81 FR 35772 - Medicare, Medicaid, and Children's Health Insurance Programs; Announcement of the Advisory Panel on Clinical Diagnostic Laboratory Tests Meeting on July 18, 2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 81, Issue 107 (June 3, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 107 (June 3, 2016)
| Page Range | 35772-35774 | |
| FR Document | 2016-13084 |
[Federal Register Volume 81, Number 107 (Friday, June 3, 2016)] [Notices] [Pages 35772-35774] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-13084] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1666-N] Medicare, Medicaid, and Children's Health Insurance Programs; Announcement of the Advisory Panel on Clinical Diagnostic Laboratory Tests Meeting on July 18, 2016 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice announces the next public meeting date of the Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) on Monday, July 18, 2016. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (DHHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) on issues related to clinical diagnostic laboratory tests. DATES: Meeting Date: The meeting of the Panel is scheduled for Monday, July 18, 2016 beginning at 9:00 a.m., Eastern Daylight Time (EDT). The morning session will be held jointly with the Public Meeting on New and Reconsidered Clinical Diagnostic Laboratory Test Codes for the Clinical Laboratory Fee Schedule (CLFS) for Calendar Year (CY) 2017 (the 2016 Laboratory Public Meeting) (see 81 FR 29863, May 13, 2016 for notice of the 2016 Laboratory Public Meeting). During the afternoon session, the Panel will deliberate and make recommendations regarding the new and reconsidered laboratory codes for CY 2017. The Panel may also hear public presentations on additional issues concerning the CY 2017 CLFS that are designated in the Panel's charter and specified in the Panel meeting agenda for the afternoon session. Meeting Registration: The public may attend the Panel meeting in- person, view via webcast, or listen via teleconference. Beginning Monday, June 6, 2016 and ending Friday, July 1, 2016 at 5:00 p.m. EDT, registration to attend the Panel meeting in-person may be completed online at http://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. On this Web page, under ``Related Links,'' double-click the ``Clinical Diagnostic Laboratory Tests FACA Panel Meeting Registration'' link and enter the required information. All the following information must be submitted when registering:Name. Company name. Address. Email addresses. Note: Participants who do not plan to attend the Panel meeting in-person on July 18, 2016 should not register. No registration is required for participants who plan to view the Panel meeting via webcast or listen via teleconference. Participants planning to attend only the morning session which includes the 2016 Laboratory Public Meeting, or both the morning and afternoon sessions, should register only once, for the 2016 Laboratory Public Meeting (see instructions for registering for the 2016 Laboratory Public Meeting at 81 FR 29863). Participants planning to attend only the afternoon session of the Panel meeting must register using the above link and instructions. Presenter Registration and Submission of Presentations and Comments: In the morning session only, we are interested in in-person presentations concerning the payment methodologies for new or reconsidered laboratory codes. The instructions for submitting such comments and presentations are also included in 2016 Laboratory Public Meeting notice (81 FR 29863). Although these comments and presentations will be made during the morning joint session of the 2016 Laboratory Public Meeting and Panel Meeting, the Panel may wish to ask follow-up questions to presenters at the afternoon session of the Panel Meeting. As previously mentioned, additional issues concerning the calendar year (CY) 2017 clinical laboratory fee schedule (CLFS) that are designated in the Panel's charter and specified in the meeting agenda, may also be discussed at the afternoon session of the Panel meeting. Any such issues to be discussed will be specified in the Panel meeting agenda, to be published approximately 3 weeks before the meeting (A preliminary agenda is described in section II. of this notice.) Should issues be added to the agenda, we would be interested in public comments or presentations related to those issues. The comments and presentations should not address issues not specified in the agenda for the Panel meeting. The deadline to register to be a presenter and to submit written presentations for agenda items for the Panel's afternoon session (that is, presentations on issues other than payment for new and reconsidered laboratory codes for CY 2017) is 5:00 p.m. EDT July 1, 2016. Presenters may register by email by contacting the person listed in the FOR FURTHER INFORMATION CONTACT section of this notice. Presentations should be sent via email to the same person's email address. Meeting Location, Webcast, and Teleconference: The Panel meetings will be held in the Auditorium of the CMS, Central Office, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Alternately, the public may either view the Panel meetings via a webcast or listen by teleconference. During the scheduled Panel meeting, webcasting is accessible online at http://cms.gov/live. Teleconference dial-in information will appear on the final Panel meeting agenda, which will be posted on the CMS Web site when available at http://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. Meeting Format: This Panel meeting is open to the public. The on- site check-in for visitors will be held from 8:30 a.m. to 9:00 a.m. on Monday, July 18, 2016, preceding the morning session of the 2016 Laboratory Public Meeting, and again at 12:30 p.m. for visitors attending only the Panel meeting (afternoon session). During the morning session, the Panel, along with the public, will hear and pose questions to presenters recommending crosswalks or gapfilling for new and reconsidered laboratory codes for calendar year (CY) 2017. During the afternoon session, the Panel will deliberate and make recommendations to the Secretary of HHS and the Acting Administrator of CMS regarding crosswalks or gapfilling for new and reconsidered laboratory codes discussed during the morning [[Page 35773]] session. The Panel may also hear public presentations (for a total time period of no more than one hour) and provide input on other CY 2017 CLFS issues that are designated in the Panel's charter and specified on meeting agenda. Both the morning and afternoon sessions are open to the public. ADDRESSES: Web site: For additional information on the Panel, please refer to our Web site at https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html . FOR FURTHER INFORMATION CONTACT: Glenn C. McGuirk, Designated Federal Official (DFO), Center for Medicare, Division of Ambulatory Services, CMS, 7500 Security Boulevard, Mail Stop C4-01-26, Baltimore, MD 21244, 410-786-5723, email [email protected] or [email protected]. Press inquiries are handled through the CMS Press Office at (202) 690- 6145. SUPPLEMENTARY INFORMATION: I. Background The Advisory Panel on Clinical Diagnostic Laboratory Tests is authorized by section 1834A(f)(1) of the Social Security Act (the Act) (42 U.S.C. 1395m-1), as established by section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93, enacted April 1, 2014).The Panel is subject to the Federal Advisory Committee Act (FACA), as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory panels. Section 1834A(f)(1) of the Act directs the Secretary of the Department of Health and Human Services (the Secretary) to consult with an expert outside advisory panel established by the Secretary, composed of an appropriate selection of individuals with expertise in issues related to clinical diagnostic laboratory tests. Such individuals may include molecular pathologists, clinical laboratory researchers, and individuals with expertise in laboratory science or health economics. The Panel will provide input and recommendations to the Secretary and the Acting Administrator of CMS, on the following: The establishment of payment rates under section 1834A of the Act for new clinical diagnostic laboratory tests, including whether to use crosswalking or gapfilling processes to determine payment for a specific new test; The factors used in determining coverage and payment processes for new clinical diagnostic laboratory tests; and Other aspects of the upcoming new payment system, to be based on private payor rates, under section 1834A of the Act. A notice announcing the establishment of the Panel and soliciting nominations for members was published in the October 27, 2014 Federal Register (79 FR 63919 through 63920). In the August 7, 2015 Federal Register (80 FR 47491), we announced membership appointments to the Panel along with the first public meeting date for the Panel, which was held on August 26, 2015. The Panel charter provides that panel meetings will be held up to four times annually. The Panel consists of 15 individuals and a Chair. The Panel Chair facilitates the meeting and the Designated Federal Official (DFO) or DFO's designee must be present at all meetings. II. Agenda The Agenda for the July 18, 2016, Panel meeting will provide for discussion and comment on the following topics as designated in the Panel's Charter: CY 2017 CLFS new and reconsidered test codes which were posted on May 12, 2016, on our Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings.html Other CY 2017 CLFS issues designated in the Panel's charter and further described on our Agenda. A detailed Agenda will be posted approximately 3 weeks before the meeting, on our Web site at http://cms.gov/Regulations-andGuidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. III. Meeting Attendance The Panel's meeting on July 18, 2016, is open to the public. Priority will be given to those who pre-register and attendance may be limited based on the number of registrants and the space available. Persons wishing to attend this meeting, which is located on federal property, must register by following the instructions in the ``Meeting Registration'' section of this notice. A confirmation email will be sent to the registrants shortly after completing the registration process. IV. Security, Building, and Parking Guidelines The following are the security, building, and parking guidelines: Persons attending the meeting, including presenters, must be pre-registered and on the attendance list by the prescribed date. Individuals who are not pre-registered in advance may not be permitted to enter the building and may be unable to attend the meeting. Attendees must present a government-issued photo identification to the Federal Protective Service or Guard Service personnel before entering the building. Without a current, valid photo ID, persons may not be permitted entry to the building. Security measures include inspection of vehicles, inside and out, at the entrance to the grounds. All persons entering the building must pass through a metal detector. All items brought into CMS including personal items, for example, laptops and cell phones, are subject to physical inspection. The public may enter the building 30 to 45 minutes before the meeting convenes each day. All visitors must be escorted in areas other than the lower and first-floor levels in the Central Building. The main-entrance guards will issue parking permits and instructions upon arrival at the building. V. Special Accommodations Individuals requiring special accommodations must include the request for these services during registration. VI. Panel Recommendations and Discussions The Panel's recommendations will be posted after the meeting on our Web site at http://cms.gov/Regulations-andGuidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. VIII. Copies of the Charter The Secretary's Charter for the Advisory Panel on Clinical Diagnostic Laboratory Tests is available on our Web site at http://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html or you may obtain a copy of the charter by submitting a request to the contact listed in the FOR FURTHER INFORMATION CONTACT section of this notice. IX. Collection of Information Requirements This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the [[Page 35774]] Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Dated: May 25, 2016. Andrew M. Slavitt, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2016-13084 Filed 6-2-16; 8:45 am] BILLING CODE 4120-01-P
![35772 Federal Register / Vol. 81, No. 107 / Friday, June 3, 2016 / Notices
We cannot assume responsibility for Laboratory Public Meeting) (see 81 FR 2017 clinical laboratory fee schedule
coordinating the receipt, transfer, 29863, May 13, 2016 for notice of the (CLFS) that are designated in the Panel’s
transport, storage, set up, safety, or 2016 Laboratory Public Meeting). charter and specified in the meeting
timely arrival of any personal During the afternoon session, the Panel agenda, may also be discussed at the
belongings or items used for will deliberate and make afternoon session of the Panel meeting.
presentation or to support a recommendations regarding the new Any such issues to be discussed will be
presentation. and reconsidered laboratory codes for specified in the Panel meeting agenda,
Note: Individuals who are not CY 2017. The Panel may also hear to be published approximately 3 weeks
registered in advance will not be public presentations on additional before the meeting (A preliminary
permitted to enter the building and will issues concerning the CY 2017 CLFS agenda is described in section II. of this
be unable to attend the meeting. The that are designated in the Panel’s charter notice.) Should issues be added to the
public may not enter the building earlier and specified in the Panel meeting agenda, we would be interested in
than 45 minutes prior to the convening agenda for the afternoon session. public comments or presentations
of the meeting. Meeting Registration: The public may related to those issues. The comments
All visitors must be escorted in areas attend the Panel meeting in-person, and presentations should not address
other than the lower and first floor view via webcast, or listen via issues not specified in the agenda for
levels in the Central Building. teleconference. Beginning Monday, June the Panel meeting. The deadline to
6, 2016 and ending Friday, July 1, 2016 register to be a presenter and to submit
Authority: Sec. 222 of the Public Health
Service Act (42 U.S.C. 217a) and sec. 10(a)
at 5:00 p.m. EDT, registration to attend written presentations for agenda items
of Pub. L. 92–463 (5 U.S.C. App. 2, sec. 10(a) the Panel meeting in-person may be for the Panel’s afternoon session (that is,
and 41 CFR 102–3). completed online at http://cms.gov/ presentations on issues other than
Regulations-and-Guidance/Guidance/ payment for new and reconsidered
Dated: May 26, 2016.
FACA/AdvisoryPanelonClinical laboratory codes for CY 2017) is 5:00
Andrew M. Slavitt, DiagnosticLaboratoryTests.html. On this p.m. EDT July 1, 2016. Presenters may
Acting Administrator, Centers for Medicare Web page, under ‘‘Related Links,’’ register by email by contacting the
& Medicaid Services. double-click the ‘‘Clinical Diagnostic person listed in the FOR FURTHER
[FR Doc. 2016–13085 Filed 6–2–16; 8:45 am] Laboratory Tests FACA Panel Meeting INFORMATION CONTACT section of this
BILLING CODE 4120–01–P Registration’’ link and enter the required notice. Presentations should be sent via
information. All the following email to the same person’s email
information must be submitted when address.
DEPARTMENT OF HEALTH AND registering: Meeting Location, Webcast, and
HUMAN SERVICES • Name. Teleconference: The Panel meetings will
• Company name. be held in the Auditorium of the CMS,
Centers for Medicare & Medicaid • Address. Central Office, 7500 Security Boulevard,
Services • Email addresses. Baltimore, Maryland 21244–1850.
[CMS–1666–N] Note: Participants who do not plan to Alternately, the public may either view
attend the Panel meeting in-person on July the Panel meetings via a webcast or
Medicare, Medicaid, and Children’s 18, 2016 should not register. No registration listen by teleconference. During the
Health Insurance Programs; is required for participants who plan to view scheduled Panel meeting, webcasting is
Announcement of the Advisory Panel the Panel meeting via webcast or listen via accessible online at http://cms.gov/live.
on Clinical Diagnostic Laboratory teleconference. Participants planning to Teleconference dial-in information will
attend only the morning session which
Tests Meeting on July 18, 2016 appear on the final Panel meeting
includes the 2016 Laboratory Public Meeting,
or both the morning and afternoon sessions, agenda, which will be posted on the
AGENCY: Centers for Medicare & CMS Web site when available at http://
Medicaid Services (CMS), HHS. should register only once, for the 2016
Laboratory Public Meeting (see instructions cms.gov/Regulations-and-Guidance/
ACTION: Notice. for registering for the 2016 Laboratory Public Guidance/FACA/AdvisoryPanelon
Meeting at 81 FR 29863). Participants ClinicalDiagnosticLaboratoryTests.html.
SUMMARY: This notice announces the planning to attend only the afternoon session Meeting Format: This Panel meeting is
next public meeting date of the of the Panel meeting must register using the open to the public. The on-site check-
Advisory Panel on Clinical Diagnostic above link and instructions.
in for visitors will be held from 8:30
Laboratory Tests (the Panel) on Monday, Presenter Registration and a.m. to 9:00 a.m. on Monday, July 18,
July 18, 2016. The purpose of the Panel Submission of Presentations and 2016, preceding the morning session of
is to advise the Secretary of the Comments: In the morning session only, the 2016 Laboratory Public Meeting, and
Department of Health and Human we are interested in in-person again at 12:30 p.m. for visitors attending
Services (DHHS) and the Administrator presentations concerning the payment only the Panel meeting (afternoon
of the Centers for Medicare & Medicaid methodologies for new or reconsidered session).
Services (CMS) (the Administrator) on laboratory codes. The instructions for During the morning session, the
issues related to clinical diagnostic submitting such comments and Panel, along with the public, will hear
laboratory tests. presentations are also included in 2016 and pose questions to presenters
DATES: Meeting Date: The meeting of the Laboratory Public Meeting notice (81 FR recommending crosswalks or gapfilling
Panel is scheduled for Monday, July 18, 29863). Although these comments and for new and reconsidered laboratory
2016 beginning at 9:00 a.m., Eastern presentations will be made during the codes for calendar year (CY) 2017.
mstockstill on DSK3G9T082PROD with NOTICES
Daylight Time (EDT). The morning morning joint session of the 2016 During the afternoon session, the Panel
session will be held jointly with the Laboratory Public Meeting and Panel will deliberate and make
Public Meeting on New and Meeting, the Panel may wish to ask recommendations to the Secretary of
Reconsidered Clinical Diagnostic follow-up questions to presenters at the HHS and the Acting Administrator of
Laboratory Test Codes for the Clinical afternoon session of the Panel Meeting. CMS regarding crosswalks or gapfilling
Laboratory Fee Schedule (CLFS) for As previously mentioned, additional for new and reconsidered laboratory
Calendar Year (CY) 2017 (the 2016 issues concerning the calendar year (CY) codes discussed during the morning
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![35774 Federal Register / Vol. 81, No. 107 / Friday, June 3, 2016 / Notices
Paperwork Reduction Act of 1995 (44 OMB No.: New Collection. information about MSHS children that
U.S.C. 3501 et seq.). Description: The Office of Planning, programs can use to inform program,
Dated: May 25, 2016. Research and Evaluation (OPRE), center and classroom practices.
Andrew M. Slavitt,
Administration for Children and Data collection will involve mail
Families (ACF), U.S. Department of surveys to selected MSHS center
Acting Administrator, Centers for Medicare
& Medicaid Services.
Health and Human Services, is directors and all MSHS program
proposing an information collection directors nationwide about operational
[FR Doc. 2016–13084 Filed 6–2–16; 8:45 am]
activity for the Migrant and Seasonal characteristics, program- and center-
BILLING CODE 4120–01–P
Head Start (MSHS) Study. level policies and practices, and
The MSHS Study will describe the services and resources offered to MSHS
characteristics and experiences of the families. The study will also conduct
DEPARTMENT OF HEALTH AND
children and families who enroll in on-site data collection with children,
HUMAN SERVICES
MSHS and the practices and services of parents, teachers, and classrooms in a
Administration for Children and the MSHS programs that serve them. nationally-representative sample of
Families The findings will provide up-to-date MSHS centers. The on-site data
information to the Office of Head Start, collection will include classroom
Proposed Information Collection other federal government agencies, local observations, teacher surveys, child
Activity; Comment Request MSHS programs, and the public. The reports and child assessments.
study will be the first national MSHS Respondents: MSHS program
Title: Migrant and Seasonal Head study to include direct child directors, center directors, teachers,
Start Study. assessments, which will provide assistant teachers, parents, and children.
ANNUAL BURDEN ESTIMATES
Total Number of Average Estimated
Instrument number of responses per burden hours annual
respondents respondent per response burden hours
Program Director survey .................................................................................. 53 1 0.5 27
Center Director survey ..................................................................................... 253 1 0.5 127
Call script for Program Directors ..................................................................... 24 1 1 24
Form for Program Directors to verify key information for selected centers .... 24 1 0.5 12
Call script for Center Directors ........................................................................ 53 1 1 53
Call script for On Site Coordinators ................................................................. 53 1 1 53
Classroom sampling form ................................................................................ 53 1 0.5 27
Child roster form .............................................................................................. 53 3 0.25 40
Teacher survey ................................................................................................ 159 1 0.5 80
Teacher child report ......................................................................................... 159 8 0.25 318
Assistant Teacher survey ................................................................................ 159 1 0.25 40
Parent consent form ........................................................................................ 1,018 1 0.25 255
Child assessments (preschoolers and older toddlers only) ............................ 848 1 0.75 636
Parent interview (including Parent child report) .............................................. 1,018 1 1 1,018
Estimated Total Annual Burden Hours: 2,710.
In compliance with the requirements practical utility; (b) the accuracy of the DEPARTMENT OF HEALTH AND
of Section 3506(c)(2)(A) of the agency’s estimate of the burden of the HUMAN SERVICES
Paperwork Reduction Act of 1995, the proposed collection of information; (c)
Administration for Children and the quality, utility, and clarity of the Food and Drug Administration
Families is soliciting public comment information to be collected; and (d)
on the specific aspects of the ways to minimize the burden of the [Docket No. FDA–2016–N–0628]
information collection described above. collection of information on
Copies of the proposed collection of respondents, including through the use Agency Information Collection
information can be obtained and of automated collection techniques or Activities; Submission for Office of
comments may be forwarded by writing other forms of information technology. Management and Budget Review;
to the Administration for Children and Comment Request; Reporting
Consideration will be given to
Families, Office of Planning, Research Associated With New Animal Drug
comments and suggestions submitted
and Evaluation, 330 C Street SW., Applications
within 60 days of this publication.
Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. Email Robert Sargis, AGENCY: Food and Drug Administration,
address: OPREinfocollection@ ACF Certifying Officer.
HHS.
acf.hhs.gov. All requests should be [FR Doc. 2016–13104 Filed 6–2–16; 8:45 am] ACTION: Notice.
identified by the title of the information
mstockstill on DSK3G9T082PROD with NOTICES
BILLING CODE 4184–22–P
collection. SUMMARY: The Food and Drug
The Department specifically requests Administration (FDA) is announcing
comments on (a) whether the proposed that a proposed collection of
collection of information is necessary information has been submitted to the
for the proper performance of the Office of Management and Budget
functions of the agency, including (OMB) for review and clearance under
whether the information shall have the Paperwork Reduction Act of 1995.
VerDate Sep<11>2014 21:20 Jun 02, 2016 Jkt 238001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\03JNN1.SGM 03JNN1](https://thefederalregister.org/doc/81_FR_35879/page/3.svg)
Document Created: 2018-02-08 07:29:37
Document Modified: 2018-02-08 07:29:37
| 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 | Meeting Date: The meeting of the Panel is scheduled for Monday, July 18, 2016 beginning at 9:00 a.m., Eastern Daylight Time (EDT). The morning session will be held jointly with the Public Meeting on New and Reconsidered Clinical Diagnostic Laboratory Test Codes for the Clinical Laboratory Fee Schedule (CLFS) for Calendar Year (CY) 2017 (the 2016 Laboratory Public Meeting) (see 81 FR 29863, May 13, 2016 for notice of the 2016 Laboratory Public Meeting). During the afternoon session, the Panel will deliberate and make recommendations regarding the new and reconsidered laboratory codes for CY 2017. The Panel may also hear public presentations on additional issues concerning the CY 2017 CLFS that are designated in the Panel's charter and specified in the Panel meeting agenda for the afternoon session. | |
| Contact | Glenn C. McGuirk, Designated Federal Official (DFO), Center for Medicare, Division of Ambulatory Services, CMS, 7500 Security Boulevard, Mail Stop C4-01-26, Baltimore, MD 21244, 410-786-5723, email [email protected] or [email protected] Press inquiries are handled through the CMS Press Office at (202) 690- 6145. | |
| FR Citation | 81 FR 35772 |
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