Primary Care First Model Demonstration Project - Nurse Practitioners as Certifying Physicians for Therapeutic Shoes and Inserts

Joint DME MAC Article
Posted on November 5, 2020

Section 1115A of the Social Security Act established a new Center for Medicare and Medicaid Innovation (the Innovation Center) within the Centers for Medicare & Medicaid Services (CMS) to test new payment and service delivery models that have the potential to reduce Medicare, Medicaid, and Children’s Health Insurance Program expenditures while maintaining or improving the quality of care for beneficiaries. In addition to special payment provisions for primary care services, there are special waivers under the model that allow for payment of other Medicare benefits under conditions that would not otherwise be paid for. When claims are paid under these special "waived" conditions, the claims are also to be tagged with the demonstration code.

Effective January 1, 2021 and extending through December 31, 2025, CMS is exercising its authority under the Primary Care First (PCF) model to waive Section 1861(s)(12) of the Act and the implementing regulations at 42 CFR 410.12 to allow nurse practitioners to certify that an order for diabetic shoes is required according to Section 1861(s)(12). Under this waiver authority, beneficiaries with diabetes are eligible for the standard Medicare diabetic shoe and shoe inserts benefit if a nurse practitioner refers or certifies the beneficiary. Normally, these items are only paid under traditional Medicare Fee-For-Service (FFS) if a physician (MD or DO) refers or certifies the beneficiary. The model is not changing the benefit coverage or limits in any way other than that of loosening the requirement for the referring or certifying provider to include nurse practitioners as well as physicians. Volume limits on supplies, any requirements regarding who can bill for the shoes and supplies, and any other edits that may be applicable to current FFS claims processing for these items shall not change under the model.

The Center for Medicare and Medicaid Innovation will launch the PCF model in 26 regions: Alaska (statewide), Arkansas (statewide), California (statewide), Colorado (statewide), Delaware (statewide), Florida (statewide), Greater Buffalo region (New York), Greater Kansas City region (Kansas and Missouri), Greater Philadelphia region (Pennsylvania), Hawaii (statewide), Louisiana (statewide), Maine (statewide), Massachusetts (statewide), Michigan (statewide), Montana (statewide), Nebraska (statewide), New Hampshire (statewide), New Jersey (statewide), North Dakota (statewide), North Hudson-Capital region (New York), Ohio and Northern Kentucky region (statewide in Ohio and partial state in Kentucky), Oklahoma (statewide), Oregon (statewide), Rhode Island (statewide), Tennessee (statewide), and Virginia (statewide). Additional information on the PCF model may be found here:

Suppliers servicing beneficiaries in the 26 model demonstration regions should be alert to this information to ensure that documentation from nurse practitioners serving as certifying physicians for therapeutic shoes and inserts are participating in the PCF demonstration project. Only nurse practitioners participating in the PCF demonstration or are billing "incident to" a physician’s services are eligible to serve as the certifying physician for therapeutic shoes and shoe inserts. For additional information on nurse practitioners billing "incident to" see the article titled Nurse Practitioners and Physician Assistants as Certifying Physicians for Therapeutic Shoes and Inserts.

Publication History

Date of Change Description
11/05/20 Originally Published


Last Updated Dec 09 , 2023