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CMS-1403-FC metropolitan statistical area and has fewer than 100 beds. We have determined that this final rule with comment period will have minimal impact on small hospitals located in rural areas. Of the 196 hospital-based ESRD facilities located in rural areas, only 40 are affiliated with hospitals with fewer than 100 beds. 1036 Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2008, that threshold is approximately $130 million. This final rule with comment period will not mandate any requirements for State, local, or tribal governments. Medicare beneficiaries are considered to be part of the private sector for this purpose. A discussion concerning the impact of this rule on beneficiaries is found later in this section. Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. The e-prescribing portions of this rule present a potential Federalism implication. No State categorically bars e-prescribing, but the scope and

CMS-1403-FC substance of State laws varies widely among the States. In recent years, many States have more actively legislated in this area. Should a State law be contrary to the Part D e-prescribing standards, or should it restrict the ability to carry out the Medicare Part D e-prescribing program, the MMA provides for preemption of that State law at section 1860D-4(e)(5) of the Act. Section 1860D-4(e)(5) provides: Relation to State Laws. The standards promulgated under the subsection shall supersede any State law or regulation that -- (A) Is contrary to the standards or restricts the ability to carry out this part; and (B) Pertains to the electronic transmission of medication history and of information on eligibility, benefits, and prescriptions with respect to covered Part D drugs under this part. For the reasons given above, we have determined that States would not incur any direct costs as a result of this rule. However, as mandated by section 1860D-4(e) of the Act, and under Executive Order 13132, we are required to minimize the extent of preemption, consistent with achieving the objectives of the Federal statute, and to meet certain other conditions. We believe that, taken as a 1037

<strong>CMS</strong>-1403-FC<br />

metropolitan statistical area and <strong>has</strong> fewer than 100 beds.<br />

We have determined that this final rule with comment period<br />

will have minimal impact on small hospitals located in<br />

rural areas. Of the 196 hospital-based ESRD facilities<br />

located in rural areas, only 40 are affiliated with<br />

hospitals with fewer than 100 beds.<br />

1036<br />

Section 202 of the Unfunded Mandates Reform Act of 1995<br />

(UMRA) also requires that agencies assess anticipated costs<br />

and benefits before issuing any rule whose mandates require<br />

spending in any 1 year of $100 million in 1995 dollars,<br />

updated annually for inflation. In 2008, that threshold is<br />

approximately $130 million. <strong>This</strong> final rule with comment<br />

period will not mandate any requirements for State, local,<br />

or tribal governments. Medicare beneficiaries are<br />

considered to be part of the private sector for this<br />

purpose. A discussion concerning the impact of this rule on<br />

beneficiaries is found later in this section.<br />

Executive Order 13132 establishes certain requirements<br />

that an agency must meet when it promulgates a proposed<br />

rule (and subsequent final rule) that imposes substantial<br />

direct requirement costs on State and local governments,<br />

preempts State law, or otherwise <strong>has</strong> Federalism<br />

implications. The e-prescribing portions of this rule<br />

present a potential Federalism implication. No State<br />

categorically bars e-prescribing, but the scope and

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