for the first six months of 2013 will be available in late Spring, early Summer

92 Pain management clinic registration Prohibitions on dispensing Practice standards for prescribing Implementation of PDMP Counterfeit-proof prescription pads Re-permitting of pharmacies No preemption of local regulation Legislative Regulatory Tools

93 60% decrease in pain management clinics 83% pain management clinics pass stricter standards on the first inspection 24% reduction in Oxycodone prescriptions written by Florida doctors since Summary Results

94 Annual Oxycodone purchases reduced from >35 million to <500,000 27% decrease in patients discharged for drug abuse 70% decrease in patients discharged for drug diversion Summary Results

95 41% decrease in out-of-state patients 51% decrease in doctor shopping >5 Summary Results

96 41% decrease in Oxycodone deaths in Florida. Source: Drugs Identified in Deceased Persons by Florida Medical Examiners 2012 Report Summary Results

97 Office of the State Attorney Fifteenth Judicial Circuit Dave Aronberg

98 #RXABUSE WASHINGTON, D.C. Drug Policy and Federal Supremacy Michael C. Barnes Executive Director Center for Lawful Access and Abuse Deterrence

99 #RXABUSE WASHINGTON, D.C. Protecting Core Values: Federal Supremacy Article VI, paragraph 2 of the Constitution The federal government regulates interstate commerce Uninformed enthusiasm led to state attempts to ban a single medication What’s next? –Ban women’s health medications? –‘Medical’ heroin ballot measures and legislation? –Importation of non-FDA-approved drugs Broader issue –Interstate commerce (e.g., 2nd Amendment Preservation Act: MO, ID, KS, AK) –Fundamental protections (e.g., privacy of health care decisions)

100 #RXABUSE WASHINGTON, D.C. Maine Importation Law Maine permits consumer importation of drugs from foreign pharmacies (Canada, U.K., Australia, and New Zealand) under 32 MRSA § –Concern re: proliferation of model across states –NY and MA health plans facilitating illegal drug importation to lower costs

101 #RXABUSE WASHINGTON, D.C. California Supply Chain Law California prohibits the distribution, purchase, and sales of counterfeit and diverted medications under SB 600 Imposes criminal penalties, including fines and imprisonment Becomes effective law on January 1, 2015

102 #RXABUSE WASHINGTON, D.C. Which Model Will Prevail? Consumers and policy makers must be aware of risks and implications of the illegal importation of foreign drugs Insurers must provide adequate coverage of FDA-approved medications The pharmaceutical industry must acknowledge the role drug costs play in the importation debate The federal government must enforce federal law

103 #RXABUSE WASHINGTON, D.C. Break

104 Center for Lawful Access and Abuse Deterrence (CLAAD) National Prescription Drug Abuse Prevention Policy Meeting December 2, 2014 – Washington, D.C. PRESCRIPTION MONITORING PROGRAMS – PATIENT AND PRESCRIBER PRIVACY Sarah Kelsey, Chief Executive Officer National Alliance for Model State Drug Laws (NAMSDL) National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902,

105 What Is a Prescription Monitoring Program? 49 states and DC have enacted PMP legislation 49 states are operational, meaning they are both collecting data and disclosing data DC is in the process of adopting regulations; will be operational months after adoption California has the oldest continuously operating PMP, but the first PMP was started in New York in 1918 Began in paper format, started converting to electronic format in Oklahoma in 1990

106 National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, What Is a Prescription Monitoring Program? Public health and safety tool Used to detect patients, prescribers, and dispensers at risk of addiction or diversion Dispensing data on Schedule II – IV or V prescriptions is collected in a central repository Reporting dispensing data is mandatory Access to the data held in the repository is limited by statute

107 National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, Access to Prescription Monitoring Programs Direct access to data is generally limited to prescribers and dispensers In most cases, prescribers and dispensers can only access information on current patients – some states allow prescribers to access data on prospective patients 17 states require law enforcement to have either a search warrant, subpoena, or court order to receive PMP data

108 National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, Access to Prescription Monitoring Programs Only 10 of 36 states responding to a NAMSDL survey allow direct access by law enforcement Of those 10, half limit the number or type of law enforcement personnel allowed direct access “Fishing expeditions” are not allowed and wrongfully accessing or using data can result in disciplinary action, civil or criminal penalties Nebraska and Vermont do not allow law enforcement to have access to PMP information through the PMP system

109 National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, Access to Prescription Monitoring Programs Most states keep records identifying who has accessed the system, when, and on which patient, prescriber, or dispenser Those records can be used to identify any wrongful access of the system, whether by law enforcement, prescriber, or dispenser

110 National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, Penalties Civil penalties for wrongfully disclosing, using, or obtaining information from PMP database range from a fine of $50 to a fine of up to $250,000 Average is $5,000 – 10,000 Criminal penalties for wrongfully disclosing, using, or obtaining information from PMP database range from misdemeanor charges carrying a sentence of 30 days to felony charges carrying a sentence of up to 10 years Penalties also include sanctions against a prescriber or dispenser who violates privacy protections by the provider’s regulatory or licensing board

111 National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, HIPAA – Health Insurance Portability and Accountability Act Addresses use and disclosure of protected health information by covered entities “Protected health information” = individually identifiable health information that is transmitted or maintained electronically or in any other form or medium “Covered entities” = health care plan, health care clearing house, or a health care provider who electronically transmits health information to carry out financial or administrative activities related to health care covered under HIPAA Ex., health care payments, coordination of benefits, health care claims

112 National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, HIPAA – Health Insurance Portability and Accountability Act PMPs are not considered to be covered entities under HIPAA and are, therefore, not subject to the HIPAA privacy rule, meaning they can disclose prescription information submitted to the PMP without violating HIPAA Dispensers are considered to be covered entities, so they must comply with HIPAA when disclosing prescription information to PMPs Disclosure without permission of the patient may be made: To certain types of agencies/officials For 12 designated public interest purposes

113 National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, HIPAA – Health Insurance Portability and Accountability Act Public interest purposes applicable to PMP activities: Disclosure required by law Legal mandate compels use or disclosure of information and is enforceable in court Ex., statutes, regulations, subpoenas, court orders Public health activities Authority/agency must be responsible for public health matters as part of official mandate Authority/agency must be authorized by law to collect or receive information for … public health surveillance, public health investigation, and public health intervention

114 National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, Electronic Health Records and PMPs Electronic health record (EHR) is a digital version of a patient’s health record Health information exchange (HIE) allows medical providers to access the medical records of patient across organizations within a region, community, or hospital system Also refers to the company or organization that facilitates the exchange of information

115 National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, Electronic Health Records and HIPAA The “Safeguards Principle in the Privacy and Security Framework” – trust in electronic health information exchange can only be achieved if reasonable administrative, technical, and physical safeguards are in place HIPAA supports the Safeguards Principle by requiring covered entities to implement appropriate administrative, technical, and physical safeguards Safeguards include: securing locations and equipment; implementing technical solutions; workforce training Standard is flexible to allow entities of different sizes, functions, and needs to protect the privacy of protected health information

116 National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, Electronic Health Records and PMPs CRISP – Chesapeake Regional Information System for Our Patients Patients may opt out of system, meaning that a patient’s record will not be returned as the result of a query by a provider Certain sensitive health information is not included in the record, including mental health information that may be restricted from disclosure by local, state, or federal law

117 National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, Electronic Health Records and PMPs CRISP provides access to the Maryland PMP Access is limited to clinical providers – prescribers, dispensers, and other licensed healthcare practitioners Law enforcement, licensing boards, and all other types of users authorized by MD law must go through the MD PMP portal

118 National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, Electronic Health Records and PMPs CRISP security protections include: Encryption Password protection Ability to track every viewer of data and audit the system Other safeguards to protect against unauthorized use of the information

119 National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, Caselaw Oregon Prescription Drug Monitoring Program vs. DEA Initiated by the Oregon PDMP in September 2012 Asking for a declaratory judgment requiring the DEA to have a warrant to access PDMP data Federal law only requires DEA to have an administrative subpoena ACLU, four individuals who receive prescriptions for controlled substances in Oregon, and an Oregon physician were granted leave to intervene

120 National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, Caselaw District Court granted the motion of the intervening Plaintiffs for summary judgment declaring that compliance with the administrative subpoenas issued by the DEA would violate the Fourth Amendment rights of the intervening Plaintiffs and enjoined the DEA from issuing further subpoenas for records DEA appealed, and the case is currently pending in the 9 th Circuit Court of Appeals

121 National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, Missouri – The Lone Holdout The Missouri legislature has been attempting to pass a PMP bill for at least the last three years and it has been stalled in the Senate every time The main obstacles to getting legislation passed have been the concerns of certain Senators regarding the privacy and security of prescription information Because MO is the only state without a PMP, pharmacists are seeing patients from all over the country come to MO to fill prescriptions New legislation is being prepared; expected to be prefiled Dec. 1 in the MO legislature

122 National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, CONTACT INFORMATION Website: SARAH KELSEY, CEO NAMSDL Headquarters 420 Park Street Charlottesville, VA Phone: , ext HEATHER GRAY, Legislative Attorney Phone: , ext

123 #RXABUSE WASHINGTON, D.C. Mitigating Unintended Consequences Part 2 Michael C. Barnes, Esq. Executive Director Center for Lawful Access and Abuse Deterrence

124 #RXABUSE WASHINGTON, D.C. Protecting Core Values: Privacy (1/4) Utah PMP: active investigation standard 1.Detective accessed PMP data (“ongoing investigation”) to steal pain medications from a couple 2.On a “hunch,” detective searched PMP records of 480 first responders (after morphine theft from ambulances). Defendant’s records exhibited “the appearance of opioid dependence.” Charged with Rx fraud (unrelated to morphine theft)

125 #RXABUSE WASHINGTON, D.C. Protecting Core Values: Privacy (2/4) TN: Detective fired for investigating director of regional drug task force on his own (active investigation) Outlier cases Severe penalties for data breach Training and oversight are necessary

126 #RXABUSE WASHINGTON, D.C. Protecting Core Values: Privacy (3/4) Oregon: U.S. District Judge ruling –Patients and physicians both have a reasonable expectation of privacy –Two types of privacy interests implicated by prescription records “Avoiding disclosure of personal matters” “Independence in making certain kinds of important decisions” –Probable cause (vs. administrative subpoena) is necessary under Fourth Amendment

127 #RXABUSE WASHINGTON, D.C. Protecting Core Values: Privacy (4/4) When PMPs are optimized, is there a need to access patient-specific data for investigative purposes? –Prescribers are obligated to check PMP data –Red flags alert PMP staff to abnormal patterns (patient or prescriber) –Persons with substance-related disorders are referred to treatment –Negligent prescribers who enable consumer misuse, abuse, or diversion are referred to the medical board –Intentional bad actors are referred to law enforcement Shouldn’t referrals from PMP staff to the medical board and then (if necessary) to law enforcement be adequate?

128 #RXABUSE WASHINGTON, D.C. Preview of 2015 Activities

129 #RXABUSE WASHINGTON, D.C. Upcoming CLAAD Activities National Prescription Drug Abuse Prevention Strategy Articles –Notre Dame Journal of Law, Ethics, & Public Policy –Therapeutic Advances in Drug Safety –Journal of Opioid Management Presentations –Home Care Association of Florida –Addiction Executives Industry (aXis) Summit –Notre Dame Journal of Law, Ethics, & Public Policy Symposium –National Rx Drug Abuse Summit –National Association of Addiction Treatment Providers –American Society for Pain Management Nursing

130 #RXABUSE WASHINGTON, D.C. Thank You COMMERCIAL SUPPORTERS


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