Home » 2012 Issues » March 28, 2012 » HLT-39-11-00007-A Medicaid Benefit Limits for Enteral Formula, Prescription Footwear, and Compression Stockings
HLT-39-11-00007-A Medicaid Benefit Limits for Enteral Formula, Prescription Footwear, and Compression Stockings
3/28/12 N.Y. St. Reg. HLT-39-11-00007-A
NEW YORK STATE REGISTER
VOLUME XXXIV, ISSUE 13
March 28, 2012
RULE MAKING ACTIVITIES
DEPARTMENT OF HEALTH
NOTICE OF ADOPTION
I.D No. HLT-39-11-00007-A
Filing No. 222
Filing Date. Mar. 13, 2012
Effective Date. Mar. 28, 2012
Medicaid Benefit Limits for Enteral Formula, Prescription Footwear, and Compression Stockings
PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:
Action taken:
Amendment of Parts 505 and 513 of Title 18 NYCRR.
Statutory authority:
Public Health Law, sections 201 and 206; and Social Services Law, sections 363-a and 365-a(2)
Subject:
Medicaid Benefit Limits for Enteral Formula, Prescription Footwear, and Compression Stockings.
Purpose:
To impose benefit limitations on Medicaid coverage of enteral formula, prescription footwear, and compression stockings.
Text or summary was published
in the September 28, 2011 issue of the Register, I.D. No. HLT-39-11-00007-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 Ceroalo, DOH, Bureau of House Counsel, Regulatory Affairs Unit, Room 2438, ESP, Tower Building, Albany, NY 12237, (518) 473-7488, email: regsqna@health.state.ny.us
Assessment of Public Comment
Public comment was received from 16 commentators: the Cystic Fibrosis Center at SUNY-Upstate, SAPS Drug Wholesale, Inc., Abbott Nutrition, a manufacturer of enteral nutritional formulas, Alzheimer's Association, Dialysis Patient Citizens, Northeast Kidney Foundation, Dr. Brett Abrams, a dietician, a registered nurse, a social worker, God's Love We Deliver, New York State Dietetic Association, Self Help, and three citizens.
Several commenters objected to coverage of enteral nutritional formulas for adults being limited to tube feeding and to treatment of inborn metabolic disorders. Various commenters urged that Medicaid also cover nutritional supplements for children with chronic kidney disease and for individuals with HIV/AIDS, cancer, diabetes, Alzheimer's disease, autism, or renal disease. One commenter requested coverage of prescription footwear for persons with leg length disparities. No changes were made to the proposed regulation as a result of these comments, since the Department lacks the authority to provide for such coverage by regulation, given the specific limitations imposed by SSL section 365-a(2)(g). However, the Department notes that SSL section 365-a(2)(g) in no way limits the ability of individuals under age 21 to receive early and periodic screening, diagnosis and treatment (EPSDT) services otherwise available pursuant to section 365-a(3).
Other comments expressed the opinion that the enteral formula limitations would harm other patient populations with a legitimate medical need for these nutritional supplements, and place a financial burden on persons who no longer have enteral formula covered by Medicaid. These comments were essentially criticisms of the legislative change to SSL section 365-a(2)(g); they were not comments on specific language in the proposed regulation, nor did they suggest that the proposed regulation failed to conform to the statutory requirements. Therefore, no changes were made to the proposed regulation as a result of these comments.
One commenter posited a diminishment in health status of persons who no longer have enteral formula covered by Medicaid, and estimated an additional cost of $8 million annually from a resulting rise in hospital admissions. The commenter submitted a cost analysis based primarily on assumptions drawn from a 2006 study published in The American Journal of Medicine entitled "A Randomized Double-blind, Placebo-controlled Trial of Nutritional Supplementation During Acute Illness". The study compared the hospital readmission rates of elderly persons who received oral medical nutrition during hospitalization and for the following six months, and those who did not. From the information submitted by the commenter, the Department could not conclude that the cited study established that the proposed regulation would result in increased Medicaid costs, let alone allow statistically reliable cost estimates to be developed. The Department concluded that the commenter's assertion, that unintended consequences of the proposed regulation would result in higher costs to the Medicaid program, is speculative.
One commenter, a community services organization, argued that the limitations on coverage of enteral formula, compression stockings, and prescription footwear violate federal requirements relating to the amount, duration, and scope of services provided under the Medicaid program, and that, at a minimum, the proposed regulation must provide a prior approval mechanism by which these services and supplies would be covered for persons with other medical conditions who established a medical need for them. The Department disagrees with the commenter's interpretation of the federal Medicaid requirements in question, and considers it inconsistent with the flexibility granted states to decide the extent to which they will cover optional Medicaid services. In any event, as indicated above, the Department cannot, by regulation, provide coverage of these services in contravention of the limitations imposed by the State Legislature in SSL section 365-a(2)(g). Therefore, no changes were made to the proposed regulation as a result of this comment.
