Evidence From Statutorily Excluded Medical Sources, 37557-37561 [2016-13744]

Download as PDF 37557 Proposed Rules Federal Register Vol. 81, No. 112 Friday, June 10, 2016 This section of the FEDERAL REGISTER contains notices to the public of the proposed issuance of rules and regulations. The purpose of these notices is to give interested persons an opportunity to participate in the rule making prior to the adoption of the final rules. SOCIAL SECURITY ADMINISTRATION 20 CFR Parts 404 and 416 [Docket No. SSA–2016–0015] RIN 0960–AH92 Evidence From Statutorily Excluded Medical Sources Social Security Administration. Notice of proposed rulemaking (NPRM). AGENCY: ACTION: In accordance with section 812 of the Bipartisan Budget Act of 2015 (BBA section 812), we propose to revise our rules to explain how we would address evidence furnished by medical sources that meet one of BBA section 812’s exclusionary categories (statutorily excluded medical sources). Under this proposed rule, we would not consider evidence furnished by a statutorily excluded medical source unless we find good cause to do so. We propose several circumstances in which we would find good cause, and we also propose to require statutorily excluded medical sources to notify us of their excluded status when they furnish evidence to us. These rules would allow us to fulfill obligations that we have under the Bipartisan Budget Act of 2015 (BBA). DATES: To ensure that we consider your comments, we must receive them by no later than August 9, 2016. ADDRESSES: You may submit comments by any one of three methods—Internet, fax, or mail. Do not submit the same comments multiple times or by more than one method. Regardless of which method you choose, please state that your comments refer to Docket No. SSA–2016–0015 so that we may associate your comments with the correct regulation. Caution: You should be careful to include in your comments only information that you wish to make publicly available. We strongly urge you not to include in your comments any personal information, such as Social asabaliauskas on DSK3SPTVN1PROD with PROPOSALS SUMMARY: VerDate Sep<11>2014 16:37 Jun 09, 2016 Jkt 238001 Security numbers or medical information. 1. Internet: We strongly recommend that you submit your comments via the Internet. Please visit the Federal eRulemaking portal at https:// www.regulations.gov. Use the ‘‘Search’’ function to find docket number SSA– 2016–0015. The system will issue a tracking number to confirm your submission. You will not be able to view your comment immediately because we must post each comment manually. It may take up to a week for your comment to be viewable. 2. Fax: Fax comments to (410) 966– 2830. 3. Mail: Mail your comments to the Office of Regulations and Reports Clearance, Social Security Administration, 3100 West High Rise Building, 6401 Security Boulevard, Baltimore, Maryland 21235–6401. Comments and background documents are available for public viewing on the Federal eRulemaking portal at www.regulations.gov or in person, during regular business hours, by arranging with the contact person identified below. FOR FURTHER INFORMATION CONTACT: Dan O’Brien, Office of Disability Policy, Social Security Administration, 6401 Security Boulevard, Baltimore, Maryland 21235–6401, (410) 597–1632. For information on eligibility or filing for benefits, call our national toll-free number, 1–800–772–1213, or TTY 1– 800–325–0778, or visit our Internet site, Social Security Online, at www.socialsecurity.gov. SUPPLEMENTARY INFORMATION: I. How BBA Section 812 Affects How We Consider Evidence We consider all evidence we receive when we determine whether an individual is blind or disabled under the Social Security Act (Act).1 We define evidence as anything you or anyone else submits to us, or that we obtain, that relates to your claim.2 The BBA was enacted on November 2, 2015.3 BBA section 812 amended section 223(d)(5) of the Act, 42 U.S.C. 423(d)(5), by adding a new paragraph ‘‘C.’’ Under this provision, when we 1 42 U.S.C. 416(i), 42 U.S.C. 423(d), and 42 U.S.C. 1382c(a). 2 20 CFR 404.1512(b) and 416.912(b). 3 Pub. L. 114–74, 129 Stat. 584. PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 make a disability determination or decision, or when we conduct a continuing disability review (CDR), under titles II or XVI of the Act, we cannot consider evidence furnished by certain sources, unless we have good cause.4 Specifically, we may not consider evidence from the following medical sources: • A medical source convicted of a felony under sections 208 or 1632 of the Act,5 • a medical source excluded from participating in any Federal health care program under section 1128 of the Act,6 or • a medical source imposed with a civil monetary penalty (CMP), 4 Public Law 114–74, sec. 812, 129 Stat. 584, 602. Excluding evidence under BBA section 812 does not constitute an exclusion of a medical source from Social Security programs under section 1136 of the Act, 42 U.S.C. 1320b–6. 5 42 U.S.C. 408 and 1383a. These sections make it a felony to give false statements or omit information to cause an improper payment, convert a payment intended for someone else, provide us with false information we need for our records concerning the individual’s true identity, or misuse a Social Security card or number for the purpose of obtaining or causing an increase in benefits to which the individual is not entitled or eligible. 6 42 U.S.C. 1320a–7. This section identifies four mandatory and 16 permissive bases for excluding a provider from participating in all Federal health care programs (as defined in section 1128B(f) of the Act). The four mandatory exclusions from participating in Federal health care programs are: (1) Conviction of program-related crimes, (2) conviction relating to patient abuse, (3) felony conviction relating to health care fraud, and (4) felony conviction relating to controlled substance. The 16 permissive exclusions from participating in Federal health care programs are: (1) Conviction relating to fraud, (2) conviction relating to obstruction of an investigation or audit, (3) misdemeanor conviction relating to controlled substance, (4) license revocation or suspension, (5) exclusion or suspension under federal or state health care program, (6) claims for excessive charges or unnecessary services and failure of certain organizations to furnish medically necessary services, (7) fraud, kickbacks, and other prohibited activities, (8) entities controlled by a sanctioned individual, (9) failure to disclose required information, (10) failure to supply requested information on subcontractors and suppliers, (11) failure to supply payment information, (12) failure to grant immediate access, (13) failure to take corrective action, (14) default on health education loan or scholarship obligations, (15) individuals controlling a sanctioned entity, and (16) making false statements or misrepresentation of a material fact. The Department of Health and Human Services’ Office of Inspector General (HHS OIG), which administers section 1128 of the Act, may grant a waiver for all but one of these bases. A mandatory exclusion for a conviction related to patient abuse may not be waived. E:\FR\FM\10JNP1.SGM 10JNP1 37558 Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Proposed Rules assessment, or both, for submitting false evidence under section 1129 of the Act.7 We refer to the individuals and entities that fall into one or more of these exclusionary categories as statutorily excluded medical sources. Our Inspector General or the Secretary of Health and Human Services (HHS) will inform us about these statutorily excluded medical sources at such times and to the extent necessary for the effective implementation of this requirement.8 BBA section 812 requires us to issue regulations to carry out the amendments to the Act by November 2, 2016.9 BBA section 812 is effective on or after the effective date of the regulations, or by November 2, 2016, whichever is earlier.10 II. Proposed Revisions to Our Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS We propose to implement BBA section 812 by adding new 20 CFR 404.1503b and 416.903b to state that we will not consider evidence from a statutorily excluded medical source under section 223(d)(5)(C) of the Act, unless we find good cause. Under our proposed rules, we may find good cause to consider evidence from an excluded medical source in the following five situations: • The evidence from the medical source consists of evidence of treatment that occurred before the date the source was convicted of a felony under section 208 or under section 1632 of the Act; • The evidence from the medical source consists of evidence of treatment that occurred during a period in which the source was not excluded from participation in any Federal health care program under section 1128 of the Act; • The evidence from the medical source consists of evidence of treatment that occurred before the date the source received a final decision imposing a CMP, assessment, or both, for submitting false evidence under section 1129 of the Act; • The sole basis for the medical source’s exclusion under section 223(d)(5)(C) of the Act is that the source cannot participate in any Federal health care program under section 1128 of the Act, but the Office of Inspector General of the Department of Health and Human 7 42 U.S.C. 1320a–8. This section permits the imposition of a CMP or assessment (or both) for certain offenses. One such offense is making a false statement or representation of a material fact for us to use in determining an initial or continuing right to Social Security disability benefits. 8 Section 812(a) of Public Law 114–74, 129 Stat. at 602. 9 Section 812(b) of Public Law 114–74, 129 Stat. at 602. 10 Section 812(c) of Public Law 114–74, 129 Stat. at 602. VerDate Sep<11>2014 16:37 Jun 09, 2016 Jkt 238001 Services granted a waiver of the section 1128 exclusion; or • The evidence is a laboratory finding about a physical impairment and there is no indication that the finding is unreliable. We may find good cause to consider evidence from an excluded medical source in any of these five enumerated situations when we make a disability determination or decision or when we conduct a CDR. The first three good cause exceptions relate to evidence that pertains to periods prior to the event that would trigger exclusion under BBA section 812, or relate to a period during which the medical source was not excluded from participating in any Federal health care program. We believe that it would be consistent with the purpose of BBA section 812 to find good cause to consider evidence furnished by a medical source of treatment that occurred: (1) Before the source is convicted of a felony under section 208 or 1632 of the Act,11 (2) outside of the period the source cannot participate in Federal health care programs under section 1128 of the Act,12 or (3) before the source is issued a final decision imposing a CMP, assessment, or both, for submitting false evidence under section 1129 of the Act.13 We propose these good cause exceptions in order to protect the public interest. In our view, an undue hardship would be placed on our claimants, and the purposes of BBA section 812 would not be served, unless we include these exceptions. In this situation, there is little risk that the evidence would be tainted by the activity for which the source has been sanctioned or convicted, but a greater risk that we could make an incorrect determination or decision by excluding probative evidence. Specifically, it would be against the public interest if we barred claimants from ever using evidence furnished by statutorily excluded medical sources concerning treatment that occurred prior to the period those sources qualify for a BBA section 812 exclusion. For example, there may be instances where a statutorily excluded medical source provided treatment to a claimant prior to the period the source qualified for a BBA section 812 exclusion or performed the acts that led to the exclusion. In those instances, and others, we would determine whether to consider the source’s evidence concerning such treatment on a case-by-case basis. In addition, section 1128 of the Act 11 42 U.S.C. 408 and 42 U.S.C. 1383a. U.S.C. 1320a–7. 13 42 U.S.C. 1320a–8. 12 42 PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 permits some medical sources to resume participating in Federal health care programs after a prescribed exclusion period if they successfully apply for reinstatement.14 We believe it would also be against the public interest for us to place an absolute bar on claimants from ever using evidence of treatment that occurred after termination of the exclusion under section 1128 when medical sources are permitted to resume their participation in Federal health care programs. We would determine whether to consider that evidence on a case-bycase basis as well. The fourth good cause exception aligns our rules with those of HHS and provides a consistent approach regarding evidence from affected medical sources. HHS’ Office of the Inspector General (HHS OIG) may waive a medical source’s exclusion 15 from participating in any Federal health care program for three of the four mandatory exclusions contained in section 1128 of the Act if: (1) It receives a written waiver request from the program’s administrator who has determined that the exclusion will pose a hardship to any beneficiary, and (2) the medical source is the sole community physician or sole source of essential specialized services in a community.16 HHS OIG may waive a medical source’s exclusion for one of the permissive exclusions if it determines that imposing the exclusion would not be in the public interest.17 All waivers may be rescinded if the basis for the waiver ceases to exist.18 Because a waiver from HHS OIG permits an otherwise excluded medical source to participate in a Federal health care program, we may find good cause to consider evidence from such a medical source consistent with the particular terms of the waiver. The fifth good cause exception relies on the unique nature of laboratory findings about physical impairments.19 Laboratory findings about physical impairments are objective, reliable, and reproducible tests that require the least amount of subjective interpretation by a medical source. They are important to help us understand fundamental information about claimants’ impairments and whether they are 14 42 U.S.C. 1320a–7. U.S.C. 1320a–7(c)(3)(B); 42 CFR 1001.1801. 16 42 U.S.C. 1320a–7(a), (c)(3)(B); 42 CFR 1001.1801(a). HHS OIG cannot waive an exclusion based on a conviction related to patient abuse. 17 42 U.S.C. 1320a–7(b); 42 CFR 1001.1801(c). 18 42 CFR 1001.1801(d), (e). 19 Laboratory findings related to a physical impairment include chemical tests (such as blood tests), electrophysiological studies (such as electrocardiograms and electroencephalograms), pathology reports, and medical imaging (such as xrays). See 20 CFR 404.1528(c) and 416.928(c). 15 42 E:\FR\FM\10JNP1.SGM 10JNP1 37559 Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Proposed Rules entitled to benefits, such as the onset date and duration of an impairment(s).20 If we would find that a laboratory finding about a physical impairment in a claim is not reliable, we would not apply the good cause exception. III. Proposed Notification Process Our long-term solution to the administration of BBA section 812 is to implement automated evidence matching within our case processing system(s) to identify excludable evidence. As part of our efforts to comply with BBA section 812’s implementation deadline of November 2, 2016, we propose to require that statutorily excluded medical sources inform us in writing of their BBA section 812 exclusion(s) each time they submit evidence to us that relates to a claim for Social Security disability benefits or payments. Regarding the content of the written statement, statutorily excluded medical sources would be required to include a heading that states, WRITTEN STATEMENT REGARDING SECTION 223(d)(5)(C) OF THE SOCIAL SECURITY ACT—DO NOT REMOVE. Immediately following this heading, sources would also need to include their name, title, and the applicable event(s) that triggered their statutory exclusion. Sources convicted of a felony under section 208 or 1632 of the Act 21 would also need to provide the date of their felony conviction. Similarly, sources imposed with a CMP, assessment, or both, for submitting false evidence Regulation section asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Number of respondents (annually) Description of public reporting requirement 404.1503b(c) 416.903b(c). Executive Order 12866, as Supplemented by Executive Order 13563 We consulted with the Office of Management and Budget (OMB) and determined that this NPRM does not meet the criteria for a significant regulatory action under Executive Order 12866, as supplemented by Executive Order 13563. Therefore, OMB has not reviewed it. Regulatory Flexibility Act We certify that this NPRM would not have a significant economic impact on a substantial number of small entities. The only economic impact on small entities from this NPRM results from BBA section 812’s requirement that we not consider evidence from statutorily excluded medical sources. As described above and in our Paperwork Reduction Act statement, below, we propose to require statutorily excluded medical sources to provide us with a brief selfreport containing basic information each time they submit evidence related to a claim for benefits under titles II or XVI of the Act. Therefore, a regulatory flexibility analysis is not required under the Regulatory Flexibility Act, as amended. Paperwork Reduction Act This proposed rule poses new public reporting burdens in the sections listed below. Because these requirements are not covered by an existing OMBapproved form, we provide burden estimates for them. Frequency of response Estimated annual burden (hours) 50 60 20 1000 ........................................................................................... 50 ........................ ........................ 1000 We submitted an Information Collection Request for clearance to OMB. We are soliciting comments on the burden estimate; the need for the information; its practical utility; ways to enhance its quality, utility, and clarity; 20 CFR 404.130, 404.1509, and 416.909. VerDate Sep<11>2014 Average burden per response (minutes) Statutorily excluded medical sources must inform us in writing that they are excluded under section 223(d)(5)(C) of the Act, as amended, each time they submit evidence related to a claim for benefits under titles II or XVI of the Act. The written statement must include: A heading stating that it is a written statement regarding section 223(d)(5)(C) of the Act; the name and title of the medical source; the applicable excluding event(s); the date of the medical source’s felony conviction if applicable; the date of the imposition of a civil monetary penalty or assessment, or both, for the submission of false evidence if applicable; the basis, effective date, anticipated length of the exclusion, and whether the Office of Inspector General of the Department of Health and Human Services waived the exclusion. Total ........... 20 See under section 1129 of the Act,22 would need to provide the date of the final imposition of the CMP, assessment, or both. Sources that cannot participate in any Federal health care program under section 1128 of the Act 23 would need to include the basis for their exclusion, its effective date and anticipated length, and whether HHS’ OIG waived it. As stated above, our proposed selfreporting requirement would apply only to statutorily excluded medical sources. This requirement applies when the statutorily excluded medical source submits evidence to us directly or indirectly through a representative, claimant, or other individual or entity. We further propose to require that no individual or entity be permitted to remove a statutorily excluded medical source’s written statement of exclusion prior to submitting the source’s evidence to us. We also seek to reserve the right to request that statutorily excluded medical sources provide us with additional information or clarify any information they submit regarding their exclusion under section 223(d)(5)(C) of the Act. If statutorily excluded medical sources do not inform us of their excluded status, we may refer the medical source to our Office of the Inspector General for any action it deems appropriate, including investigation and CMP pursuit. 16:37 Jun 09, 2016 Jkt 238001 PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 E:\FR\FM\10JNP1.SGM 10JNP1 37560 Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Proposed Rules and ways to minimize the burden on respondents, including the use of automated techniques or other forms of information technology. If you would like to submit comments, please send them to the following locations: Office of Management and Budget, Attn: Desk Officer for SSA, Fax Number: 202–395–6974, Email address: OIRA_ Submission@omb.eop.gov Social Security Administration, Attn: Reports Clearance Officer, 1333 Annex, 6401 Security Blvd., Baltimore, MD 21235–0001, Fax Number: 410–965–6400, Email: OR.Reports.Clearance@ssa.gov You can submit comments until August 9, 2016, which is 60 days after the publication of this notice. However, your comments will be most useful if you send them to SSA by July 11, 2016, which is 30 days after publication. To receive a copy of the OMB clearance package, contact our Reports Clearance Officer using any of the above contact methods. We prefer to receive comments by email or fax. (Catalog of Federal Domestic Assistance Program Nos. 96.001, Social Security— Disability Insurance; 96.002, Social Security—Retirement Insurance; and 96.004, Social Security—Survivors Insurance) List of Subjects 20 CFR Part 404 Administrative practice and procedure, Blind, Disability benefits, Old-Age, Survivors, and Disability Insurance, Reporting and recordkeeping requirements, Social Security. 20 CFR Part 416 Administrative practice and procedure, Reporting and recordkeeping requirements, Supplemental Security Income (SSI). Dated: May 27, 2016. Carolyn W. Colvin, Acting Commissioner of Social Security. For the reasons set out in the preamble, we propose to amend 20 CFR part 404 subpart P and part 416 subpart I as set forth below: asabaliauskas on DSK3SPTVN1PROD with PROPOSALS PART 404—FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950– ) Subpart P—Determining Disability and Blindness 1. The authority citation for subpart P of part 404 continues to read as follows: ■ Authority: Secs. 202, 205(a)–(b) and (d)– (h), 216(i), 221(a), (i), and (j), 222(c), 223, 225, and 702(a)(5) of the Social Security Act (42 U.S.C. 402, 405(a)–(b) and (d)–(h), 416(i), 421(a), (i), and (j), 422(c), 423, 425, and VerDate Sep<11>2014 16:37 Jun 09, 2016 Jkt 238001 902(a)(5)); sec. 211(b), Pub. L. 104–193, 110 Stat. 2105, 2189; sec. 202, Pub. L. 108–203, 118 Stat. 509 (42 U.S.C. 902 note). ■ 2. Add § 404.1503b to read as follows: § 404.1503b Evidence from statutorily excluded medical sources. (a) General. We will not consider evidence from the following medical sources statutorily excluded under section 223(d)(5)(C) of the Social Security Act (Act), as amended, unless we find good cause under paragraph (b) of this section: (1) Any medical source that has been convicted of a felony under section 208 or under section 1632 of the Act; (2) Any medical source that has been excluded from participation in any Federal health care program under section 1128 of the Act; or (3) Any medical source that has received a final decision imposing a civil monetary penalty or assessment, or both, for submitting false evidence under section 1129 of the Act. (b) Good cause. We may find good cause to consider evidence from a statutorily excluded medical source under section 223(d)(5)(C) of the Act, as amended, if: (1) The evidence from the medical source consists of evidence of treatment that occurred before the date the source was convicted of a felony under section 208 or under section 1632 of the Act; (2) The evidence from the medical source consists of evidence of treatment that occurred during a period in which the source was not excluded from participation in any Federal health care program under section 1128 of the Act; (3) The evidence from the medical source consists of evidence of treatment that occurred before the date the source received a final decision imposing a civil monetary penalty or assessment, or both, for submitting false evidence under section 1129 of the Act; (4) The sole basis for the medical source’s exclusion under section 223(d)(5)(C) of the Act, as amended, is that the source cannot participate in any Federal health care program under section 1128 of the Act, but the Office of Inspector General of the Department of Health and Human Services granted a waiver of the section 1128 exclusion; or (5) The evidence is a laboratory finding about a physical impairment and there is no indication that the finding is unreliable. (c) Statutorily excluded medical sources’ reporting requirements. Statutorily excluded medical sources (as described in paragraph (a) of this section) must inform us in writing that they are excluded under section PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 223(d)(5)(C) of the Act, as amended, each time they submit evidence related to a claim for benefits under titles II or XVI of the Act. This reporting requirement applies to evidence that statutorily excluded medical sources submit to us either directly or through a representative, claimant, or other individual or entity. (1) Statutorily excluded medical sources must provide a written statement, which contains the following information: (i) A heading stating: ‘‘WRITTEN STATEMENT REGARDING SECTION 223(d)(5)(C) OF THE SOCIAL SECURITY ACT—DO NOT REMOVE’’ (ii) The name and title of the medical source; (iii) The applicable excluding event(s) stated in paragraphs (a)(1)–(a)(3) of this section; (iv) The date of the medical source’s felony conviction under sections 208 or 1632 of the Act, if applicable; (v) The date of the imposition of a civil monetary penalty or assessment, or both, for the submission of false evidence, under section 1129 of the Act, if applicable; and (vi) The basis, effective date, anticipated length of the exclusion, and whether the Office of the Inspector General of the Department of Health and Human Services waived the exclusion, if the excluding event was the medical source’s exclusion from participation in any Federal health care program under section 1128 of the Act. (2) The written statement provided by an excluded medical source may not be removed by any individual or entity prior to submitting evidence to us. (3) We may request that the excluded medical source provide us with additional information or clarify any information submitted that bears on the medical source’s exclusion(s) under section 223(d)(5)(C) of the Act, as amended. PART 416—SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED Subpart I—Determining Disability and Blindness 3. The authority citation for subpart I of part 416 continues to read as follows: ■ Authority: Secs. 221(m), 702(a)(5), 1611, 1614, 1619, 1631(a), (c), (d)(1), and (p), and 1633 of the Social Security Act (42 U.S.C. 421(m), 902(a)(5), 1382, 1382c, 1382h, 1383(a), (c), (d)(1), and (p), and 1383(b); secs. 4(c) and 5, 6(c)–(e), 14(a), and 15, Pub. L. 98– 460, 98 Stat. 1794, 1801, 1802, and 1808 (42 U.S.C. 421 note, 423 note, and 1382h note). ■ 4. Add § 416.903b to read as follows: E:\FR\FM\10JNP1.SGM 10JNP1 Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS § 416.903b Evidence from statutorily excluded medical sources. (a) General. We will not consider evidence from the following medical sources statutorily excluded under section 223(d)(5)(C) of the Social Security Act (Act), as amended, unless we find good cause under paragraph (b) of this section: (1) Any medical source that has been convicted of a felony under section 208 or under section 1632 of the Act; (2) Any medical source that has been excluded from participation in any Federal health care program under section 1128 of the Act; or (3) Any medical source that has received a final decision imposing a civil monetary penalty or assessment, or both, for submitting false evidence under section 1129 of the Act. (b) Good cause. We may find good cause to consider evidence from a statutorily excluded medical source under section 223(d)(5)(C) of the Act, as amended, if: (1) The evidence from the medical source consists of evidence of treatment that occurred before the date the source was convicted of a felony under section 208 or under section 1632 of the Act; (2) The evidence from the medical source consists of evidence of treatment that occurred during a period in which the source was not excluded from participation in any Federal health care program under section 1128 of the Act; (3) The evidence from the medical source consists of evidence of treatment that occurred before the date the source received a final decision imposing a civil monetary penalty or assessment, or both, for submitting false evidence under section 1129 of the Act; (4) The sole basis for the medical source’s exclusion under section 223(d)(5)(C) of the Act, as amended, is that the source cannot participate in any Federal health care program under section 1128 of the Act, but the Office of Inspector General of the Department of Health and Human Services granted a waiver of the section 1128 exclusion; or (5) The evidence is a laboratory finding about a physical impairment and there is no indication that the finding is unreliable. (c) Statutorily excluded medical sources’ reporting requirements. Statutorily excluded medical sources (as described in paragraph (a) of this section) must inform us in writing that they are excluded under section 223(d)(5)(C) of the Act, as amended, each time they submit evidence related to a claim for benefits under titles II or XVI of the Act. This reporting requirement applies to evidence that VerDate Sep<11>2014 16:37 Jun 09, 2016 Jkt 238001 statutorily excluded medical sources submit to us either directly or through a representative, claimant, or other individual or entity. (1) Statutorily excluded medical sources must provide a written statement, which contains the following information: (i) A heading stating: ‘‘WRITTEN STATEMENT REGARDING SECTION 223(d)(5)(C) OF THE SOCIAL SECURITY ACT—DO NOT REMOVE’’ (ii) The name and title of the medical source; (iii) The applicable excluding event(s) stated in paragraphs (a)(1)–(a)(3) of this section; (iv) The date of the medical source’s felony conviction under sections 208 or 1632 of the Act, if applicable; (v) The date of the imposition of a civil monetary penalty or assessment, or both, for the submission of false evidence, under section 1129 of the Act, if applicable; and (vi) The basis, effective date, anticipated length of the exclusion, and whether the Office of the Inspector General of the Department of Health and Human Services waived the exclusion, if the excluding event was the medical source’s exclusion from participation in any Federal health care program under section 1128 of the Act. (2) The written statement provided by an excluded medical source may not be removed by any individual or entity prior to submitting evidence to us. (3) We may request that the excluded medical source provide us with additional information or clarify any information submitted that bears on the medical source’s exclusion(s) under section 223(d)(5)(C) of the Act, as amended. [FR Doc. 2016–13744 Filed 6–9–16; 8:45 am] BILLING CODE 4191–02–P PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 37561 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 175, 176, 177, and 178 [Docket No. FDA–2016–F–1253] Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids’ Environment, Learning Disabilities Association of America, and Natural Resources Defense Council; Filing of Food Additive Petition; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition; correction. The Food and Drug Administration (FDA or we) is correcting a notice entitled ‘‘Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids’ Environment, Learning Disabilities Association of America, and Natural Resources Defense Council; Filing of Food Additive Petition’’ that appeared in the Federal Register of May 20, 2016 (81 FR 31877). The document announced that Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids’ Environment, Learning Disabilities Association of America, and Natural Resources Defense Council filed a petition proposing that we amend and/or revoke specified regulations to no longer provide for the food contact use of specified orthophthalates, but omitted two items. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Kelly Randolph, Center for Food Safety and Applied Nutrition (HFS–275), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740– 3835, 240–402–1188. SUPPLEMENTARY INFORMATION: In FR Doc. 2016–11866, appearing on page 31878 in the Federal Register of Friday, May 20, 2016, the following correction is made: On page 31878, in the third column, under the heading ‘‘§ 175.300 Resinous and Polymeric Coatings,’’ the SUMMARY: E:\FR\FM\10JNP1.SGM 10JNP1

Agencies

Social Security Administration

[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Proposed Rules]
[Pages 37557-37561]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13744]


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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / 
Proposed Rules

[[Page 37557]]



SOCIAL SECURITY ADMINISTRATION

20 CFR Parts 404 and 416

[Docket No. SSA-2016-0015]
RIN 0960-AH92


Evidence From Statutorily Excluded Medical Sources

AGENCY: Social Security Administration.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: In accordance with section 812 of the Bipartisan Budget Act of 
2015 (BBA section 812), we propose to revise our rules to explain how 
we would address evidence furnished by medical sources that meet one of 
BBA section 812's exclusionary categories (statutorily excluded medical 
sources). Under this proposed rule, we would not consider evidence 
furnished by a statutorily excluded medical source unless we find good 
cause to do so. We propose several circumstances in which we would find 
good cause, and we also propose to require statutorily excluded medical 
sources to notify us of their excluded status when they furnish 
evidence to us. These rules would allow us to fulfill obligations that 
we have under the Bipartisan Budget Act of 2015 (BBA).

DATES: To ensure that we consider your comments, we must receive them 
by no later than August 9, 2016.

ADDRESSES: You may submit comments by any one of three methods--
Internet, fax, or mail. Do not submit the same comments multiple times 
or by more than one method. Regardless of which method you choose, 
please state that your comments refer to Docket No. SSA-2016-0015 so 
that we may associate your comments with the correct regulation.
    Caution: You should be careful to include in your comments only 
information that you wish to make publicly available. We strongly urge 
you not to include in your comments any personal information, such as 
Social Security numbers or medical information.
    1. Internet: We strongly recommend that you submit your comments 
via the Internet. Please visit the Federal eRulemaking portal at https://www.regulations.gov. Use the ``Search'' function to find docket number 
SSA-2016-0015. The system will issue a tracking number to confirm your 
submission. You will not be able to view your comment immediately 
because we must post each comment manually. It may take up to a week 
for your comment to be viewable.
    2. Fax: Fax comments to (410) 966-2830.
    3. Mail: Mail your comments to the Office of Regulations and 
Reports Clearance, Social Security Administration, 3100 West High Rise 
Building, 6401 Security Boulevard, Baltimore, Maryland 21235-6401.
    Comments and background documents are available for public viewing 
on the Federal eRulemaking portal at www.regulations.gov or in person, 
during regular business hours, by arranging with the contact person 
identified below.

FOR FURTHER INFORMATION CONTACT: Dan O'Brien, Office of Disability 
Policy, Social Security Administration, 6401 Security Boulevard, 
Baltimore, Maryland 21235-6401, (410) 597-1632. For information on 
eligibility or filing for benefits, call our national toll-free number, 
1-800-772-1213, or TTY 1-800-325-0778, or visit our Internet site, 
Social Security Online, at www.socialsecurity.gov.

SUPPLEMENTARY INFORMATION:

I. How BBA Section 812 Affects How We Consider Evidence

    We consider all evidence we receive when we determine whether an 
individual is blind or disabled under the Social Security Act (Act).\1\ 
We define evidence as anything you or anyone else submits to us, or 
that we obtain, that relates to your claim.\2\
---------------------------------------------------------------------------

    \1\ 42 U.S.C. 416(i), 42 U.S.C. 423(d), and 42 U.S.C. 1382c(a).
    \2\ 20 CFR 404.1512(b) and 416.912(b).
---------------------------------------------------------------------------

    The BBA was enacted on November 2, 2015.\3\ BBA section 812 amended 
section 223(d)(5) of the Act, 42 U.S.C. 423(d)(5), by adding a new 
paragraph ``C.'' Under this provision, when we make a disability 
determination or decision, or when we conduct a continuing disability 
review (CDR), under titles II or XVI of the Act, we cannot consider 
evidence furnished by certain sources, unless we have good cause.\4\
---------------------------------------------------------------------------

    \3\ Pub. L. 114-74, 129 Stat. 584.
    \4\ Public Law 114-74, sec. 812, 129 Stat. 584, 602. Excluding 
evidence under BBA section 812 does not constitute an exclusion of a 
medical source from Social Security programs under section 1136 of 
the Act, 42 U.S.C. 1320b-6.
---------------------------------------------------------------------------

    Specifically, we may not consider evidence from the following 
medical sources:
     A medical source convicted of a felony under sections 208 
or 1632 of the Act,\5\
---------------------------------------------------------------------------

    \5\ 42 U.S.C. 408 and 1383a. These sections make it a felony to 
give false statements or omit information to cause an improper 
payment, convert a payment intended for someone else, provide us 
with false information we need for our records concerning the 
individual's true identity, or misuse a Social Security card or 
number for the purpose of obtaining or causing an increase in 
benefits to which the individual is not entitled or eligible.
---------------------------------------------------------------------------

     a medical source excluded from participating in any 
Federal health care program under section 1128 of the Act,\6\ or
---------------------------------------------------------------------------

    \6\ 42 U.S.C. 1320a-7. This section identifies four mandatory 
and 16 permissive bases for excluding a provider from participating 
in all Federal health care programs (as defined in section 1128B(f) 
of the Act). The four mandatory exclusions from participating in 
Federal health care programs are: (1) Conviction of program-related 
crimes, (2) conviction relating to patient abuse, (3) felony 
conviction relating to health care fraud, and (4) felony conviction 
relating to controlled substance. The 16 permissive exclusions from 
participating in Federal health care programs are: (1) Conviction 
relating to fraud, (2) conviction relating to obstruction of an 
investigation or audit, (3) misdemeanor conviction relating to 
controlled substance, (4) license revocation or suspension, (5) 
exclusion or suspension under federal or state health care program, 
(6) claims for excessive charges or unnecessary services and failure 
of certain organizations to furnish medically necessary services, 
(7) fraud, kickbacks, and other prohibited activities, (8) entities 
controlled by a sanctioned individual, (9) failure to disclose 
required information, (10) failure to supply requested information 
on subcontractors and suppliers, (11) failure to supply payment 
information, (12) failure to grant immediate access, (13) failure to 
take corrective action, (14) default on health education loan or 
scholarship obligations, (15) individuals controlling a sanctioned 
entity, and (16) making false statements or misrepresentation of a 
material fact. The Department of Health and Human Services' Office 
of Inspector General (HHS OIG), which administers section 1128 of 
the Act, may grant a waiver for all but one of these bases. A 
mandatory exclusion for a conviction related to patient abuse may 
not be waived.
---------------------------------------------------------------------------

     a medical source imposed with a civil monetary penalty 
(CMP),

[[Page 37558]]

assessment, or both, for submitting false evidence under section 1129 
of the Act.\7\
---------------------------------------------------------------------------

    \7\ 42 U.S.C. 1320a-8. This section permits the imposition of a 
CMP or assessment (or both) for certain offenses. One such offense 
is making a false statement or representation of a material fact for 
us to use in determining an initial or continuing right to Social 
Security disability benefits.

We refer to the individuals and entities that fall into one or more of 
---------------------------------------------------------------------------
these exclusionary categories as statutorily excluded medical sources.

    Our Inspector General or the Secretary of Health and Human Services 
(HHS) will inform us about these statutorily excluded medical sources 
at such times and to the extent necessary for the effective 
implementation of this requirement.\8\ BBA section 812 requires us to 
issue regulations to carry out the amendments to the Act by November 2, 
2016.\9\ BBA section 812 is effective on or after the effective date of 
the regulations, or by November 2, 2016, whichever is earlier.\10\
---------------------------------------------------------------------------

    \8\ Section 812(a) of Public Law 114-74, 129 Stat. at 602.
    \9\ Section 812(b) of Public Law 114-74, 129 Stat. at 602.
    \10\ Section 812(c) of Public Law 114-74, 129 Stat. at 602.
---------------------------------------------------------------------------

II. Proposed Revisions to Our Rules

    We propose to implement BBA section 812 by adding new 20 CFR 
404.1503b and 416.903b to state that we will not consider evidence from 
a statutorily excluded medical source under section 223(d)(5)(C) of the 
Act, unless we find good cause. Under our proposed rules, we may find 
good cause to consider evidence from an excluded medical source in the 
following five situations:
     The evidence from the medical source consists of evidence 
of treatment that occurred before the date the source was convicted of 
a felony under section 208 or under section 1632 of the Act;
     The evidence from the medical source consists of evidence 
of treatment that occurred during a period in which the source was not 
excluded from participation in any Federal health care program under 
section 1128 of the Act;
     The evidence from the medical source consists of evidence 
of treatment that occurred before the date the source received a final 
decision imposing a CMP, assessment, or both, for submitting false 
evidence under section 1129 of the Act;
     The sole basis for the medical source's exclusion under 
section 223(d)(5)(C) of the Act is that the source cannot participate 
in any Federal health care program under section 1128 of the Act, but 
the Office of Inspector General of the Department of Health and Human 
Services granted a waiver of the section 1128 exclusion; or
     The evidence is a laboratory finding about a physical 
impairment and there is no indication that the finding is unreliable.

We may find good cause to consider evidence from an excluded medical 
source in any of these five enumerated situations when we make a 
disability determination or decision or when we conduct a CDR.

    The first three good cause exceptions relate to evidence that 
pertains to periods prior to the event that would trigger exclusion 
under BBA section 812, or relate to a period during which the medical 
source was not excluded from participating in any Federal health care 
program. We believe that it would be consistent with the purpose of BBA 
section 812 to find good cause to consider evidence furnished by a 
medical source of treatment that occurred: (1) Before the source is 
convicted of a felony under section 208 or 1632 of the Act,\11\ (2) 
outside of the period the source cannot participate in Federal health 
care programs under section 1128 of the Act,\12\ or (3) before the 
source is issued a final decision imposing a CMP, assessment, or both, 
for submitting false evidence under section 1129 of the Act.\13\ We 
propose these good cause exceptions in order to protect the public 
interest. In our view, an undue hardship would be placed on our 
claimants, and the purposes of BBA section 812 would not be served, 
unless we include these exceptions. In this situation, there is little 
risk that the evidence would be tainted by the activity for which the 
source has been sanctioned or convicted, but a greater risk that we 
could make an incorrect determination or decision by excluding 
probative evidence.
---------------------------------------------------------------------------

    \11\ 42 U.S.C. 408 and 42 U.S.C. 1383a.
    \12\ 42 U.S.C. 1320a-7.
    \13\ 42 U.S.C. 1320a-8.
---------------------------------------------------------------------------

    Specifically, it would be against the public interest if we barred 
claimants from ever using evidence furnished by statutorily excluded 
medical sources concerning treatment that occurred prior to the period 
those sources qualify for a BBA section 812 exclusion. For example, 
there may be instances where a statutorily excluded medical source 
provided treatment to a claimant prior to the period the source 
qualified for a BBA section 812 exclusion or performed the acts that 
led to the exclusion. In those instances, and others, we would 
determine whether to consider the source's evidence concerning such 
treatment on a case-by-case basis. In addition, section 1128 of the Act 
permits some medical sources to resume participating in Federal health 
care programs after a prescribed exclusion period if they successfully 
apply for reinstatement.\14\ We believe it would also be against the 
public interest for us to place an absolute bar on claimants from ever 
using evidence of treatment that occurred after termination of the 
exclusion under section 1128 when medical sources are permitted to 
resume their participation in Federal health care programs. We would 
determine whether to consider that evidence on a case-by-case basis as 
well.
---------------------------------------------------------------------------

    \14\ 42 U.S.C. 1320a-7.
---------------------------------------------------------------------------

    The fourth good cause exception aligns our rules with those of HHS 
and provides a consistent approach regarding evidence from affected 
medical sources. HHS' Office of the Inspector General (HHS OIG) may 
waive a medical source's exclusion \15\ from participating in any 
Federal health care program for three of the four mandatory exclusions 
contained in section 1128 of the Act if: (1) It receives a written 
waiver request from the program's administrator who has determined that 
the exclusion will pose a hardship to any beneficiary, and (2) the 
medical source is the sole community physician or sole source of 
essential specialized services in a community.\16\ HHS OIG may waive a 
medical source's exclusion for one of the permissive exclusions if it 
determines that imposing the exclusion would not be in the public 
interest.\17\ All waivers may be rescinded if the basis for the waiver 
ceases to exist.\18\ Because a waiver from HHS OIG permits an otherwise 
excluded medical source to participate in a Federal health care 
program, we may find good cause to consider evidence from such a 
medical source consistent with the particular terms of the waiver.
---------------------------------------------------------------------------

    \15\ 42 U.S.C. 1320a-7(c)(3)(B); 42 CFR 1001.1801.
    \16\ 42 U.S.C. 1320a-7(a), (c)(3)(B); 42 CFR 1001.1801(a). HHS 
OIG cannot waive an exclusion based on a conviction related to 
patient abuse.
    \17\ 42 U.S.C. 1320a-7(b); 42 CFR 1001.1801(c).
    \18\ 42 CFR 1001.1801(d), (e).
---------------------------------------------------------------------------

    The fifth good cause exception relies on the unique nature of 
laboratory findings about physical impairments.\19\ Laboratory findings 
about physical impairments are objective, reliable, and reproducible 
tests that require the least amount of subjective interpretation by a 
medical source. They are important to help us understand fundamental 
information about claimants' impairments and whether they are

[[Page 37559]]

entitled to benefits, such as the onset date and duration of an 
impairment(s).\20\ If we would find that a laboratory finding about a 
physical impairment in a claim is not reliable, we would not apply the 
good cause exception.
---------------------------------------------------------------------------

    \19\ Laboratory findings related to a physical impairment 
include chemical tests (such as blood tests), electrophysiological 
studies (such as electrocardiograms and electroencephalograms), 
pathology reports, and medical imaging (such as x-rays). See 20 CFR 
404.1528(c) and 416.928(c).
    \20\ See 20 CFR 404.130, 404.1509, and 416.909.
---------------------------------------------------------------------------

III. Proposed Notification Process

    Our long-term solution to the administration of BBA section 812 is 
to implement automated evidence matching within our case processing 
system(s) to identify excludable evidence. As part of our efforts to 
comply with BBA section 812's implementation deadline of November 2, 
2016, we propose to require that statutorily excluded medical sources 
inform us in writing of their BBA section 812 exclusion(s) each time 
they submit evidence to us that relates to a claim for Social Security 
disability benefits or payments.
    Regarding the content of the written statement, statutorily 
excluded medical sources would be required to include a heading that 
states,

WRITTEN STATEMENT REGARDING SECTION 223(d)(5)(C) OF THE SOCIAL 
SECURITY ACT--DO NOT REMOVE.

Immediately following this heading, sources would also need to include 
their name, title, and the applicable event(s) that triggered their 
statutory exclusion. Sources convicted of a felony under section 208 or 
1632 of the Act \21\ would also need to provide the date of their 
felony conviction. Similarly, sources imposed with a CMP, assessment, 
or both, for submitting false evidence under section 1129 of the 
Act,\22\ would need to provide the date of the final imposition of the 
CMP, assessment, or both. Sources that cannot participate in any 
Federal health care program under section 1128 of the Act \23\ would 
need to include the basis for their exclusion, its effective date and 
anticipated length, and whether HHS' OIG waived it.
    As stated above, our proposed self-reporting requirement would 
apply only to statutorily excluded medical sources. This requirement 
applies when the statutorily excluded medical source submits evidence 
to us directly or indirectly through a representative, claimant, or 
other individual or entity. We further propose to require that no 
individual or entity be permitted to remove a statutorily excluded 
medical source's written statement of exclusion prior to submitting the 
source's evidence to us. We also seek to reserve the right to request 
that statutorily excluded medical sources provide us with additional 
information or clarify any information they submit regarding their 
exclusion under section 223(d)(5)(C) of the Act.
    If statutorily excluded medical sources do not inform us of their 
excluded status, we may refer the medical source to our Office of the 
Inspector General for any action it deems appropriate, including 
investigation and CMP pursuit.

Executive Order 12866, as Supplemented by Executive Order 13563

    We consulted with the Office of Management and Budget (OMB) and 
determined that this NPRM does not meet the criteria for a significant 
regulatory action under Executive Order 12866, as supplemented by 
Executive Order 13563. Therefore, OMB has not reviewed it.

Regulatory Flexibility Act

    We certify that this NPRM would not have a significant economic 
impact on a substantial number of small entities. The only economic 
impact on small entities from this NPRM results from BBA section 812's 
requirement that we not consider evidence from statutorily excluded 
medical sources. As described above and in our Paperwork Reduction Act 
statement, below, we propose to require statutorily excluded medical 
sources to provide us with a brief self-report containing basic 
information each time they submit evidence related to a claim for 
benefits under titles II or XVI of the Act. Therefore, a regulatory 
flexibility analysis is not required under the Regulatory Flexibility 
Act, as amended.

Paperwork Reduction Act

    This proposed rule poses new public reporting burdens in the 
sections listed below. Because these requirements are not covered by an 
existing OMB-approved form, we provide burden estimates for them.

----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden     Estimated
   Regulation section     Description of public     respondents    Frequency of    per response    annual burden
                          reporting requirement     (annually)       response        (minutes)        (hours)
----------------------------------------------------------------------------------------------------------------
404.1503b(c)             Statutorily excluded                 50              60              20            1000
 416.903b(c).             medical sources must
                          inform us in writing
                          that they are excluded
                          under section
                          223(d)(5)(C) of the
                          Act, as amended, each
                          time they submit
                          evidence related to a
                          claim for benefits
                          under titles II or XVI
                          of the Act. The
                          written statement must
                          include: A heading
                          stating that it is a
                          written statement
                          regarding section
                          223(d)(5)(C) of the
                          Act; the name and
                          title of the medical
                          source; the applicable
                          excluding event(s);
                          the date of the
                          medical source's
                          felony conviction if
                          applicable; the date
                          of the imposition of a
                          civil monetary penalty
                          or assessment, or
                          both, for the
                          submission of false
                          evidence if
                          applicable; the basis,
                          effective date,
                          anticipated length of
                          the exclusion, and
                          whether the Office of
                          Inspector General of
                          the Department of
                          Health and Human
                          Services waived the
                          exclusion.
                                                 ---------------------------------------------------------------
    Total..............  .......................              50  ..............  ..............            1000
----------------------------------------------------------------------------------------------------------------

    We submitted an Information Collection Request for clearance to 
OMB. We are soliciting comments on the burden estimate; the need for 
the information; its practical utility; ways to enhance its quality, 
utility, and clarity;

[[Page 37560]]

and ways to minimize the burden on respondents, including the use of 
automated techniques or other forms of information technology. If you 
would like to submit comments, please send them to the following 
locations:

Office of Management and Budget, Attn: Desk Officer for SSA, Fax 
Number: 202-395-6974, Email address: OIRA_Submission@omb.eop.gov
Social Security Administration, Attn: Reports Clearance Officer, 1333 
Annex, 6401 Security Blvd., Baltimore, MD 21235-0001, Fax Number: 410-
965-6400, Email: OR.Reports.Clearance@ssa.gov

    You can submit comments until August 9, 2016, which is 60 days 
after the publication of this notice. However, your comments will be 
most useful if you send them to SSA by July 11, 2016, which is 30 days 
after publication. To receive a copy of the OMB clearance package, 
contact our Reports Clearance Officer using any of the above contact 
methods. We prefer to receive comments by email or fax.

(Catalog of Federal Domestic Assistance Program Nos. 96.001, Social 
Security--Disability Insurance; 96.002, Social Security--Retirement 
Insurance; and 96.004, Social Security--Survivors Insurance)

List of Subjects

20 CFR Part 404

    Administrative practice and procedure, Blind, Disability benefits, 
Old-Age, Survivors, and Disability Insurance, Reporting and 
recordkeeping requirements, Social Security.

20 CFR Part 416

    Administrative practice and procedure, Reporting and recordkeeping 
requirements, Supplemental Security Income (SSI).

    Dated: May 27, 2016.
Carolyn W. Colvin,
Acting Commissioner of Social Security.

    For the reasons set out in the preamble, we propose to amend 20 CFR 
part 404 subpart P and part 416 subpart I as set forth below:

PART 404--FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE 
(1950- )

Subpart P--Determining Disability and Blindness

0
1. The authority citation for subpart P of part 404 continues to read 
as follows:

    Authority:  Secs. 202, 205(a)-(b) and (d)-(h), 216(i), 221(a), 
(i), and (j), 222(c), 223, 225, and 702(a)(5) of the Social Security 
Act (42 U.S.C. 402, 405(a)-(b) and (d)-(h), 416(i), 421(a), (i), and 
(j), 422(c), 423, 425, and 902(a)(5)); sec. 211(b), Pub. L. 104-193, 
110 Stat. 2105, 2189; sec. 202, Pub. L. 108-203, 118 Stat. 509 (42 
U.S.C. 902 note).

0
2. Add Sec.  404.1503b to read as follows:


Sec.  404.1503b  Evidence from statutorily excluded medical sources.

    (a) General. We will not consider evidence from the following 
medical sources statutorily excluded under section 223(d)(5)(C) of the 
Social Security Act (Act), as amended, unless we find good cause under 
paragraph (b) of this section:
    (1) Any medical source that has been convicted of a felony under 
section 208 or under section 1632 of the Act;
    (2) Any medical source that has been excluded from participation in 
any Federal health care program under section 1128 of the Act; or
    (3) Any medical source that has received a final decision imposing 
a civil monetary penalty or assessment, or both, for submitting false 
evidence under section 1129 of the Act.
    (b) Good cause. We may find good cause to consider evidence from a 
statutorily excluded medical source under section 223(d)(5)(C) of the 
Act, as amended, if:
    (1) The evidence from the medical source consists of evidence of 
treatment that occurred before the date the source was convicted of a 
felony under section 208 or under section 1632 of the Act;
    (2) The evidence from the medical source consists of evidence of 
treatment that occurred during a period in which the source was not 
excluded from participation in any Federal health care program under 
section 1128 of the Act;
    (3) The evidence from the medical source consists of evidence of 
treatment that occurred before the date the source received a final 
decision imposing a civil monetary penalty or assessment, or both, for 
submitting false evidence under section 1129 of the Act;
    (4) The sole basis for the medical source's exclusion under section 
223(d)(5)(C) of the Act, as amended, is that the source cannot 
participate in any Federal health care program under section 1128 of 
the Act, but the Office of Inspector General of the Department of 
Health and Human Services granted a waiver of the section 1128 
exclusion; or
    (5) The evidence is a laboratory finding about a physical 
impairment and there is no indication that the finding is unreliable.
    (c) Statutorily excluded medical sources' reporting requirements. 
Statutorily excluded medical sources (as described in paragraph (a) of 
this section) must inform us in writing that they are excluded under 
section 223(d)(5)(C) of the Act, as amended, each time they submit 
evidence related to a claim for benefits under titles II or XVI of the 
Act. This reporting requirement applies to evidence that statutorily 
excluded medical sources submit to us either directly or through a 
representative, claimant, or other individual or entity.
    (1) Statutorily excluded medical sources must provide a written 
statement, which contains the following information:
    (i) A heading stating: ``WRITTEN STATEMENT REGARDING SECTION 
223(d)(5)(C) OF THE SOCIAL SECURITY ACT--DO NOT REMOVE''
    (ii) The name and title of the medical source;
    (iii) The applicable excluding event(s) stated in paragraphs 
(a)(1)-(a)(3) of this section;
    (iv) The date of the medical source's felony conviction under 
sections 208 or 1632 of the Act, if applicable;
    (v) The date of the imposition of a civil monetary penalty or 
assessment, or both, for the submission of false evidence, under 
section 1129 of the Act, if applicable; and
    (vi) The basis, effective date, anticipated length of the 
exclusion, and whether the Office of the Inspector General of the 
Department of Health and Human Services waived the exclusion, if the 
excluding event was the medical source's exclusion from participation 
in any Federal health care program under section 1128 of the Act.
    (2) The written statement provided by an excluded medical source 
may not be removed by any individual or entity prior to submitting 
evidence to us.
    (3) We may request that the excluded medical source provide us with 
additional information or clarify any information submitted that bears 
on the medical source's exclusion(s) under section 223(d)(5)(C) of the 
Act, as amended.

PART 416--SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND 
DISABLED

Subpart I--Determining Disability and Blindness

0
3. The authority citation for subpart I of part 416 continues to read 
as follows:

    Authority:  Secs. 221(m), 702(a)(5), 1611, 1614, 1619, 1631(a), 
(c), (d)(1), and (p), and 1633 of the Social Security Act (42 U.S.C. 
421(m), 902(a)(5), 1382, 1382c, 1382h, 1383(a), (c), (d)(1), and 
(p), and 1383(b); secs. 4(c) and 5, 6(c)-(e), 14(a), and 15, Pub. L. 
98-460, 98 Stat. 1794, 1801, 1802, and 1808 (42 U.S.C. 421 note, 423 
note, and 1382h note).

0
4. Add Sec.  416.903b to read as follows:

[[Page 37561]]

Sec.  416.903b  Evidence from statutorily excluded medical sources.

    (a) General. We will not consider evidence from the following 
medical sources statutorily excluded under section 223(d)(5)(C) of the 
Social Security Act (Act), as amended, unless we find good cause under 
paragraph (b) of this section:
    (1) Any medical source that has been convicted of a felony under 
section 208 or under section 1632 of the Act;
    (2) Any medical source that has been excluded from participation in 
any Federal health care program under section 1128 of the Act; or
    (3) Any medical source that has received a final decision imposing 
a civil monetary penalty or assessment, or both, for submitting false 
evidence under section 1129 of the Act.
    (b) Good cause. We may find good cause to consider evidence from a 
statutorily excluded medical source under section 223(d)(5)(C) of the 
Act, as amended, if:
    (1) The evidence from the medical source consists of evidence of 
treatment that occurred before the date the source was convicted of a 
felony under section 208 or under section 1632 of the Act;
    (2) The evidence from the medical source consists of evidence of 
treatment that occurred during a period in which the source was not 
excluded from participation in any Federal health care program under 
section 1128 of the Act;
    (3) The evidence from the medical source consists of evidence of 
treatment that occurred before the date the source received a final 
decision imposing a civil monetary penalty or assessment, or both, for 
submitting false evidence under section 1129 of the Act;
    (4) The sole basis for the medical source's exclusion under section 
223(d)(5)(C) of the Act, as amended, is that the source cannot 
participate in any Federal health care program under section 1128 of 
the Act, but the Office of Inspector General of the Department of 
Health and Human Services granted a waiver of the section 1128 
exclusion; or
    (5) The evidence is a laboratory finding about a physical 
impairment and there is no indication that the finding is unreliable.
    (c) Statutorily excluded medical sources' reporting requirements. 
Statutorily excluded medical sources (as described in paragraph (a) of 
this section) must inform us in writing that they are excluded under 
section 223(d)(5)(C) of the Act, as amended, each time they submit 
evidence related to a claim for benefits under titles II or XVI of the 
Act. This reporting requirement applies to evidence that statutorily 
excluded medical sources submit to us either directly or through a 
representative, claimant, or other individual or entity.
    (1) Statutorily excluded medical sources must provide a written 
statement, which contains the following information:
    (i) A heading stating: ``WRITTEN STATEMENT REGARDING SECTION 
223(d)(5)(C) OF THE SOCIAL SECURITY ACT--DO NOT REMOVE''
    (ii) The name and title of the medical source;
    (iii) The applicable excluding event(s) stated in paragraphs 
(a)(1)-(a)(3) of this section;
    (iv) The date of the medical source's felony conviction under 
sections 208 or 1632 of the Act, if applicable;
    (v) The date of the imposition of a civil monetary penalty or 
assessment, or both, for the submission of false evidence, under 
section 1129 of the Act, if applicable; and
    (vi) The basis, effective date, anticipated length of the 
exclusion, and whether the Office of the Inspector General of the 
Department of Health and Human Services waived the exclusion, if the 
excluding event was the medical source's exclusion from participation 
in any Federal health care program under section 1128 of the Act.
    (2) The written statement provided by an excluded medical source 
may not be removed by any individual or entity prior to submitting 
evidence to us.
    (3) We may request that the excluded medical source provide us with 
additional information or clarify any information submitted that bears 
on the medical source's exclusion(s) under section 223(d)(5)(C) of the 
Act, as amended.

[FR Doc. 2016-13744 Filed 6-9-16; 8:45 am]
 BILLING CODE 4191-02-P

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