Kalamazoo Pharmacists Association May 10, 2012 Pharmacy Law Updates

1. Kalamazoo Pharmacists AssociationMay 10, 2012Pharmacy Law Updates Jesse Vivian, RPh, JD Professor of Pharmacy Practice Detroit, Michigan 48201 Office: (313) 577-5389 jessevivian@wayne.edu jessevivian.net Blog

2. Slogans • The Leaders and the Best • Those who stay will be champions • Where students learn from the real world, and are prepared not just for graduation, but for life • Aim Higher

4. Learning Objectives At the completion of this activity, pharmacists will be able to: • Discuss recent changes to federal laws and regulations that govern the practice of pharmacy. • Summarize important recent and proposed changes to the Michigan Administrative Rules that affect pharmacists. • List actions for pharmacists to take during 2012 to be in compliance with federal and state changes applicable to pharmacy practice. • Identify emerging federal legislative and regulatory developments that may affect the practice of pharmacy.

5. Hodgepodge HIPAA Enforcement Federal Health Care Reform Agent Communication Michigan Health Reorganization REMS DEA Regulations Electronic Prescribing of CS drugs Michigan Legislation Prescribing by Non-Physicians Michigan Regulatory Changes Medication Therapy Management Marijuana (Marihuana) Changes to face or CS-2 scripts Disposal of CS meds Data Mining

6. Real Goals • Leave here with resources to look up recent law changes. • Have knowledge of pending changes and where to look to find their status. • Understand how and why pharmacists have opportunities to advance the profession.

7. Federal Laws • DEA Controlled Substances Policies • Health Care Reform • FDA changes

8. Electronic Controlled Substances Prescriptions • C-2 Through C-5 may be electronically prescribed and filed by a pharmacy. • Very few physicians know electronic C-2 prescribing is permitted and very few pharmacists know of this change. • “My software does not allow C-2 prescribing.”

9. Electronic Prescribing of CS Meds • Vol. No: 33:8 Posted: 8/19/2008, “A Boost to E-prescribing” • http://legacy.uspharmacist.com/index.asp?show=article&page=8_2330.htm. US Pharm. 2008;33(8):60-66. • It has been estimated that fewer than 10%, or only 35,000, U.S. physicians prescribe drugs using electronic methods of communicating with a pharmacy. This does not take into consideration the dentists, podiatrists, or other heath care providers who are authorized to prescribe medications. This means that only about 35 million of the 3.5 billion prescriptions annually filled by U.S. pharmacies are electronically prescribed. Couple that with the fact that only about 70% of the nation's pharmacies are capable of receiving electronically prescribed prescriptions. Based on available numbers, about 17,000 of the country's 57,000 pharmacies are not taking advantage of this technology.

10. Electronic Controlled Substances Prescriptions • US Pharm. 2010;35(7):65-68. Posted 7/20/2010http://uspharmacist.com/content/d/pharmacy_law/c/21533/ • The Drug Enforcement Administration (DEA) has released its Interim Final Rule on Electronic Prescriptions for Controlled Substances With Request for Comment, which was published in the Federal Register on March 31, 2010, and went into effect on June 1, 2010.1-4 According to the DEA, “The rule revises DEA regulations to provide practitioners with the option of writing prescriptions for controlled substances electronically. The regulations also permit pharmacies to receive, dispense, and archive these electronic prescriptions.

11. Requirements

12. DEA Policy Updates • June 15, 2011 • http://www.deadiversion.usdoj.gov/mtgs/drug_chemical/2011/gallagher.pdf • Changes to Face of C-2 script by pharmacist • Old Policy • On November 19, 2007, DEA published in the FR the Final Rule entitled Issuance of Multiple Prescriptions for Schedule II Controlled Substances. • The instructions contained in the Rule’s preamble are in opposition to policy posted on the DEA Diversion Website regarding changes a pharmacist may make to a CII prescription after oral consultation with the prescriber. • the website instructed regarding C-2s that a “pharmacist may change or add the dosage form, drug strength, drug quantity, direction for use, or issue date only after consultation with and agreement of the prescribing practitioner.

13. New Policy • DEA recognized the confusion regarding this conflict and plans to resolve this matter through a future rulemaking. • Advice: Until that time, pharmacists are instructed to adhere to state regulations or policy regarding those changes that a pharmacist may make to a schedule II prescription after oral consultation with the prescriber.

14. Agent of a Practitioner • Where a DEA-registered practitioner has made a valid oral prescription for a controlled substance in III-V by conveying all the required information to the his/her authorized agent, that agent may telephone the pharmacy and convey that prescription information to the pharmacist. • Communication by facsimile of a valid prescription for CIII-V substance maybe delegated to an authorized agent.

15. Agent of a Practitioner • Where an agent communicates a CS prescription on behalf of a registrant, it is important that: • The such person be clearly identified • Their activities be subject to evaluation to ensure they do not exceed the bounds of the agency relationship and the legal limits of an agent’s role under the CSA. • Pharmacist should have copy of agency authorization.

16. Agent of a Practitioner • Generally, a valid CII prescription may not be communicated by facsimile. • Exception: A CII prescription for persons in a Hospice or Long Term Care Facility may be communicated by facsimile and that communication may be delegated to an authorized agent.

17. Communication of Prescribed CS drugs from a prescriber’s agent “DEA Restates Position on Authorized Prescriber Use of Agents in Long Term Care Facilities” • Health Law Alert Newsletter • 2010 Volume 2, By: Howard L. Sollins • http://www.ober.com/publications/1099-dea-restates-position-authorized-prescriber-use-agents-long-term-care-facilities

18. Conclusion • The pharmacist is never permitted to make changes to the patient’s name, controlled substance prescribed (except for generic interchange permitted by state law) or the prescriber’s signature. • Other information that does not change the essentials of the prescribing may be added to the face of a C-2 script. • Add Prescribers DEA # to Rx if omitted

19. Disposal of CS Drugs • Secure and Responsible Drug Disposal Act of 2009 (effective 10/12/2010). • Provides for disposal of controlled substances by certain persons: • Ultimate Users • Long Term Care Facilities • Survivor of decedent • DEA is in the process of drafting regulations to implement the Act. “Take Back Days” with local police Transcript is available on DEA’s website at www.deadiversion.usdoj.

20. April 28, 2012 Announcement • National Drug Take-Back Day Scheduled For April 29The DEA scheduled a National Prescription Drug Take-Back Day, allowing people to safely throw away their unused prescription drugs at designated collection sites around the country. With the cooperation of nearly 4,000 state and local law enforcement agencies across the U.S., the DEA collected more than 309 tons of pills on two previous collection days held in September 2010 and April 2011. The DEA plans to continue collecting unwanted prescription drugs every six months until it finishes developing a process for people to safely dispose of medications.

21. Take Back Results • April 25, 2011: • 376,590 lbs (188 tons) • September 30, 2010: • 242,000 lbs (121 tons) DEA announced another ‘take back day would be scheduled in October, 2011

22. Program Advertising Event Baltimore, MD

23. Federal Health Law Reforms • Brief History: • On December 24, 2009, the Senate passed the Patient Protection and Affordable Care Act (PPACA). On March 21, 2010, the House of Representatives approved the PPACA and, on the same day, passed the Health Care and Education Reconciliation Act of 2010 (the “Reconciliation Act”), which modified certain tax, revenue, and Medicare and Medicaid provisions of the PPACA. • On March 23, 2010, President Barack Obama signed the PPACA into law and the amendments in the Reconciliation Act were sent to the Senate for passage. • On March 25, 2010, the Senate adopted the Reconciliation Act with additional amendments and returned the legislation to the House for approval. • On March 25, 2010, the House passed the Senate amendments, and the amended Reconciliation Act was signed by the president on March 30, 2010. • http://www.uspharmacist.com/content/d/pharmacy_law/c/20824/ • Regulations just now being implemented for $$$ disbursements.

24. Federal Health Law Reforms • By 2014, approximately 32 million Americans who are currently uninsured will gain access to health care benefits including prescription drugs through Medicaid, Medicare, and other insurance programs. • The most prominent outcome of this development is that there will surely be a lot more prescriptions generated. • More prescriptions mean a demand for more pharmacists and pharmacy personnel, and, if supply-and-demand economic theory holds true, pharmacy wages are sure to rise as well.

25. Federal Health Law Reforms • Reduced the dramatic cuts in Medicaid reimbursement rates for generic drugs that were in the original bills • Exempts most pharmacies from the Medicare Part D Durable Medical Equipment, Prosthetics, and Supplies (DMEPOS) accreditation requirements. • Eliminates Medicare Part D “Doughnut Hole” by 2020

26. Transparency Reforms • Enacted transparency provisions that have shielded prescription drug benefit managers (PBMs) from disclosing business practices that have allegedly afforded them greater profits at the expense of employers and employees who thought they were reaping savings that never seemed to match expectations. • However, the Congressional Budget Office (CBO) determined that these measures were budget neutral, meaning no practical impact. Based on the CBO analysis, critics argue that pharmacy will experience no net benefit from the transparency legislation.

27. Health Insurance Mandates • Mandates every American must have Health Insurance • will not begin until 2014, • However, there are some provisions that will start almost immediately. • Some group health plans will not be able to impose lifetime or annual limits on health care expenditures, including prescription drug reimbursements, beginning later this year

28. Health Insurance Mandates • The fine starts at $95 for an individual in 2014 and goes up each year until 2016, when the fine will be the greater of either $695 or 2.5% of the person’s annual income. • State and federal subsidies to insurance companies and high-risk insurance pools have been designed to keep the cost of purchasing mandatory health care insurance affordable for most individuals and families. • In addition, there will be free or very low-cost programs available to the poorest people. The Foundation for Health Coverage Education (www.coverageforall.org) is available to help direct people to the entities that will make this coverage available.

29. Health Insurance Mandates • By 2014, no group health plans or group health insurers will be allowed to enforce any annual spending limits on covered employees and dependants and will be only allowed to impose lifetime benefit limits on nonessential health care spending. • Likewise, insurers cannot rescind specified covered benefits (except in cases of fraud or intentional misrepresentation by a benefit applicant) after they are offered.

30. Pre-Existing Conditions • The Health Care Reform Legislation will prohibit insurance companies from refusing coverage because of an individual’s medical history or health risk. • Insurance companies will be required to renew any policy as long as the policyholder pays their premium in full and will be prohibited from dropping or watering down insurance coverage for those who are or become ill. • Those provisions will start taking effect in 2014. • However, later this year, insurers will be prohibited from rejecting payments for covered individuals under the age of 19 years

31. Controversies • One federal Court of Appeals has ruled the mandatory health insurance provisions are unconstitutional and Congress overstepped its authority with this bill • Two other federal Courts of Appeals have determined the mandatory insurance plans are constitutionally permissible. • Question WILL be decided by US Supreme Court—three full days of oral arguments • When is anybody’s guess

32. Pharmacy Opportunities • One projected outcome is that by 2016, when the majority of the reform measures will have been implemented, 141 million more prescriptions will be dispensed over current levels. • http://www.uspharmacist.com/content/d/pharmacy_law/c/21149/

33. Medication Therapy Management • The legislation establishes a stand-alone grant program to ensure pharmacist-provided medication therapy management (MTM) services as defined by the pharmacy profession’s consensus definition on the core elements of an MTM program. • This program provides mechanisms for the testing of practice and care delivery models, such as patient-centered self-management programs that improve patient outcomes through team-based collaborations between prescribers and, hopefully, pharmacists.

34. Medication Therapy Management • The Department of Health and Human Services (HHS) has launched a Patient Safety Research Center as part of the Agency for Healthcare Research and Quality (AHRQ) to provide, in part, grants and/or contracts to fund pilot projects implementing pharmacist-provided MTM services. • While the funding of this project is not mandated, it will be administered by the Center for Medicare and Medicaid Services (CMS) Innovation Group that will be charged with testing payment and service-delivery models. • http://www.uspharmacist.com/content/d/pharmacy_law/c/21149/

35. Federal Register / Vol. 77, No. 66 Thursday, April 5, 2012 / Notices Request for Information on Prescription Medication Adherence AGENCY: Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health, Office of the Surgeon General of the United States Public Health Service. ACTION: Request for information. SUMMARY: The Office of the Assistant Secretary for Health is seeking information about causes, impact and potential solutions associated with the public health problem of prescription medication non-adherence in adults with chronic conditions. The purpose of this notice is to provide individuals and organizations with the opportunity to identify issues relevant to all levels of government, as well as individuals, health care providers, and industry and private organizations in efforts to improve medication adherence in adults with chronic conditions. 

36. HIPAA Enforcement • “Fourth HIPAA Settlement in a Year Highlights Increasing Enforcement Trend, by Adam H. Greene, 07/12/11 • https://mail.google.com/mail/?shva=1#search/HIPAA+enforcement/1312004785bc8d80 • “On July 6, 2011, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced an $865,500 settlement with UCLA Health System, its sixth Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule settlement, and the fourth within a year. This news has only further raised the question that has been stirring since the Mass General and Cignet cases: Has OCR reached a new level of enforcement?”

37. Other Legislation • Integrated-Care Models for Patient-Centered Medical Homes • Independence at Home • New Definition for AMP • Workforce Monitoring and Development • Waste Reduction in Medicare Part D • DMEPOS Accreditation for Part B

38. Pharmacy Implementation • The future of pharmacy depends squarely on the initiatives of pharmacy organizations taking advantage of the policy changes mandated by these reforms. • Competition: Other professionals (PAs, NPs, PBMs, Prescriber groups, etc.) all want the same slice of pie. • How are you going to insure your future livelihood?

39. FDA Changes • REMS (Risk Evaluation and Mitigation Strategy). • FDA: “No new duties for Pharmacists” “REMS is focused on the prescribers, on the patients,” and ‘the program “will not put new responsibilities on pharmacists.” Thompson CA. No new pharmacist responsibilities with upcoming opioid REMS. ASHP Pharmacy News. April 19, 2011. www.ashp.org/menu/News/ PharmacyNews/NewsArticle.aspx? id=3525. Accessed June 14, 2011. • That statement is so dead wrong and so misleading that it is incomprehensible it could have been uttered by a sane person. • Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER), April, 2011, while speaking to a group of health care providers and manufacturers on the REMS for long-acting and extended-release opioid products. • http://www.uspharmacist.com/content/d/pharmacy_law/c/29047/

40. REMS and Pharmacy • The FDA does not concern itself with litigation or liability against pharmacists or pharmacies when a patient claims to have been harmed by a drug. • It does not address the admissibility of literature or other testimony that a pharmacist failed to warn of the known REMS risks in a civil suit. • Nor does it address the educational responsibilities that might be placed on the shoulders of pharmacists to instruct physicians and patients prescribing or taking REMS drugs. • It is also silent on the question of whether a pharmacist who does not pass along REMS information about a drug to a physician or patient might result in administrative sanctions, such as the suspension or revocation of licenses by a state Board of Pharmacy. 

41. Real Purposes of REMS Program • Addressing Drug Abuse • Focus on the issue of ever-increasing abuse of prescription drugs, especially opioids. • Prescription Drug Abuse Prevention Plan • Thompson CA. No new pharmacist responsibilities with upcoming opioid REMS. ASHP Pharmacy News. April 19, 2011. www.ashp.org/menu/News/ PharmacyNews/NewsArticle.aspx? id=3525. Accessed June 14, 2011 • Internet and Other Sources for Drugs of Abuse

42. What REMS DOES Require • A medication guide for patients • Training of health care providers who prescribe the product • Information that prescribers can use to educate patients in the safe use, storage, and disposal of opioid-containing products • Announcements to prescribers about the existence of the REMS and their need to complete the training • Assessments, evaluations, and surveillance • Instructions for companies to develop a “single, shared system.”  • Pharmacies will be expected to provide the patient with medication guides

43. http://michiganpharmacists.org/news/publications/michiganPharmacist/2011/journal0911.pdfhttp://michiganpharmacists.org/news/publications/michiganPharmacist/2011/journal0911.pdf

44. Michigan Law Update • Gov. Snyder Signs New Pseudoephedrine Bills Into Law, Posted 7/20/2011, http://michiganpharmacists.org/news/article.php?x=2237 • Laws were enacted to reduce the continued problem related to the illicit manufacture of methamphetamine.

45. Pseudoephedrine • Save the Date: Pseudoephedrine Logbook Requirements Webinar, posted: 08/17/2011MPA is hosting a webinar entitled “Regulatory Pseudoephedrine: Recently Enacted Logbook Requirements” on Tuesday, Oct. 25 from 7-8 p.m. Members are encouraged to save the date for this upcoming opportunity to learn more about recently enacted requirements for logging the sale of pseudoephedrine products.  • The webinar will be hosted by MPA and guest speaker Nick Norcross, MPA professional practice assistant.  • The deadline to register is Oct. 21, so be sure to register early! One hour of live continuing education credit will be offered. • http://michiganpharmacists.org/news/article.php?x=2310

46. Pseudoephedrine • Beginning Jan. 1, 2012, purchasers of medications containing ephedrine or pseudoephedrine will be required to produce an ID and have their names entered into a law enforcement database. Retailers will enter this information electronically into the National Precursor Log Exchange (NPLEx), which is administered by the National Association of Drug Diversion Investigators (NADDI). The legislation mandates that the retailer shall not be required to pay a fee for the utilization of the NPLEx system.  • The NPLEx system is capable of generating a stop sale alert notifying the retailer that completion of the sale would result in the seller or purchaser violating the quantity limits set forth in the state regulations and the Federal Combat Methamphetamine Act of 2005.

47. Pseudoephedrine • The previous quantity limits prohibited the sale of pseudoephedrine to two packages, or 48 tablets or capsules, of any product described in the section. • The new limitations are consistent with federal regulations limiting the sale to not more than 3.6 grams of ephedrine or pseudoephedrine alone or in a mixture within a single calendar day, and not more than nine grams of ephedrine or pseudoephedrine alone or in a mixture within a 30-day period.

48. New Law: Physician Assistants Gain Prescribing Authority • Senate Bill 384, Public Act 210 of 2011, effective November 8, 2011. • This law supersedes the Board of Medicine and Board of Osteopathic Medicine rules and allows physician assistants to prescribe Schedule 2 controlled substances from offices and clinics without quantity limitations. • Passage of this bill removes the previous restrictions that limited a physician’s assistant to prescribing not more than a seven-day supply of Schedule 2 controlled substances and only when discharging a patient from a hospital, free-standing surgical center or hospice. In addition to removing these restrictions, the bill also requires the name of the prescriber, or if prescribed under the prescriber’s delegating authority, the name of the delegatee who wrote the prescription, to be listed on the prescription label. • This bill did not give authority to advanced practice nurses, nurse practitioners and nurse midwives for prescribing Schedule 2 controlled substances without limitations, only physician assistants. This provides differences in the state statute between the mid-level prescribers who are given delegated authority for prescribing Schedule 2 controlled substances. Therefore, pharmacists, student pharmacists and pharmacy technicians will need to be cautious when dispensing prescriptions for Schedule 2 controlled substances written by mid-level providers.

49. Pharmacists Allowed toDispense Out-of-State Dentist'sControlled Substance Prescriptions Amendment to §§ 333.17763 and 333.7405 of the of the Michigan Public Health Code to allow pharmacists to dispense controlled substance (Schedules 2-5) prescriptions written by an out-of-state dentist.  Senate Bill 213 is now Public Act 155 of 2011

50. Proposed Statutes • SB 591 • Would require Pharmacy Technicians be licensed. • MCL 17705 (5) "PHARMACY TECHNICIAN" MEANS AN INDIVIDUAL WHO IS REQUIRED TO HOLD A HEALTH PROFESSION SUBFIELD LICENSE UNDER THIS PART TO SERVE AS A PHARMACY TECHNICIAN.