HLT-04-08-00003-A Non-Prescription Emergency Contraceptive Drugs

7/23/08 N.Y. St. Reg. HLT-04-08-00003-A

NEW YORK STATE REGISTER

VOLUME XXX, ISSUE 31

July 23, 2008

RULE MAKING ACTIVITIES

DEPARTMENT OF HEALTH

NOTICE OF ADOPTION

 

I.D No. HLT-04-08-00003-A

Filing No. 706

Filing Date. Jul. 08, 2008

Effective Date. Jul. 08, 2008

Non-Prescription Emergency Contraceptive Drugs

PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:

Action taken:

Amendment of section 505.3(b)(1) of Title 18 NYCRR.

Statutory authority:

Public Health Law, sections 201(1)(v) and 206; and Social Services Law, section 363-a(2)

Subject:

Non-prescription emergency contraceptive drugs.

Purpose:

FDA approved non-prescription contraceptive drugs dispensed by a pharmacy without a fiscal order to women 18 years of age and older.

Text or summary was published

in the January 23, 2008 issue of the Register, I.D. No. HLT-04-08-00003-P.

Final rule as compared with last published rule:

No changes.

Text of rule and any required statements and analyses may be obtained from:

Katherine E. Ceroalo, Department of Health, Office of Regulatory Affairs, Corning Tower, Rm. 2438, Empire State Plaza, Albany, NY 12237-0097, [phone], fax: [phone], e-mail: [e-mail]

Assessment of Public Comment

The Department received three letters and one e-mail communication commenting on the proposed emergency contraception regulation. The Family Planning Advocates of New York State (FPA) submitted the first letter. In its letter, FPA supported the regulations as promoting the public health and generating cost savings. FPA stated that the regulation reflected a patient-centered approach by removing an unnecessary barrier to accessing a time-sensitive medication that can prevent an unintended pregnancy.

The Department received a second letter from the New York City Department of Mental Hygiene (NYC DOHMH) strongly supporting the proposed regulations but expressing several concerns. The City agency questioned the coverage limits set for emergency contraception. The dispensing limit for over-the-counter (OTC) emergency contraceptive drugs is six courses of treatment per twelve-month period. The Department developed this dispensing limit in consultation with Department pharmacists and physicians, family planning professionals, and family planning advocacy groups. The Department is satisfied that the dispensing limit proposed in the regulation is adequate to meet emergency needs. If a woman requests more frequent courses of treatment, the Department believes that the woman should be seeking a family planning consultation concerning the use of reliable and consistent methods of birth control. The New York State Education Department, through its Board of Pharmacy, has informed pharmacists that when emergency contraceptive drugs are dispensed to women over the age of 18, pharmacists are not required to counsel because the packaging for the drug contains adequate information approved by the Federal Food and Drug Administration. Women may, however, request such counseling.

The City agency also strongly recommended that the requirement for a fiscal order for condoms be suspended as well. NYC DOHMH stated that restricting condom availability through this unnecessary barrier compromises the indigent Medicaid recipient's ability to protect him or herself from unwanted pregnancy and disease. By eliminating the requirement for a fiscal order for emergency contraceptive drugs, the Department is foregoing federal financial participation in the cost of those drugs. Federal regulations require that each claim for payment for an OTC drug be supported by a written order of a qualified practitioner. The Department will be paying for the emergency contraceptive drugs with 100 percent state funds. The federal government also requires written orders from a practitioner to support claims for coverage of condoms under the Medicaid program. If the Department were to remove the fiscal order requirement for condoms, Medicaid would also have to pay for those items with 100 percent State funds. The Department has no plan to incur the additional State expenditure that this policy would require at this time. The City mental health agency also expressed general concerns about barriers to access that uninsured women and teens under the age of 18 are facing and asked that the Department consider requiring pharmacists to inform women who cannot afford to purchase contraceptive services and teens under 18 years of age that there are Title X clinics where they can access the various contraceptive services for free or on a sliding scale. This larger concern is beyond the scope of the regulation. The Department does not plan on imposing any additional obligations on pharmacies, through the Medicaid program, to educate clients at this time.

The third letter was a letter of support for the proposed regulation from the New York State Association of Licensed Midwives.

The last set of comments was submitted by a consultant to FPA concerning how the Department calculated the proposed regulation's fiscal impact. The consultant asked how we estimated that the cost of implementation of the regulation to the state would $1.5 million. The State costs for dispensing OTC emergency contraceptive drugs were determined from past Medicaid utilization of these drugs. The consultant asked how we determined that 2 in 100 claims for OTC emergency contraceptives would have resulted in a birth and delivery. In addition to reviewing the pharmaceutical inserts which accompany emergency contraceptive medication, the Department's staff studied the effectiveness of trials of emergency contraceptive drugs as reported in several publications, including The Lancet, Obstetrics and Gynecology, Contraception, The Journal of Midwifery & Women's Health, The Australian and New Zealand Journal of Obstetrics and Gynaecology and the emergency contraception website operated by the Office of Population Research at Princeton University and by the Association of Reproductive Health Professionals. (http://ec.princeton.edu/questions/eceffect.html) The website is peer reviewed by a panel of independent experts and is not associated with any pharmaceutical company or for-profit organization. The pregnancy rates with the use of the emergency contraceptive drugs reported in the studies ranged from 0.69 percent to 2.0 percent. The Department chose to estimate pregnancies at the higher range, 2.0 percent or 2 births per 100, in order to avoid over-estimating savings. The consultant asked how we estimated the cost of a birth and delivery in 2006 and asked whether this was the cost to Medicaid for a birth and delivery. The Department calculated costs for 2006 associated with birth and delivery (the year for which data was available at the time of preparation of the estimate) by using actual Medicaid expenditures for birth and delivery from the Medicaid DataMart database. The estimated costs were approximately $11,700 per birth. Finally, the commentator asked why the cost for abortions averted was not included in the calculation of savings. The Department used only birth and delivery costs to determine savings because the Department did not want to over-estimate savings and create a potential unfunded liability for the State.

The assessment of public comment concludes that there are no issues which would impede the adoption of the regulation and that the regulation does not require amendment or revision.