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.
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.
- 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.