License Directory - Pennsylvania

License Directory for CBIC States

Pennsylvania

Suppliers submitting a bid for a product category in a competitive bidding area (CBA) must meet all Durable Medical Equipment, Orthotics, and Supplies (DMEPOS) state licensure requirements and other applicable state licensure requirements, if any, for that product category for every state in that CBA. Prior to submitting a bid for a CBA and product category, the supplier must have a copy of the applicable state licenses on file with the National Supplier Clearinghouse (NSC). As part of the bid evaluation, the Competitive Bidding Implementation Contractor (CBIC) will verify with the NSC that the supplier has on file a copy of all applicable required state license(s).

The following is a guide outlining the licenses required by the Commonwealth of Pennsylvania for each

competitive bidding product category for suppliers that have a physical location(s) in the state. Suppliers

that do not have a physical location in the state but provide DMEPOS to Medicare beneficiaries in

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Oxygen Supplies & Equipment

DME Supplier License

?1? *

**

Standard Power Wheelchairs, Scooters & Related Accessories

DME Supplier License

?1? *

Complex Rehabilitative Power Wheelchairs & Related Accessories

DME Supplier License

?1? *

Mail-Order Diabetic Supplies DME Supplier License

?1? *

Enteral Nutrients, Equipment & Supplies DME Supplier License

?

1

?

*

License is required for equipment only (pumps, etc.)

CPAP/RADs & Related Supplies & Accessories

DME Supplier License

?1? *

**

Hospital Beds & Related Accessories Bedding & Upholstery Registration

?2

***

Walkers & Related Accessories DME Supplier License

?1? *

DMEPOS Competitive Bidding Program

September 2009

License Issuing Agencies

1 Pennsylvania Department of Health, Drug Registration Section

DME Supplier License Phone: 717-787-4779 Web:

2 Bureau of Occupational & Industrial Safety, Bedding & Upholstery Section

Bedding & Upholstery Registration Phone: 717-787-6848 Web:

NOTES

Any business (each location) in the Commonwealth who is manufacturing, distributing, or retailing drugs (prescription, controlled substances or over-the-counter), medical devices, and/or medicated cosmetics in accordance with the Controlled Substance, Drug, Device and Cosmetic Act (Act 233 of 1972)(DD&C Act) must register with the Pennsylvania Department of Health. A Certificate of Registration will be issued to the applicant upon registration. In addition to the registration requirement, any distributor of prescription drugs, controlled substances, and/or medical gases needs to comply with the licensure requirements under the Wholesale Prescription Drug Distributors Licensure Act (Act 145 of1992)(WPDDL Act). A Certificate of Licensure will be issued to the applicant upon licensure registration. Again, any distributor of prescription drugs, controlled substances, and/or medical gases needs both registration and licensure.

* Pharmacies only need to register/obtain licensure if more than 5 percent of their business

activities (total dollar sales) include the manufacture/distribution of drugs or devices. Registration is required if the facility is operating as a retailer of over-the-counter drug products with no pharmacist on duty or pharmacist supervision.

** Oxygen and/or medical gases for medical purposes are considered prescription drugs under

registration and licensure requirements. If a facility is manufacturing or transfilling oxygen or other medical gases, they must register as a Manufacturer of prescription products and apply for licensure. A facility that is purchasing and reselling filled oxygen units/cylinders to another facility or business must register as a Distributor of prescription products and apply for licensure. A facility selling filled oxygen units/cylinders directly to the ultimate user/patient only needs to register as a Distributor of prescription products (application for licensure is not required). Note: Registration as a Distributor of prescription products permits the handling and selling of other medical devices or durable medical equipment.

*** No person shall sell or lease, or have in his possession with intent to sell or lease, in the

Commonwealth of Pennsylvania, any mattresses, pillows, bolsters, feather beds, and other filled bedding, cushions, upholstered furniture and bulk materials, unless there be affixed to the tag required by this act by the person manufacturing, selling, or leasing the same, an adhesive stamp prepared and issued by the department, except that any person desiring to do so may make application to the secretary on an approved form for a license which, if issued, will relieve him of the requirement that an adhesive stamp be attached to every tag. Each license shall expire one year from the date of issue unless revoked prior thereto.

License Directory for CBIC States - Pennsylvania

DMEPOS Competitive Bidding Program

September 2009

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