House Committee on Health, Insurance & Environment (02/12/2013)

Final
STAFF SUMMARY OF MEETING

HOUSE COMMITTEE ON HEALTH, INSURANCE & ENVIRONMENT

Date:	02/12/2013	ATTENDANCE

Time:	09:45 AM to 12:25 PM	Conti	*
		Fields	*
Place:	HCR 0107	Ginal	X
		Humphrey	X
This Meeting was called to order by		Joshi	X
	Representative McCann	Primavera	X
		Stephens	*
This Report was prepared by		Swalm	*
	Amanda King	Young	X
		Schafer	X
		McCann	X
		X = Present, E = Excused, A = Absent, * = Present after roll call

Bills Addressed:		Action Taken:
State Auditor Presentation HB13-1121		Witness Testimony and/or Committee Discussion Only Amended, Referred to the Committee of the Whole

09:46 AM -- State Auditor Presentation

Kerri Hunter, Crystal Dorsey, and Eric Johnson, Office of the State Auditor, presented the Annual Report of Audit Recommendations Not Fully Implemented - October 2012, which can be found at http://www.leg.state.co.us/OSA/coauditor1.nsf/All/959435877AEC6E5C87257A94005E2B37/$FILE/2191%20Rec%20Database%20Annual%20Report%20Oct%202012.pdf. Ms. Hunter discussed the audit recommendation process. Ms. Dorsey provided a general overview of the outstanding financial audit recommendations contained in the report. She discussed the only outstanding financial audit recommendation for the Department of Public Health and Environment, which concerns the requirement that the department monitor its excess uncommitted reserves.

09:54 AM

Mr. Johnson provided a general overview of the outstanding performance and information technology audit recommendations contained in the report. He discussed the three outstanding performance and information technology audit recommendations for the Department of Public Health and Environment, which related to the Automobile Inspection and Readjustment Program and the Vehicle Emissions Program. Mr. Johnson responded to questions from Representative Primavera about the Vehicle Emissions Program testing fees.

09:59 AM -- House Bill 13-1121

Representative Murray and Representative Schafer presented House Bill 13-1121, concerning the ability of a pharmacist to substitute a biosimilar product for a prescribed biological product when certain conditions are satisfied. The bill allows pharmacists to substitute a biosimilar product for a prescribed biological product if:

the federal Food and Drug Administration (FDA) has determined that the biosimilar product is interchangeable with the prescribed biological product;
the practitioner who prescribed the biological product has not prohibited a substitution; and
the biosimilar product costs less than the biological product.

A biosimilar product that is higher in price may be substituted if the prescribed biological product is not available. The bill requires pharmacists to notify practitioners within three days when such substitutions occurs. Pharmacists must maintain a record of the substitution for five years.

Representative Schafer discussed a handout that was distributed to the committee that illustrates the timeline of biosimilar substitutions (Attachment A). Representative Murray discussed what could happen if the bill is not enacted. Representative Schafer and Representative Murray responded to questions from the committee about how the bill addresses biosimilar product substitutions for institutionalized patients and the types of illnesses that biosimilar products are used to treat.

130212 AttachA.pdf

10:20 AM -- April Giles, Colorado BioScience Association, testified in support of the bill. She provided a packet of information to the committee, which included a copy of her testimony and a statement from the Biotechnology Industry Organization (Attachments B, C, and D). She discussed how the FDA designates biological products as interchangeable, dispense as written practices, notification requirements for physicians and patients, and record retainment. Ms. Giles responded to questions from the committee about the testing process for biosimilar products, whether pharmacists currently have a responsibility to update patient records, and the status of the FDA's approval process for biosimilar products.

130212 AttachB.pdf

130212 AttachC.pdf

130212 AttachD.pdf

10:34 AM -- Ron Hartmann and Dr. Mark McCamish, Sandoz, testified against the bill. Barbara Boner, Novartis, signed up against the bill but did not make any statements. Mr. Hartmann and Dr. McCamish discussed Sandoz's involvement in developing biosimilar products. Dr. McCamish discussed patient access to and the approval process for biosimilar products. Dr. McCamish and Mr. Hartmann responded to questions from the committee about the physician notification contained in the bill, the occurrence of adverse events with biosimilar products, and the use of biosimilar products in European countries.

10:55 AM -- Christine Simmons, Generic Pharmaceutical Association, testified against the bill. She discussed the FDA approval process for biosimilar products and concerns about cost and access issues related to biosimilar products. Ms. Simmons responded to questions from the committee about the processes that generic products were subjected to when they were allowed on the prescription drug market, why physician notification could be a barrier, and the terminology used for biosimilar products.

11:05 AM -- Allen Todd, Global Healthy Living Foundation, testified in support of the bill. He discussed how the physician notification and record retention requirements of the bill could help with patient safety. Mr. Todd responded to questions from the committee about the funding for the Global Healthy Living Foundation, and physician notification and patient care as they relate to biosimilar products.

11:19 AM -- Val Kalnins, Colorado Pharmacists Society, Rx Plus, and Colorado Retail Council - Chain Pharmacy Committee, testified against the bill. He provided a handout to the committee outlining the coalitions working on House Bill 13-1121 (Attachment E). Mr. Kalnins discussed the role pharmacists have in patient safety and his concerns about the physician notification and record retention requirements of the bill.

130212 AttachE.pdf

11:28 AM -- Patrick Boyle, Express Scripts, testified against the bill. He discussed the physician notification requirement contained in the bill.

11:31 AM -- Marc Reece, Colorado Association of Health Plans, testified against the bill. He discussed the physician notification requirement contained in the bill and cost savings realized by generic drugs.

11:33 AM -- Miz Cordero, Colorado Competitive Council, testified against the bill. He discussed concerns about the physician notification requirement contained in the bill.

11:35 AM

Mr. Kalnins responded to questions from the committee about the physician notification requirement contained in the bill and whether vaccines are biologic products.

11:41 AM

Representative Schafer stated that the Colorado Medical Society is monitoring the bill. She provided a packet of letters concerning the bill to the committee (Attachments F, G, H, I, and J) and a list of organizations that support House Bill 13-1121 (Attachment K).

130212 AttachK.pdf

11:42 AM -- Dr. Kiki Traylor and Gustavo "Gino" Grampp, Amgen, testified in support of the bill. Dr. Traylor discussed access and cost savings related to biosimilar products, FDA guidance for biosimilar products, and the physician notification requirement contained in the bill. Mr. Grampp discussed the physician notification requirement contained in the bill. Dr. Traylor responded to questions about what would be done once a physician receives the notification, the dispense-as-written instruction used on prescriptions, and how the bill would address vaccines. Dr. Traylor responded to questions about the FDA approval process and guidance for biosimilar products.

12:02 PM -- David McCord, Colorado State Grange, testified in support of the bill. He discussed rural health care issues.

12:05 PM -- Maureen Maker, Colorado Citizens for Science in Medicine, testified in support of the bill. She discussed the physician notification requirement contained in the bill.

12:08 PM -- Yvonne Baca, Rocky Mountain Stroke Center, testified in support of the bill. She discussed issues concerning stroke patients.

12:11 PM

Representative Schafer and Representative Murray provided concluding remarks about the bill. Representative Murray read from three letters that had been distributed to the committee earlier in the meeting (Attachments G, H, and I).

12:15 PM

Representative Schafer explained amendment L.003 (Attachment L).

130212 AttachL.pdf


BILL:	HB13-1121
TIME:	12:17:16 PM
MOVED:	Schafer
MOTION:	Adopt amendment L.003 (Attachment L). The motion passed without objection.
SECONDED:	Stephens
		VOTE
	Conti
	Fields
	Ginal
	Humphrey
	Joshi
	Primavera
	Stephens
	Swalm
	Young
	Schafer
	McCann

YES: 0 NO: 0 EXC: 0 ABS: 0 FINAL ACTION: Pass Without Objection

12:17 PM

Representative Swalm explained amendment L.002 (Attachment M).

130212 AttachM.pdf


BILL:	HB13-1121
TIME:	12:17:50 PM
MOVED:	Swalm
MOTION:	Adopt amendment L.002 (Attachment M). The motion failed on a vote of 4-7.
SECONDED:	Conti
		VOTE
	Conti	Yes
	Fields	No
	Ginal	No
	Humphrey	Yes
	Joshi	Yes
	Primavera	No
	Stephens	No
	Swalm	Yes
	Young	No
	Schafer	No
	McCann	No

YES: 4 NO: 7 EXC: 0 ABS: 0 FINAL ACTION: FAIL

12:20 PM

The committee discussed the physician notification requirement contained in the bill and the FDA approval process of biosimilar products.


BILL:	HB13-1121
TIME:	12:24:07 PM
MOVED:	Schafer
MOTION:	Refer House Bill 13-1121, as amended, to the Committee of the Whole. The motion passed on a vote of 10-1.
SECONDED:	Ginal
		VOTE
	Conti	Yes
	Fields	Yes
	Ginal	Yes
	Humphrey	No
	Joshi	Yes
	Primavera	Yes
	Stephens	Yes
	Swalm	Yes
	Young	Yes
	Schafer	Yes
	McCann	Yes

Final YES: 10 NO: 1 EXC: 0 ABS: 0 FINAL ACTION: PASS

12:25 PM

The committee adjourned.