<p> REGULATORY ANALYSIS for Amendments to 5 CCR 1005-4, Newborn Screening and Second Newborn Screening </p><p>Adopted by the Board of Health on April 20, 2016.</p><p>1. A description of the classes of persons who will be affected by the proposed rule, including classes that will bear the costs of the proposed rule and classes that will benefit from the proposed rule. </p><p>Screening for Pompe disease may have assisted a small number of Colorado parents and providers in detecting the disease early. Pompe disease can still be detected early but including it on the panel provided consistent early screening. Removing it from the panel also impacts the Department’s ability to better understand its prevalence. </p><p>2. To the extent practicable, a description of the probable quantitative and qualitative impact of the proposed rule, economic or otherwise, upon affected classes of persons. </p><p>It was assumed that inclusion on the panel would increase early detection and thus, it is assumed that removing it from the panel will adversely impact those families with a newborn that did not receive early screening for Pompe disease. It is unknown if the estimated three newborns in Colorado with a significant treatable defect will be discovered every two years if Pompe disease is not included on the panel. This impacts the introduction of treatment procedures1, life expectancy2, quality of life, and health care costs associated with late or lack of treatment. Though the Department requests that Pompe disease be removed from the panel at this time, the Department is committed to assessing the costs and needs of our stakeholders. If the result of the continued analysis is that Pompe disease should be included on the panel, the Department will return to the Board of Health with that recommendation.</p><p>3. The probable costs to the agency and to any other agency of the implementation and enforcement of the proposed rule and any anticipated effect on state revenues. </p><p>There are no costs to the agency to remove Pompe disease. Removing Pompe disease from the panel will remove the need to increase the cost of the panel by $9-16 dollars. This ensures that panel is not cost prohibitive to families that benefit from newborn screening for the other thirty-five conditions on the newborn screening panel. State revenue from the fee will continue unchanged. </p><p>4. A comparison of the probable costs and benefits of the proposed rule to the probable costs and benefits of inaction. </p><p>It is estimated that it will cost about $900,000 annually to include Pompe disease on the newborn screening panel. Removing Pompe disease from the panel eliminates this additional cost. A detailed cost projection, “Adding Conditions to the NBS panel” follows and is incorporated into this Regulatory Analysis.</p><p>5. A determination of whether there are less costly methods or less intrusive methods for achieving the purpose of the proposed rule.</p><p>1 See Statement of Basis and Purpose, footnote 11. 2 See Statement of Basis and Purpose, footnote 4. The alternative is to delay Pompe disease screening on the newborn screening panel. At this time it is unknown if, after fully assessing the implications of screening for Pompe disease, the Department and the stakeholder community will continue to recommend that Pompe disease be included in the panel. The public health policy and financial analyses are complex and the Department wants to be thorough and include stakeholders when assessing whether a condition should be recommended to the Board of Health for inclusion on the panel. </p><p>6. Alternative Rules or Alternatives to Rulemaking Considered and Why Rejected.</p><p>Pompe disease is currently included on the panel and screening is to begin on July 1, 2016. Due to the increased implementation costs, the Department is not prepared to implement screening on July 1. Further, given the increased projection in cost, the Department must reassess its recommendation to include Pompe disease on the panel.</p><p>7. To the extent practicable, a quantification of the data used in the analysis; the analysis must take into account both short-term and long-term consequences.</p><p>Data was analyzed from the two largest cohorts of patients with infantile onset Pompe disease on treatment with a focus on outcome and age of initiation of enzyme replacement therapy. The Department has also considered the new cost projections. </p><p>Adding Conditions to the NBS panel</p><p>Pompe Only Pomple and MPS I Pomple, MPS I, and ALD</p><p>Additional Screening Cost: Pompe Pompe MPS I Pompe MPS I ALD</p><p># of additional FTE 1.0 0.5 0.5 0.5 0.5 0.0</p><p>FTE - personnel cost $ 89,050.00 $ 44,525.00 $ 44,525.00 $ 44,525.00 $ 44,525.00 $ - </p><p>Operating costs, non-vendor $ 25,000.00 $ 12,500.00 $ 12,500.00 $ 12,500.00 $ 12,500.00 $ - </p><p>Sub-specialist follow-up $ 63,000.00 $ 63,000.00 $ 69,500.00 $ 63,000.00 $ 69,500.00 $ 69,500.00 </p><p>Lab build-out costs $ 5,000.00 $ 2,500.00 $ 2,500.00 $ 2,500.00 $ 2,500.00 $ - </p><p>Vendor costs for </p><p> either equipment - straight purchase $ 471,000.00 $ 250,000.00 $ 90,000.00 $ 250,000.00 $ 90,000.00 $ 210,000.00 </p><p> equipment - 3-year reagent lease $ 157,000.00 $ 83,333.33 $ 30,000.00 $ 83,333.33 $ 30,000.00 $ 70,000.00 </p><p> supplies $ 250,000.00 $ 250,000.00 $ 90,000.00 $ 250,000.00 $ 90,000.00 $ 210,000.00 </p><p>Costs per year with equipment purchase $ 903,050.00 $931,550.00 $1,421,050.00</p><p>Costs per year with equipment lease $ 589,050.00 $704,883.33 $1,054,383.33</p><p>Additional Cost per NBS test $ 8.93 $10.68 $15.98</p>