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1 Saving the Details for Guidance EXAMPLE 1: Under Medicare EHR (electronic health records) incentive payment program, hospitals and physicians must meaningfully use EHR. The statute authorizes CMS to specify the specific objectives a hospital or physician must meet in order to qualify for the EHR incentive payment. For example, CMS could require the hospital or physician to use computer physician order entry for at least 80% of all orders for diagnostic test. Would the following regulatory provisions raise any legal concerns? Example A: Meaningful Use Objectives. To qualify as a meaningful EHR user, a physician or hospital must meet such objectives specified by CMS. Example B: *CMS plans to specify the objectives in future guidance Meaningful Use Objectives. To qualify as a meaningful EHR user, a physician or hospital must meet the following objectives: (a) Record demographics: The physician or hospital must record in a patient s EHR the patient s gender, age, race, and ethnicity for at least the percentage of patients seen by the physician or hospital, as specified by CMS.... Example C: * CMS plans to specify the applicable percentage (e.g., 80%) in future guidance Meaningful Use Objectives. To qualify as a meaningful EHR user, a physician or hospital must meet the following objectives: (a) Record demographics: The physician or hospital must record in a patient s EHR the patient s gender, age, race, and ethnicity for a substantial percentage of patients seen by the physician or hospital.... * CMS plans to specify the applicable percentage (e.g., 80%) in future guidance.

2 REGULATORY DEFINITIONS EXAMPLE 2: Definitions EHR reporting period means any continuous 3 month period within a calendar year. Eligible Hospital means a hospital subject to the Medicare prospective payment system established under section 1886(d) of the Social Security Act Meaningful Use Objectives (a) To qualify as a meaningful EHR user, during the three-month reporting period a hospital must meet the following requirements....

3 EXAMPLE 3: Definitions Eligible Hospital means a hospital subject to the Medicare prospective payment system established under section 1886 of the Social Security Act. Qualifying Hospital means an eligible hospital that is also a meaningful EHR user. Meaningful EHR user means an eligible hospital that, for an EHR reporting period for a payment year, demonstrates meaningful use of EHR technology by meeting the requirements set forth in (a) General rule. An eligible hospital that is a meaningful EHR user shall receive an incentive payment in the amount....

4 EXAMPLE Definitions. Eligible Hospital means a hospital subject to the Medicare prospective payment system established under section 1886 of the Social Security Act. [* Note: Hospitals subject to the Medicare prospective payment system include (1) subsection (d) hospitals, and (2) critical access hospitals (CAHs)] Qualifying Hospital means an eligible hospital that is also a meaningful EHR user. Meaningful EHR user means an eligible hospital that, for an EHR reporting period for a payment year, demonstrates meaningful use of EHR technology by meeting the requirements set forth in (a) General rule. A qualifying hospital shall receive an incentive payment in the amount determined under paragraph (b). (b) Payment Amount: The incentive payment for a payment year is calculated as the product of the following: (i) The initial amount (as determined under paragraph (c) of this section) (ii) The Medicare share fraction (as determined under paragraph (c) of this section). (iii) The transition factor for the payment year (as determined under paragraph (c) of this section) (c) [sets forth the rules for calculating the initial payment amount, Medicare share fraction, and transition factor for purposes of paragraph (b)] Incentive Payment to CAHs (a) General rule. A qualifying CAH receives an incentive payment amount equal to the product of its reasonable costs incurred for the purchase of certified EHR technology (as determined under paragraph (b) of this section) and the Medicare share percentage (as determined under paragraph (b) of this section). (b) [Sets forth manner for calculating a CAH s (1) reasonable costs incurred for the purchase of certified EHR technology, and (2) Medicare share percentage]

5 REVISED EXAMPLE 4 Eligible critical access hospital (CAH) means a facility that has been certified as a critical access hospital under section 1820(e) of the Social Security Act. Qualifying CAH means an eligible CAH that is also a meaningful EHR user. Eligible hospital means a hospital subject to the Medicare prospective payment system established under section 1886 of the Social Security Act other than an eligible CAH. Qualifying hospital means an eligible hospital that is also a meaningful EHR user. Meaningful EHR user means an eligible hospital or eligible CAH that, for an EHR reporting period for a payment year, demonstrates meaningful use of EHR technology by meeting the requirements set forth in (a) General rule. A qualifying hospital shall receive an incentive payment in the amount determined under paragraph (b). (b) Payment Amount: The incentive payment for a payment year is calculated as the product of the following: (i) The initial amount (as determined under paragraph (c) of this section) (ii) The Medicare share fraction (as determined under paragraph (c) of this section). (iii) The transition factor for the payment year (as determined under paragraph (c) of this section) (c) [sets forth the rules for calculating the initial payment amount, Medicare share fraction, and transition factor for purposes of paragraph (b)] Incentive Payment to CAHs (a) General rule. A qualifying CAH receives an incentive payment amount equal to the product of its reasonable costs incurred for the purchase of certified EHR technology (as determined under paragraph (b) of this section) and the Medicare share percentage (as determined under paragraph (b) of this section). (b) [Sets forth manner for calculating a CAH s (1) reasonable costs incurred for the purchase of certified EHR technology, and (2) Medicare share percentage]

6 MAKING SURE THE MOVING PARTS WORK TOGETHER EXAMPLE 5 Eligible critical access hospital (CAH) means a facility that has been certified as a critical access hospital under section 1820(e) of the Social Security Act. Qualifying CAH means an eligible CAH that is also a meaningful EHR user. Eligible hospital means a hospital subject to the Medicare prospective payment system established under section 1886 of the Social Security Act other than an eligible CAH. Qualifying hospital means an eligible hospital that is also a meaningful EHR user. Meaningful EHR user means an eligible hospital or eligible CAH that, for an EHR reporting period for a payment year, demonstrates meaningful use of EHR technology by meeting the requirements set forth in Meaningful Use Objectives. (b) To qualify as a meaningful EHR user, an eligible hospital or eligible CAH must meet the following requirements....

7 EXAMPLE 6 Proposed Provisions (a) General rule. A qualifying hospital shall receive an incentive payment in the amount determined under paragraph (b). (b) Payment Amount: The incentive payment for a payment year is calculated as the product of the following: (i) The initial amount (as determined under paragraph (c) of this section) (ii) The Medicare share fraction (as determined under paragraph (c) of this section). (iii) The transition factor for the payment year (as determined under paragraph (c) of this section) (c) [sets forth the rules for calculating the initial payment amount, Medicare share fraction, and transition factor for purposes of paragraph (b)] Revised Provisions (a) General rule. A qualifying hospital may shall receive an incentive payment in the amount determined under paragraph (b). (b) Payment Amount: The incentive payment for a payment year is calculated as the product of the following: (i) The initial amount (as determined under paragraph (c) of this section) (ii) The Medicare share fraction (as determined under paragraph (c) of this section). (iii) The transition factor for the payment year (as determined under paragraph (c) of this section) (c) [sets forth the rules for calculating the initial payment amount] (d) [sets forth the rules for calculating the share fraction] (e) [sets forth the rules for calculating the transition factor]

8 Imprecise Language EXAMPLE Meaningful Use Objectives [Note: To be a meaningful EHR user for a calendar year, a physician or other health professional must meet the below objectives during any 3-month period selected by the health professional. This period is referred to as the EHR reporting period. ] (c) To qualify as a meaningful EHR user, during the EHR reporting period an eligible health professional must meet the following objectives: (i) Record demographics: The eligible health professional must record in a patient s electronic health record (EHR) the patient s gender, age, race, and ethnicity for at least 80% all patients seen by the eligible health professional. (ii) Record vital signs: The eligible health professional must record in a patient s electronic health record (EHR) the patient s height, weight, and blood pressure for at least 80% of all patients seen by the eligible health professional. (iii) Immunization Registries. The eligible professional must submit electronically to immunization registries patient immunization data as required under state law.

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