Sewickley Valley Hospital v. Commonwealth ( 1979 )

Opinion by

Judge Wilkinson, Jr.,

These petitions for review which have been consolidated for purposes of review present the appeals of Sewickley Valley Hospital, Community Hospital, and Union City Memorial Hospital from final administrative action of the Department of Public Welfare (Department) denying their claims for reimbursement in five cases of voluntary nontherapeutic sterilizations performed on otherwise eligible medical assistance patients. We reverse and remand.

Under the Medical Assistance Program, the Department makes payments to participating hospitals for services provided to eligible patients pursuant to Section 443.1 of the Public Welfare Code, Act of June 13.1967, P.L. 31, as amended, added by the Act of July 31.1968, P.L. 904, 62 P.S. §443.1 which provides in pertinent part: “The following medical assistance payments shall be made in behalf of eligible persons whose institutional care is prescribed by physicians: (1) The reasonable cost of inpatient hospital care, as specified by regulations of the department adopted under Title XIX of the Federal Social Security Act [42 U.S.C. §1396 etseq.]....”

The United States Congress has authorized the funding of a full range of family planning services, which of particular interest to us here is the funding made available through the Medicaid program in SubchapterXIX of the Social Security Act, 42 U.S.C. §1396 et seq. The Department of Health, Education and Welfare has promulgated regulations governing the funding of sterilizations as a family planning alternative.¹

The Department issued Memorandum No. 74, effective January 1, 1975, explaining the Federal restrictions on reimbursement for nontherapeutic sterilizations. Included with the memorandum was the Department’s Form MA-71, “Consent Document For Sterilization Procedure”, which was to be submitted with each claim for reimbursement.

The MA-71 is composed of two distinct parts. Part 1 consists of a numerical list of the elements of informed consent that must be conveyed to the patient. Following the list, which tracks the elements of informed consent set out in the Federal regulations albeit in somewhat briefer form, the MA-71 provides for the patient’s signed affirmation that: “Based upon the explanation provided to me by [name of physician or designee] according to the above, I hereby request and consent to a sterilization procedure.” There is similarly an opportunity provided for an auditor-witness selected by the patient to affirm that, “I was present when the above was orally explained to the patient in detail and to my best knowledge and belief it was understood.”

Part 2 of the consent document, “Summary or [sic] Oral Presentation oe the Basic Elements oe Informed Consent,” consists of a restatement of each of the elements followed by a space for summarizing the details of the explanation given. This part of the document is to be signed by the physician or his designee who made the oral presentation and the auditor-witness.

In each of the five cases presented by the instant petitions, it is undisputed that Part 1 had been fully and properly executed; the difficulties here arise because Part 2 of the forms submitted by the hospitals was not filled out completely.²

The issue in these consolidated appeals is the propriety of the Department’s policy refusing post-submission supplementation of the consent documents. In each of the cases, the petitioning hospitals have offered to supply documentary and testimonial evidence to fill in the gaps on the documents which allegedly re-suited from inadvertence or clerical error. The Department maintains that its refusal to consider such evidence at this time is necessary to insure the availability of matching funds. We must disagree.

Informed consent “means the voluntary, knowing assent from the individual on whom any sterilization is to be performed after he has been given”³ an oral presentation of the six elements of informed consent. Part 1 of the MA-71 signed by the patient supplies, at least facially, evidencé of informed consent. The remainder of the document simply provides additional evidence that the oral presentation given the patient was full and adequate and that the informed consent, apparent from Part 1, was actually knowing and voluntary.

Whether informed consent has been obtained from the patient depends in no way upon the completion of Part 2 of the consent document. Indeed informed consent and the oral presentation necessary to its obtainment has occurred or not prior to the time the summary is prepared. The Department certainly has authority to devise a mechanism such as Part 2 for verifying the existence of informed consent. We don’t, however, agree that such authority extends to the point where the Department can declare Part 2 of Form MA-71, or at least its pre-submission completion, the exclusive means of verification.

We are unable to accept the Department’s contention that permitting post-submission supplementation at an appeal hearing will create an undue administrative burden. In cases where the consent documents are incomplete, the burden of marshalling the necessary evidence will appropriately fall upon the hospital. We think in the great majority of cases documentary evidence such as affidavits of the participants will suffice and of course the evidentiary burden in such a case should rest with the party seeking reimbursement. We perceive no valid reason to deny to the petitioning hospitals an opportunity to demonstrate that the informed consent evidenced by the patients’ signatures was knowing and voluntary and that if Part 2 had been accurately and completely filled out it would support Part 1.

Accordingly, we will enter the following

Order

And Now, December 27,1979, the orders of the Department of Public Welfare in the above captioned cases constituting the final administrative action therein, denying the appeals of Sewickley Valley Hospital, dated August 24,1978; Union City Memorial Hospital, dated September 27, 1978; and Community Hospital, dated September 25, 1978 are hereby reversed and the records in each of the respective cases shall be remanded to the Department of Public Welfare for a hearing and other appropriate administrative proceedings consistent with the above opinion.

1 The chronological evolution of the Federal regulations with respect to sterilization is complex and an understanding of which is unnecessary to the resolution of the issues here presented. For that history see 43 Fed. Reg. 52146 et seq. (1978). The regulations which at the time of their issuance were termed “interim regulations” were codified at 45 O.F.B. §205.35 and provided pertinently as follows:

(2) As used in this paragraph:

(i) Informed consent means the voluntary, knowing assent from the individual on whom any sterilization is to be performed after he has been given (as evidenced by a document executed by such individual) :

(A) A fair explanation of the procedures to be followed ;

(B) A description of the attendant discomforts and risks;

(C) A description of the benefits to be expected;

(D) Oounseling concerning appropriate alternative methods; and the effect and impact of the proposed sterilization including the fact that it must be considered to be an irreversible procedure;

(E) An offer to answer any inquiries concerning the procedures;

(F) An instruction that the individual is free to withhold or withdraw his or her consent to the procedure at any time prior to the sterilization without prejudicing his or her future care and without loss of other project or program benefits to which the patient might otherwise be entitled.

2 The appeal of Sewickley Valley Hospital, 2240 C.D. 1978 involved a single claim for reimbursement. The omission was item No. 5 indicating that an offer to answer the patient’s questions had been made. Unlike the cases of the other two hospitals, conflicting evidence was presented as to whether the form as submitted was incomplete, this issue being resolved against the hospital by the hearing examiner. Community Hospital’s appeal, 2452 C.D. 1978 presented two claims for which item No. 5 had been neglected. The appeal of Union City Memorial Hospital, 2453 C.D. 1978 concerned two cases in which item No. 6, an instruction that the patient is free to withhold or withdraw his consent, was incomplete in addition to which the signature of the physician or his designee was undated.

3 45 C.F.R. §205.35(a) (2) (i).