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Who cares
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Sponsors
No co-sponsors yet.
History
- Referred to health
- Substituted by A301
- Advanced to third reading
- 2nd report cal.
- 1st report cal.377
- Reported and committed to finance
- Referred to health
Full text
The text isn't available here yet. Check nysenate.gov.
Sponsor's memo
Title of bill
An act to amend the public health law and the insurance law, in relation to protocol for treatment of rare disease
Purpose
To establish evidentiary standards for utilization review (UR) and external appeal when determining whether to pay for a rare disease treatment.
Summary of provisions
Section 1 of the bill amends PHI.
§4900 to define rare disease treatment for disabling and life-threatening conditions and diseases, referencing federal guidelines.
Sections 2 and 4 amend PHL §§ 4905 and 4914 to establish evidentiary standards for utilization review (UR) and external appeal when determining whether to pay for a rare disease treatment, using the standard already in law for treatments under federally approved clinical trials:; "likely to benefit" the patient, providing that the treatment is not excluded from coverage for other reasons.
Section 3 amends PHI. §4910 to include the DR denial of payment for a rare disease treatment among the cases that can be taken to external appeal for review.
Section 5-8 amends Insurance law §§ 4900,4905,4910 and 4914 to track the changes made to PHL §§ 4900,4905,4910 and 4914.
Existing law
None.
Justification
The utilization review and external appeal law works well to expand access to treatments in clinical trials by providing a special standard for coverage determinations. However, the law fails to to provide for a small sub-class of individuals who are stricken with disabling and life threatening rare disease.
The ordinary standard for proving "medical necessity" does not apply for patients in clinical trials because, by definition, the treatment is still on trial. So the utilization review and external appeal process uses the standard of "likely to benefit."
This standard should apply to patients who need rare disease treatment. Because there is little economic incentive for undertaking expensive clinical trials for rare disease treatments, these patients are also inherently unable to meet the ordinary standards for proving medical necessity. A list of rare diseases is maintained by the National Institutes of Health Office of Rare Diseases under the federal Rare Disease Act of 2002.
Legislative history
This is a new bill.
Fiscal implications
None.
Local fiscal implications
None.
Effective date
Immediately.
Summaries, headlines and scores are AI-generated from the official bill text. How we score bills. Source: NYS Open Legislation.