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Laws and Regulations


Laws and Regulations

Updates on regulations and laws that impact pharmacy practice, including Centers for Medicare and Medicaid Services news, Board of Pharmacy information, Michigan bills, federal legislation and more.

Notice from the Bureau of Professional Licensing: Current stance on enforcement of USP <800>

The Michigan Bureau of Professional Licensing released the following regarding its current stance on plans for enforcing USP <800> standards.

The Michigan Public Health Code defines USP standards as those that are officially published. Since USP 800 has not been formally written in a final and official publication, it is not required by the Code for applicant seeing initial licensure or current licensees seeing to renew their licenses. However, as part of their obligation to exercise due care and to practice within minimal standards for their professions, Michigan licensees may want to familiarize themselves with the information chapter 800. Please note once USP 800 have been officially published, licensees will be required to follow and meet the new standards.

Posted in: Laws and Regulations
Expanding Pharmacy Technician Roles in Michigan

Marla M. Ekola, Pharm.D., BCPS, MBA, director of pharmacy, McLaren Greater Lansing, Lansing

Over the past several years, pharmacy technicians have experienced increased responsibility and an elevation in duties in the workplace. Technicians have always been the heart and soul of the health-system pharmacy. They keep operations running, preserve pharmacist’s sanity and strive to keep nurses happy. More and more pharmacy technicians are now nationally certified and all Michigan pharmacy technicians are licensed. The last time the Michigan Pharmacy Board rules were written, pharmacy technicians were referenced as pharmacy supportive personnel. Today’s pharmacy technicians provide many valuable services to our organizations. The Board of Pharmacy is in the process of rewriting rules to include expanded pharmacy technician roles. Formalization of these rules solidifies the pharmacy technician roles for pharmacy practice in Michigan. One of the prominent rule changes is expected to include product verification (previously known as tech-check-tech). The use of technology such as bar code scanning will allow technicians to perform product verification. The implication of this verification process will be significant for many of our health systems. Technicians already utilize bar code scanning in product verification. The implementation of these rules provides a venue for technicians to utilize this type of technology to pick and fill from automatic dispensing systems without a pharmacist verification. The efficiencies gained through these new rules and processes allow pharmacists more time for clinical tasks.

Michigan Department of Licensing and Regulatory Affairs (LARA) estimates the rules will take one year to complete.  The Request for Rule Making (RFR) was released on June 24, 2019.  On July 31, 2019 the Michigan Office of Administrative Hearings and Rules (MOAHR) concluded there was sufficient policy and legal bases for approving the RFR.  LARA has held pharmacy workgroup meetings to discuss the technician draft language (May 6, 2019, June 12, 2019 and Nov. 15, 2019). These are public meetings and have been well attended by various pharmacy representation. These workgroups help to develop applicable rules. Once the rules are finalized there will be a Regulatory Impact Statement (RIS) released 28 days before the public hearing. Once the public hearing happens, there is only one final, post-hearing workgroup where you can only discuss items that were brought up at the hearing.  Once approved by the Director of LARA, the rules move to the Joint Committee of Administrative Rules (lawmakers of this committee are from both the House and Senate). No changes to the rules proposed by LARA are allowed during this part of the process. The proposal is either “approved or not approved” and the rules are either accepted in their entirety or sent back to LARA for revision. All approved items become part of the rules which determines our pharmacy practice. The current general rules have been in place for many years without revision despite multiple efforts to update them. There has been careful scrutiny and deliberate thought to ensure that these rules provide a structure and framework that will last for many years without the need for significant revision.  It is an exciting time in Michigan as we continue to shape the future of pharmacy and expanding the roles of pharmacy technicians.

Special thanks to Paige Fults, Michigan Health & Hospital Association (MHA) and the MPA legislative team for collaboration on this topic. 

Posted in: Laws and Regulations
Advocacy: Every Professional’s Responsibility

By Bridget Caito, specialty pharmacy 340B analyst, Ascension Michigan Pharmacy and Deb Sopo, R.Ph., MBA, FMPA, pharmacy manager, Ascension Michigan Pharmacy, Warren

 

Dozens of times a day, nuances come up in the pharmacy that make our job more difficult. Today, it may be another uninsured case that we lost hundreds of dollars on, or a needed drug that is not on formulary. As pharmacists and pharmacy technicians, our roles go beyond making sure our patients receive their medications when they are in our care. We have a responsibility to get involved in matters like: immunizations, medication therapy management (MTM), transparency within pharmacy benefit managers (PBM), MAC pricing, medication safety and patient access to pharmacy services that influence the safety and ease of taking care of patients. This is no easy task, but you are not alone in advocating for key issues with an organization like the Michigan Pharmacists Association (MPA) Political Action Council (PAC).

 

The MPA PAC was created in 1968 as a voluntary, nonpartisan committee of 527 pharmacy professionals. This group of professionals actively sought to promote good government and good public health policy. Contributions to Pharmacy PAC support legislators who support pharmacy, drive advocacy efforts and facilitate pharmacy participating in notable political events. Pharmacy PAC sponsors annual legislative events that encourage student pharmacists and pharmacy professionals to speak with key legislators and educate them and their staff on issues that are important to our profession. PAC also works to inform MPA members of legislative changes that impact our practice.

 

Proper funding the Michigan Pharmacy PAC elevates the status of MPA and pharmacy within the state. MPA, in collaboration with the practice sections, works on critical issues like provider status with Medicare, appropriate prescribing of opioids, reimbursement rates, technician product verification, direct and indirect remuneration fees and PBM transparency. Supporting Pharmacy PAC and MPA gives Michigan pharmacists and pharmacy technicians a voice, and of course, there is strength in numbers. In 2018 alone, MPA was involved in over 60 introduced bills. As our advocates, MPA ensures that the bills that effect the pharmacy profession and our patients are addressed.

 

Advocating on behalf of our profession and patients does not have to be an overwhelming task especially if you support the Michigan Pharmacy PAC and MPA’s Pharmacy Advocacy Response Team (PART). Our profession, by nature, is one that protects and serves, and advocating is an effective way to do just that. Consider following the mission of PART: participate, advocate, respect and teach. Become a member of PART by signing up today at www.MichiganPharmacists.org/advocacy/part.

 

If you want to see pharmacy friendly legislation, what are you willing to do to make it happen? Changes will not happen without our active participation and advocacy. Call or write your local legislators. Find out what your local legislators stand for, and how they vote on the topics that matter to us. Share with them what needs to change and why. If you want a guide on what to cover and how to phrase it, check the MPA’s website Advocacy page at www.MichiganPharmacists.org/advocacy. It contains talking points for a fair number of current issues.

 

Advocate with our patients. Cultivate a respectful atmosphere where you can educate and communicate to them what is important in terms of good public health policy and what is good for their care. How many times have we helped patients understand because they were unaware of their own insurance policies? Chances are they are also unaware of legislation that impacts pharmacy, and ultimately themselves.

 

Spreading knowledge will create a momentum to get issues noticed. Voice your opinions. Be heard! Amplify your voice by supporting Michigan Pharmacy PAC. MPA will make the connections for you, provide resources and inform you of legislative events and educational opportunities. Advocacy can take shape in many different forms and many times without ever leaving the pharmacy. We can create change if we all do our small PART.

Posted in: Laws and Regulations
Impact of New Legislation on Informatics and Technology

By Heather Somand, Pharm.D., BCPS, manager medication use informatics, Michigan Medicine, Sinai Grace Hospital, Ann Arbor

 

During the last week of 2017, Lt. Gov. Calley signed into law a number of bills addressing opioid prescribing, monitoring, education and consent. As clinical informatics pharmacists, we will be asked to develop functionality within our electronic health records (EHR) to address the new requirements and/or capture data for auditing purposes to assist providers in complying with the new requirements. In the following paragraphs, a description of each law, the date it goes into effect and potential implications to the EHR are described.
 

Senate Bill 166 (Public Act 248) is significant for prescribers and those that support the EHR. Effective Friday, June 1, 2018:

  • All licensed prescribers in Michigan must be registered with the Michigan Automated Prescription System (MAPS) before prescribing or dispensing a controlled substance
  • Prescribers will be required to run and review a MAPS report on all patients who receive a controlled substance prescription for greater than a three-day supply.

As a result, IT teams across the state may be asked to help facilitate compliance with these requirements by integrating the MAPS vendor, Appriss, into your EHR . This will make it easier for providers to check MAPS and/or develop a way to capture a MAPS check either automatically or through an attestation statement. Appriss is able to integrate within certain EHRs and provide single-sign on functionality. Of note, the latter requirement to check MAPS prior to prescribing a controlled substance does not apply to hospital inpatient orders, freestanding surgical clinic orders or veterinary prescriptions filled by a pharmacist.

Senate Bill 274 (Public Act 251) is also significant in that it limits a prescription containing an opioid for treatment of acute pain to a seven-day supply in a seven-day period. The bill does define “acute pain” and goes into effect July 1, 2018. IT teams should start brainstorming options to remind prescribers of this limitation. Options that may be considered include pop-up alerts to the providers during the prescribing process, education built into the short-acting opioid prescription orders, defaulting the sig and quantity in the orders to a seven-day supply, if possible, or limiting the prescription fields.

Some additional details about schedule II controlled substance prescriptions were mentioned in the bill including permitting a pharmacist to do partial fills for CII prescriptions in certain situations.

Senate Bill 47 (Public Act 252) requires prescribers to obtain and review a MAPS report before prescribing or dispensing buprenorphine, a buprenorphine containing medication or methadone to a patient in a substance use disorder program. Any actions taken to enhance your EHR to comply with Senate Bill 166 above should be followed here as well.

House Bill 4408 (Public Act 246) requires education and signed informed consent documents when prescribing an opioid to an adult or minor. In the case of minors, a specific form called the “Start Talking Consent Form” for parental consent is required before prescribing the first prescription in a single course of treatment for a controlled substance containing an opioid. This form must be a separate document from any other informed consent documents a prescriber may use. To see an example of the “Start Talking” document, see Ohio’s version here. The state of Michigan has indicated it will release the Michigan version by May, just in time for the June 1, 2018, due date. IT teams across the state should engage their Health Information Management teams now, since initially, this consent document will need to be uploaded into the EHR and easily accessible.

The bill does outline certain exceptions to parental consent of a minor’s treatment if related to a medical emergency, surgery, hospice or oncologic treatment. See the full bill here.

The second part of House Bill 4408 addresses education to all other patients prior to prescribing an opioid containing prescription and obtaining their signature indicating they received the education. The consent form will also be specific; although, the bill only indicates it will come from the Department of Health and Human Services. This document will also need to reside within the patient’s EHR.

Senate Bill 273 (Public Act 250) requires a licensee or registrant who treats a patient for opioid related overdose to provide information on substance abuse disorder services. Conveniently, the MAPS vendor Appriss provides some resources on their website by zip code, so the need to develop something home grown may not be necessary until the state further defines what information must be provided. This requirement goes into effect March 27, 2018.

Lastly, Senate Bill 167 (Public Act 249) and SB 270 (Public Act 247) both speak to the requirement of a bona fide prescriber-patient relationship. Although this may not directly affect IT teams, details are included incase you receive questions. Some providers initially questioned what this meant in relation to ambulatory clinic visits where a patient may see multiple providers within the practice. However, a bona fide relationship is defined as a prescriber who has all of the following:

  • Reviewed the patient's relevant medical or clinical records and completed a full assessment of the patient's medical history and current medical condition, including a relevant medical evaluation of the patient conducted in person or via telehealth.
  • Created and maintained records of the patient's condition in accordance with medically accepted standards.

If you would like to read the full bills, you can find them at www.Legislature.mi.gov/. Collectively as a state, we should identify the best methods within the EHR to address the legislative requirements from a technology perspective. I encourage you to get involved in the MSHP Informatics and Technology Committee. If you have questions about the Committee, feel free to reach out to me at hsomand@med.umich.edu. Our next meeting is Thursday, May 3, 2018, in Okemos, Mich. We also have a Google group to post questions, benchmark with your colleagues and share experiences. If you’re interested, request membership by visiting groups.Google.com/forum/#!forum/mshp-informatics

Posted in: Laws and Regulations
Pharmacy Benefit Manager Legislation Introduced in Michigan Senate

On Oct. 20, 2016, Senate Bill 1151 was introduced in the Michigan Senate and referred to the Senate Committee on Insurance. This bi-partisan legislation introduced by Senators Tonya Schuitmaker (R-Lawton) and David Knezek (D-Dearborn Heights) creates the regulatory framework for Pharmacy Benefit Managers (PBMs) for the first time in the State of Michigan. The bill addresses PBM transparency, pharmacy audits, retrospective recoupments and several other key issues important to pharmacists and the patients we serve.

 

A PDF version of the legislation that was introduced can be found here: www.Legislature.mi.gov/documents/2015- 2016/billintroduced/Senate/pdf/2016-SIB-1151.pdf.

 

If you have any questions, concerns or would like more information about next steps, please contact Amanda Lick, manager of advocacy, governmental and regulatory affairs, at Amanda@MichiganPharmacists.org. Or to take action and learn more, visit the advocacy action center here

Posted in: Laws and Regulations
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