THE OPIOID EPIDEMIC IN PENNSYLVANIA

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1 THE OPIOID EPIDEMIC IN PENNSYLVANIA TOP TEN LEGAL CONSIDERATIONS FOR HEALTH CARE PROVIDERS PBI 24 th Annual Health Law Institute March 14, 2018 Douglas Moak Counsel Independence Blue Cross

4 Retail opioid prescriptions dispensed per 100 persons (2016) Source: Centers for Disease Control, U.S. Prescribing Rate Maps. Available online at: maps.html

5 Retail opioid prescriptions dispensed per 100 persons (2016) Source: Centers for Disease Control, U.S. Prescribing Rate Maps. Available online at: maps.html

6 Source: PA Dept. of Health, Prescription Drug Monitoring Program Interactive Data Report. Available online at: Department of Health/Offices%20and%20Bureaus/PaPrescriptionDrugMonitoringProgram/Pages/Interactive Data Report.aspx#.Wp1rM7pFyAg

7 TOP TEN LEGAL CONSIDERATIONS FOR HEALTH CARE PROVIDERS

8 1. Recent Regulatory Changes to Prescribing Requirements Act 122 of 2016: Safe Emergency Prescribing Act 7 day supply limit in ER, urgent care and observation status settings, with no refills Requirement to refer for treatment if risk of SUD Act 124 of 2016: PDMP Revisions Prescribers must query the PDMP: (1) first prescription; (2) reason to believe abuse or diversion; (3) each prescription of an opioid or benzodiazepine New requirement of 2 hours of pain management or addiction training

9 1. Recent Regulatory Changes to Prescribing Requirements Act 125 of 2016: Prescribing Opioids to Minors 7 day supply limitation for minors, with certain exceptions Specified procedure required prior to prescribing Act 126 of 2016: Opioid Education and Patient Directive Licensing boards to implement safe prescribing training curriculum DOH authorized to develop a voluntary non opioid directive form

10 1. Recent Regulatory Changes to Prescribing Requirements Medicare Part D Proposed Rule (Nov. 28, 2017) Part D sponsors may limit an at risk beneficiary s access to coverage of opioids beginning in 2019 through POS claim edit or through a selected pharmacy/prescriber. Comment period ended Jan. 16, Announcements by Governor Wolf re: Medical Assistance Ordering, prescribing or referring providers must be enrolled in MA. Cash payments from MA recipients prohibited. Increased program integrity review. March 1, 2018: Announcement that Medical Assistance prior authorization requirements will be waived for MAT.

11 2. Reimbursement Managed Care New medical necessity, limited supply and prior authorization restrictions specific to opioids Increased access/coverage for treatment (e.g., removal of cost sharing for naloxone) Direction of payment to out of network providers Parity Financial requirements Treatment limitations Private Pay Cash payments avoid certain safeguards

12 3. Illegal Prescribing and Obtaining of Opioids Doctor shopping by patients, and obtaining prescription opioids by deception, forgery or diversion: U.S. Controlled Substances Act: unlawful to knowingly or intentionally acquire or obtain possession of a controlled substance by misrepresentation, fraud, forgery, deception, or subterfuge. 21 U.S.C. 843(a). PA Controlled Substance, Drug, Device and Cosmetic Act: the acquisition or obtaining of possession of a controlled substance by misrepresentation, fraud, forgery, deception or subterfuge is prohibited. 35 P.S (a)(12). PA Pharmacy Act: unlawful to procure or attempt to procure any drug: (i) by fraud, deceit, misrepresentation or subterfuge; (ii) by the forgery or alteration of a prescription or any written order; (iii) by the concealment of a material fact; (iv) by use of a false statement in any prescription, order or report. 63 P.S (13).

13 3. Illegal Prescribing and Obtaining of Opioids Drug pushing by prescribers, and prescribing opioids to a drug dependent person: U.S. Controlled Substances Act: Prescribing drugs for other than a legitimate medical purpose can be a basis for liability under 841(a). United States v. Rottschaefer, 178 Fed. Appx. 145 (3d Cir. 2006). PA Controlled Substance, Drug, Device and Cosmetic Act: Prohibits prescribing a controlled substance to any person known to such practitioner to be or whom such practitioner has reason to know is a drug dependent person P.S (a)(13). PA Controlled Substance, Drug, Device and Cosmetic Act: Prohibits prescribing a controlled substance unless (i) in good faith in the course of professional practice; (ii) within scope of patient relationship; (iii) in accordance with treatment principles accepted by a responsible segment of the medical profession. 35 P.S (a)(14).

14 4. Sharing of Patient Information among Treating Providers Privacy regulations layer on top of each other DDAP Regulations Pennsylvania Drug and Alcohol Abuse Control Act CFR Part 2 HIPAA/HITECH

15 4. Sharing of Patient Information among Treating Providers 83 Fed. Reg (Jan. 3, 2018)

16 4. Sharing of Patient Information among Treating Providers 83 Fed. Reg (Jan. 3, 2018)

17 4. Sharing of Patient Information among Treating Providers To whom does the restriction apply? What information is covered by the restriction? To what extent may treating providers share patient information without obtaining patient consent or authorization? HIPAA A health care provider who transmits any health information in electronic form in connection with a transaction covered by HIPAA. 45 C.F.R (a)(3). Protected health information (PHI), as defined at 45 C.F.R Use and disclosure without an authorization permitted for treatment, payment and health care operations. 45 C.F.R CFR Part 2 A part 2 program, which is federally assisted (as defined at 42 C.F.R. 2.12(b)), and (1) An individual or entity (other than a general medical facility) who holds itself out as providing, and provides, substance use disorder diagnosis, treatment, or referral for treatment; or (2) An identified unit within a general medical facility that holds itself out as providing, and provides, substance use disorder diagnosis, treatment, or referral for treatment; or (3) Medical personnel or other staff in a general medical facility whose primary function is the provision of substance use disorder diagnosis, treatment, or referral for treatment and who are identified as such providers. 42 C.F.R Any information, whether recorded or not, and (1) would identify a patient as having or having had a substance use disorder either directly, by reference to publicly available information, or through verification of such identification by another person; and (2) is drug abuse information obtained by a federally assisted drug abuse program. 42 C.F.R. 2.12(a) Communication within a part 2 program or between a part 2 program and an entity having direct administrative control over that part 2 program. 42 C.F.R. 2.12(c)(3). Communications between a part 2 program and a qualified service organization of information needed by the qualified service organization to provide services to the program. 42 C.F.R. 2.12(c)(4). To medical personnel to the extent necessary to meet a bona fide medical emergency in which the patient's prior informed consent cannot be obtained. 42. C.F.R (note: special procedures apply following disclosure). Drug and Alcohol Abuse Control Act Anyone who prepares or obtains patient records pursuant to the Drug and Alcohol Abuse Control Act (DAAC). 71 P.S (b). Private practitioners, hospitals, clinics, drug rehabilitation or drug treatment centers. 71 P.S (c). For persons who prepare/obtain patient records pursuant to the DAAC: all patient records (including all records relating to any commitment proceeding) prepared or obtained pursuant to DAAC, and all information contained therein. 71 P.S (b). Disclosure only with the patient's consent and only to medical personnel exclusively for purposes of diagnosis and treatment of the patient, except in emergency medical situations where the patient's life is in immediate jeopardy. 71 P.S (b) and (c). For private practitioners, hospitals, clinics, drug rehabilitation or drug treatment centers: all patient records and all information contained therein relating to drug or alcohol abuse/dependence. 71 P.S (b). Regulations of the PA Dept. of Drug and Alcohol Programs A project, which is defined as [t]he public or private organization responsible for the administration and delivery of drug or alcohol services, or both, through one or more facilities. A project is a component of an SCA drug and alcohol program. 28 Pa. Code Client oriented data which reasonably may be utilized to identify the client. 4 Pa. Code No disclosure to another provider without patient consent, except emergency medical situations where the life of the client is in immediate jeopardy. 4 Pa. Code

18 4. Sharing of Patient Information among Treating Providers Potential risks to patients of unauthorized disclosure of SUD treatment information: Violation of patient choice Patient exposure to criminal liability Patient exposure to adverse employment action Stigma Discouragement of treatment Clinical integration and care management considerations: One vs. several authorization/consent disclosure forms? Policies and procedures to ensure uniform application EHR system compatibility, protections Identification of sensitive codes

19 5. Minors Prescribing to minors 7 day supply limitation. Procedures required by statute, including written consent of parent/guardian. Approved form of consent available at 47 Pa.B. 671 (Feb. 4, 2017) Treatment of minors Minors can always consent on their own behalf to SUD treatment Provider not obligated to inform parent/guardian of treatment. Parent/guardian may petition court for involuntary commitment. Caution with respect to varying age of consent for co occurring physical and mental health conditions.

6. Mandated Reporting Child abuse Mandated reporting of child abuse to county children & youth service agency. Newborn/infant affected by drugs: immediate report required by statute.

20 6. Mandated Reporting Child abuse Mandated reporting of child abuse to county children & youth service agency. Newborn/infant affected by drugs: immediate report required by statute. Positive drug screen by pregnant mother: law is developing. See, In the Interest of L.B., 2017 Pa. Super 411 (December 27, 2017). Positive drug screen by parent: additional factors likely required.

21 6. Mandated Reporting Impaired driver Mandated reporting to PennDOT every person over 15 years of age diagnosed as having a disorder/disability specified by Medical Advisory Board. Use of any drug or substance, including alcohol, known to impair skill or functions, regardless of whether the drug or substance is medically prescribed. Injuries by firearm or criminal act Report to police any person injured by a firearm or upon whom injuries have been inflicted in violation of PA criminal law.

22 7. Older Populations SAMHSA: Nearly half of older Americans suffer from a chronic pain disorder, and incidence of chronic pain increases with age. Medicare Part D 1 in 3 Medicare Part D beneficiaries received a prescription opioid in OIG has increased fraud and abuse investigations of opioids in connection with the Part D program. Opioid use (whether as prescribed or not) may be a factor in assessing decision making capacity with respect to: Informed consent. Advance directives and other end of life care decisions. Guardianship determinations.

23 7. Older Populations PA Pharmaceutical Assistance Contract for the Elderly (PACE) Offers low cost prescription medication to qualified residents age 65 and above. Prohibits kickbacks and false claims in connection with prescribing. Criminal penalty requires payment of 3x material gain. Detailed record keeping and documentation requirements regarding prescriptions.

24 8. Quality Measures Revised HCAHPS Questions: Effective Jan. 1, 2018 Q12: During this hospital stay, did you need medicine for have any pain? Q13: During this hospital stay, how often was your pain well controlled did hospital staff talk with you about how much pain you had? Q14: During this hospital stay, how often did the hospital staff do everything they could to help you with talk with you about how to treat your pain?

8. Quality Measures Revised HEDIS performance measures for 2018: New assessment of the rate of health plan members 18 years and older who receive long term

25 8. Quality Measures Revised HEDIS performance measures for 2018: New assessment of the rate of health plan members 18 years and older who receive long term opioids at high dosage. New assessment of the rate of health plan members 18 years and older who receive opioids from multiple prescribers and multiple pharmacies.

26 9. Professional Liability

27 9. Professional Liability Negligent prescribing A plaintiff must prove a duty owed by the physician to the patient, a breach of that duty by the physician, that the breach was the proximate cause of the harm suffered, and the damages suffered were a direct result of the harm." Increased risk of harm. Informed consent Under PA case law, informed consent generally does not apply to drugs. MCARE: informed consent required for experimental medication or use of approved medication in experimental manner. Consent of parent/guardian required for prescription to minor.

28 9. Professional Liability Doctrine of comparative fault may apply when patient does not use opioids as prescribed. Statutory immunity for prescribing/dispensing naloxone if not done with intent to harm or reckless indifference to a substantial risk of harm. Direct facility liability for failure to train staff and implement appropriate policies/procedures. Liability to third parties.

29 10. Health Care Fraud and Abuse

30 10. Health Care Fraud and Abuse U.S. allegations against Galena Biopharma: Providing more than 85 free meals to doctors and staff from a single, high prescribing practice. Paying $5,000 attendance fees and $6,000 speaker fees plus expenses for doctors to attend a conference partly planned and attended by Galena s sales team. Paying $92,000 to a physician owned pharmacy under a performancebased rebate agreement. Making payments to doctors to refer patients to Galena s patient registry study, which was alleged to be nothing more than a means to induce doctors to prescribe Abstral.

and sentenced to prison for offenses related to Abstral

31 10. Health Care Fraud and Abuse Doctors who received remuneration from Galena: Two doctors were tried, convicted and sentenced to prison for offenses related to Abstral prescriptions. Galena cooperated in the prosecution against the doctors.

32 10. Health Care Fraud and Abuse New Jersey: New administrative rule NJAC 13:45J 1.1 et seq. Applies to conduct as of and after January 16, Prohibits prescribers from receiving more than $10,000 per year in aggregate from all drug manufacturers for the prescriber s bona fide services (e.g., speaking at promotional activities, participating on advisory boards, consulting arrangements, etc.). Requires a written services agreement between prescriber and drug manufacturer. Services must be paid at fair market value. Specifies in detail gifts/payments to prescribers which are prohibited and permitted (e.g., a prescriber s acceptance of theater/sports tickets from a pharmaceutical manufacturer is categorically prohibited).

33 10. Health Care Fraud and Abuse

34 10. Health Care Fraud and Abuse Patient Brokering [A] health care provider may not compensate or give anything of value to a person to recommend or secure the provider's service to a patient or as a reward for having made a recommendation resulting in the provider's service to a patient; except that the provider may pay the reasonable cost of advertising or written communication as permitted by rules of professional conduct. 18 Pa. C.S Laboratory Kickbacks for Urine Testing It is unlawful to [p]ay or receive a commission, bonus, kickback, or rebate or engage in a split fee arrangement in any form with a health care provider or health care practitioner, either directly or indirectly, for patients or their specimens referred to any clinical laboratory operating within this Commonwealth or testing a specimen accepted or collected within this Commonwealth. 35 P.S (b)(1).

35 11. Things We Didn t Get to Talk About Class action litigation against pharmaceutical manufacturers, accrediting agencies, and providers. Obligations of providers with respect to responding to requests from elements of the criminal justice system. Obligations and exposure to liability when a provider s DEA number is stolen. Disability and worker s compensation issues. Impaired physician medical staff issues.

36 Questions?

37 Thank you Douglas Moak Counsel Independence Blue Cross 1901 Market Street, 43rd Floor Philadelphia, PA Phone:

FAQ s - Drugs and Alcohol

FAQ s - Drugs and Alcohol Q. What laws regulate employee drug and alcohol testing? A. Workplace drug and alcohol testing is regulated by both the Americans with Disabilities Act and the Fair Labor Standards