Laws and Regulations

The pharmacy news section of the MPA Web site is designed to provide members with immediate access to timely and relevant information about pharmacy and our Association. In this section, you will find information on MPA activities, Association members, the latest issues impacting the pharmacy profession and press releases from MPA and its affiliates.

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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.

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
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
Waste Documentation Sterile Compounding and Biologic Substitution…Oh My!

by Prabah Vogel, Pharm.D., pharmacy manager, Henry Ford Hospital, Royal Oak

Drug Waste Billing (i.e. JW modifier): Effective Jan. 1, 2017
The Centers for Medicare & Medicaid Services (CMS) is revising its policy to require that Medicare Administrative Contractors (MACs) uniformly utilize the JW modifier for all claims with discarded Part B drugs and biologicals. Use the modifier JW to identify unused drugs or biologicals from single use vials or single use packages that are appropriately discarded, allowing for payment for the discarded drug or biological. Availability of package sizes and the dosage definitions for the HCPCS codes to correctly bill the drugs are two factors that make implementing this requirement challenging. Note that waste will only be reimbursed for single dose vials utilizing the smallest package size. On the day a patient is being treated, the smallest package size must be utilized to minimize waste. If the smallest package size is not utilized, there will be no reimbursement for waste. The above requirement will not apply to drugs or biologicals under the Competitive Acquisition Program (CAP).

Sterile Compounding Certification: Effective June 30, 2017
The Michigan legislature passed Public Act 280 of 2014, setting forth new requirements for pharmacists or pharmacies that compound sterile and non-sterile pharmaceuticals. The act requires licensed pharmacies that provide compounding services for sterile pharmaceuticals to obtain accreditation through a national accrediting organization approved by the Michigan Board of Pharmacy (BOP). National organizations able to provide this certification include the Pharmacy Compounding Accreditation Board (PCAB), The Joint Commission (TJC) and the National Association of Boards of Pharmacy (NABP). All accrediting bodies will be assessing the compounding process based on USP <797> standards.

During the August 2016 meeting, the Michigan BOP also clarified that if an organization submits an application for accreditation prior to Sept. 30, 2016, the organization would be considered as meeting the requirement to be “in the accreditation process.” However, the expectation is that all pharmacies have completed the certification process prior to June 30, 2017. Included below are the links to the application process for the approved national organizations able to provide certification.

Approved Organizations Website
Pharmacy Compounding National Board (PCAB) cc.ACHC.org/
The Joint Commission (TJC)* www.CVent.com/surveys/Welcome.aspx?s=e661f01e-9114-4fe0-b17e-68af3a1c7d24
Verified Pharmacy Program (VPP)/ National Association of Boards of Pharmacy (NABP) www.NABP.net/programs/licensure/verified-pharmacy-program
*TJC will only provide certification to facilities currently accredited by TJC

Biologic Product Substitution: Michigan House Bill No. 4812
HB 4812 would allow pharmacists upon the receipt of a prescription for a brand name biologic product to substitute it for an interchangeable biologic product, if available, without physician intervention. Pharmacist/pharmacies must maintain an electronic record of interchangeable products dispensed for a period of two years. In November 2015, HB 4812 passed 101 to five in the House. In February 2016, the Senate recommended that the policy be adopted and the bill passed.

References:
  • Department of Health and Human Services. JW Modifier: Drug Amount Discarded/Not Administered to Patient. Centers for Medicare & Medicaid Services website. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM9603.pdf. Published June 2016. Accessed September 2016.
  • Michigan Legislature. House Bill 4812. Legislature.mi.gov. http://www.legislature.mi.gov/(S(egfwudzlks23hdb1m4mtumni))/mileg.aspx?page=GetObject&objectname=2015-HB-4812. Accessed September 2016.
Posted in: Laws and Regulations
Good Samaritan Legislation Presented to the Governor Last Week

Last week, legislation was presented to Governor Rick Snyder regarding Public Act 307 and 308 which removes the age cap from legislation signed earlier this year for those who call 911 in an overdose situation. This is another strategy that other states have adopted to fight the prescription drug abuse and heroin epidemic. Specifically, this would allow for any individual to call 911 when they witness an overdose, and by doing so, that individual, under certain circumstances, would receive immunity from prosecution of certain drug related offenses. Late last year, Public Act 220, the Good Samaritan legislation passed with an age provision of 21 and under. Michigan Pharmacists Association (MPA) along with other advocacy groups worked to remove the age requirement to ensure that more lives can be saved. A copy of the legislation can be found here.

Posted in: Laws and Regulations
Scope of Pharmaceutical Services

The Bureau of Professional Licensing (BPL) within the Michigan Department of Licensing and Regulatory Affairs (LARA) has partnered with the National Association of Boards of Pharmacy (NABP) to conduct a survey of pharmacies. The purpose of this is to determine the scope of pharmaceutical services provided by licensed pharmacies located in Michigan. Please note that this is different from the Cost of Dispensing Survey issued by MDHHS and Myers & Stauffer.

This is a follow-up to a similar questionnaire that LARA conducted in 2012. As a way to keep LARA’s information up-to-date and accurate about the pharmaceutical services your pharmacy provides, it is critical that you complete this electronic survey by Aug. 20, 2016. The survey should take no more than 10 minutes to complete and is mandatory for all pharmacies to complete. Please contact NABP with any questions at the following email: MIPharmacy@nabp.net.

INSTRUCTIONS FOR SURVEY COMPLETION
  1. In your web browser, type the following: www.surveymonkey.com/r/mipharmacy
  2. Follow the instructions to complete the survey.
  3. Print a copy of the final screen as proof of completion of the survey.
  4. Please refer to the information below for a summary of what you will need to provide in the survey. 

NOTE: Once you begin the survey, you must complete the survey in its entirety. To prepare for completion of the survey, we advise that you use the following checklist to obtain the necessary information:

Michigan state pharmacy license number
Pharmacy name as it appears on the Michigan license
Pharmacy address, phone number, email address
Other states in which the pharmacy holds a license
FDA registration number (if an outsourcing facility)
Activities/services performed
Volume and frequency of sterile and/or nonsterile compounding
Total dosage units of non-patient-specific sterile and/or nonsterile compounded medications in an average week
Percentages of Low, Medium and High risk sterile compounding, as defined by USP
Volume of top five drugs your pharmacy compounds
Average number of prescriptions dispensed per week
Date of last inspection
Accreditations held by whom and what date

NOTE: If for some reason you are unable to complete the survey before you reach the final screen, and you need to resume, please use the same computer and browser to access the link. You should be directed to where you left off, but we advise you to complete the survey in its entirety once you begin to ensure you do not lose your work.

Posted in: Laws and Regulations
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