Senate Introduced Bill B00619

SENATE BILL No. 619

July 12, 2001, Introduced by Senator SCHWARZ and referred to the Committee on Health Policy.

A bill to amend 1978 PA 368, entitled

"Public health code,"

(MCL 333.1101 to 333.25211) by adding part 135A.

THE PEOPLE OF THE STATE OF MICHIGAN ENACT:

1 PART 135A. MAGNETIC RESONANCE IMAGING

2 SEC. 13551. (1) BEGINNING UPON THE EXPIRATION OF 90 DAYS

3 AFTER THE EFFECTIVE DATE OF THE AMENDATORY ACT THAT ADDED THIS

4 SECTION, A PERSON SHALL NOT USE A MAGNETIC RESONANCE IMAGER TO

5 PERFORM A PATIENT STUDY UNLESS THE MAGNETIC RESONANCE IMAGER IS

6 REGISTERED WITH THE DEPARTMENT UNDER THIS SECTION AND DEPARTMENT

7 RULES FOR REGISTRATION OF MAGNETIC RESONANCE IMAGERS.

8 (2) THE DEPARTMENT SHALL AUTHORIZE A MAGNETIC RESONANCE

9 IMAGER FOR USE FOR PATIENT STUDIES IF THE MAGNETIC RESONANCE

10 IMAGER, THE PERSONNEL OPERATING THE MAGNETIC RESONANCE IMAGER,

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1 AND THE FACILITY IN WHICH THE MAGNETIC RESONANCE IMAGER IS USED

2 MEET ALL OF THE FOLLOWING STANDARDS:

3 (A) THE MAGNETIC RESONANCE IMAGER AND THE FACILITY IN WHICH

4 THE MAGNETIC RESONANCE IMAGER IS USED MEET THE CRITERIA FOR THE

5 AMERICAN COLLEGE OF RADIOLOGY MAGNETIC RESONANCE IMAGER ACCREDIT-

6 ATION PROGRAM APPROVED BY THE AMERICAN COLLEGE OF RADIOLOGY COUN-

7 CIL AT ITS 1994 ANNUAL MEETING AND BASED ON AMERICAN COLLEGE OF

8 RADIOLOGY MAGNETIC RESONANCE IMAGER STANDARDS IN EXISTENCE AT

9 THAT TIME, AS APPROVED BY THE DEPARTMENT. THE DEPARTMENT SHALL

10 MAKE COPIES OF THOSE CRITERIA AND STANDARDS AVAILABLE TO THE

11 PUBLIC AND MAY BY RULE ADOPT MODIFIED CRITERIA AND STANDARDS.

12 THE DEPARTMENT MAY ACCEPT AN EVALUATION REPORT ISSUED BY THE

13 AMERICAN COLLEGE OF RADIOLOGY AS EVIDENCE THAT A MAGNETIC RESO-

14 NANCE IMAGER, THE PERSONNEL OPERATING THE MAGNETIC RESONANCE

15 IMAGER, AND THE FACILITY IN WHICH THE MAGNETIC RESONANCE IMAGER

16 IS USED MEET THOSE CRITERIA. IF AT ANY TIME THE DEPARTMENT

17 DETERMINES THAT IT WILL NOT ACCEPT ANY EVALUATION REPORTS ISSUED

18 BY THE AMERICAN COLLEGE OF RADIOLOGY AS EVIDENCE THAT A MAGNETIC

19 RESONANCE IMAGER, THE PERSONNEL OPERATING THE MAGNETIC RESONANCE

20 IMAGER, AND THE FACILITY IN WHICH THE MAGNETIC RESONANCE IMAGER

21 IS USED MEET THOSE CRITERIA, THE DEPARTMENT SHALL PROMPTLY NOTIFY

22 EACH PERSON WHO HAS REGISTERED A MAGNETIC RESONANCE IMAGER UNDER

23 THIS PART AND THE RULES PROMULGATED UNDER THIS PART.

24 (B) THE MAGNETIC RESONANCE IMAGER AND THE FACILITY IN WHICH

25 THE MAGNETIC RESONANCE IMAGER IS USED MEET STATE AND FEDERAL

26 REQUIREMENTS.

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1 (C) THE FACILITY IN WHICH THE MAGNETIC RESONANCE IMAGER IS

2 USED DOES ALL OF THE FOLLOWING:

3 (i) MAINTAINS DOCUMENTED POLICIES FOR ALL OF THE FOLLOWING:

4 (A) ADMINISTRATION OF CONTRAST AND SEDATION ADMINISTERED IN

5 ACCORDANCE WITH AMERICAN COLLEGE OF RADIOLOGY STANDARDS.

6 (B) AN APPROPRIATELY EQUIPPED EMERGENCY CART THAT IS IMMEDI-

7 ATELY AVAILABLE.

8 (C) PATIENT AND PERSONNEL SAFETY.

9 (ii) AT LEAST ANNUALLY HAS A QUALIFIED MEDICAL PHYSICIST

10 PROVIDE ON-SITE CONSULTATION TO THE FACILITY, INCLUDING, BUT NOT

11 LIMITED TO, A COMPLETE EVALUATION OF THE ENTIRE MAGNETIC RESO-

12 NANCE IMAGER TO ENSURE COMPLIANCE WITH THIS PART AND THE RULES

13 PROMULGATED UNDER THIS PART.

14 (iii) MAINTAINS FOR AT LEAST 7 YEARS RECORDS OF THE CONSUL-

15 TATION REQUIRED IN SUBPARAGRAPH (ii) AND THE FINDINGS OF THE

16 CONSULTATION.

17 (iv) DESIGNATES AN ALLOPATHIC PHYSICIAN OR OSTEOPATHIC PHY-

18 SICIAN LICENSED UNDER ARTICLE 15 TO BE RESPONSIBLE FOR ALL

19 ASPECTS OF EACH MAGNETIC RESONANCE IMAGING STUDY, INCLUDING, BUT

20 NOT LIMITED TO, RECEIVING ALL INDICATION FOR THE STUDY, SPECIFY-

21 ING ALL OF THE FOLLOWING:

22 (A) THE PULSE SEQUENCES TO BE PERFORMED.

23 (B) THE USE AND DOSAGE OF CONTRAST AGENTS.

24 (C) AN INTERPRETATION OF THE IMAGES OBTAINED.

25 (D) GENERATING WRITTEN REPORTS.

26 (E) THE ASSURANCE OF THE QUALITY OF IMAGES AND THE

27 INTERPRETATIONS. A PHYSICIAN DESIGNATED UNDER THIS SUBPARAGRAPH

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1 MUST MEET THE AMERICAN COLLEGE OF RADIOLOGY STANDARDS FOR THE

2 PERFORMANCE OF MAGNETIC RESONANCE IMAGING, AS APPROVED BY THE

3 DEPARTMENT.

4 (D) EACH TECHNOLOGIST WHO OPERATES THE MAGNETIC RESONANCE

5 IMAGER MEETS 1 OF THE FOLLOWING REQUIREMENTS OF THE AMERICAN COL-

6 LEGE OF RADIOLOGY'S ACCREDITATION PROGRAM FOR THE ACCREDITATION

7 OF MAGNETIC RESONANCE IMAGERS, AS APPROVED BY THE DEPARTMENT:

8 (i) BE CERTIFIED BY THE AMERICAN REGISTRY OF RADIOLOGIC

9 TECHNOLOGISTS, AS APPROVED BY THE DEPARTMENT, AS A MAGNETIC RESO-

10 NANCE TECHNOLOGIST.

11 (ii) BE CERTIFIED BY THE AMERICAN REGISTRY OF RADIOLOGIC

12 TECHNOLOGISTS, AS APPROVED BY THE DEPARTMENT, AND HAVE NOT LESS

13 THAN 6 MONTHS OF SUPERVISED CLINICAL MAGNETIC RESONANCE IMAGING

14 SCANNING.

15 (iii) HAVE AN ASSOCIATE'S DEGREE IN AN ALLIED HEALTH FIELD

16 OR A BACHELOR'S DEGREE AND CERTIFICATION IN ANOTHER CLINICAL

17 IMAGING FIELD, AS APPROVED BY THE DEPARTMENT, AND NOT LESS THAN 6

18 MONTHS OF SUPERVISED CLINICAL MAGNETIC RESONANCE IMAGING

19 SCANNING.

20 (3) THE DEPARTMENT MAY ISSUE A NONRENEWABLE TEMPORARY AUTHO-

21 RIZATION FOR A MAGNETIC RESONANCE IMAGER IF ADDITIONAL TIME IS

22 NEEDED TO ALLOW SUBMISSION OF EVIDENCE SATISFACTORY TO THE

23 DEPARTMENT THAT THE MAGNETIC RESONANCE IMAGER, THE PERSONNEL

24 OPERATING THE MAGNETIC RESONANCE IMAGER, AND THE FACILITY IN

25 WHICH THE MAGNETIC RESONANCE IMAGER IS USED MEET THE STANDARDS

26 SET FORTH IN SUBSECTION (2) FOR AUTHORIZATION. A TEMPORARY

27 AUTHORIZATION GRANTED UNDER THIS SUBSECTION IS EFFECTIVE FOR NO

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1 MORE THAN 12 MONTHS. THE DEPARTMENT MAY WITHDRAW A TEMPORARY

2 AUTHORIZATION BEFORE ITS EXPIRATION IF THE MAGNETIC RESONANCE

3 IMAGER, THE PERSONNEL OPERATING THE MAGNETIC RESONANCE IMAGER, OR

4 THE FACILITY IN WHICH THE MAGNETIC RESONANCE IMAGER IS USED DOES

5 NOT MEET 1 OR MORE OF THE STANDARDS SET FORTH IN SUBSECTION (2).

6 (4) TO OBTAIN AUTHORIZATION FROM THE DEPARTMENT TO USE A

7 MAGNETIC RESONANCE IMAGER, THE PERSON WHO OWNS OR LEASES THE MAG-

8 NETIC RESONANCE IMAGER OR AN AUTHORIZED AGENT OF THE PERSON SHALL

9 APPLY TO THE DEPARTMENT FOR AUTHORIZATION ON AN APPLICATION FORM

10 PROVIDED BY THE DEPARTMENT AND SHALL PROVIDE ALL OF THE INFORMA-

11 TION REQUIRED BY THE DEPARTMENT AS SPECIFIED ON THE APPLICATION

12 FORM. A PERSON WHO OWNS OR LEASES MORE THAN 1 MAGNETIC RESONANCE

13 IMAGER SHALL OBTAIN AUTHORIZATION FOR EACH MAGNETIC RESONANCE

14 IMAGER. THE DEPARTMENT SHALL PROCESS AND RESPOND TO AN APPLICA-

15 TION WITHIN 30 DAYS AFTER THE DATE OF RECEIPT OF THE

16 APPLICATION. UPON DETERMINING TO GRANT AUTHORIZATION FOR A MAG-

17 NETIC RESONANCE IMAGER, THE DEPARTMENT SHALL ISSUE A CERTIFICATE

18 OF REGISTRATION SPECIFYING MAGNETIC RESONANCE IMAGER AUTHORIZA-

19 TION FOR EACH AUTHORIZED MAGNETIC RESONANCE IMAGER. AN AUTHORI-

20 ZATION ISSUED UNDER THIS SUBSECTION IS EFFECTIVE FOR 3 YEARS CON-

21 TINGENT UPON THE MAGNETIC RESONANCE IMAGER, THE PERSONNEL OPERAT-

22 ING THE MAGNETIC RESONANCE IMAGER, AND THE FACILITY IN WHICH THE

23 MAGNETIC RESONANCE IMAGER IS OPERATED FOR WHICH THE AUTHORIZATION

24 IS ISSUED MEETING 1 OF THE FOLLOWING REQUIREMENTS:

25 (A) MAINTAINING CONTINUED MAGNETIC RESONANCE IMAGER ACCRED-

26 ITATION BY THE AMERICAN COLLEGE OF RADIOLOGY, AS APPROVED BY THE

27 DEPARTMENT.

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1 (B) HAVING AN ACTIVE MAGNETIC RESONANCE IMAGER ACCREDITATION

2 APPLICATION IN PROCESS WITH THE AMERICAN COLLEGE OF RADIOLOGY.

3 (C) MAINTAINING APPROVAL OR BEING IN THE PROCESS OF OBTAIN-

4 ING APPROVAL UNDER A DEPARTMENT EVALUATION PROCESS EQUIVALENT TO

5 THAT DESCRIBED IN SUBDIVISIONS (A) AND (B).

6 (5) NO LATER THAN 60 DAYS AFTER INITIAL AUTHORIZATION OF A

7 MAGNETIC RESONANCE IMAGER UNDER THIS SECTION, THE DEPARTMENT

8 SHALL INSPECT THE MAGNETIC RESONANCE IMAGER MACHINE. AFTER THAT

9 INITIAL INSPECTION, THE DEPARTMENT SHALL ANNUALLY INSPECT THE

10 MAGNETIC RESONANCE IMAGER AND MAY INSPECT THE MAGNETIC RESONANCE

11 IMAGER MORE FREQUENTLY. THE DEPARTMENT SHALL MAKE REASONABLE

12 EFFORTS TO COORDINATE THE INSPECTIONS UNDER THIS SUBSECTION WITH

13 THE DEPARTMENT'S OTHER INSPECTIONS OF THE FACILITY IN WHICH THE

14 MAGNETIC RESONANCE IMAGER IS LOCATED.

15 (6) AFTER EACH SATISFACTORY INSPECTION BY THE DEPARTMENT,

16 THE DEPARTMENT SHALL ISSUE A CERTIFICATE OF MAGNETIC RESONANCE

17 IMAGER INSPECTION OR A SIMILAR DOCUMENT IDENTIFYING THE FACILITY

18 AND MAGNETIC RESONANCE IMAGER INSPECTED AND PROVIDING A RECORD OF

19 THE DATE THE MAGNETIC RESONANCE IMAGER WAS INSPECTED. THE FACIL-

20 ITY SHALL POST THE CERTIFICATE OR OTHER DOCUMENT NEAR THE

21 INSPECTED MAGNETIC RESONANCE IMAGER.

22 (7) THE DEPARTMENT MAY WITHDRAW THE AUTHORIZATION FOR A MAG-

23 NETIC RESONANCE IMAGER IF IT DOES NOT MEET 1 OR MORE OF THE STAN-

24 DARDS SET FORTH IN SUBSECTION (2).

25 (8) THE DEPARTMENT SHALL PROVIDE AN OPPORTUNITY FOR A HEAR-

26 ING IN CONNECTION WITH A DENIAL OR WITHDRAWAL OF AUTHORIZATION

27 UNDER THIS SECTION.

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1 (9) UPON FINDING THAT A DEFICIENCY IN A MAGNETIC RESONANCE

2 IMAGER OR A VIOLATION OF THIS PART OR THE RULES PROMULGATED UNDER

3 THIS PART SERIOUSLY AFFECTS THE HEALTH, SAFETY, AND WELFARE OF

4 INDIVIDUALS UPON WHOM THE MAGNETIC RESONANCE IMAGER IS USED, THE

5 DEPARTMENT MAY ISSUE AN EMERGENCY ORDER SUMMARILY WITHDRAWING THE

6 AUTHORIZATION OF THE MAGNETIC RESONANCE IMAGER. THE DEPARTMENT

7 SHALL INCORPORATE ITS FINDINGS IN THE ORDER AND SHALL PROVIDE AN

8 OPPORTUNITY FOR A HEARING WITHIN 5 WORKING DAYS AFTER ISSUANCE OF

9 THE ORDER. THE ORDER IS EFFECTIVE DURING THE PROCEEDINGS.

10 (10) IF THE DEPARTMENT WITHDRAWS THE AUTHORIZATION OF A MAG-

11 NETIC RESONANCE IMAGER, THE MAGNETIC RESONANCE IMAGER SHALL NOT

12 BE USED FOR PATIENT STUDIES. AN APPLICATION FOR REINSTATEMENT OF

13 A MAGNETIC RESONANCE IMAGER AUTHORIZATION SHALL BE FILED AND PRO-

14 CESSED IN THE SAME MANNER AS AN APPLICATION FOR MAGNETIC RESO-

15 NANCE IMAGER AUTHORIZATION UNDER SUBSECTION (4), EXCEPT THAT THE

16 DEPARTMENT SHALL NOT ISSUE A REINSTATED CERTIFICATE OF MAGNETIC

17 RESONANCE IMAGER REGISTRATION UNTIL THE DEPARTMENT RECEIVES THE

18 REINSPECTION FEE REQUIRED UNDER SUBSECTION (11), INSPECTS THE

19 MAGNETIC RESONANCE IMAGER, AND DETERMINES THAT IT MEETS THE STAN-

20 DARDS SET FORTH IN SUBSECTION (2). THE DEPARTMENT SHALL CONDUCT

21 AN INSPECTION REQUIRED UNDER THIS SUBSECTION NO LATER THAN 60

22 DAYS AFTER RECEIVING A PROPER APPLICATION FOR REINSTATEMENT OF A

23 MAGNETIC RESONANCE IMAGER AUTHORIZATION.

24 (11) EXCEPT AS OTHERWISE PROVIDED IN SUBSECTION (12), THE

25 DEPARTMENT SHALL ASSESS THE FOLLOWING NONREFUNDABLE FEES IN CON-

26 NECTION WITH MAGNETIC RESONANCE IMAGER AUTHORIZATION:

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1 (A) INSPECTION, PER MAGNETIC RESONANCE IMAGER... $ 100.00

2 (B) REINSPECTION FOR REINSTATEMENT OF MAGNETIC

3 RESONANCE IMAGER AUTHORIZATION, PER MAGNETIC RESO-

4 NANCE IMAGER......................................... $ 100.00

5 (C) DEPARTMENT EVALUATION OF COMPLIANCE WITH

6 SUBSECTION (2)(A), PER MAGNETIC RESONANCE IMAGER..... $ 700.00

7 EACH REEVALUATION OF A MAGNETIC RESONANCE

8 IMAGER DUE TO FAILURE DURING THE PREVIOUS EVALUATION,

9 RELOCATION OF THE MAGNETIC RESONANCE IMAGER, OR SIMI-

10 LAR CHANGES THAT COULD AFFECT EARLIER EVALUATION

11 RESULTS.............................................. $ 300.00.

12 (12) IF AN APPLICANT FOR MAGNETIC RESONANCE IMAGER AUTHORI-

13 ZATION SUBMITS AN EVALUATION REPORT ISSUED BY THE AMERICAN COL-

14 LEGE OF RADIOLOGY THAT EVIDENCES COMPLIANCE WITH

15 SUBSECTION (2)(A), THE DEPARTMENT SHALL WAIVE THE FEE UNDER

16 SUBSECTION (11) FOR DEPARTMENT EVALUATION OF COMPLIANCE WITH THAT

17 PROVISION.

18 (13) THE DEPARTMENT SHALL ADJUST ON AN ANNUAL BASIS THE FEES

19 PRESCRIBED BY SUBSECTION (11) BY AN AMOUNT DETERMINED BY THE

20 STATE TREASURER TO REFLECT THE CUMULATIVE ANNUAL PERCENTAGE

21 CHANGE IN THE DETROIT CONSUMER PRICE INDEX, NOT TO EXCEED 5%. AS

22 USED IN THIS SUBSECTION, "DETROIT CONSUMER PRICE INDEX" MEANS THE

23 MOST COMPREHENSIVE INDEX OF CONSUMER PRICES AVAILABLE FOR THE

24 DETROIT AREA FROM THE BUREAU OF LABOR STATISTICS OF THE UNITED

25 STATES DEPARTMENT OF LABOR.

26 (14) IN ADDITION TO THE REINSPECTION FEE REQUIRED UNDER

27 SUBSECTION (11), IF A PERSON VIOLATES SUBSECTION (1), THE

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1 DEPARTMENT MAY IMPOSE AN ADMINISTRATIVE FINE AGAINST THE OWNER OF

2 THE MAGNETIC RESONANCE IMAGER OR, IF A LESSEE OF THE MAGNETIC

3 RESONANCE IMAGER HAS EFFECTIVE CONTROL OF THE MAGNETIC RESONANCE

4 IMAGER, THE LESSEE, OF NOT MORE THAN $500.00 FOR EACH CALENDAR

5 WEEK IN WHICH STUDIES ARE PERFORMED IN VIOLATION OF

6 SUBSECTION (1). IF A PERSON CONTINUES TO VIOLATE SUBSECTION (1)

7 FOR A PERIOD OF 2 WEEKS AFTER A FINE IS IMPOSED UNDER THIS SUB-

8 SECTION, THE DEPARTMENT SHALL POST A CONSPICUOUS NOTICE ON THE

9 UNAUTHORIZED MAGNETIC RESONANCE IMAGER AND AT THE ENTRY TO THE

10 FACILITY WHERE THE MAGNETIC RESONANCE IMAGER IS LOCATED WARNING

11 THE PUBLIC THAT THE FACILITY IS PERFORMING STUDIES USING A MAG-

12 NETIC RESONANCE IMAGER THAT IS A SUBSTANTIAL HAZARD TO THE PUBLIC

13 HEALTH.

14 (15) THE DEPARTMENT MAY PROMULGATE RULES NECESSARY TO IMPLE-

15 MENT THIS SECTION.

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