82 FR 58400 - Medicare Program; Extension of Prior Authorization for Repetitive Scheduled Non-Emergent Ambulance Transports
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 82, Issue 237 (December 12, 2017)
Centers for Medicare & Medicaid Services
Federal Register Volume 82, Issue 237 (December 12, 2017)
| Page Range | 58400-58403 | |
| FR Document | 2017-26759 |
[Federal Register Volume 82, Number 237 (Tuesday, December 12, 2017)] [Notices] [Pages 58400-58403] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26759] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-6063-N3] Medicare Program; Extension of Prior Authorization for Repetitive Scheduled Non-Emergent Ambulance Transports AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice announces a 1-year extension of the Medicare Prior Authorization Model for Repetitive Scheduled Non-Emergent Ambulance Transport. The extension of this model is applicable to the following states and the District of Columbia: Delaware, Maryland, New Jersey, North Carolina, Pennsylvania, South Carolina, Virginia, and West Virginia. DATES: This extension began on December 5, 2017 and ends on December 1, 2018. However, prior authorization is available upon provider, supplier, or beneficiary request for dates of service between December 2, 2017 and December 4, 2017. FOR FURTHER INFORMATION CONTACT: Angela Gaston, (410) 786-7409. Questions regarding the Medicare Prior Authorization Model Extension for Repetitive Scheduled Non-Emergent [[Page 58401]] Ambulance Transport should be sent to [email protected]. SUPPLEMENTARY INFORMATION: I. Background Medicare may cover ambulance services, including air ambulance (fixed-wing and rotary-wing) services, if the ambulance service is furnished to a beneficiary whose medical condition is such that other means of transportation are contraindicated. The beneficiary's condition must require both the ambulance transportation itself and the level of service provided in order for the billed service to be considered medically necessary. Non-emergent transportation by ambulance is appropriate if either the--(1) beneficiary is bed-confined and it is documented that the beneficiary's condition is such that other methods of transportation are contraindicated; or (2) beneficiary's medical condition, regardless of bed confinement, is such that transportation by ambulance is medically required. Thus, bed confinement is not the sole criterion in determining the medical necessity of non-emergent ambulance transportation; rather, it is one factor that is considered in medical necessity determinations.\1\ --------------------------------------------------------------------------- \1\ 42 CFR 410.40(d)(1). --------------------------------------------------------------------------- A repetitive ambulance service is defined as medically necessary ambulance transportation that is furnished in 3 or more round trips during a 10-day period, or at least 1 round trip per week for at least 3 weeks.\2\ Repetitive ambulance services are often needed by beneficiaries receiving dialysis or cancer treatment. --------------------------------------------------------------------------- \2\ Program Memorandum Intermediaries/Carriers, Transmittal AB- 03-106. --------------------------------------------------------------------------- Medicare may cover repetitive, scheduled non-emergent transportation by ambulance if the--(1) medical necessity requirements described previously are met; and (2) ambulance provider/supplier, before furnishing the service to the beneficiary, obtains a written order from the beneficiary's attending physician certifying that the medical necessity requirements are met (see 42 CFR 410.40(d)(1) and (2)).\3\ --------------------------------------------------------------------------- \3\ Per 42 CFR 410.40(d)(2), the physician's order must be dated no earlier than 60 days before the date the service is furnished. --------------------------------------------------------------------------- In addition to the medical necessity requirements, the service must meet all other Medicare coverage and payment requirements, including requirements relating to the origin and destination of the transportation, vehicle and staff, and billing and reporting. Additional information about Medicare coverage of ambulance services can be found in 42 CFR 410.40, 410.41, and in the Medicare Benefit Policy Manual (Pub. L. 100-02), Chapter 10, at http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c10.pdf. According to a study published by the Government Accountability Office in October 2012, entitled ``Costs and Medicare Margins Varied Widely; Transports of Beneficiaries Have Increased,'' \4\ the number of basic life support (BLS) non-emergent transports for Medicare Fee-For- Service beneficiaries increased by 59 percent from 2004 to 2010. A similar finding published by the Department of Health and Human Services' Office of Inspector General in a 2006 study, entitled ``Medicare Payments for Ambulance Transports,'' \5\ indicated a 20 percent nationwide improper payment rate for non-emergent ambulance transport. Likewise, in June 2013, the Medicare Payment Advisory Commission published a report \6\ that included an analysis of non- emergent ambulance transports to dialysis facilities and found that, during the 5-year period between 2007 and 2011, the volume of transports to and from a dialysis facility increased 20 percent, more than twice the rate of all other ambulance transports combined. --------------------------------------------------------------------------- \4\ Government Accountability Office Cost and Medicare Margins Varied Widely; Transports of Beneficiaries Have Increased (October 2012). \5\ Office of Inspector General Medicare Payment for Ambulance Transport (January 2006). \6\ Medicare Payment Advisory Commission, June 2013, pages 167- 193. --------------------------------------------------------------------------- Section 1115A of the Social Security Act (the Act) authorizes the Secretary to test innovative payment and service delivery models to reduce program expenditures, while preserving or enhancing the quality of care furnished to Medicare, Medicaid, and Children's Health Insurance Program beneficiaries. Section 1115A(d)(1) of the Act authorizes the Secretary to waive such requirements of Titles XI and XVIII, as well as sections 1902(a)(1), 1902(a)(13), 1903(m)(2)(A)(iii), and 1934 (other than subsections (b)(1)(A) and (c)(5)) of the Act as may be necessary solely for purposes of carrying out section 1115A of the Act with respect to testing models described in section 1115A(b) of the Act. Consistent with this standard, we will continue to waive the same provisions for the extension of this model as have been waived for the initial three years of the model. Additionally, we have determined that the implementation of this model does not require the waiver of any fraud and abuse law, including sections 1128A, 1128B, and 1877 of the Act. Thus providers and suppliers affected by this model must comply with all applicable fraud and abuse laws. In the November 14, 2014 Federal Register (79 FR 68271), we published a notice entitled ``Medicare Program; Prior Authorization of Repetitive Scheduled Non-emergent Ambulance Transports,'' which announced the implementation of a 3-year Medicare Prior Authorization model that established a process for requesting prior authorization for repetitive, scheduled non-emergent ambulance transport rendered by ambulance providers/suppliers garaged in 3 states (New Jersey, Pennsylvania, and South Carolina). These states were selected as the initial states for the model because of their high utilization and improper payment rates for these services. The model began on December 1, 2014, and was originally scheduled to end in all 3 states on December 1, 2017. In the October 23, 2015 Federal Register (80 FR 64418), we published a notice titled ``Medicare Program; Expansion of Prior Authorization of Repetitive Scheduled Non-emergent Ambulance Transports,'' which announced the inclusion of 6 additional states (Delaware, the District of Columbia, Maryland, North Carolina, West Virginia, and Virginia) in the Repetitive Scheduled Non-Emergent Ambulance Transport Prior Authorization model in accordance with section 515(a) of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10). These 6 states began participation on January 1, 2016, and the model was originally scheduled to end in all nine model states on December 1, 2017. II. Provisions of the Notice This notice announces that the Medicare Prior Authorization Model for Repetitive Scheduled Non-Emergent Ambulance Transport is being extended in the current model states of Delaware, the District of Columbia, Maryland, New Jersey, North Carolina, Pennsylvania, South Carolina, Virginia, and West Virginia, effective December 5, 2017, for an additional year to allow for additional evaluation of the model. Repetitive, scheduled non-emergent ambulance transport claims with dates of service of December 2, 2017 through December 4, 2017 will not be stopped for prepayment review if prior authorization is not requested before the fourth round trip in a 30-day period; however, providers, suppliers, and beneficiaries may request prior authorization for these dates of service. The model will now end in all states on December 1, 2018. Prior authorization will not be available for repetitive [[Page 58402]] scheduled non-emergent ambulance transportation services furnished after that date. We will continue to test whether prior authorization helps reduce expenditures, while maintaining or improving quality of care, using the established prior authorization process for repetitive, scheduled non- emergent ambulance transport to reduce utilization of services that do not comply with Medicare policy. We will continue to use this prior authorization process to help ensure that all relevant clinical or medical documentation requirements are met before services are furnished to beneficiaries and before claims are submitted for payment. This prior authorization process further helps to ensure that payment complies with Medicare documentation, coverage, payment, and coding rules. The use of prior authorization does not create new clinical documentation requirements. Instead, it requires the same information that is already required to support Medicare payment, just earlier in the process. Prior authorization allows providers and suppliers to address coverage issues prior to furnishing services. The prior authorization process under this model will continue to apply in the nine states listed previously for the following codes for Medicare payment:A0426 Ambulance service, advanced life support, non- emergency transport, Level 1 (ALS1). A0428 Ambulance service, BLS, non-emergency transport. While prior authorization is not needed for the mileage code, A0425, a prior authorization decision for an A0426 or A0428 code will automatically include the associated mileage code. We have conducted and will continue to conduct outreach and education to ambulance providers/suppliers, as well as beneficiaries, through such methods as updating the operational guide, frequently asked questions (FAQs) on our website, a physician letter explaining the ambulance providers/suppliers' need for the proper documentation, and educational events and materials issued by the Medicare Administrative Contractors (MACs). We are also working to implement a new process that will help identify alternate transportation resources for beneficiaries who receive non-affirmative decisions. Additional information about the implementation of the prior authorization model is available on the CMS website at http://go.cms.gov/PAAmbulance. Under this model, submitting a prior authorization request is voluntary. However, an ambulance provider/supplier or beneficiary is encouraged to submit to the MAC a request for prior authorization along with all relevant documentation to support Medicare coverage of a repetitive, scheduled non-emergent ambulance transport. If prior authorization has not been requested by the fourth round trip in a 30- day period, the subsequent claims will be stopped for prepayment review. In order for a prior authorization request to be provisionally affirmed, the request for prior authorization must meet all applicable rules and policies, including any local coverage determination (LCD) requirements for ambulance transport claims. A provisional affirmation is a preliminary finding that a future claim submitted to Medicare for the service likely meets Medicare's coverage, coding, and payment requirements. After receipt of all relevant documentation, the MACs will make every effort to conduct a review and postmark the notification of their decision on a prior authorization request within 10 business days for an initial submission. Notification will be provided to the ambulance provider/supplier and to the beneficiary. If a subsequent prior authorization request is submitted after a non- affirmative decision on an initial prior authorization request, the MACs will make every effort to conduct a review and postmark the notification of their decision on the resubmitted request within 20 business days. An ambulance provider/supplier or beneficiary may request an expedited review when the standard timeframe for making a prior authorization decision could jeopardize the life or health of the beneficiary. If the MAC agrees that the standard review timeframe would put the beneficiary at risk, the MAC will make reasonable efforts to communicate a decision within 2 business days of receipt of all applicable Medicare-required documentation. As this model is for non- emergent services only, we expect requests for expedited reviews to be extremely rare. A provisional affirmative prior authorization decision may affirm a specified number of trips within a specific amount of time. The prior authorization decision, justified by the beneficiary's condition, may affirm up to 40 round trips (which equates to 80 one-way trips) per prior authorization request in a 60-day period. Alternatively, a provisional affirmative decision may affirm less than 40 round trips in a 60-day period, or may affirm a request that seeks to provide a specified number of transports (40 round trips or less) in less than a 60-day period. A provisional affirmative decision can be for all or part of the requested number of trips. Transports exceeding 40 round trips (or 80 one-way trips) in a 60-day period require an additional prior authorization request. The following describes examples of various prior authorization scenarios: Scenario 1: When an ambulance provider/supplier or beneficiary submits a prior authorization request to the MAC with appropriate documentation and all relevant Medicare coverage and documentation requirements are met for the ambulance transport, the MAC will send a provisional affirmative prior authorization decision to the ambulance provider/supplier and the beneficiary. When the subsequent claim is submitted to the MAC by the ambulance provider/supplier, it is linked to the prior authorization decision via the claims processing system, and the claim will be paid so long as all Medicare coding, billing, and coverage requirements are met. However, the claim could be denied for technical reasons, such as the claim was a duplicate claim or the claim was for a deceased beneficiary. In addition, a claim denial could occur because certain documentation, such as the trip record, needed in support of the claim cannot be submitted with a prior authorization request because it is not available until after the service is provided. Scenario 2: When an ambulance provider/supplier or beneficiary submits a prior authorization request, but all relevant Medicare coverage requirements are not met, the MAC will send a non- affirmative prior authorization decision to the ambulance provider/ supplier and to the beneficiary advising them that Medicare will not pay for the service. The provider/supplier or beneficiary may then resubmit the request with additional documentation showing that Medicare requirements have been met. Alternatively, an ambulance provider/supplier could furnish the service and submit a claim with a non-affirmative prior authorization tracking number, at which point the MAC would deny the claim. The ambulance provider/supplier and the beneficiary would then have the Medicare denial for secondary insurance purposes and would have the opportunity to submit an appeal of the claim denial if they think Medicare coverage was denied inappropriately. Scenario 3: When an ambulance provider/supplier or beneficiary submits a prior authorization request with incomplete documentation, a detailed decision letter will be sent to the ambulance provider/supplier and to the beneficiary, with an explanation of what [[Page 58403]] information is missing. The ambulance provider/supplier or beneficiary can rectify the error(s) and resubmit the prior authorization request with appropriate documentation. Scenario 4: If an ambulance provider or supplier renders a service to a beneficiary and does not request prior authorization by the fourth round trip in a 30-day period, and the claim is submitted to the MAC for payment, then the claim will be stopped for prepayment review and documentation will be requested. ++ If the claim is determined to be for services that were not medically necessary or for which there was insufficient documentation, the claim will be denied, and all current policies and procedures regarding liability for payment will apply. The ambulance provider/ supplier or the beneficiary, or both, can appeal the claim denial if they believe the denial was inappropriate. ++ If the claim is determined to be payable, it will be paid. Under the model, we will work to limit any adverse impact on beneficiaries and to educate beneficiaries about the process. If a prior authorization request is non-affirmed, and the claim is still submitted by the ambulance provider/supplier, the claim will be denied, but beneficiaries will continue to have all applicable administrative appeal rights. We will also work to implement a process that will help identify alternate transportation resources for beneficiaries who receive non-affirmative decisions. Only one prior authorization request per beneficiary per designated time period can be provisionally affirmed. If the initial ambulance provider/supplier cannot complete the total number of prior authorized transports (for example, the initial ambulance company closes or no longer services that area), the initial request is cancelled. In this situation, a subsequent prior authorization request may be submitted for the same beneficiary and must include the required documentation in the submission. If multiple ambulance providers/suppliers are providing transports to the beneficiary during the same or overlapping time period, the prior authorization decision will only cover the ambulance provider/supplier indicated in the provisionally affirmed prior authorization request. Any ambulance provider/supplier submitting claims for repetitive, scheduled non-emergent ambulance transports for which no prior authorization request is submitted by the fourth round trip in a 30-day period will be subject to 100 percent prepayment medical review of those claims. Additional information is available on the CMS website at http://go.cms.gov/PAAmbulance. III. Collection of Information Requirements Section 1115A(d)(3) of the Act states that chapter 35 of title 44, United States Code (the Paperwork Reduction Act of 1995), shall not apply to the testing and evaluation of models or expansion of such models under this section. Consequently, this document need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995. IV. Regulatory Impact Statement This document announces a 1-year extension of the Medicare Prior Authorization Model for Repetitive Scheduled Non-Emergent Ambulance Transport. Therefore, there are no regulatory impact implications associated with this notice. Authority: Section 1115A of the Social Security Act. Dated: November 16, 2017. Seema Verma, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2017-26759 Filed 12-8-17; 4:15 pm] BILLING CODE 4120-01-P
![58400 Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices
margin requirements for derivatives that Treasury repo transactions in the GCF The Regulatory Flexibility Act (5
reference SOFR and would help market market, and FICC-cleared bilateral U.S.C. 601 et seq.) (RFA) generally
participants compare SOFR to existing Treasury repo transactions. For each of requires an agency to perform an initial
benchmarks. The Board recognizes that these market segments, each dealer will and a final regulatory flexibility analysis
market participants might benefit from report its aggregate borrowing activity on the impact a rule is expected to have
historical data. While longer histories of (excluding, to the extent possible, on small entities. The RFA imposes
comparable commercially produced transactions between affiliated entities these requirements in situations where
repo rates are publicly available, the and transactions in which the Federal an agency is required by law to publish
Board believes that a significantly Reserve is a counterparty), along with a general notice of proposed rulemaking
longer history of the Treasury repo rates the weighted-average rate of its for any proposed rule. The production
may not be possible due to limitations borrowing. If FRBNY publishes of the rates does not create any
on the availability of data. The Board Treasury repo rates that use survey data obligations or rights for any private
and FRBNY will work with BNYM and and subsequently receives updated data, parties, including any small entities,
DTCC to determine whether FRBNY can FRBNY would issue same-day revisions and so the Board was not required to
publish additional historical data for the at or around 2:30 p.m. ET if the use of publish a notice of proposed
Treasury repo rates. updated data would result in the rulemaking. Accordingly, the RFA does
Two commenters suggested that the published rate changing by more than not apply and an initial and final
proposed threshold of ‘‘greater than one one basis point. regulatory flexibility analysis is not
basis point’’ for revising the proposed Finally, two commenters asked that required.
rates was too sensitive. Another FRBNY begin publishing the Treasury The Board did not receive any
commenter explained that its members repo rates as soon as possible. FRBNY comments regarding the Paperwork
had not achieved consensus on the intends to begin publishing the Treasury Reduction Act or the RFA.
threshold at which FRBNY should repo rates in the second quarter of 2018. By order of the Board of Governors of the
revise errors, but the commenter Federal Reserve System, December 7, 2017.
emphasized that FRBNY should 4. Governance
Ann E. Misback,
articulate a clear rationale for its
A commenter suggested that Secretary of the Board.
revision policy. The Board notes that,
governance arrangements for the [FR Doc. 2017–26761 Filed 12–11–17; 8:45 am]
because FRBNY will round the Treasury
Treasury repo rates should align with
repo rates to the nearest whole basis BILLING CODE 6210–01–P
point, the threshold is effectively two the Principles for Financial Benchmarks
basis points. The Board also notes that published by the International
this is the same threshold employed for Organization of Securities Commissions DEPARTMENT OF HEALTH AND
EFFR and OBFR, for which revisions are (IOSCO) in July 2013.12 FRBNY plans to HUMAN SERVICES
very rare. The Federal Reserve will publish an IOSCO statement of
periodically review the revision compliance covering the Treasury repo Centers for Medicare & Medicaid
threshold to ensure that revisions are rates in the first half of 2018. Services
very rare and do not impose undue III. Conclusion [CMS–6063–N3]
operational costs on users of the
Treasury repo rates. After considering public comments, Medicare Program; Extension of Prior
A commenter asked whether FRBNY the Board concludes that the public Authorization for Repetitive Scheduled
would publish the proposed rates if would benefit if FRBNY publishes the Non-Emergent Ambulance Transports
relevant data sources were unavailable three Treasury repo rates as proposed,
and, if so, whether FRBNY would with certain modifications described AGENCY: Centers for Medicare &
correct such rates retroactively when above. Medicaid Services (CMS), HHS.
data becomes available. Another ACTION: Notice.
IV. Administrative Law
commenter suggested that FRBNY SUMMARY: This notice announces a 1-
should provide more information In accordance with the Paperwork
year extension of the Medicare Prior
regarding the back-up repo market Reduction Act of 1995 (44 U.S.C. 3506;
Authorization Model for Repetitive
survey it would conduct if standard data 5 CFR part 1320, Appendix A.1), the
Scheduled Non-Emergent Ambulance
sources are unavailable. As noted in the Board reviewed the Request for
Transport. The extension of this model
Request for Information, in the event Information and this final notice under
is applicable to the following states and
that data sources are unavailable, the the authority delegated to the Board by
the District of Columbia: Delaware,
Treasury repo rates would be calculated the Office of Management and Budget.
Maryland, New Jersey, North Carolina,
based upon back-up repo market survey For purposes of calculating burden
Pennsylvania, South Carolina, Virginia,
data collected from FRBNY’s primary under the Paperwork Reduction Act, a
and West Virginia.
dealer counterparties. FRBNY currently ‘‘collection of information’’ involves 10
DATES: This extension began on
collects repo data from primary dealers or more respondents. As noted above,
each morning. Going forward, FRBNY the data to be used to produce the rates December 5, 2017 and ends on
will also collect data each afternoon. will be obtained solely from (1) BNYM December 1, 2018. However, prior
The afternoon survey will capture that with respect to tri-party GC repo data authorization is available upon
day’s activity by primary dealers and and (2) DTCC Solutions with respect to provider, supplier, or beneficiary
will be available as a contingency data GCF repo data and DVP bilateral repo request for dates of service between
ethrower on DSK3G9T082PROD with NOTICES
source for the following morning’s data. Therefore, producing the rates will December 2, 2017 and December 4,
publication of the Treasury repo rates. not involve a collection of information 2017.
The survey will request aggregated pursuant to the Paperwork Reduction FOR FURTHER INFORMATION CONTACT:
primary dealer activity in each of the Act. Angela Gaston, (410) 786–7409.
market segments captured in the Questions regarding the Medicare Prior
Treasury repo rates: Overnight tri-party 12 See https://www.iosco.org/library/pubdocs/pdf/ Authorization Model Extension for
Treasury repo transactions, overnight IOSCOPD415.pdf. Repetitive Scheduled Non-Emergent
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![Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices 58403
information is missing. The ambulance percent prepayment medical review of comments be faxed to the Office of
provider/supplier or beneficiary can those claims. Information and Regulatory Affairs,
rectify the error(s) and resubmit the Additional information is available on OMB, Attn: FDA Desk Officer, Fax:
prior authorization request with the CMS website at http://go.cms.gov/ 202–395–7285, or emailed to oira_
appropriate documentation. PAAmbulance. submission@omb.eop.gov. All
• Scenario 4: If an ambulance comments should be identified with the
provider or supplier renders a service to III. Collection of Information
OMB control number 0910–0001. Also
a beneficiary and does not request prior Requirements
include the FDA docket number found
authorization by the fourth round trip in Section 1115A(d)(3) of the Act states in brackets in the heading of this
a 30-day period, and the claim is that chapter 35 of title 44, United States document.
submitted to the MAC for payment, then Code (the Paperwork Reduction Act of
FOR FURTHER INFORMATION CONTACT:
the claim will be stopped for 1995), shall not apply to the testing and
prepayment review and documentation evaluation of models or expansion of Domini Bean, Office of Operations,
will be requested. such models under this section. Food and Drug Administration, Three
++ If the claim is determined to be for Consequently, this document need not White Flint North, 10A–12M, 11601
services that were not medically be reviewed by the Office of Landsdown St., North Bethesda, MD
necessary or for which there was Management and Budget under the 20852, 301–796–5733, PRAStaff@
insufficient documentation, the claim authority of the Paperwork Reduction fda.hhs.gov.
will be denied, and all current policies Act of 1995. SUPPLEMENTARY INFORMATION: In
and procedures regarding liability for compliance with 44 U.S.C. 3507, FDA
payment will apply. The ambulance IV. Regulatory Impact Statement
has submitted the following proposed
provider/supplier or the beneficiary, or This document announces a 1-year collection of information to OMB for
both, can appeal the claim denial if they extension of the Medicare Prior review and clearance.
believe the denial was inappropriate. Authorization Model for Repetitive
++ If the claim is determined to be Scheduled Non-Emergent Ambulance Application for FDA Approval To
payable, it will be paid. Transport. Therefore, there are no Market a New Drug
Under the model, we will work to regulatory impact implications OMB Control Number 0910–0001—
limit any adverse impact on associated with this notice. Extension
beneficiaries and to educate
Authority: Section 1115A of the Social Under section 505(a) of the Federal
beneficiaries about the process. If a prior
Security Act. Food, Drug, and Cosmetic Act (the
authorization request is non-affirmed,
and the claim is still submitted by the Dated: November 16, 2017. FD&C Act) (21 U.S.C. 355(a)), a new
ambulance provider/supplier, the claim Seema Verma, drug may not be commercially marketed
will be denied, but beneficiaries will Administrator, Centers for Medicare & in the United States, imported, or
continue to have all applicable Medicaid Services. exported from the United States, unless
administrative appeal rights. We will [FR Doc. 2017–26759 Filed 12–8–17; 4:15 pm] an approval of an application filed with
also work to implement a process that BILLING CODE 4120–01–P
FDA under section 505(b) or (j) of the
will help identify alternate FD&C Act is effective with respect to
transportation resources for such drug. The Agency has codified
beneficiaries who receive non- DEPARTMENT OF HEALTH AND regulations regarding applications for
affirmative decisions. HUMAN SERVICES FDA approval to market a new drug
Only one prior authorization request under 21 CFR part 314. This collection
per beneficiary per designated time Food and Drug Administration of information supports the regulatory
period can be provisionally affirmed. If [Docket No. FDA–2013–N–0523] requirements found in those regulations.
the initial ambulance provider/supplier The collection of information is
cannot complete the total number of Agency Information Collection necessary for FDA to make a scientific
prior authorized transports (for Activities: Submission for Office of and technical determination whether
example, the initial ambulance Management and Budget Review; the product is safe and effective for use,
company closes or no longer services Comment Request; Applications for and is summarized as follows:
that area), the initial request is Food and Drug Administration Section 314.50(a) requires that an
cancelled. In this situation, a Approval To Market a New Drug application form (Form FDA 356h) be
subsequent prior authorization request submitted that includes information
may be submitted for the same AGENCY: Food and Drug Administration, about the applicant, the submission, and
beneficiary and must include the HHS. a checklist of enclosures.
required documentation in the ACTION: Notice. Section 314.50(b) requires that an
submission. If multiple ambulance index be submitted with the archival
providers/suppliers are providing SUMMARY: The Food and Drug copy of the application and that it
transports to the beneficiary during the Administration (FDA) is announcing reference certain sections of the
same or overlapping time period, the that a proposed collection of application.
prior authorization decision will only information has been submitted to the Section 314.50(c) requires that a
cover the ambulance provider/supplier Office of Management and Budget summary of the application be
indicated in the provisionally affirmed (OMB) for review and clearance under submitted that presents a good general
ethrower on DSK3G9T082PROD with NOTICES
prior authorization request. Any the Paperwork Reduction Act of 1995. synopsis of all the technical sections
ambulance provider/supplier submitting DATES: Fax written comments on the and other information in the
claims for repetitive, scheduled non- collection of information by January 11, application.
emergent ambulance transports for 2018. Section 314.50(d) requires that the
which no prior authorization request is ADDRESSES: To ensure that comments on new drug application (NDA) contain the
submitted by the fourth round trip in a the information collection are received, following technical sections about the
30-day period will be subject to 100 OMB recommends that written new drug: Chemistry, manufacturing,
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Document Created: 2018-10-25 10:49:01
Document Modified: 2018-10-25 10:49:01
| 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 | This extension began on December 5, 2017 and ends on December 1, 2018. However, prior authorization is available upon provider, supplier, or beneficiary request for dates of service between December 2, 2017 and December 4, 2017. | |
| Contact | Angela Gaston, (410) 786-7409. Questions regarding the Medicare Prior Authorization Model Extension for Repetitive Scheduled Non-Emergent Ambulance Transport should be sent to [email protected] | |
| FR Citation | 82 FR 58400 |
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