Automated Summary
Key Facts
Family Foot and Leg Center, P.A. sought judicial review of a denial of Medicare Part B coverage for Procenta injections administered to six beneficiaries between February 9 and June 10, 2022. The injections were intended to treat osteophytes (bone spurs) and enthesopathy in feet, ankles, and knees. The Secretary denied coverage, finding Procenta was not safe and effective for these conditions. The Appeals Council reversed an Administrative Law Judge's favorable decision, determining that Procenta was not medically reasonable and necessary for the beneficiaries' conditions. The Court affirmed the Secretary's decision, finding substantial evidence supported the Appeals Council's conclusion that Procenta was not appropriate for treating musculoskeletal conditions and that the provider was not entitled to limitation of liability under § 1879 of the Social Security Act.
Issues
- The court reviews whether substantial evidence supports the Appeals Council's finding that Plaintiff failed to demonstrate Medicare Part B coverage was medically reasonable and necessary for Procenta injections used to treat osteophytes and enthesopathy in foot, ankle, and knee. The Appeals Council concluded the Procenta patent and HCPCS applications indicated Procenta is a wound covering for chronic non-healing wounds, not an injectable for orthopedic purposes, and no medical literature supported its use for musculoskeletal conditions.
- The court examines whether substantial evidence supports the Appeals Council's determination that Plaintiff could have reasonably been expected to know Medicare would not cover the Procenta injections, and thus is not entitled to limitation of liability under § 1879 of the Social Security Act. The Appeals Council found sufficient information was available to establish that amniotic fluid products for orthopedic use were not covered, including a February 2022 TDL on experimental biologics and the Procenta patent/HCPCS applications indicating wound covering use only.
Holdings
The Court affirms the Secretary's decision denying Medicare Part B coverage for Procenta injections administered to treat osteophytes and enthesopathy. The Court finds substantial evidence supports the Appeals Council's determination that the injections were not medically reasonable and necessary, and that the Plaintiff is not entitled to a limitation of liability under § 1395pp(a) of the Social Security Act. Judgment is entered for Defendants, case is terminated, and closed.
Remedies
- The Clerk is directed to enter judgment for Defendants and against Plaintiff, terminate any deadlines, and close the case.
- The case was terminated with deadlines closed and the case formally closed by the Clerk following the affirmation of the Secretary's decision.
- The court affirmed the decision of the Secretary under sentence four of 42 U.S.C. § 405(g). The Secretary's decision denying Medicare Part B coverage for Procenta injections was upheld with substantial evidence supporting the Appeals Council's finding that the Plaintiff failed to show entitlement to coverage. Judgment was entered for Defendants and against Plaintiff, with all deadlines terminated and the case closed.
Legal Principles
- Providers may be entitled to limitation of liability under § 1879 of the Social Security Act if they did not know or could not reasonably be expected to know that payment would not be made. The Appeals Council found Plaintiff should have known Medicare would not cover Procenta injections for orthopedic purposes based on available guidance and documentation.
- Medicare only covers items and services that are reasonable and necessary for diagnosis or treatment of illness or injury or to improve functioning of a malformed body member. Services must be safe and effective, not experimental or investigational, and appropriate. The Procenta injections were denied coverage as they were not medically reasonable and necessary for treating osteophytes and enthesopathy.
- The provider/claimant bears the burden of proving entitlement to Medicare benefits. To determine if a service is reasonable and necessary, adjudicators must assess whether the service is safe and effective, not experimental or investigational, and appropriate based on the strongest evidence possible. The provider must demonstrate services meet Medicare coverage requirements.
- Judicial review of the Secretary's Medicare decision is limited to whether there is substantial evidence to support the findings and whether correct legal standards were applied. The Appeals Council's decision is the one under review, not the ALJ's. Substantial evidence means relevant evidence a reasonable person would accept as adequate to support a conclusion. The court cannot substitute its judgment for the agency's concerning wisdom or prudence of the action.
Precedent Name
- Wilson v. Barnhart
- Parker v. Bowen
- Int'l Rehab. Scis. Inc. v. Sebelius
- Almy v. Sebelius
- Gordon v. Azar
- Crawford v. Comm'r of Soc. Sec.
- Vitreo Retinal Consultants of the Palm Beaches, P.A. v. U.S. Dep't of Health & Hum. Servs.
- Gulfcoast Med. Supply, Inc. v. Sec'y, Dep't of Health & Hum. Servs.
Cited Statute
- Medicare Coverage Requirements
- Social Security Act
- Limitation of Liability
Judge Name
Sheri Polster Chappell
Passage Text
- Judicial review of the Secretary's decision regarding a claim for Medicare benefits is limited to whether there is substantial evidence to support the findings of the Secretary, and whether the correct legal standards were applied.
- 1. The decision of the Secretary is AFFIRMED under sentence four of 42 U.S.C. § 405(g). 2. The Clerk is DIRECTED to enter judgment for Defendants and against Plaintiff, terminate any deadlines, and close the case.
- The Appeals Council found that the record evidence did not support Medicare coverage for the Procenta injections at issue and that Plaintiff was liable for the uncovered costs. It found that the ALJ did not apply the correct standard when evaluating Plaintiff's claim and thus erred as a matter of law.