PHARMACY LAW UPDATE Greg Reybold, J.D.

LEARNING OBJECTIVES Program attendees will be able to Explain recent laws/regulations at the state and federal level that may impact pharmacies as well as pharmacy specific regulations Describe existing laws/regulations which pharmacies need to be aware of and learn to develop policies and procedures to assist with compliance

DISCLOSURE I DO NOT have (nor does any immediate family member have) actual or potential conflict of interest, within the last twelve months, a vested interest in or affiliation with any corporate organization offering financial support or grant monies for this continuing education activity, or any affiliation with an organization whose philosophy could potentially bias my presentation. Attending this presentation, or using the information it contains does not create an attorney-client relationship. No information provided should be construed to constitute legal advice. If you have questions about these or other legal issues please contact an attorney.

GEORGIA Some positive and exciting developments in Georgia Through work of GPhA, AIP, GDNA, Board of Pharmacy and Legislators

Georgia – Pharmacy Audit Bill of Rights O.C.G.A. § 26-4-118 Entity conducting on-site audit must give pharmacy 14 days notice (previous requirement was one week). (b)(1). PBMs can’t recoup for corrected clerical errors under the law unless the error resulted in an overpayment and then they are limited to recouping the amount overpaid {previously were able to recoup full amount reimbursed}!. (b)(3). Entity conducting the audit may not pay the agent or employee conducting audit based on percentage of the amount recovered. (h). Commissioner of Insurance now has enforcement authority over the Pharmacy Audit Bill of Rights.

Georgia MAC Pricing Bring fairness and transparency to reimbursements Effective January 1, 2016 Give pharmacies the ability to appeal Oversight – teeth This puts responsibilities & obligations on the PBMs not on the Pharmacies – but pharmacies need to be aware of their rights to get maximum protection

Georgia MAC Pricing Provides that new and renewal contracts must identify the sources used to determine multi-source generic drug pricing and update such pricing at least every 5 business days (14 days for DCH). Provides PBMs must maintain a procedure for eliminating products from multi-source generic drug pricing lists within 5 business days when drugs no longer meet the standards of the code section. Requires PBMs to reimburse pharmacies for drugs subject to multi-source generic drug pricing based upon information which has been updated within 5 business days.

Georgia MAC Pricing Restricts what can be placed on multi-source generic lists to drugs that have at least 2 therapeutic equivalent multi-source drugs or have at least 1 generic drug available from only 1 manufacturer. These drugs must be generally available for purchase from national or regional wholesalers. This provides at least some restriction as to what drugs PBMs can subject to multi-source generic drug pricing formulas. The reason this is important is because some PBMs have been known to MAC drugs with no therapeutic equivalents or generics available.

Georgia MAC Pricing Requires PBM contracts to have an appeal process for disputes arising out of multi-source generic drug pricing. Right for pharmacies to appeal is limited to 14 calendar days following reimbursement of initial claim and PBM has 14 calendar days from date appeal was received to respond (not resolve). Requires PBMs to provide reason for appeal denials and to identify the NDC of a drug product that may be purchased at or below the MAC. When appeals are successful, PBMs are required to adjust the cost effective on the day after the appeal is decided; apply the adjusted price to all similarly situated pharmacies (as determined by health plan issuer or PBM); and allow pharmacy that succeeded in appeal to reverse and rebill the claim.

Georgia MAC Pricing Mandates that appeals be upheld when the drug at issue was not reimbursed based upon pricing information updated within 5 business days or when the drug does not meet the requirements necessary to be placed on a multi-source generic list. Provides the Commissioner has enforcement over code section.

Georgia – Immunization Influenza Pneumococcal Shingles Meningitis

Georgia – Immunization Requirements are many – GPhA Immunization Toolkit can assist with getting started All Pharmacists who want to administer immunizations must enter into new Vaccine Protocol Agreements {old Vaccine Protocol Agreements not in compliance with the law}

Georgia – Immunization Examples of Threshold requirements Completion of CDC recognized immunology training program Program recognized by the Center for Disease Control and Prevention on the basics of immunology Hold a current certification in basic CPR and complete course of training accredited by ACPE or similar health authority approved by Georgia Board of Pharmacy Enter into Vaccine Protocol Agreement with eligible physician Other

Georgia – Immunization Agreement itself has numerous requirements Docs to be provided to patients Case history / contraindications / consents Privacy / observation / primary care notifications Policies and procedures / document retention

Georgia – Annual Drug Update Bill Previously name of “physician prescribing the drug” Now name of “practitioner prescribing the drug” Consistent with Board rule which provides “The name of the prescribing practitioner” Board Rule 480-22-.10 Board of Pharmacy and GDNA were extremely helpful in dealing with this issue both with regard to this legislation and with their interim policy which was issued on September 29, 2014.

Georgia – Board of Pharmacy Rules Recently adopted (May 13, 2015) 480-2-.05 Reciprocity 480-48-.01 Definitions, 480-48-.02 Conditions for Use of Delivery by Mail 480-48-.03 Delivery by Pharmacy

Georgia – Board of Pharmacy Rules Monitor Board of Pharmacy website for new rules and amendments Proposed rules to be considered at meeting Wednesday, July 15th

FDA – 2013 Drug Quality and Security Act Prescription for an identified individual patient; anticipatory compounding in limited quantities before receipt of prescription Note: Compliance with Board of Pharmacy Rule (480-11-.02 (2)(b) – Pharmacist for Distribution to Practitioner) would still run you afoul of 503(a).

FDA – 2013 Drug Quality and Security Act Cannot compound regularly or in inordinate amounts what are essentially copies of commercially available products Interstate distribution – limited to 5% of the total prescription orders dispensed or distributed by pharmacy unless they are located in a state that has entered into a Memorandum of Understanding (30% limit for pharmacies in states that have entered into per draft MOU) FDA draft MOU accepted public comments on the draft MOU until June 19th. FDA will finalize the MOU and then make it available to the states for consideration (likely 180 days).

FDA – 2013 Drug Quality and Security Act Discussion

FDA – 2013 Drug Quality and Security Act Signed into law late 2013 National system to trace pharmaceutical products through supply chain Standard for wholesaler & 3rd party logistic providers

FDA – 2013 Drug Quality and Security Act January 1, 2015 – Dispensers must only purchase products from authorized trading partners / have systems in place to verify suspect/illegitimate products July 1, 2015 – Dispensers must pass, capture, and maintain certain types of information with respect to transactions.

Other HIPAA OSHA Exposure Control Plan/Hazard Comm. Plan Anti-kickback GA Anti-kickback False Claims Diversion GA PDMP Biosimilars

QUIZ

Can a PA’s name appear on a prescription label? Yes, if the PA was the prescriber. Under Georgia law, can a pharmacist fill a prescription for in office use? What about under Federal law? No and no. Can a PBM deny an appeal of MAC reimbursement if the drug at issue was not reimbursed based upon pricing information updated within 5 business days? No, the law mandates that the appeal be granted. Can a pharmacist take a physician out to dinner or buy a physician a gift while marketing his/her services? No.

QUESTIONS/COMMENTS?

CONTACT INFORMATION Greg Reybold, JD greybold@daleykoster.com (678) 213-2401 – office (404) 290-9279 - cell