83 FR 33223 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 83, Issue 137 (July 17, 2018)
Centers for Medicare & Medicaid Services
Federal Register Volume 83, Issue 137 (July 17, 2018)
| Page Range | 33223-33224 | |
| FR Document | 2018-15169 |
[Federal Register Volume 83, Number 137 (Tuesday, July 17, 2018)] [Notices] [Pages 33223-33224] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-15169] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier CMS-10008, CMS-R-234, and CMS-R-194] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Centers for Medicare & Medicaid Services. 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 17, 2018. 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' website 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-10008 Eligibility of Drugs, Biologicals, and Radiopharmaceutical Agents for Transitional Pass-Through Status Under the Hospital Outpatient Prospective Payment System (OPPS) CMS-R-234 Subpart D-Private Contracts CMS-R-194 Medicare Disproportionate Share Adjustment Procedures and Criteria 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 [[Page 33224]] requirement, CMS is publishing this notice. Information Collection 1. Type of Information Collection Request: Reinstatement with a change of a previously approved collection; Title of Information Collection: Eligibility of Drugs, Biologicals, and Radiopharmaceutical Agents for Transitional Pass-Through Status Under the Hospital Outpatient Prospective Payment System (OPPS); Use: Section 201(b) of the BBRA 1999 amended section 1833(t) of the Act by adding new section 1833(t)(6). This provision requires the Secretary to make additional payments to hospitals for a period of 2 to 3 years for certain drugs, radiopharmaceuticals, biological agents, medical devices and brachytherapy devices. Section 1833(t)(6)(A)(iv) establishes the criteria for determining the application of this provision to new items. Section 1833(t)(6)(C)(i) provides that the additional payment for drugs and biologicals be the amount by which the amount determined under section 1842(o) of the Act exceeds the portion of the otherwise applicable hospital outpatient department fee schedule amount that the Secretary determines to be associated with the drug or biological. Section 1833(t)(6)(D)(i) of the Act sets the payment rate for pass- through eligible drugs and biologicals (assuming that no pro rata reduction in pass-through payment is necessary) as the amount determined under section 1842(o) of the Act. Section 303(c) of Public Law 108-173 amended Title XVIII of the Act by adding new section 1847A. This new section establishes the use of the average sales price (ASP) methodology for payment for drugs and biologicals described in section 1842(o)(1)(C) of the Act furnished on or after January 1, 2005. Therefore, as we stated in the November 15, 2004 Federal Register (69 FR 65776), in CY 2005, we will pay under the OPPS for drugs, biologicals and radiopharmaceuticals with pass-through status consistent with the provisions of section 1842(o) of the Act as amended by Public Law 108-173 at a rate that is equivalent to the payment these drugs and biologicals will receive in the physician office setting, and established in accordance with the methodology described in the CY 2005 Physician Fee Schedule final rule. Information on Average Sales Price is found at http://www.cms.hhs.gov/McrPartBDrugAvgSalesPrice/. The intent of these provisions is to ensure that timely beneficiary access to new pharmacological technologies is not jeopardized by inadequate payment levels. Form Number: CMS-10008 (OMB Control Number 0938-0802); Frequency: Yearly; Affected Public: Private sector (Business or other for-profits); Number of Respondents: 30; Total Annual Responses: 30; Total Annual Hours: 480. (For policy questions regarding this collection contact Raymond Bulls at 410-786-7267). 2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Subpart D-- Private Contracts; Use: Section 4507 of the Balanced Budget Act of 1997 (BBA 1997) amended section 1802 of the Social Security Act (the Act) to permit certain physicians and practitioners to opt-out of Medicare and to provide through private contracts services that would otherwise be covered by Medicare. Under such contracts the mandatory claims submission and limiting charge rules of section 1848(g) of the Act would not apply. Subpart D and the supporting regulations contained in 42 CFR 405.410, 405.430, 405.435, 405.440, 405.445, and 405.455, counters the effect of certain provisions of Medicare law that, absent section 1802 of the Act, preclude physicians and practitioners from contracting privately with Medicare beneficiaries to pay without regard to Medicare limits. The most recent approval of this information collection request (ICR) was issued by the Office of Management and Budget on March 2, 2016. We are now seeking to renew this approval before it expires on March 31, 2019. We have made no changes to the information being collected. We updated our burden estimate to reflect changes in the number of physicians and practitioners who have opted out and refinements to our methodology for estimating the burden associated with contracts. We have also updated the cost estimate to account for the current Bureau of Labor Statistics (BLS) wage estimates and to include the estimated costs for Medicare Advantage plans. Form Number: CMS-R-234 (OMB Control Number 0938-0730); Frequency: Yearly; Affected Public: Private sector (Business or other for-profits); Number of Respondents: 57,722; Total Annual Responses: 57,722; Total Annual Hours: 23,557. (For policy questions regarding this collection contact Frederick Grabau at 410-786-0206). 3. Type of Information Collection Request: Reinstatement without a change of a previously approved collection; Title of Information Collection: Medicare Disproportionate Share Adjustment Procedures and Criteria; Use: Section 1886(d)(5)(F) of the Social Security Act established the Medicare disproportionate share adjustment (DSH) for hospitals, which provides additional payment to hospitals that serve a disproportionate share of the indigent patient population. This payment is an add-on to the set amount per case the Centers for Medicare and Medicaid Services (CMS) pays to hospitals under the Medicare Inpatient Prospective Payment System (IPPS). Under current regulations at 42 CFR 412.106, in order to meet the qualifying criteria for this additional DSH payment, a hospital must prove that a disproportionate percentage of its patients are low income using Supplemental Security Income (SSI) and Medicaid as proxies for this determination. This percentage includes two computations: (1) The ``Medicare fraction'' or the ``SSI ratio'' which is the percent of patient days for beneficiaries who are eligible for Medicare Part A and SSI and (2) the ``Medicaid fraction'' which is the percent of patient days for patients who are eligible for Medicaid but not Medicare. Once a hospital qualifies for this DSH payment, CMS also determines a hospital's payment adjustment based on these two fractions. 42 CFR 412.106 allows hospitals to request that the Medicare fraction of the DSH adjustment be calculated on a cost reporting basis rather than a federal fiscal year. Once requested, the hospital must accept the result irrespective of whether it increases or decreases their DSH payment. The routine use procedure and the DUA allows hospitals to request the detailed Medicare data so they can make an informed choice before deciding whether to request that the Medicare fraction be calculated on the basis of a cost reporting period rather than a federal fiscal year. Form Number: CMS-R-194 (OMB Control Number 0938-0691); Frequency: Yearly; Affected Public: Private sector (Business or other for-profits); Number of Respondents: 800; Total Annual Responses: 800; Total Annual Hours: 400. (For policy questions regarding this collection contact Emily Lipkin at 410-786-3633). Dated: July 11, 2018. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2018-15169 Filed 7-16-18; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 83, No. 137 / Tuesday, July 17, 2018 / Notices 33223
determined that the following class of Authority: 42 U.S.C.7384q. address: CMS, Office of Strategic
employees does not meet the statutory John J. Howard, Operations and Regulatory Affairs,
criteria for addition to the SEC as Division of Regulations Development,
Director, National Institute for Occupational
authorized under EEOICPA: Safety and Health. Attention: Document Identifier/OMB
‘‘(1) All employees of the Department of Control Number _________, Room C4–
[FR Doc. 2018–15093 Filed 7–16–18; 8:45 am]
Energy (DOE), its predecessor agencies, and 26–05, 7500 Security Boulevard,
BILLING CODE 4163–19–P
their contractors and subcontractors who Baltimore, Maryland 21244–1850.
worked in any area of the Feed Materials To obtain copies of a supporting
Production Center at Fernald, Ohio, from statement and any related forms for the
January 1, 1984, through December 31, 1989; DEPARTMENT OF HEALTH AND
HUMAN SERVICES proposed collection(s) summarized in
and (2) all employees of the DOE, its
this notice, you may make your request
predecessor agencies, National Lead of Ohio,
or NLO, Inc., in any area of the Feed Centers for Medicare & Medicaid using one of following:
Materials Production Center from January 1, Services 1. Access CMS’ website address at
1979, through December 31, 1983.’’ https://www.cms.gov/Regulations-and-
[Document Identifier CMS–10008, CMS–R–
Authority: 42 U.S.C.7384q. 234, and CMS–R–194] Guidance/Legislation/
PaperworkReductionActof1995/PRA-
John J. Howard, Agency Information Collection Listing.html.
Director, National Institute for Occupational Activities: Proposed Collection; 2. Email your request, including your
Safety and Health. Comment Request address, phone number, OMB number,
[FR Doc. 2018–15094 Filed 7–16–18; 8:45 am] and CMS document identifier, to
BILLING CODE 4163–19–P
AGENCY: Centers for Medicare & Paperwork@cms.hhs.gov.
Medicaid Services. 3. Call the Reports Clearance Office at
ACTION: Notice. (410) 786–1326.
DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT:
SUMMARY: The Centers for Medicare &
HUMAN SERVICES William Parham at (410) 786–4669.
Medicaid Services (CMS) is announcing
Centers for Disease Control and an opportunity for the public to SUPPLEMENTARY INFORMATION:
Prevention comment on CMS’ intention to collect
information from the public. Under the Contents
Determination Concerning a Petition Paperwork Reduction Act of 1995 (the This notice sets out a summary of the
To Add a Class of Employees to the PRA), federal agencies are required to use and burden associated with the
Special Exposure Cohort publish notice in the Federal Register following information collections. More
concerning each proposed collection of detailed information can be found in
AGENCY: National Institute for information (including each proposed each collection’s supporting statement
Occupational Safety and Health extension or reinstatement of an existing and associated materials (see
(NIOSH), Centers for Disease Control collection of information) and to allow ADDRESSES).
and Prevention, Department of Health 60 days for public comment on the
and Human Services (HHS). CMS–10008 Eligibility of Drugs,
proposed action. Interested persons are Biologicals, and
ACTION: Notice. invited to send comments regarding our Radiopharmaceutical Agents for
burden estimates or any other aspect of Transitional Pass-Through Status
SUMMARY: HHS gives notice of a
this collection of information, including
determination concerning a petition to Under the Hospital Outpatient
the necessity and utility of the proposed
add a class of employees from the Grand Prospective Payment System
information collection for the proper
Junction Facilities, in Grand Junction, (OPPS)
performance of the agency’s functions,
Colorado, to the Special Exposure CMS–R–234 Subpart D-Private
the accuracy of the estimated burden,
Cohort (SEC) under the Energy Contracts
ways to enhance the quality, utility, and
Employees Occupational Illness clarity of the information to be CMS–R–194 Medicare Disproportionate
Compensation Program Act of 2000 collected, and the use of automated Share Adjustment Procedures and
(EEOICPA). collection techniques or other forms of Criteria
FOR FURTHER INFORMATION CONTACT: information technology to minimize the Under the PRA (44 U.S.C. 3501–
Stuart L. Hinnefeld, Director, Division information collection burden. 3520), federal agencies must obtain
of Compensation Analysis and Support, DATES: Comments must be received by approval from the Office of Management
National Institute for Occupational September 17, 2018. and Budget (OMB) for each collection of
Safety and Health (NIOSH), 1090 ADDRESSES: When commenting, please information they conduct or sponsor.
Tusculum Avenue, MS C–46, reference the document identifier or The term ‘‘collection of information’’ is
Cincinnati, OH 45226–1938, Telephone OMB control number. To be assured defined in 44 U.S.C. 3502(3) and 5 CFR
1–877–222–7570. Information requests consideration, comments and 1320.3(c) and includes agency requests
can also be submitted by email to recommendations must be submitted in or requirements that members of the
DCAS@CDC.GOV. any one of the following ways: public submit reports, keep records, or
SUPPLEMENTARY INFORMATION: On June 1. Electronically. You may send your provide information to a third party.
21, 2018, the Secretary of HHS comments electronically to http:// Section 3506(c)(2)(A) of the PRA
determined that the following class of www.regulations.gov. Follow the requires federal agencies to publish a
daltland on DSKBBV9HB2PROD with NOTICES
employees does not meet the statutory instructions for ‘‘Comment or 60-day notice in the Federal Register
criteria for addition to the SEC as Submission’’ or ‘‘More Search Options’’ concerning each proposed collection of
authorized under EEOICPA: to find the information collection information, including each proposed
‘‘All employees who worked in any area of document(s) that are accepting extension or reinstatement of an existing
the Grand Junction Facilities in Grand comments. collection of information, before
Junction, Colorado, from January 1, 1986, 2. By regular mail. You may mail submitting the collection to OMB for
through July 31, 2010.’’ written comments to the following approval. To comply with this
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![33224 Federal Register / Vol. 83, No. 137 / Tuesday, July 17, 2018 / Notices
requirement, CMS is publishing this levels. Form Number: CMS–10008 Criteria; Use: Section 1886(d)(5)(F) of
notice. (OMB Control Number 0938–0802); the Social Security Act established the
Frequency: Yearly; Affected Public: Medicare disproportionate share
Information Collection
Private sector (Business or other for- adjustment (DSH) for hospitals, which
1. Type of Information Collection profits); Number of Respondents: 30; provides additional payment to
Request: Reinstatement with a change of Total Annual Responses: 30; Total hospitals that serve a disproportionate
a previously approved collection; Title Annual Hours: 480. (For policy share of the indigent patient population.
of Information Collection: Eligibility of questions regarding this collection This payment is an add-on to the set
Drugs, Biologicals, and contact Raymond Bulls at 410–786– amount per case the Centers for
Radiopharmaceutical Agents for 7267). Medicare and Medicaid Services (CMS)
Transitional Pass-Through Status Under 2. Type of Information Collection
the Hospital Outpatient Prospective pays to hospitals under the Medicare
Request: Extension of a currently
Payment System (OPPS); Use: Section Inpatient Prospective Payment System
approved collection; Title of
201(b) of the BBRA 1999 amended Information Collection: Subpart D— (IPPS). Under current regulations at 42
section 1833(t) of the Act by adding new Private Contracts; Use: Section 4507 of CFR 412.106, in order to meet the
section 1833(t)(6). This provision the Balanced Budget Act of 1997 (BBA qualifying criteria for this additional
requires the Secretary to make 1997) amended section 1802 of the DSH payment, a hospital must prove
additional payments to hospitals for a Social Security Act (the Act) to permit that a disproportionate percentage of its
period of 2 to 3 years for certain drugs, certain physicians and practitioners to patients are low income using
radiopharmaceuticals, biological agents, opt-out of Medicare and to provide Supplemental Security Income (SSI)
medical devices and brachytherapy through private contracts services that and Medicaid as proxies for this
devices. Section 1833(t)(6)(A)(iv) would otherwise be covered by determination. This percentage includes
establishes the criteria for determining Medicare. Under such contracts the two computations: (1) The ‘‘Medicare
the application of this provision to new mandatory claims submission and fraction’’ or the ‘‘SSI ratio’’ which is the
items. Section 1833(t)(6)(C)(i) provides limiting charge rules of section 1848(g) percent of patient days for beneficiaries
that the additional payment for drugs of the Act would not apply. Subpart D who are eligible for Medicare Part A and
and biologicals be the amount by which and the supporting regulations SSI and (2) the ‘‘Medicaid fraction’’
the amount determined under section contained in 42 CFR 405.410, 405.430, which is the percent of patient days for
1842(o) of the Act exceeds the portion 405.435, 405.440, 405.445, and 405.455, patients who are eligible for Medicaid
of the otherwise applicable hospital counters the effect of certain provisions but not Medicare. Once a hospital
outpatient department fee schedule of Medicare law that, absent section
qualifies for this DSH payment, CMS
amount that the Secretary determines to 1802 of the Act, preclude physicians
be associated with the drug or also determines a hospital’s payment
and practitioners from contracting
biological. Section 1833(t)(6)(D)(i) of the privately with Medicare beneficiaries to adjustment based on these two fractions.
Act sets the payment rate for pass- pay without regard to Medicare limits. 42 CFR 412.106 allows hospitals to
through eligible drugs and biologicals The most recent approval of this request that the Medicare fraction of the
(assuming that no pro rata reduction in information collection request (ICR) was DSH adjustment be calculated on a cost
pass-through payment is necessary) as issued by the Office of Management and reporting basis rather than a federal
the amount determined under section Budget on March 2, 2016. We are now fiscal year. Once requested, the hospital
1842(o) of the Act. Section 303(c) of seeking to renew this approval before it must accept the result irrespective of
Public Law 108–173 amended Title expires on March 31, 2019. We have whether it increases or decreases their
XVIII of the Act by adding new section made no changes to the information DSH payment. The routine use
1847A. This new section establishes the being collected. We updated our burden procedure and the DUA allows hospitals
use of the average sales price (ASP) estimate to reflect changes in the to request the detailed Medicare data so
methodology for payment for drugs and number of physicians and practitioners they can make an informed choice
biologicals described in section who have opted out and refinements to before deciding whether to request that
1842(o)(1)(C) of the Act furnished on or our methodology for estimating the the Medicare fraction be calculated on
after January 1, 2005. Therefore, as we burden associated with contracts. We the basis of a cost reporting period
stated in the November 15, 2004 Federal have also updated the cost estimate to rather than a federal fiscal year. Form
Register (69 FR 65776), in CY 2005, we account for the current Bureau of Labor Number: CMS–R–194 (OMB Control
will pay under the OPPS for drugs, Statistics (BLS) wage estimates and to Number 0938–0691); Frequency: Yearly;
biologicals and radiopharmaceuticals include the estimated costs for Medicare Affected Public: Private sector (Business
with pass-through status consistent with Advantage plans. Form Number: CMS–
or other for-profits); Number of
the provisions of section 1842(o) of the R–234 (OMB Control Number 0938–
Respondents: 800; Total Annual
Act as amended by Public Law 108–173 0730); Frequency: Yearly; Affected
Responses: 800; Total Annual Hours:
at a rate that is equivalent to the Public: Private sector (Business or other
payment these drugs and biologicals for-profits); Number of Respondents: 400. (For policy questions regarding this
will receive in the physician office 57,722; Total Annual Responses: collection contact Emily Lipkin at 410–
setting, and established in accordance 57,722; Total Annual Hours: 23,557. 786–3633).
with the methodology described in the (For policy questions regarding this Dated: July 11, 2018.
CY 2005 Physician Fee Schedule final collection contact Frederick Grabau at William N. Parham, III,
daltland on DSKBBV9HB2PROD with NOTICES
rule. Information on Average Sales Price 410–786–0206). Director, Paperwork Reduction Staff, Office
is found at http://www.cms.hhs.gov/ 3. Type of Information Collection of Strategic Operations and Regulatory
McrPartBDrugAvgSalesPrice/. The Request: Reinstatement without a Affairs.
intent of these provisions is to ensure change of a previously approved [FR Doc. 2018–15169 Filed 7–16–18; 8:45 am]
that timely beneficiary access to new collection; Title of Information
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pharmacological technologies is not Collection: Medicare Disproportionate
jeopardized by inadequate payment Share Adjustment Procedures and
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Document Created: 2018-07-17 01:39:43
Document Modified: 2018-07-17 01:39:43
| 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 17, 2018. | |
| Contact | William Parham at (410) 786-4669. | |
| FR Citation | 83 FR 33223 |
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