TITLE 410 INDIANA STATE DEPARTMENT OF HEALTH
Final Rule
LSA Document #06-139(F)
DIGEST
Adds
410 IAC 28 to establish reporting of any death, serious side effect, or major complication of a patient by physicians who perform a surgical treatment for the treatment of morbid obesity. Effective 30 days after filing with the Publisher.
SECTION 1.
410 IAC 28 IS ADDED TO READ AS FOLLOWS:
ARTICLE 28. REPORTING OF COMPLICATIONS FROM SURGICAL TREATMENT OF MORBID OBESITY
Rule 1. Definitions
Authority:
IC 16-40-3-5
Sec. 1. The definitions in this rule apply throughout this article.
(Indiana State Department of Health; 410 IAC 28-1-1; filed Apr 3, 2007, 8:42 a.m.: 20070502-IR-410060139FRA)
Authority:
IC 16-40-3-5
Sec. 2. "Body mass index" means weight in kilograms divided by height in meters squared.
(Indiana State Department of Health; 410 IAC 28-1-2; filed Apr 3, 2007, 8:42 a.m.: 20070502-IR-410060139FRA)
Authority:
IC 16-40-3-5
Sec. 3. "Department" means the Indiana state department of health.
(Indiana State Department of Health; 410 IAC 28-1-3; filed Apr 3, 2007, 8:42 a.m.: 20070502-IR-410060139FRA)
410 IAC 28-1-4 "Major complication" defined
Authority:
IC 16-40-3-5
Sec. 4. "Major complication" means a complication from surgical treatment for morbid obesity that:
(1) requires an extended hospitalization, additional surgical treatment, or invasive drug therapy within thirty (30) days of the original surgical treatment; or
(2) results in a permanent disability.
(Indiana State Department of Health; 410 IAC 28-1-4; filed Apr 3, 2007, 8:42 a.m.: 20070502-IR-410060139FRA)
Authority:
IC 16-40-3-5
Sec. 5. "Morbid obesity" means a body mass index of at least:
(1) thirty-five (35) kilograms per meter squared, with comorbidity or coexisting medical conditions such as hypertension, cardiopulmonary conditions, sleep apnea, or diabetes; or
(2) forty (40) kilograms per meter squared without comorbidity.
(Indiana State Department of Health; 410 IAC 28-1-5; filed Apr 3, 2007, 8:42 a.m.: 20070502-IR-410060139FRA)
Authority:
IC 16-40-3-5
Sec. 6. "Physician" means a person licensed under IC 25-22.5.
(Indiana State Department of Health; 410 IAC 28-1-6; filed Apr 3, 2007, 8:42 a.m.: 20070502-IR-410060139FRA)
410 IAC 28-1-7 "Serious side effect" defined
Authority:
IC 16-40-3-5
Sec. 7. "Serious side effect" means a nutritional deficiency that requires extensive hospitalization or invasive therapy.
(Indiana State Department of Health; 410 IAC 28-1-7; filed Apr 3, 2007, 8:42 a.m.: 20070502-IR-410060139FRA)
410 IAC 28-1-8 "Surgical treatment" defined
Authority:
IC 16-40-3-5
Sec. 8. "Surgical treatment" means any of the following procedures:
| |
| | Current Procedural Terminology (CPT) Codes |
| 43644 | Laparoscopy, surgical, gastric restrictive procedure; with gastric bypass and Roux-en Y gastroenterostomy (roux limb 150 cm or less) |
| 43645 | Laparoscopic, gastric restrictive surgery, with gastric bypass and Roux-en Y gastroenterostomy (roux limb 150 cm or less) with small bowel reconstruction to limit absorption |
| 43770 | Laparoscopic surgical gastric restrictive procedure. Placement of adjustable gastric band |
| 43842 | Gastric restrictive procedure, without gastric bypass; vertical-banded gastroplasty (VBG) |
| 43843 | Gastric restrictive procedure, other than vertical-banded gastroplasty |
| 43845 | Biliopancreatic diversion with duodenal switch |
| 43846 | Gastric restrictive surgery, with gastric bypass for morbid obesity; with short limb (150 cm or less) Roux-en Y gastroenterostomy |
| 43847 | Gastric restrictive surgery, with gastric bypass and Roux-en Y gastroenterostomy (roux limb 150 cm or less) with small bowel reconstruction to limit absorption |
| 43848 | Revision of gastric restrictive procedure for morbid obesity (separate procedure) |
(Indiana State Department of Health; 410 IAC 28-1-8; filed Apr 3, 2007, 8:42 a.m.: 20070502-IR-410060139FRA)
Rule 2. Reporting Requirements
Authority:
IC 16-40-3-5
Sec. 1. This rule applies to physicians who perform a surgical treatment for the treatment of morbid obesity.
(Indiana State Department of Health; 410 IAC 28-2-1; filed Apr 3, 2007, 8:42 a.m.: 20070502-IR-410060139FRA)
Authority:
IC 16-40-3-5
Sec. 2. A physician who performs a surgical treatment for the treatment of morbid obesity shall do the following:
(1) Monitor the patient for five (5) years following the patient's surgery, unless the physician is unable to locate the patient after making reasonable efforts.
(2) Report before June 30 for the cases in the last six (6) months of the preceding year and December 31 for the first half of the current year to the department any:
(A) death;
(B) serious side effect; or
(C) major complication;
of the patient.
(Indiana State Department of Health; 410 IAC 28-2-2; filed Apr 3, 2007, 8:42 a.m.: 20070502-IR-410060139FRA)
Authority:
IC 16-40-3-5
Sec. 3. (a) A physician who performs a surgical treatment for the treatment of morbid obesity shall report to the department the following information regarding the patient:
(1) Date of birth.
(2) Sex.
(3) Race.
(4) Ethnicity.
(5) County of residence at the time of the surgical treatment for the treatment of morbid obesity.
(b) A physician shall report to the department the following medical information regarding the surgical treatment for the treatment of morbid obesity:
(1) The date of the surgical treatment for the treatment of morbid obesity.
(2) Diagnoses.
(3) Existing comorbidities, body mass index, and waist circumference of patient:
(A) at the time of surgery; and
(B) thirty (30), sixty (60), ninety (90) days, and one (1) year after surgical treatment.
(4) Whether the patient has had previous abdominal surgery.
(5) Surgical procedures performed.
(6) Facility where the surgery was performed.
(c) A physician shall report to the department the following medical information regarding the death, serious side effect, or major complication of the patient:
(1) The date of the event.
(2) If death, the cause of death.
(3) If a serious side effect or major complication, the type of serious side effect or major complication.
(4) Hospitalization associated with the death, serious side effect, or major complication, including the following:
(A) The length of the stay.
(B) The discharge status.
(5) Procedures performed to treat the serious side effect or major complication.
(d) A physician shall report to the department using forms provided by the department.
(Indiana State Department of Health; 410 IAC 28-2-3; filed Apr 3, 2007, 8:42 a.m.: 20070502-IR-410060139FRA)
Authority:
IC 16-40-3-5
Sec. 4. (a) The reports made under this article are confidential.
(b) The department may compile statistical reports from the information contained in the reports made under section 3 of this rule. Any statistical report is subject to public inspection.
(Indiana State Department of Health; 410 IAC 28-2-4; filed Apr 3, 2007, 8:42 a.m.: 20070502-IR-410060139FRA)
Notice of Intent: June 1, 2006; 29 IR 3043
Hearing Held: February 13, 2007
Approved by Attorney General: March 28, 2007
Approved by Governor: April 2, 2007
Filed with Publisher: April 3, 2007, 8:42 a.m.
Documents Incorporated by Reference: None Received by Publisher
Small Business Regulatory Coordinator: Joe Hunt, Indiana State Department of Health, 2 North Meridian Street, 5A, Indianapolis, Indiana 46204, (317) 233-7524, jhunt@isdh.state.in.us
Posted: 05/02/2007 by Legislative Services Agency
DIN: 20070502-IR-410060139FRA
Composed: May 02,2024 12:52:32AM EDT
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