82 FR 30867 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 82, Issue 126 (July 3, 2017)
Centers for Medicare & Medicaid Services
Federal Register Volume 82, Issue 126 (July 3, 2017)
| Page Range | 30867-30868 | |
| FR Document | 2017-13973 |
[Federal Register Volume 82, Number 126 (Monday, July 3, 2017)] [Notices] [Pages 30867-30868] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-13973] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10307] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. DATES: Comments must be received by September 1, 2017. ADDRESSES: When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways: 1. Electronically. You may send your comments electronically to http://www.regulations.gov. Follow the instructions for ``Comment or Submission'' or ``More Search Options'' to find the information collection document(s) that are accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number __, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following: 1. Access CMS' Web site address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected]. 3. Call the Reports Clearance Office at (410) 786-1326. FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669. SUPPLEMENTARY INFORMATION: Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES). CMS-10307 Medical Necessity Disclosure Under MHPAEA and Claims Denial Disclosure Under MHPAEA Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term ``collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice. Information Collection 1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medical Necessity Disclosure Under MHPAEA and Claims Denial Disclosure Under MHPAEA; Use: The Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) (Pub. L. 110-343) generally requires that group health plans and group health insurance issuers offering mental health or substance use disorder (MH/SUD) benefits in addition to medical and surgical (med/surg) benefits ensure that they do not apply any more restrictive financial requirements (e.g., co-pays, deductibles) and/or treatment limitations (e.g., visit limits) to MH/ SUD benefits than those requirements and/or limitations applied to substantially all med/surg benefits. The Patient Protection and Affordable Care Act, Public Law 111-148, was enacted on March 23, 2010, and the Health Care and Education Reconciliation Act of 2010, Public Law 111-152, was enacted on March 30, 2010. These statutes are collectively known as the ``Affordable Care Act.'' The Affordable Care Act extended MHPAEA to apply to the individual health insurance market. Additionally, the Department of Health and Human Services (HHS) final regulation regarding essential health benefits (EHB) requires health insurance issuers offering non- grandfathered health insurance coverage in the individual and small group markets, through an Exchange or outside of an Exchange, to comply with the requirements of the MHPAEA regulations in order to satisfy the requirement to cover EHB (45 CFR 147.150 and 156.115). [[Page 30868]] Medical Necessity Disclosure Under MHPAEA MHPAEA section 512(b) specifically amends the Public Health Service (PHS) Act to require plan administrators or health insurance issuers to provide, upon request, the criteria for medical necessity determinations made with respect to MH/SUD benefits to current or potential participants, beneficiaries, or contracting providers. The Interim Final Rules Under the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (75 FR 5410, February 2, 2010) and the Final Rules under the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 set forth rules for providing criteria for medical necessity determinations. CMS oversees non-Federal governmental plans and health insurance issuers. Claims Denial Disclosure Under MHPAEA MHPAEA section 512(b) specifically amends the PHS Act to require plan administrators or health insurance issuers to supply, upon request, the reason for any denial or reimbursement of payment for MH/ SUD services to the participant or beneficiary involved in the case. The Interim Final Rules Under the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (75 FR 5410, February 2, 2010) and the Final Rules under the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 implement 45 CFR 146.136(d)(2), which sets forth rules for providing reasons for claims denial. CMS oversees non-Federal governmental plans and health insurance issuers, and the regulation provides a safe harbor such that non-Federal governmental plans (and issuers offering coverage in connection with such plans) are deemed to comply with requirements of paragraph (d)(2) of 45 CFR 146.136 if they provide the reason for claims denial in a form and manner consistent with ERISA requirements found in 29 CFR 2560.503-1. Section 146.136(d)(3) of the final rule clarifies that PHS Act section 2719 governing internal claims and appeals and external review as implemented by 45 CFR 147.136, covers MHPAEA claims denials and requires that, when a non-quantitative treatment limitation (NQTL) is the basis for a claims denial, that a non-grandfathered plan or issuer must provide the processes, strategies, evidentiary standard, and other factors used in developing and applying the NQTL with respect to med/surg benefits and MH/SUD benefits. Disclosure Request Form Group health plan participants, beneficiaries, covered individuals in the individual market, or persons acting on their behalf, may use this optional model form to request information from plans regarding NQTLs that may affect patients' MH/SUD benefits or that may have resulted in their coverage being denied. Form Number: CMS-10307; Frequency: On Occasion; Affected Public: State, Local, or Tribal Governments, Private Sector, Individuals; Number of Respondents: 267,538; Number of Responses: 1,081,929; Total Annual Hours: 43,327. (For policy questions regarding this collection contact Usree Bandyopadhyay at 410-786-6650). Dated: June 28, 2017. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2017-13973 Filed 6-30-17; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 82, No. 126 / Monday, July 3, 2017 / Notices 30867
Related Injury (R01), CE17–003 and PHS information collection for the proper approval from the Office of Management
2016–02 Omnibus Solicitation of the performance of the agency’s functions, and Budget (OMB) for each collection of
NIH, CDC FDA, and ACF for Small the accuracy of the estimated burden, information they conduct or sponsor.
Business Innovation Research Grant ways to enhance the quality, utility, and The term ‘‘collection of information’’ is
Applications (Parent SBIR [R43/R44]). clarity of the information to be defined in 44 U.S.C. 3502(3) and 5 CFR
SUMMARY: This meeting was announced collected, and the use of automated 1320.3(c) and includes agency requests
in the Federal Register on June 12, collection techniques or other forms of or requirements that members of the
2017, Volume 82, Number 111, pages information technology to minimize the public submit reports, keep records, or
26933 and 26934. This meeting is information collection burden. provide information to a third party.
canceled in its entirety. DATES: Comments must be received by Section 3506(c)(2)(A) of the PRA
CONTACT PERSON FOR MORE INFORMATION: September 1, 2017. requires federal agencies to publish a
Gwendolyn H. Cattledge, Ph.D., ADDRESSES: When commenting, please 60-day notice in the Federal Register
M.S.E.H., Deputy Associate Director for reference the document identifier or concerning each proposed collection of
Science, National Center for Injury OMB control number. To be assured information, including each proposed
Prevention and Control, CDC, 4770 consideration, comments and extension or reinstatement of an existing
Buford Highway NE., Mailstop F–63, recommendations must be submitted in collection of information, before
Atlanta, Georgia 30341, Telephone (770) any one of the following ways: submitting the collection to OMB for
488–1430. 1. Electronically. You may send your approval. To comply with this
The Director, Management Analysis comments electronically to http:// requirement, CMS is publishing this
and Services Office, has been delegated www.regulations.gov. Follow the notice.
the authority to sign Federal Register instructions for ‘‘Comment or
notices pertaining to announcements of Information Collection
Submission’’ or ‘‘More Search Options’’
meetings and other committee to find the information collection 1. Type of Information Collection
management activities, for both the document(s) that are accepting Request: Revision of a currently
Centers for Disease Control and comments. approved collection; Title of
Prevention and the Agency for Toxic 2. By regular mail. You may mail Information Collection: Medical
Substances and Disease Registry. written comments to the following Necessity Disclosure Under MHPAEA
address: CMS, Office of Strategic and Claims Denial Disclosure Under
Elaine L. Baker,
Operations and Regulatory Affairs, MHPAEA; Use: The Paul Wellstone and
Director, Management Analysis and Services
Division of Regulations Development, Pete Domenici Mental Health Parity and
Office, Centers for Disease Control and
Prevention. Attention: Document Identifier/OMB Addiction Equity Act of 2008
Control Number ll, Room C4–26–05, (MHPAEA) (Pub. L. 110–343) generally
[FR Doc. 2017–13925 Filed 6–30–17; 8:45 am]
7500 Security Boulevard, Baltimore, requires that group health plans and
BILLING CODE 4163–18–P
Maryland 21244–1850. group health insurance issuers offering
To obtain copies of a supporting mental health or substance use disorder
DEPARTMENT OF HEALTH AND statement and any related forms for the (MH/SUD) benefits in addition to
HUMAN SERVICES proposed collection(s) summarized in medical and surgical (med/surg)
this notice, you may make your request benefits ensure that they do not apply
Centers for Medicare & Medicaid using one of following: any more restrictive financial
Services 1. Access CMS’ Web site address at
requirements (e.g., co-pays, deductibles)
https://www.cms.gov/Regulations-and-
[Document Identifier: CMS–10307] and/or treatment limitations (e.g., visit
Guidance/Legislation/
limits) to MH/SUD benefits than those
PaperworkReductionActof1995/PRA-
Agency Information Collection requirements and/or limitations applied
Listing.html.
Activities: Proposed Collection; to substantially all med/surg benefits.
2. Email your request, including your
Comment Request The Patient Protection and Affordable
address, phone number, OMB number,
AGENCY: Centers for Medicare & and CMS document identifier, to Care Act, Public Law 111–148, was
Medicaid Services, HHS. Paperwork@cms.hhs.gov. enacted on March 23, 2010, and the
ACTION: Notice. 3. Call the Reports Clearance Office at Health Care and Education
(410) 786–1326. Reconciliation Act of 2010, Public Law
SUMMARY: The Centers for Medicare & FOR FURTHER INFORMATION CONTACT: 111–152, was enacted on March 30,
Medicaid Services (CMS) is announcing William Parham at (410) 786–4669. 2010. These statutes are collectively
an opportunity for the public to SUPPLEMENTARY INFORMATION:
known as the ‘‘Affordable Care Act.’’
comment on CMS’ intention to collect The Affordable Care Act extended
information from the public. Under the Contents MHPAEA to apply to the individual
Paperwork Reduction Act of 1995 (the This notice sets out a summary of the health insurance market. Additionally,
PRA), federal agencies are required to use and burden associated with the the Department of Health and Human
publish notice in the Federal Register following information collections. More Services (HHS) final regulation
concerning each proposed collection of detailed information can be found in regarding essential health benefits (EHB)
information (including each proposed each collection’s supporting statement requires health insurance issuers
extension or reinstatement of an existing offering non-grandfathered health
sradovich on DSK3GMQ082PROD with NOTICES
and associated materials (see
collection of information) and to allow ADDRESSES). insurance coverage in the individual
60 days for public comment on the and small group markets, through an
proposed action. Interested persons are CMS–10307 Medical Necessity Exchange or outside of an Exchange, to
invited to send comments regarding our Disclosure Under MHPAEA and Claims comply with the requirements of the
burden estimates or any other aspect of Denial Disclosure Under MHPAEA MHPAEA regulations in order to satisfy
this collection of information, including Under the PRA (44 U.S.C. 3501– the requirement to cover EHB (45 CFR
the necessity and utility of the proposed 3520), federal agencies must obtain 147.150 and 156.115).
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![30868 Federal Register / Vol. 82, No. 126 / Monday, July 3, 2017 / Notices
Medical Necessity Disclosure Under Disclosure Request Form DATES: Although you can comment on
MHPAEA Group health plan participants, any guidance at any time (see 21 CFR
MHPAEA section 512(b) specifically beneficiaries, covered individuals in the 10.115(g)(5)), to ensure that the Agency
amends the Public Health Service (PHS) individual market, or persons acting on considers your comment on this draft
Act to require plan administrators or their behalf, may use this optional guidance before it begins work on the
health insurance issuers to provide, model form to request information from final version of the guidance, submit
upon request, the criteria for medical plans regarding NQTLs that may affect either electronic or written comments
necessity determinations made with patients’ MH/SUD benefits or that may on the draft guidance by September 1,
respect to MH/SUD benefits to current have resulted in their coverage being 2017.
or potential participants, beneficiaries, denied. Form Number: CMS–10307; ADDRESSES: You may submit comments
or contracting providers. The Interim Frequency: On Occasion; Affected as follows:
Final Rules Under the Paul Wellstone Public: State, Local, or Tribal Electronic Submissions
and Pete Domenici Mental Health Parity Governments, Private Sector,
Submit electronic comments in the
and Addiction Equity Act of 2008 (75 Individuals; Number of Respondents:
following way:
FR 5410, February 2, 2010) and the 267,538; Number of Responses: • Federal eRulemaking Portal:
Final Rules under the Paul Wellstone 1,081,929; Total Annual Hours: 43,327. https://www.regulations.gov. Follow the
and Pete Domenici Mental Health Parity (For policy questions regarding this instructions for submitting comments.
and Addiction Equity Act of 2008 set collection contact Usree Comments submitted electronically,
forth rules for providing criteria for Bandyopadhyay at 410–786–6650). including attachments, to https://
medical necessity determinations. CMS Dated: June 28, 2017. www.regulations.gov will be posted to
oversees non-Federal governmental William N. Parham, III, the docket unchanged. Because your
plans and health insurance issuers. comment will be made public, you are
Director, Paperwork Reduction Staff, Office
Claims Denial Disclosure Under of Strategic Operations and Regulatory solely responsible for ensuring that your
MHPAEA Affairs. comment does not include any
[FR Doc. 2017–13973 Filed 6–30–17; 8:45 am] confidential information that you or a
MHPAEA section 512(b) specifically
BILLING CODE 4120–01–P third party may not wish to be posted,
amends the PHS Act to require plan
such as medical information, your or
administrators or health insurance
anyone else’s Social Security number, or
issuers to supply, upon request, the
DEPARTMENT OF HEALTH AND confidential business information, such
reason for any denial or reimbursement
HUMAN SERVICES as a manufacturing process. Please note
of payment for MH/SUD services to the
that if you include your name, contact
participant or beneficiary involved in Food and Drug Administration information, or other information that
the case. The Interim Final Rules Under
[Docket No. FDA–2017–D–2232] identifies you in the body of your
the Paul Wellstone and Pete Domenici
comments, that information will be
Mental Health Parity and Addiction
Product Identifier Requirements Under posted on https://www.regulations.gov.
Equity Act of 2008 (75 FR 5410, • If you want to submit a comment
the Drug Supply Chain Security Act—
February 2, 2010) and the Final Rules with confidential information that you
Compliance Policy; Draft Guidance for
under the Paul Wellstone and Pete do not wish to be made available to the
Industry; Availability
Domenici Mental Health Parity and public, submit the comment as a
Addiction Equity Act of 2008 AGENCY: Food and Drug Administration, written/paper submission and in the
implement 45 CFR 146.136(d)(2), which HHS. manner detailed (see ‘‘Written/Paper
sets forth rules for providing reasons for ACTION: Notice of availability. Submissions’’ and ‘‘Instructions’’).
claims denial. CMS oversees non-
Federal governmental plans and health SUMMARY: The Food and Drug Written/Paper Submissions
insurance issuers, and the regulation Administration (FDA or Agency) is Submit written/paper submissions as
provides a safe harbor such that non- announcing the availability of a draft follows:
Federal governmental plans (and issuers guidance for industry entitled ‘‘Product • Mail/Hand delivery/Courier (for
offering coverage in connection with Identifier Requirements Under the Drug written/paper submissions): Dockets
such plans) are deemed to comply with Supply Chain Security Act— Management Staff (HFA–305), Food and
requirements of paragraph (d)(2) of 45 Compliance Policy.’’ This draft Drug Administration, 5630 Fishers
CFR 146.136 if they provide the reason guidance describes FDA’s intention Lane, Rm. 1061, Rockville, MD 20852.
for claims denial in a form and manner with regard to enforcement of • For written/paper comments
consistent with ERISA requirements requirements related to product submitted to the Dockets Management
found in 29 CFR 2560.503–1. Section identifiers under the Drug Supply Chain Staff, FDA will post your comment, as
146.136(d)(3) of the final rule clarifies Security Act (DSCSA). Specifically, this well as any attachments, except for
that PHS Act section 2719 governing guidance addresses manufacturers’ information submitted, marked, and
internal claims and appeals and external product identifier and verification identified, as confidential, if submitted
review as implemented by 45 CFR requirements, which begin November as detailed in ‘‘Instructions.’’
147.136, covers MHPAEA claims 27, 2017. This guidance also addresses Instructions: All submissions received
denials and requires that, when a non- certain requirements for repackagers, must include the Docket No. FDA–
quantitative treatment limitation wholesale distributors, and dispensers 2017–D–2232 for ‘‘Product Identifier
sradovich on DSK3GMQ082PROD with NOTICES
(NQTL) is the basis for a claims denial, to only engage in transactions involving Requirements Under the Drug Supply
that a non-grandfathered plan or issuer products with product identifiers and to Chain Security Act—Compliance Policy;
must provide the processes, strategies, verify the product identifier when Draft Guidance for Industry;
evidentiary standard, and other factors investigating suspect product, in Availability.’’ Received comments,
used in developing and applying the addition to repackager and wholesale those filed in a timely manner (see
NQTL with respect to med/surg benefits distributor requirements related to DATES), will be placed in the docket and,
and MH/SUD benefits. saleable returned products. except for those submitted as
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Document Created: 2018-11-14 10:19:41
Document Modified: 2018-11-14 10:19:41
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments must be received by September 1, 2017. | |
| Contact | William Parham at (410) 786-4669. | |
| FR Citation | 82 FR 30867 |
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