2016-04785. Medicare and Medicaid Programs; Electronic Health Record Initiative Program-Stage 3 and Modifications to Meaningful Use in 2015 Through 2017; Corrections and Correcting Amendment

AGENCY:

Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION:

Final rule; corrections and correcting amendment.

SUMMARY:

This document corrects certain technical and typographical errors that appeared in the October 16, 2015 final rule with comment period titled “Medicare and Medicaid Programs; Electronic Health Record Incentive Program—Stage 3 and Modifications to Meaningful Use in 2015 through 2017.”

DATES:

This document is effective on March 4, 2016.

FOR FURTHER INFORMATION CONTACT:

Kateisha Martin, [phone].

SUPPLEMENTARY INFORMATION:

I. Background

In FR Doc. 2015-25595 of October 16, 2015 (80 FR 62762), in the final rule with comment period titled “Medicare and Medicaid Programs; Electronic Health Record Incentive Program—Stage 3 and Modifications to Meaningful Use in 2015 through 2017” (hereafter referred to as the “2015 EHR Incentive Programs final rule with comment period”), there were a number of technical errors that are identified and corrected in this correcting amendment. The provisions in this document are treated as if they had been included in the 2015 EHR Incentive Programs final rule with comment period.

In the 2015 EHR Incentive Programs final rule with comment period, we specified the requirements that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must meet in order to participate in the Medicare and Medicaid EHR Incentive Programs and successfully demonstrate meaningful use of certified EHR technology. In addition, it changed the Medicare and Medicaid EHR Incentive Programs reporting period in 2015 to a 90-day period aligned with the calendar year. It also removed reporting requirements on measures that have become redundant, duplicative, or topped out from the Medicare and Medicaid EHR Incentive Programs. In addition, it established the requirements for Stage 3 of the program as optional in 2017 and required for all participants beginning in 2018. The final rule with comment period continues to encourage the electronic submission of clinical quality measure (CQM) data, establishes requirements to transition the program to a single stage, and aligns reporting for providers in the Medicare and Medicaid EHR Incentive Programs.

II. Summary of Errors

A. Summary of Errors in the Preamble

On page 62767, in our discussion of certified EHR technology requirements for the EHR Incentive Program, we made a typographical error in the word “use” in the sentence specifying that providers may continue to use technology certified to the 2014 Edition until EHR technology certified to the 2015 Edition is required with an EHR reporting period beginning in 2018.

On page 62801, in our response to the public comment regarding “Objective 4: Electronic Prescribing” we made a typographical error in the word “distinguish” in the sentence specifying that we will no longer distinguish between prescriptions for controlled substances.

On page 62806, in our response to a public comment regarding “Objective 4: Electronic Prescribing” and the pathways acceptable for transmitting Summary of Care records, we inadvertently omitted the word “have” in the sentence specifying that to count in the numerator the sending provider must have reasonable certainty of receipt of the summary of care document. In addition, there is typographical error and the word “obtain” was omitted causing an incomplete sentence which reads “Instead, r the referring provider must confirmation”. This sentence is corrected to read “Instead, the referring provider must obtain confirmation”.

On page 62819, we made a typographical error in our discussion regarding previous registrations with a public health agency or clinical data registry that occurred in a previous stage of meaningful use could count toward Active Engagement Option 1 for any of the EHR reporting periods in 2015, 2016 or 2017.

On page 62825, in Table 6—PUBLIC HEALTH REPORTING OBJECTIVE MEASURES FOR EPs, ELIGIBLE HOSPITALS, AND CAHs IN 2015 THROUGH 2017, we inadvertently included the phrase “with a public health agency” in the description of the Measure 3 Specialized Registry Reporting “Measure Specification” in error.

On page 62834, in our response to a public comment regarding the eventual progression toward universal inclusion of controlled substances in electronic prescribing as a desired goal, we made a grammatical error.

On page 62868, in our response to a public comment regarding reporting to specialized registries, we made a typographical error in the cross-reference for the section outlining the Specialized Registry Reporting measure for 2015 through 2017.

On page 62885, in Table 15—EP OBJECTIVES, MEASURES, AND CERTIFICATION CRITERIA FOR STAGE 3 IN 2018 AND SUBSEQUENT YEARS, we made technical errors in the descriptions of Measures 1 and 2 of Objective 6—Coordination of Care through Patient Engagement where the table text does not match the correct text in the preamble and regulation text for the correct year.

On page 62883, in TABLE 14—ELIGIBLE HOSPITAL/CAH OBJECTIVES, MEASURES, AND CERTIFICATION CRITERIA FOR STAGE 3 IN 2017, we made technical errors in the threshold description for Measures 1 and 2 of Objective 6 where the table text does not match the correct text in the preamble and regulation text for the correct year.

On page 62928, in Table 25—ESTIMATED ANNUAL INFORMATION COLLECTION BURDEN, we made typographical errors in the regulatory citations listed in the first column of the table.

B. Summary of Errors in the Regulations Text

On page 62945, in § 495.22(e)(3)(ii)(C)(3), we erroneously stated that the alternate exclusion applies for only measure 3 for EPs scheduled to be in Stage 1 in 2016 instead of stating that the exclusion applies for both measures 2 and 3 for EPs scheduled to be in Stage 1 in 2016.

On page 62948, in § 495.22(e)(10)(ii)(C)(3), we incorrectly referenced EPs instead of eligible hospitals or CAHs in specifying the exclusion for the immunization registry reporting measure.

On page 62951, in § 495.24(d)(7)(i)(B)(3), we erroneously stated that the provider must implement clinical information reconciliation for “two of the following three” clinical information sets instead of stating that the provider must implement clinical information reconciliation for “the following three” clinical information sets, which is consistent with the proposed regulation text (80 FR 16800) and the description in the final rule preamble (80 FR 62862).

On page 62952, in § 495.24(d)(7)(ii)(B)(3), we erroneously stated that the provider must implement clinical information reconciliation for “two of the following three” clinical information sets instead of stating that the provider must implement clinical information reconciliation for “the following three” clinical information sets, which is consistent with the proposed regulation text (80 FR 16801) and the description in the final rule preamble (80 FR 62862).

III. Waiver of Proposed Rulemaking, 60-Day Comment Period, and Delay in Effective Date

Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA), the agency is required to publish a notice of the proposed rule in the Federal Register before the provisions of a rule take effect. Similarly, section 1871(b)(1) of the Act requires the Secretary to provide for notice of the proposed rule in the Federal Register and provide a period of not less than 60 days for public comment. In addition, section 553(d) of the APA, and section 1871(e)(1)(B)(i) of the Act mandate a 30-day delay in effective date after issuance or publication of a rule. Sections 553(b)(B) and 553(d)(3) of the APA provide for exceptions from the notice and comment and delay in effective date APA requirements; in cases in which these exceptions apply, sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the Act provide exceptions from the notice and 60-day comment period and delay in effective date requirements of the Act as well. Section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize an agency to dispense with normal rulemaking requirements for good cause if the agency makes a finding that the notice and comment process are impracticable, unnecessary, or contrary to the public interest. In addition, both section 553(d)(3) of the APA and section 1871(e)(1)(B)(ii) of the Act allow the agency to avoid the 30-day delay in effective date where such delay is contrary to the public interest and an agency includes a statement of support.

We believe that this document does not constitute a rulemaking that would be subject to these requirements. This document corrects technical and typographic errors in the preamble and regulation text included in the 2015 EHR Incentive Programs final rule with comment period. The corrections contained in this document are consistent with, and do not make substantive changes to, the policies that were adopted subject to notice and comment procedures in the final rule with comment period. As a result, the corrections made through this document are intended to ensure that the 2015 EHR Incentive Programs final rule with comment period accurately reflects the policies adopted in that rule. In addition, even if this were a rulemaking to which the notice and comment procedures and delayed effective date requirements applied, we find that there is good cause to waive such requirements. Undertaking further notice and comment procedures to incorporate the corrections in this document into the final rule with comment period or delaying the effective date would be contrary to the public interest because it is in the public's interest for eligible professionals, eligible hospitals, and critical access hospitals to be advised, in a timely manner, of the meaningful use criteria and EHR reporting periods that they must meet in order to qualify for Medicare and Medicaid electronic health record incentive payments and avoid payment reductions under Medicare, and to ensure that the final rule with comment period accurately reflects our policies as of the date they take effect and are applicable. Furthermore, such procedures would be unnecessary, as we are not altering our policies; rather, we are simply implementing correctly the policies that we previously proposed, received comment on, and subsequently finalized. This correcting document is intended solely to ensure that the 2015 EHR Incentive Programs final rule with comment period accurately reflects these policies. Therefore, we believe we have good cause to waive the notice and comment and effective date requirements.

IV. Correction of Errors

In FR Doc. 2015-25595 of October 16, 2015 (80 FR 62762), we are making the following corrections:

1. On page 62767, first column, first full paragraph, line 16, the phrase “continue to usher” is corrected to read “continue to use”.

2. On page 62801, second column, first full paragraph, line 32, the phrase “longer distinguishing between” is corrected to read “longer distinguish between”.

3. On page 62806, third column, first paragraph—

a. Lines 4 and 5, the phrase “must reasonable certainty” is corrected to read “must have reasonable certainty”.

b. Line 9 and 10, the phrase “Instead, r the referring provider must confirmation” is corrected to read “Instead, the referring provider must obtain confirmation”.

4. On page 62819, second column, last paragraph, line 12, the phrase “a previous stages” is corrected to read “a previous stage”.

5. On page 62825, in TABLE 6—PUBLIC HEALTH REPORTING OBJECTIVE MEASURES FOR EPS, ELIGIBLE HOSPITALS, AND CAHS IN 2015 THROUGH 2017, second column (Measure specification column for Measure 3) lines 5 and 6, the phrase “The EP, eligible hospital, or CAH is in active engagement with a public health agency to submit data to a specialized registry” is corrected to read “The EP, eligible hospital, or CAH is in active engagement to submit data to a specialized registry”.

6. On page 62834, first column, last paragraph, line 22, the phrase “distinguishing between” is corrected to read “distinguish between”.

7. On page 62868, second column, first full paragraph, lines 39 and 40, the phrase “section aII.B.2.b.x for further information” is corrected to read “Objective 10 in section II.B.2.a. of this final rule for further information”.

8. On page 62883, in Table 14—ELIGIBLE HOSPITAL/CAH OBJECTIVES, MEASURES, AND CERTIFICATION CRITERIA FOR STAGE 3 IN 2017—CONTINUED, second column—

a. Second set of paragraphs, second paragraph (Measure 1 of Objective 6), line 2, the phrase “more than 10 percent” is corrected to read “more than 5 percent”.

b. Third set of paragraphs, last paragraph (Measure 2 of Objective 6) line 1, the phrase “more than 25%” is corrected to read “more than 5%”.

9. On page 62885, in TABLE 15—EP OBJECTIVES, MEASURES, AND CERTIFICATION CRITERIA FOR STAGE 3 IN 2018 AND SUBSEQUENT YEARS, second column—

a. Line 17 from the bottom of the column (Measure 1 of Objective 6), the phrase “Measure 1: For 2017, during the EHR reporting period” is corrected to read “Measure 1: During the EHR reporting period”.

b. Line 6 from the bottom of the column (Measure 2 of Objective 6), the phrase “Measure 2: For 2017, more than 25%” is corrected to read “Measure 2: More than 25%”.

10. On page 62928, in TABLE 25—ESTIMATED ANNUAL INFORMATION COLLECTION BURDEN, the first column (Reg. Section)—

a. Line 1, the citation “§ 495.x” is corrected to read “§ 495.24”

b. Line 3, the citation “§ 495.6” is corrected to read “§ 495.22”.

List of Subjects in 42 CFR Part 495

• Administrative practice and procedure
• Electronic health records
• Health facilities
• Health professions
• Health maintenance organizations (HMO)
• Medicaid
• Medicare
• Penalties
• Privacy
• Reporting and recordkeeping requirements

As noted in section II.B. of this document, the Centers for Medicare & Medicaid Services is making the following correcting amendments to 42 CFR part 495:

PART 495—STANDARDS FOR THE ELECTRONIC HEALTH RECORD TECHNOLOGY INCENTIVE PROGRAM

1. The authority citation for part 495 continues to read as follows:

Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).

§ 495.22

[Amended]

2. Section 495.22 is amended as follows:

a. In paragraph (e)(3)(ii)(C)( 3) by removing the phrase “paragraph (e)(3)(ii)(A)(3) of this section in 2016” and adding in its place the phrase “paragraphs (e)(3)(ii)(A)(2) and (e)(3)(ii)(A)(3) of this section in 2016.”

b. In paragraph (e)(10)(ii)(C)( 3) introductory text by removing the phrase “if the EP:” and adding in its place the phrase “if the eligible hospital or CAH:”.

§ 495.24

[Amended]

3. Section 495.24 is amended as follows:

a. In paragraph (d)(7)(i)(B)( 3) introductory text by removing the phrase “for two of the following three clinical information sets:” and adding in its place the phrase “for the following three clinical information sets:”.

b. In paragraph (d)(7)(ii)(B)( 3) introductory text by removing the phrase “for two of the following three clinical information sets:” and adding in its place the phrase “for the following three clinical information sets:”.

Dated: February 25, 2016.

Wilma Robinson,

Deputy Executive Secretary to the Department, Department of Health and Human Services.