Question

Prepare an analysis of an Advisory Opinion in healthcare law. Choose Advisory Opinion 18-10 (regarding a surgical device and wound care product manufacturer's proposal to offer hospital customers a warranty program covering a suite of three products). Write 800 words

Answer 1

Analysis:

1. Under the proposed warranty, requestor would offer hospital patient customers – value in exchange for the purchase of the product suite, which could be reimbursable by a federal health care program.
2. Anti-kickback statue to be used.
3. Safe warranty clearly tells about the remedial actions about the manufacturing and supplying product.
4. As a threshold matter, warranty program should involve a bundle of 3 products in the product suite, which will qualify the protection of the product suite.
5. The warranties safe harbor protects the remuneration consisting of following factors.
   1. Any payment or exchange of anything of value under a warranty provided by a manufacturer or supplier of an item to the buyer of the item.
   2. Buyer and seller comply with the safe harbor’s requirements.
6. Discount safe harbor clearly communicates which bundle of items would satisfy the conditions of the safe harbor.it supports the concept of requested bundled discounts when the goods or services are reimbursed by the same payment methodology.
7. A warranty arrangement involving a bundle of items that were separately reimbursable which result in overutilization of one or more items included in the bundle and could unnecessarily increase costs to federal health care programs.
8. They are following analyses steps:
9. Step 1
   1. Medicare reimburses hospitals, the product suite’s buyers, through one bundled payment for all of the items and services the hospitals furnish in connection with an inpatient stay for the particular surgical equipment.
   2. Certification of the requestor for the warranty program
   3. All 3 products in the product suite would be covered by one Medicare payment to the hospital.
   4. There should be reducing the risk of overutilization and inappropriate use of the products and diminishing concerns of increased costs.
10. Step 2
    1. Certified requestor should meet all the obligations of a seller under the warranty
    2. He should report the existence of the warranty program fully and accurately on the invoice or statement
    3. Notify the hospital about reporting the refund which clearly stated by the warranty program, which will inform to federal health care program.
    4. They should clearly mention about the transparency of the program and the diminishing the concern of the increased costs to federal health care program.
11. Step 3:
    1. Refundable should be done in a consistent manner
    2. Decrease the risk of the products used in clinically inappropriate or medically unnecessary manner.
12. Step 4:
    1. Proposed warranty program should reduce the incidence of readmissions due to surgical site infection
    2. Products should be designed to reduce the incidence of infection- related readmissions and required revision.
13. Step 5:
    1. It should include any quotas, minimums or any other eligibility criteria.
    2. There should be specific communications to physicians about performed surgeries in the hospital
    3. There should be maintenance of flexibility to purchase of the products.
    4. Based on warranty program, purchasing decisions to be decided.