81_FR_37669 81 FR 37557 - Evidence From Statutorily Excluded Medical Sources

81 FR 37557 - Evidence From Statutorily Excluded Medical Sources

SOCIAL SECURITY ADMINISTRATION

Federal Register Volume 81, Issue 112 (June 10, 2016)

Page Range37557-37561
FR Document2016-13744

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).

Federal Register, Volume 81 Issue 112 (Friday, June 10, 2016)
[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Proposed Rules]
[Pages 37557-37561]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-13744]


========================================================================
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.

========================================================================


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 http://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\
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    \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).
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    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\
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    \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.
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    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\
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    \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.
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     a medical source excluded from participating in any 
Federal health care program under section 1128 of the Act,\6\ or
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    \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.
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     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\
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    \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 
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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\
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    \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.
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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.
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    \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.
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    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.
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    \14\ 42 U.S.C. 1320a-7.
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    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.
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    \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).
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    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.
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    \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.
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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)
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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: [email protected]
Social Security Administration, Attn: Reports Clearance Officer, 1333 
Annex, 6401 Security Blvd., Baltimore, MD 21235-0001, Fax Number: 410-
965-6400, Email: [email protected]

    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



                                                                                                                                                                                                                 37557

                                                      Proposed Rules                                                                                                  Federal Register
                                                                                                                                                                      Vol. 81, No. 112

                                                                                                                                                                      Friday, June 10, 2016



                                                      This section of the FEDERAL REGISTER                    Security numbers or medical                             make a disability determination or
                                                      contains notices to the public of the proposed          information.                                            decision, or when we conduct a
                                                      issuance of rules and regulations. The                     1. Internet: We strongly recommend                   continuing disability review (CDR),
                                                      purpose of these notices is to give interested          that you submit your comments via the                   under titles II or XVI of the Act, we
                                                      persons an opportunity to participate in the            Internet. Please visit the Federal                      cannot consider evidence furnished by
                                                      rule making prior to the adoption of the final
                                                      rules.
                                                                                                              eRulemaking portal at http://                           certain sources, unless we have good
                                                                                                              www.regulations.gov. Use the ‘‘Search’’                 cause.4
                                                                                                              function to find docket number SSA–                        Specifically, we may not consider
                                                      SOCIAL SECURITY ADMINISTRATION                          2016–0015. The system will issue a                      evidence from the following medical
                                                                                                              tracking number to confirm your                         sources:
                                                      20 CFR Parts 404 and 416                                submission. You will not be able to                        • A medical source convicted of a
                                                                                                              view your comment immediately                           felony under sections 208 or 1632 of the
                                                      [Docket No. SSA–2016–0015]                              because we must post each comment                       Act,5
                                                                                                              manually. It may take up to a week for
                                                      RIN 0960–AH92                                                                                                      • a medical source excluded from
                                                                                                              your comment to be viewable.
                                                                                                                                                                      participating in any Federal health care
                                                      Evidence From Statutorily Excluded                         2. Fax: Fax comments to (410) 966–
                                                                                                                                                                      program under section 1128 of the Act,6
                                                      Medical Sources                                         2830.
                                                                                                                                                                      or
                                                                                                                 3. Mail: Mail your comments to the
                                                      AGENCY: Social Security Administration.                 Office of Regulations and Reports                          • a medical source imposed with a
                                                            Notice of proposed rulemaking
                                                      ACTION:                                                 Clearance, Social Security                              civil monetary penalty (CMP),
                                                      (NPRM).                                                 Administration, 3100 West High Rise
                                                                                                                                                                         4 Public Law 114–74, sec. 812, 129 Stat. 584, 602.
                                                                                                              Building, 6401 Security Boulevard,
                                                      SUMMARY:    In accordance with section                  Baltimore, Maryland 21235–6401.                         Excluding evidence under BBA section 812 does
                                                      812 of the Bipartisan Budget Act of 2015                                                                        not constitute an exclusion of a medical source
                                                                                                                 Comments and background                              from Social Security programs under section 1136
                                                      (BBA section 812), we propose to revise                 documents are available for public                      of the Act, 42 U.S.C. 1320b–6.
                                                      our rules to explain how we would                       viewing on the Federal eRulemaking                         5 42 U.S.C. 408 and 1383a. These sections make
                                                      address evidence furnished by medical                   portal at www.regulations.gov or in                     it a felony to give false statements or omit
                                                      sources that meet one of BBA section                    person, during regular business hours,
                                                                                                                                                                      information to cause an improper payment, convert
                                                      812’s exclusionary categories                                                                                   a payment intended for someone else, provide us
                                                                                                              by arranging with the contact person                    with false information we need for our records
                                                      (statutorily excluded medical sources).                 identified below.                                       concerning the individual’s true identity, or misuse
                                                      Under this proposed rule, we would not                                                                          a Social Security card or number for the purpose
                                                                                                              FOR FURTHER INFORMATION CONTACT: Dan
                                                      consider evidence furnished by a                                                                                of obtaining or causing an increase in benefits to
                                                      statutorily excluded medical source                     O’Brien, Office of Disability Policy,                   which the individual is not entitled or eligible.
                                                      unless we find good cause to do so. We                  Social Security Administration, 6401                       6 42 U.S.C. 1320a–7. This section identifies four

                                                                                                              Security Boulevard, Baltimore,                          mandatory and 16 permissive bases for excluding
                                                      propose several circumstances in which                                                                          a provider from participating in all Federal health
                                                      we would find good cause, and we also                   Maryland 21235–6401, (410) 597–1632.                    care programs (as defined in section 1128B(f) of the
                                                      propose to require statutorily excluded                 For information on eligibility or filing                Act). The four mandatory exclusions from
                                                      medical sources to notify us of their                   for benefits, call our national toll-free               participating in Federal health care programs are:
                                                                                                              number, 1–800–772–1213, or TTY 1–                       (1) Conviction of program-related crimes, (2)
                                                      excluded status when they furnish                                                                               conviction relating to patient abuse, (3) felony
                                                      evidence to us. These rules would allow                 800–325–0778, or visit our Internet site,               conviction relating to health care fraud, and (4)
                                                      us to fulfill obligations that we have                  Social Security Online, at                              felony conviction relating to controlled substance.
                                                      under the Bipartisan Budget Act of 2015                 www.socialsecurity.gov.                                 The 16 permissive exclusions from participating in
                                                                                                                                                                      Federal health care programs are: (1) Conviction
                                                      (BBA).                                                  SUPPLEMENTARY INFORMATION:                              relating to fraud, (2) conviction relating to
                                                      DATES: To ensure that we consider your                                                                          obstruction of an investigation or audit, (3)
                                                                                                              I. How BBA Section 812 Affects How                      misdemeanor conviction relating to controlled
                                                      comments, we must receive them by no                    We Consider Evidence                                    substance, (4) license revocation or suspension, (5)
                                                      later than August 9, 2016.                                                                                      exclusion or suspension under federal or state
                                                                                                                 We consider all evidence we receive                  health care program, (6) claims for excessive
                                                      ADDRESSES: You may submit comments
                                                                                                              when we determine whether an                            charges or unnecessary services and failure of
                                                      by any one of three methods—Internet,
                                                                                                              individual is blind or disabled under                   certain organizations to furnish medically necessary
                                                      fax, or mail. Do not submit the same                                                                            services, (7) fraud, kickbacks, and other prohibited
                                                                                                              the Social Security Act (Act).1 We
                                                      comments multiple times or by more                                                                              activities, (8) entities controlled by a sanctioned
                                                                                                              define evidence as anything you or                      individual, (9) failure to disclose required
                                                      than one method. Regardless of which
                                                                                                              anyone else submits to us, or that we                   information, (10) failure to supply requested
                                                      method you choose, please state that
                                                                                                              obtain, that relates to your claim.2                    information on subcontractors and suppliers, (11)
                                                      your comments refer to Docket No.
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                                                                                                                 The BBA was enacted on November 2,                   failure to supply payment information, (12) failure
                                                      SSA–2016–0015 so that we may                                                                                    to grant immediate access, (13) failure to take
                                                                                                              2015.3 BBA section 812 amended                          corrective action, (14) default on health education
                                                      associate your comments with the
                                                                                                              section 223(d)(5) of the Act, 42 U.S.C.                 loan or scholarship obligations, (15) individuals
                                                      correct regulation.
                                                                                                              423(d)(5), by adding a new paragraph                    controlling a sanctioned entity, and (16) making
                                                         Caution: You should be careful to                                                                            false statements or misrepresentation of a material
                                                                                                              ‘‘C.’’ Under this provision, when we
                                                      include in your comments only                                                                                   fact. The Department of Health and Human
                                                      information that you wish to make                                                                               Services’ Office of Inspector General (HHS OIG),
                                                                                                                1 42 U.S.C. 416(i), 42 U.S.C. 423(d), and 42 U.S.C.
                                                                                                                                                                      which administers section 1128 of the Act, may
                                                      publicly available. We strongly urge you                1382c(a).                                               grant a waiver for all but one of these bases. A
                                                      not to include in your comments any                       2 20 CFR 404.1512(b) and 416.912(b).
                                                                                                                                                                      mandatory exclusion for a conviction related to
                                                      personal information, such as Social                      3 Pub. L. 114–74, 129 Stat. 584.                      patient abuse may not be waived.



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                                                      37558                      Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Proposed Rules

                                                      assessment, or both, for submitting false               Services granted a waiver of the section               permits some medical sources to resume
                                                      evidence under section 1129 of the Act.7                1128 exclusion; or                                     participating in Federal health care
                                                      We refer to the individuals and entities                   • The evidence is a laboratory finding              programs after a prescribed exclusion
                                                      that fall into one or more of these                     about a physical impairment and there                  period if they successfully apply for
                                                      exclusionary categories as statutorily                  is no indication that the finding is                   reinstatement.14 We believe it would
                                                      excluded medical sources.                               unreliable.                                            also be against the public interest for us
                                                         Our Inspector General or the Secretary               We may find good cause to consider                     to place an absolute bar on claimants
                                                      of Health and Human Services (HHS)                      evidence from an excluded medical                      from ever using evidence of treatment
                                                      will inform us about these statutorily                  source in any of these five enumerated                 that occurred after termination of the
                                                      excluded medical sources at such times                  situations when we make a disability                   exclusion under section 1128 when
                                                      and to the extent necessary for the                     determination or decision or when we                   medical sources are permitted to resume
                                                                                                              conduct a CDR.                                         their participation in Federal health care
                                                      effective implementation of this
                                                                                                                 The first three good cause exceptions               programs. We would determine whether
                                                      requirement.8 BBA section 812 requires
                                                                                                              relate to evidence that pertains to                    to consider that evidence on a case-by-
                                                      us to issue regulations to carry out the
                                                                                                              periods prior to the event that would                  case basis as well.
                                                      amendments to the Act by November 2,                                                                              The fourth good cause exception
                                                      2016.9 BBA section 812 is effective on                  trigger exclusion under BBA section
                                                                                                              812, or relate to a period during which                aligns our rules with those of HHS and
                                                      or after the effective date of the                                                                             provides a consistent approach
                                                      regulations, or by November 2, 2016,                    the medical source was not excluded
                                                                                                              from participating in any Federal health               regarding evidence from affected
                                                      whichever is earlier.10                                                                                        medical sources. HHS’ Office of the
                                                                                                              care program. We believe that it would
                                                      II. Proposed Revisions to Our Rules                     be consistent with the purpose of BBA                  Inspector General (HHS OIG) may waive
                                                                                                              section 812 to find good cause to                      a medical source’s exclusion 15 from
                                                         We propose to implement BBA
                                                                                                              consider evidence furnished by a                       participating in any Federal health care
                                                      section 812 by adding new 20 CFR
                                                                                                              medical source of treatment that                       program for three of the four mandatory
                                                      404.1503b and 416.903b to state that we
                                                                                                              occurred: (1) Before the source is                     exclusions contained in section 1128 of
                                                      will not consider evidence from a
                                                                                                              convicted of a felony under section 208                the Act if: (1) It receives a written
                                                      statutorily excluded medical source                                                                            waiver request from the program’s
                                                      under section 223(d)(5)(C) of the Act,                  or 1632 of the Act,11 (2) outside of the
                                                                                                              period the source cannot participate in                administrator who has determined that
                                                      unless we find good cause. Under our                                                                           the exclusion will pose a hardship to
                                                      proposed rules, we may find good cause                  Federal health care programs under
                                                                                                              section 1128 of the Act,12 or (3) before               any beneficiary, and (2) the medical
                                                      to consider evidence from an excluded                                                                          source is the sole community physician
                                                      medical source in the following five                    the source is issued a final decision
                                                                                                              imposing a CMP, assessment, or both,                   or sole source of essential specialized
                                                      situations:                                                                                                    services in a community.16 HHS OIG
                                                         • The evidence from the medical                      for submitting false evidence under
                                                                                                              section 1129 of the Act.13 We propose                  may waive a medical source’s exclusion
                                                      source consists of evidence of treatment                                                                       for one of the permissive exclusions if
                                                      that occurred before the date the source                these good cause exceptions in order to
                                                                                                              protect the public interest. In our view,              it determines that imposing the
                                                      was convicted of a felony under section                                                                        exclusion would not be in the public
                                                      208 or under section 1632 of the Act;                   an undue hardship would be placed on
                                                                                                              our claimants, and the purposes of BBA                 interest.17 All waivers may be rescinded
                                                         • The evidence from the medical                                                                             if the basis for the waiver ceases to
                                                      source consists of evidence of treatment                section 812 would not be served, unless
                                                                                                              we include these exceptions. In this                   exist.18 Because a waiver from HHS OIG
                                                      that occurred during a period in which                                                                         permits an otherwise excluded medical
                                                      the source was not excluded from                        situation, there is little risk that the
                                                                                                              evidence would be tainted by the                       source to participate in a Federal health
                                                      participation in any Federal health care                                                                       care program, we may find good cause
                                                      program under section 1128 of the Act;                  activity for which the source has been
                                                                                                              sanctioned or convicted, but a greater                 to consider evidence from such a
                                                         • The evidence from the medical                                                                             medical source consistent with the
                                                      source consists of evidence of treatment                risk that we could make an incorrect
                                                                                                              determination or decision by excluding                 particular terms of the waiver.
                                                      that occurred before the date the source                                                                          The fifth good cause exception relies
                                                      received a final decision imposing a                    probative evidence.
                                                                                                                 Specifically, it would be against the               on the unique nature of laboratory
                                                      CMP, assessment, or both, for                                                                                  findings about physical impairments.19
                                                                                                              public interest if we barred claimants
                                                      submitting false evidence under section                                                                        Laboratory findings about physical
                                                                                                              from ever using evidence furnished by
                                                      1129 of the Act;                                                                                               impairments are objective, reliable, and
                                                                                                              statutorily excluded medical sources
                                                         • The sole basis for the medical                                                                            reproducible tests that require the least
                                                                                                              concerning treatment that occurred
                                                      source’s exclusion under section                                                                               amount of subjective interpretation by a
                                                                                                              prior to the period those sources qualify
                                                      223(d)(5)(C) of the Act is that the source              for a BBA section 812 exclusion. For                   medical source. They are important to
                                                      cannot participate in any Federal health                example, there may be instances where                  help us understand fundamental
                                                      care program under section 1128 of the                  a statutorily excluded medical source                  information about claimants’
                                                      Act, but the Office of Inspector General                provided treatment to a claimant prior                 impairments and whether they are
                                                      of the Department of Health and Human                   to the period the source qualified for a
                                                                                                                                                                       14 42  U.S.C. 1320a–7.
                                                        7 42
                                                                                                              BBA section 812 exclusion or performed
                                                              U.S.C. 1320a–8. This section permits the                                                                 15 42  U.S.C. 1320a–7(c)(3)(B); 42 CFR 1001.1801.
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                                                      imposition of a CMP or assessment (or both) for
                                                                                                              the acts that led to the exclusion. In                   16 42 U.S.C. 1320a–7(a), (c)(3)(B); 42 CFR
                                                      certain offenses. One such offense is making a false    those instances, and others, we would                  1001.1801(a). HHS OIG cannot waive an exclusion
                                                      statement or representation of a material fact for us   determine whether to consider the                      based on a conviction related to patient abuse.
                                                      to use in determining an initial or continuing right    source’s evidence concerning such                        17 42 U.S.C. 1320a–7(b); 42 CFR 1001.1801(c).
                                                      to Social Security disability benefits.
                                                         8 Section 812(a) of Public Law 114–74, 129 Stat.
                                                                                                              treatment on a case-by-case basis. In                    18 42 CFR 1001.1801(d), (e).
                                                                                                                                                                       19 Laboratory findings related to a physical
                                                      at 602.                                                 addition, section 1128 of the Act
                                                                                                                                                                     impairment include chemical tests (such as blood
                                                         9 Section 812(b) of Public Law 114–74, 129 Stat.
                                                                                                                                                                     tests), electrophysiological studies (such as
                                                                                                                11 42 U.S.C. 408 and 42 U.S.C. 1383a.
                                                      at 602.                                                                                                        electrocardiograms and electroencephalograms),
                                                         10 Section 812(c) of Public Law 114–74, 129 Stat.      12 42 U.S.C. 1320a–7.                                pathology reports, and medical imaging (such as x-
                                                      at 602.                                                   13 42 U.S.C. 1320a–8.                                rays). See 20 CFR 404.1528(c) and 416.928(c).



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                                                                                     Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Proposed Rules                                                                                       37559

                                                      entitled to benefits, such as the onset                                 under section 1129 of the Act,22 would                             Executive Order 12866, as
                                                      date and duration of an impairment(s).20                                need to provide the date of the final                              Supplemented by Executive Order
                                                      If we would find that a laboratory                                      imposition of the CMP, assessment, or                              13563
                                                      finding about a physical impairment in                                  both. Sources that cannot participate in                             We consulted with the Office of
                                                      a claim is not reliable, we would not                                   any Federal health care program under                              Management and Budget (OMB) and
                                                      apply the good cause exception.                                         section 1128 of the Act 23 would need to                           determined that this NPRM does not
                                                      III. Proposed Notification Process                                      include the basis for their exclusion, its                         meet the criteria for a significant
                                                                                                                              effective date and anticipated length,                             regulatory action under Executive Order
                                                         Our long-term solution to the
                                                                                                                              and whether HHS’ OIG waived it.                                    12866, as supplemented by Executive
                                                      administration of BBA section 812 is to
                                                      implement automated evidence                                               As stated above, our proposed self-                             Order 13563. Therefore, OMB has not
                                                      matching within our case processing                                     reporting requirement would apply only                             reviewed it.
                                                      system(s) to identify excludable                                        to statutorily excluded medical sources.                           Regulatory Flexibility Act
                                                      evidence. As part of our efforts to                                     This requirement applies when the
                                                                                                                                                                                                    We certify that this NPRM would not
                                                      comply with BBA section 812’s                                           statutorily excluded medical source
                                                                                                                                                                                                 have a significant economic impact on
                                                      implementation deadline of November                                     submits evidence to us directly or
                                                                                                                                                                                                 a substantial number of small entities.
                                                      2, 2016, we propose to require that                                     indirectly through a representative,
                                                                                                                                                                                                 The only economic impact on small
                                                      statutorily excluded medical sources                                    claimant, or other individual or entity.                           entities from this NPRM results from
                                                      inform us in writing of their BBA                                       We further propose to require that no                              BBA section 812’s requirement that we
                                                      section 812 exclusion(s) each time they                                 individual or entity be permitted to                               not consider evidence from statutorily
                                                      submit evidence to us that relates to a                                 remove a statutorily excluded medical                              excluded medical sources. As described
                                                      claim for Social Security disability                                    source’s written statement of exclusion                            above and in our Paperwork Reduction
                                                      benefits or payments.                                                   prior to submitting the source’s                                   Act statement, below, we propose to
                                                         Regarding the content of the written                                 evidence to us. We also seek to reserve                            require statutorily excluded medical
                                                      statement, statutorily excluded medical                                 the right to request that statutorily                              sources to provide us with a brief self-
                                                      sources would be required to include a                                  excluded medical sources provide us                                report containing basic information each
                                                      heading that states,
                                                                                                                              with additional information or clarify                             time they submit evidence related to a
                                                      WRITTEN STATEMENT REGARDING                                             any information they submit regarding                              claim for benefits under titles II or XVI
                                                      SECTION 223(d)(5)(C) OF THE SOCIAL                                      their exclusion under section                                      of the Act. Therefore, a regulatory
                                                      SECURITY ACT—DO NOT REMOVE.
                                                                                                                              223(d)(5)(C) of the Act.                                           flexibility analysis is not required under
                                                      Immediately following this heading,                                        If statutorily excluded medical                                 the Regulatory Flexibility Act, as
                                                      sources would also need to include their                                                                                                   amended.
                                                                                                                              sources do not inform us of their
                                                      name, title, and the applicable event(s)
                                                                                                                              excluded status, we may refer the                                  Paperwork Reduction Act
                                                      that triggered their statutory exclusion.
                                                      Sources convicted of a felony under                                     medical source to our Office of the                                  This proposed rule poses new public
                                                      section 208 or 1632 of the Act 21 would                                 Inspector General for any action it                                reporting burdens in the sections listed
                                                      also need to provide the date of their                                  deems appropriate, including                                       below. Because these requirements are
                                                      felony conviction. Similarly, sources                                   investigation and CMP pursuit.                                     not covered by an existing OMB-
                                                      imposed with a CMP, assessment, or                                                                                                         approved form, we provide burden
                                                      both, for submitting false evidence                                                                                                        estimates for them.

                                                                                                                                                                                                                             Average
                                                                                                                                                                              Number of                                                              Estimated
                                                          Regulation                                                                                                                          Frequency of                 burden per
                                                                                          Description of public reporting requirement                                        respondents                                                           annual burden
                                                           section                                                                                                                              response                    response
                                                                                                                                                                              (annually)                                                              (hours)
                                                                                                                                                                                                                            (minutes)

                                                      404.1503b(c)             Statutorily excluded medical sources must inform us in                                                   50                       60                         20             1000
                                                        416.903b(c).             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 state-
                                                                                 ment 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 imposi-
                                                                                 tion of a civil monetary penalty or assessment, or
                                                                                 both, for the submission of false evidence if applica-
                                                                                 ble; the basis, effective date, anticipated length of the
                                                                                 exclusion, and whether the Office of Inspector Gen-
                                                                                 eral of the Department of Health and Human Services
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                                                                                 waived the exclusion.

                                                           Total ...........   ...........................................................................................              50   ........................   ........................           1000



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

                                                        20 See   20 CFR 404.130, 404.1509, and 416.909.



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                                                      37560                     Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Proposed Rules

                                                      and ways to minimize the burden on                      902(a)(5)); sec. 211(b), Pub. L. 104–193, 110          223(d)(5)(C) of the Act, as amended,
                                                      respondents, including the use of                       Stat. 2105, 2189; sec. 202, Pub. L. 108–203,           each time they submit evidence related
                                                      automated techniques or other forms of                  118 Stat. 509 (42 U.S.C. 902 note).                    to a claim for benefits under titles II or
                                                      information technology. If you would                    ■   2. Add § 404.1503b to read as follows:             XVI of the Act. This reporting
                                                      like to submit comments, please send                                                                           requirement applies to evidence that
                                                      them to the following locations:                        § 404.1503b Evidence from statutorily                  statutorily excluded medical sources
                                                                                                              excluded medical sources.
                                                      Office of Management and Budget, Attn:                                                                         submit to us either directly or through
                                                         Desk Officer for SSA, Fax Number:                       (a) General. We will not consider                   a representative, claimant, or other
                                                         202–395–6974, Email address: OIRA_                   evidence from the following medical                    individual or entity.
                                                         Submission@omb.eop.gov                               sources statutorily excluded under                        (1) Statutorily excluded medical
                                                      Social Security Administration, Attn:                   section 223(d)(5)(C) of the Social                     sources must provide a written
                                                         Reports Clearance Officer, 1333                      Security Act (Act), as amended, unless                 statement, which contains the following
                                                         Annex, 6401 Security Blvd.,                          we find good cause under paragraph (b)                 information:
                                                         Baltimore, MD 21235–0001, Fax                        of this section:                                          (i) A heading stating: ‘‘WRITTEN
                                                         Number: 410–965–6400, Email:                            (1) Any medical source that has been                STATEMENT REGARDING SECTION
                                                         OR.Reports.Clearance@ssa.gov                         convicted of a felony under section 208                223(d)(5)(C) OF THE SOCIAL
                                                                                                              or under section 1632 of the Act;                      SECURITY ACT—DO NOT REMOVE’’
                                                         You can submit comments until                           (2) Any medical source that has been
                                                      August 9, 2016, which is 60 days after                                                                            (ii) The name and title of the medical
                                                                                                              excluded from participation in any                     source;
                                                      the publication of this notice. However,                Federal health care program under
                                                      your comments will be most useful if                                                                              (iii) The applicable excluding event(s)
                                                                                                              section 1128 of the Act; or                            stated in paragraphs (a)(1)–(a)(3) of this
                                                      you send them to SSA by July 11, 2016,                     (3) Any medical source that has
                                                      which is 30 days after publication. To                                                                         section;
                                                                                                              received a final decision imposing a                      (iv) The date of the medical source’s
                                                      receive a copy of the OMB clearance                     civil monetary penalty or assessment, or
                                                      package, contact our Reports Clearance                                                                         felony conviction under sections 208 or
                                                                                                              both, for submitting false evidence                    1632 of the Act, if applicable;
                                                      Officer using any of the above contact                  under section 1129 of the Act.
                                                      methods. We prefer to receive                                                                                     (v) The date of the imposition of a
                                                                                                                 (b) Good cause. We may find good
                                                      comments by email or fax.                                                                                      civil monetary penalty or assessment, or
                                                                                                              cause to consider evidence from a
                                                      (Catalog of Federal Domestic Assistance                                                                        both, for the submission of false
                                                                                                              statutorily excluded medical source
                                                      Program Nos. 96.001, Social Security—                                                                          evidence, under section 1129 of the Act,
                                                                                                              under section 223(d)(5)(C) of the Act, as
                                                      Disability Insurance; 96.002, Social                                                                           if applicable; and
                                                                                                              amended, if:
                                                      Security—Retirement Insurance; and 96.004,                                                                        (vi) The basis, effective date,
                                                                                                                 (1) The evidence from the medical
                                                      Social Security—Survivors Insurance)                                                                           anticipated length of the exclusion, and
                                                                                                              source consists of evidence of treatment
                                                                                                                                                                     whether the Office of the Inspector
                                                      List of Subjects                                        that occurred before the date the source
                                                                                                                                                                     General of the Department of Health and
                                                                                                              was convicted of a felony under section
                                                      20 CFR Part 404                                                                                                Human Services waived the exclusion,
                                                                                                              208 or under section 1632 of the Act;
                                                        Administrative practice and                              (2) The evidence from the medical                   if the excluding event was the medical
                                                      procedure, Blind, Disability benefits,                  source consists of evidence of treatment               source’s exclusion from participation in
                                                      Old-Age, Survivors, and Disability                      that occurred during a period in which                 any Federal health care program under
                                                      Insurance, Reporting and recordkeeping                  the source was not excluded from                       section 1128 of the Act.
                                                      requirements, Social Security.                          participation in any Federal health care                  (2) The written statement provided by
                                                                                                              program under section 1128 of the Act;                 an excluded medical source may not be
                                                      20 CFR Part 416                                                                                                removed by any individual or entity
                                                                                                                 (3) The evidence from the medical
                                                        Administrative practice and                           source consists of evidence of treatment               prior to submitting evidence to us.
                                                      procedure, Reporting and recordkeeping                  that occurred before the date the source                  (3) We may request that the excluded
                                                      requirements, Supplemental Security                     received a final decision imposing a                   medical source provide us with
                                                      Income (SSI).                                           civil monetary penalty or assessment, or               additional information or clarify any
                                                                                                              both, for submitting false evidence                    information submitted that bears on the
                                                        Dated: May 27, 2016.
                                                                                                              under section 1129 of the Act;                         medical source’s exclusion(s) under
                                                      Carolyn W. Colvin,
                                                                                                                 (4) The sole basis for the medical                  section 223(d)(5)(C) of the Act, as
                                                      Acting Commissioner of Social Security.                                                                        amended.
                                                                                                              source’s exclusion under section
                                                        For the reasons set out in the                        223(d)(5)(C) of the Act, as amended, is
                                                      preamble, we propose to amend 20 CFR                                                                           PART 416—SUPPLEMENTAL
                                                                                                              that the source cannot participate in any
                                                      part 404 subpart P and part 416                                                                                SECURITY INCOME FOR THE AGED,
                                                                                                              Federal health care program under
                                                      subpart I as set forth below:                                                                                  BLIND, AND DISABLED
                                                                                                              section 1128 of the Act, but the Office
                                                      PART 404—FEDERAL OLD-AGE,                               of Inspector General of the Department                 Subpart I—Determining Disability and
                                                      SURVIVORS AND DISABILITY                                of Health and Human Services granted                   Blindness
                                                      INSURANCE (1950– )                                      a waiver of the section 1128 exclusion;
                                                                                                              or                                                     ■ 3. The authority citation for subpart I
                                                                                                                 (5) The evidence is a laboratory                    of part 416 continues to read as follows:
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      Subpart P—Determining Disability and
                                                      Blindness                                               finding about a physical impairment                      Authority: Secs. 221(m), 702(a)(5), 1611,
                                                                                                              and there is no indication that the                    1614, 1619, 1631(a), (c), (d)(1), and (p), and
                                                      ■ 1. The authority citation for subpart P               finding is unreliable.                                 1633 of the Social Security Act (42 U.S.C.
                                                      of part 404 continues to read as follows:                  (c) Statutorily excluded medical                    421(m), 902(a)(5), 1382, 1382c, 1382h,
                                                                                                              sources’ reporting requirements.                       1383(a), (c), (d)(1), and (p), and 1383(b); secs.
                                                        Authority: Secs. 202, 205(a)–(b) and (d)–
                                                                                                              Statutorily excluded medical sources (as               4(c) and 5, 6(c)–(e), 14(a), and 15, Pub. L. 98–
                                                      (h), 216(i), 221(a), (i), and (j), 222(c), 223,
                                                                                                              described in paragraph (a) of this                     460, 98 Stat. 1794, 1801, 1802, and 1808 (42
                                                      225, and 702(a)(5) of the Social Security Act
                                                                                                              section) must inform us in writing that                U.S.C. 421 note, 423 note, and 1382h note).
                                                      (42 U.S.C. 402, 405(a)–(b) and (d)–(h), 416(i),
                                                      421(a), (i), and (j), 422(c), 423, 425, and             they are excluded under section                        ■   4. Add § 416.903b to read as follows:


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                                                                                Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Proposed Rules                                             37561

                                                      § 416.903b Evidence from statutorily                    statutorily excluded medical sources                   DEPARTMENT OF HEALTH AND
                                                      excluded medical sources.                               submit to us either directly or through                HUMAN SERVICES
                                                         (a) General. We will not consider                    a representative, claimant, or other
                                                      evidence from the following medical                     individual or entity.                                  Food and Drug Administration
                                                      sources statutorily excluded under
                                                                                                                 (1) Statutorily excluded medical
                                                      section 223(d)(5)(C) of the Social                                                                             21 CFR Parts 175, 176, 177, and 178
                                                      Security Act (Act), as amended, unless                  sources must provide a written
                                                      we find good cause under paragraph (b)                  statement, which contains the following                [Docket No. FDA–2016–F–1253]
                                                      of this section:                                        information:
                                                                                                                                                                     Breast Cancer Fund, Center for
                                                         (1) Any medical source that has been                    (i) A heading stating: ‘‘WRITTEN                    Environmental Health, Center for Food
                                                      convicted of a felony under section 208                 STATEMENT REGARDING SECTION                            Safety, Center for Science in the Public
                                                      or under section 1632 of the Act;                       223(d)(5)(C) OF THE SOCIAL                             Interest, Clean Water Action,
                                                         (2) Any medical source that has been                 SECURITY ACT—DO NOT REMOVE’’                           Consumer Federation of America,
                                                      excluded from participation in any
                                                                                                                 (ii) The name and title of the medical              Earthjustice, Environmental Defense
                                                      Federal health care program under
                                                                                                              source;                                                Fund, Improving Kids’ Environment,
                                                      section 1128 of the Act; or
                                                         (3) Any medical source that has                         (iii) The applicable excluding event(s)             Learning Disabilities Association of
                                                      received a final decision imposing a                    stated in paragraphs (a)(1)–(a)(3) of this             America, and Natural Resources
                                                      civil monetary penalty or assessment, or                                                                       Defense Council; Filing of Food
                                                                                                              section;
                                                      both, for submitting false evidence                                                                            Additive Petition; Correction
                                                                                                                 (iv) The date of the medical source’s
                                                      under section 1129 of the Act.                          felony conviction under sections 208 or                AGENCY:   Food and Drug Administration,
                                                         (b) Good cause. We may find good                                                                            HHS.
                                                                                                              1632 of the Act, if applicable;
                                                      cause to consider evidence from a
                                                                                                                 (v) The date of the imposition of a                 ACTION:   Notice of petition; correction.
                                                      statutorily excluded medical source
                                                      under section 223(d)(5)(C) of the Act, as               civil monetary penalty or assessment, or               SUMMARY:   The Food and Drug
                                                      amended, if:                                            both, for the submission of false                      Administration (FDA or we) is
                                                         (1) The evidence from the medical                    evidence, under section 1129 of the Act,               correcting a notice entitled ‘‘Breast
                                                      source consists of evidence of treatment                if applicable; and                                     Cancer Fund, Center for Environmental
                                                      that occurred before the date the source                   (vi) The basis, effective date,                     Health, Center for Food Safety, Center
                                                      was convicted of a felony under section                                                                        for Science in the Public Interest, Clean
                                                                                                              anticipated length of the exclusion, and
                                                      208 or under section 1632 of the Act;                                                                          Water Action, Consumer Federation of
                                                         (2) The evidence from the medical                    whether the Office of the Inspector
                                                                                                              General of the Department of Health and                America, Earthjustice, Environmental
                                                      source consists of evidence of treatment                                                                       Defense Fund, Improving Kids’
                                                      that occurred during a period in which                  Human Services waived the exclusion,
                                                                                                              if the excluding event was the medical                 Environment, Learning Disabilities
                                                      the source was not excluded from                                                                               Association of America, and Natural
                                                      participation in any Federal health care                source’s exclusion from participation in
                                                                                                              any Federal health care program under                  Resources Defense Council; Filing of
                                                      program under section 1128 of the Act;                                                                         Food Additive Petition’’ that appeared
                                                         (3) The evidence from the medical                    section 1128 of the Act.
                                                                                                                                                                     in the Federal Register of May 20, 2016
                                                      source consists of evidence of treatment                   (2) The written statement provided by               (81 FR 31877). The document
                                                      that occurred before the date the source                an excluded medical source may not be                  announced that Breast Cancer Fund,
                                                      received a final decision imposing a                    removed by any individual or entity                    Center for Environmental Health, Center
                                                      civil monetary penalty or assessment, or                prior to submitting evidence to us.                    for Food Safety, Center for Science in
                                                      both, for submitting false evidence                                                                            the Public Interest, Clean Water Action,
                                                      under section 1129 of the Act;                             (3) We may request that the excluded
                                                                                                              medical source provide us with                         Consumer Federation of America,
                                                         (4) The sole basis for the medical
                                                                                                              additional information or clarify any                  Earthjustice, Environmental Defense
                                                      source’s exclusion under section
                                                                                                              information submitted that bears on the                Fund, Improving Kids’ Environment,
                                                      223(d)(5)(C) of the Act, as amended, is
                                                                                                              medical source’s exclusion(s) under                    Learning Disabilities Association of
                                                      that the source cannot participate in any
                                                                                                              section 223(d)(5)(C) of the Act, as                    America, and Natural Resources Defense
                                                      Federal health care program under
                                                                                                                                                                     Council filed a petition proposing that
                                                      section 1128 of the Act, but the Office                 amended.
                                                                                                                                                                     we amend and/or revoke specified
                                                      of Inspector General of the Department                  [FR Doc. 2016–13744 Filed 6–9–16; 8:45 am]             regulations to no longer provide for the
                                                      of Health and Human Services granted                    BILLING CODE 4191–02–P                                 food contact use of specified ortho-
                                                      a waiver of the section 1128 exclusion;
                                                                                                                                                                     phthalates, but omitted two items. This
                                                      or
                                                                                                                                                                     document corrects that error.
                                                         (5) The evidence is a laboratory
                                                      finding about a physical impairment                                                                            FOR FURTHER INFORMATION CONTACT:
                                                      and there is no indication that the                                                                            Kelly Randolph, Center for Food Safety
                                                      finding is unreliable.                                                                                         and Applied Nutrition (HFS–275), Food
                                                         (c) Statutorily excluded medical                                                                            and Drug Administration, 5100 Paint
                                                      sources’ reporting requirements.                                                                               Branch Pkwy., College Park, MD 20740–
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      Statutorily excluded medical sources (as                                                                       3835, 240–402–1188.
                                                      described in paragraph (a) of this                                                                             SUPPLEMENTARY INFORMATION: In FR Doc.
                                                      section) must inform us in writing that                                                                        2016–11866, appearing on page 31878
                                                      they are excluded under section                                                                                in the Federal Register of Friday, May
                                                      223(d)(5)(C) of the Act, as amended,                                                                           20, 2016, the following correction is
                                                      each time they submit evidence related                                                                         made:
                                                      to a claim for benefits under titles II or                                                                       On page 31878, in the third column,
                                                      XVI of the Act. This reporting                                                                                 under the heading ‘‘§ 175.300
                                                      requirement applies to evidence that                                                                           Resinous and Polymeric Coatings,’’ the


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Document Created: 2018-02-08 07:35:45
Document Modified: 2018-02-08 07:35:45
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionNotice of proposed rulemaking (NPRM).
DatesTo ensure that we consider your comments, we must receive them by no later than August 9, 2016.
ContactDan 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.
FR Citation81 FR 37557 
RIN Number0960-AH92
CFR Citation20 CFR 404
20 CFR 416
CFR AssociatedAdministrative Practice and Procedure; Blind; Disability Benefits; Old-Age; Survivors; Disability Insurance; Reporting and Recordkeeping Requirements; Social Security and Supplemental Security Income (ssi)

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