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Kathryn Ottinger v. Kathleen Sebelius

November 28, 2012

KATHRYN OTTINGER, PLAINTIFF,
v.
KATHLEEN SEBELIUS, SECRETARY OF THE UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, DEFENDANT.



The opinion of the court was delivered by: John M. Conroy United States Magistrate Judge

OPINION AND ORDER

(Docs. 6, 7)

Plaintiff Kathryn Ottinger, appearing pro se, brings this action against Defendant Kathleen Sebelius, Secretary of the United States Department of Health and Human Services ("Secretary"), seeking review of the Secretary's determination that she is not entitled to coverage under Medicare Part B for the cost of intravenous (IV) daptomycin,*fn1 an external infusion pump, and infusion supplies, all of which were provided to her in her home from September 11, 2009 through September 25, 2009. Pending before the Court are Ottinger's motion seeking an order reversing the Secretary's decision (Doc. 6), and the Secretary's motion for judgment on the pleadings seeking dismissal of Ottinger's Complaint (Doc. 7). On November 20, 2012, the Court held a hearing on the motions. Both parties attended the hearing and presented oral argument.

For the foregoing reasons, the Court GRANTS the Secretary's motion, and DENIES Ottinger's motion.

Background

I. Factual Background

Since 2009, Ottinger has treated with the Fletcher Allen Health Care Infectious Disease Clinic. (AR 153.) In May 2009, when she was approximately seventy-four years old, she had spinal fusion surgery. (AR 85, 153.) Thereafter, she developed complications, including a gallbladder rupture and a serious surgical wound infection, requiring several trips back to the operating room and multiple courses of IV antibiotics. (Id.) From August until the beginning of September 2009, Ottinger underwent acute rehabilitation at the Burlington Health and Rehabilitation Center for her surgical infection. (AR 85, 152.) After developing an allergic reaction to the antibiotic vancomycin, she was switched to daptomycin. (AR 152.) In a letter from March 2010, Dr. Susan Shull, Ottinger's physician at the Rehabilitation Center, explained that, "[r]ehab was indicated for, but not limited to, surgical wound infection with coag [sic] negative Staph requiring IV antibiotics and vacuum drainage, subsequent large pulmonary embolism requiring anticoagulation and ruptured gall bladder." (Id.) Dr. Shull further explained that Ottinger "required PT and OT in addition to wound vacuum drainage, dressing changes[,] and IV antibiotics via [a peripherally-inserted central catheter] line." (Id.)

As of mid-September 2009, Ottinger had improved, and the only remaining care she required was the provision of IV antibiotics and wound care. (AR 152.) Meanwhile, she was suffering from depression as a result of the emotional and psychological stress associated with enduring multiple prolonged medical admissions and living away from home for an extended period. (AR 151-53, 179-81.) In consideration of these issues, as well as Ottinger's physical condition, Ottinger's physicians, including Dr. Shull and Dr. Kristen Pierce, who treated Ottinger at the Fletcher Allen Health Care Infectious Disease Clinic, decided that the best physical and emotional treatment plan for Ottinger was to send her home and continue her IV antibiotic therapy there. (AR 152-53.) Accordingly, on September 11, 2009, Ottinger was discharged, and daptomycin was administered to her at home via IV for approximately two weeks. (AR 148.) At or around the time of her discharge, Ottinger signed an Advance Beneficiary Notice of Noncoverage (ABN) which stated that "[d]aptomycin administered via pump is not covered in the home setting by Medicare A or B." (AR 46 (emphasis added).) The ABN was issued by Apria Healthcare, Inc. (Apria), the company that provided Ottinger with the IV daptomycin and related supplies at her home.

II. Procedural Background

Apria submitted Medicare claims for Ottinger's IV daptomycin and supplies in the amount of approximately $14,000. (AR 148.) NHIC Corp., a durable medical equipment Medicare Part B contractor for the State of Vermont, denied coverage for these claims. (AR 126.) Ottinger requested reconsideration, and NHIC again denied coverage. (AR 138-39.) Ottinger, through her husband, requested review of NHIC's denial by a qualified independent contractor (QIC), arguing that, "the use of [d]aptomycin and related equipment was medically necessary, and this was determined by a team of well- qualified doctors." (AR 125.) The QIC upheld NHIC's decision, and denied coverage, explaining: "Medicare does not allow an external infusion pump, infusion supplies, and maintenance of a catheter when the drug used in the infusion therapy is not a covered drug. Daptomycin is not covered because an infusion pump is not needed to dispense the drug." (AR 118.)

Ottinger requested a hearing before an administrative law judge (ALJ), which was held on April 14, 2011. (AR 162-85.) Ottinger was represented at the hearing by Attorney William Dysart, and her husband and daughter testified on her behalf. Ottinger's husband, Harvey Ottinger, testified that Ottinger's discharge and receipt of IV daptomycin at home was a "medical decision" that was made by Drs. Pierce and Scholl and not by Ottinger or her family members. (AR 178.) He explained that Ottinger and her family were "just following the best medical advice given to us." (Id.) Ottinger's daughter, Judy Gover, testified that, had she known she could have administered daptomycin to Ottinger by injection, she "would have done it," but she did not know that was an option. (AR 181.)

III. ALJ/MAC Decision

In May 2011, the ALJ issued a decision finding that the costs of the infusion pump and supplies provided to Ottinger in September 2009 were not covered under Medicare Part B. (AR 20-26.) The ALJ reasoned that there was no evidence indicating Ottinger's daptomycin was "required"to be administered by infusion pump, and thus Ottinger had failed to meet the coverage criteria set forth in the applicable Local Coverage Determination (LCD), LCD L5044. (AR 25.) Ottinger appealed the ALJ's decision to the Medicare Appeals Council (MAC). (AR 10-13.) In November 2011, the MAC issued a decision concurring with the ALJ's ultimate decision but modifying the analysis contained therein "to clarify the legal basis" for the denial of coverage. (AR 4; see AR 3-8.) Specifically, the MAC found that, regardless of whether the administration of daptomycin to Ottinger via IV was medically appropriate or whether the drug was needed to treat Ottinger's condition, Ottinger failed to demonstrate that the drug and associated supplies satisfied the coverage criteria set forth in LCD L5044. (AR 5-6.) The MAC further determined that, given Ottinger's signature on the applicable ABN, Ottinger "knew or could reasonably be expected to know that the items would likely not be covered by Medicare," and thus Ottinger "is liable for the non-covered costs." (AR 8.)

The MAC's decision was the final determination of the Secretary. On January 6, 2012, having exhausted all administrative remedies, Ottinger filed a Complaint against the ...


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