Request for Information; Reducing Administrative Burden To Put Patients Over Paperwork, 27070-27072 [2019-12215]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 84, Number 112 (Tuesday, June 11, 2019)]
[Proposed Rules]
[Pages 27070-27072]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12215]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Ch. IV

[CMS-6082-NC]
RIN 0938-ZB54


Request for Information; Reducing Administrative Burden To Put 
Patients Over Paperwork

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS; Department 
of the Treasury.

ACTION: Request for information.

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SUMMARY: CMS is committed to transforming the health care delivery 
system--and the Medicare and Medicaid programs--by putting additional 
focus on patient-centered care, innovation, and outcomes. As part of 
our continuing Patients over Paperwork initiative, we have actively 
solicited feedback from the medical community through Requests for 
Information (RFIs), listening sessions, and clinical onsite engagements 
with front-line clinicians and staff to learn how our administrative 
requirements and processes affect their daily work and ability to 
innovate in care delivery. This RFI solicits additional public comment 
on ideas for regulatory, subregulatory, policy, practice, and 
procedural changes that reduce unnecessary administrative burdens for 
clinicians, providers, patients and their families. Through these 
efforts, we aim to increase quality of care, lower costs, improve 
program integrity, and make the health care system more effective, 
simple, and accessible.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on August 12, 2019.

ADDRESSES: In commenting, refer to file code CMS-6082-NC. Because of 
staff and resource limitations, we cannot accept comments by facsimile 
(FAX) transmission.
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulation to https://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-6082-NC, P.O. Box 8016, 
Baltimore, MD 21244-8016.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-6082-NC, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Morgan Taylor, Centers for Medicare & 
Medicaid Services, Department of Health and Human Services, at (410) 
786-3458.
    Mary G. Greene, Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, at (410) 786-1244.

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments 
received before the close of the comment period are available for

[[Page 27071]]

viewing by the public, including any personally identifiable or 
confidential business information that is included in a comment. We 
post all comments received before the close of the comment period on 
the following website as soon as possible after they have been 
received: https://www.regulations.gov. Follow the search instructions on 
that website to view public comments.

I. Background

    CMS is committed to transforming the health care delivery system--
and the Medicare and Medicaid programs--by putting additional focus on 
patient-centered care, innovation, and outcomes. Our top priority is 
putting patients first and empowering them to make the best decisions 
for themselves and their families. Our continued goal is to eliminate 
overly burdensome and unnecessary regulations and subregulatory 
guidance in order to allow clinicians and providers to spend less time 
on paperwork and more time on their primary mission--improving their 
patients' health. We are also modernizing or eliminating outdated 
regulations to remove barriers to innovation. By reducing unnecessary 
paperwork, we are unleashing the most powerful force in our healthcare 
system for improving health outcomes: The clinician-patient 
relationship.
    We launched our Patients over Paperwork initiative in 2017 to focus 
all of CMS on finding opportunities to modernize or eliminate rules and 
requirements that are outdated, duplicative, or getting in the way of 
good patient care. Public input has been critical to CMS achieving more 
flexibilities and efficiencies. As part of the Patients over Paperwork 
initiative, we actively solicited feedback from the medical community 
through requests for information (RFI), listening sessions, and 
clinical onsite engagements with front-line clinicians and staff to 
learn how our administrative requirements and processes affect their 
daily work and ability to innovate in care delivery. Through the RFI 
process alone, we received over 3,000 responses that outlined current 
burden and recommendations, which resulted in 1,146 distinct burden 
topics to address. Topics included, but were not limited to: Audits and 
Claims; Documentation Requirements; Health Information Technology; 
Interoperability; Provider Participation Requirements; Quality Measures 
and Reporting; Payment Policy and Coverage Determinations; the 
Physician Self-Referral Law; and Telehealth.
    Over 2,000 clinicians, administrative staff and leaders, and 
beneficiaries have participated in our listening sessions and onsite 
engagements and we continue to send teams out into the field to learn 
more. This fieldwork helped elucidate how our rules affect workflow and 
decision-making, and potentially impede innovation. As of February 8, 
2019, after reviewing and adjudicating all 1,146 burden topics with 
executive leadership across the agency, we have resolved or are 
actively addressing over 80 percent of the actionable RFI burden topics 
through changes to our regulations, subregulatory guidance, operations, 
or direct education and outreach to providers and beneficiaries. Please 
see the Appendix for a sample of what we have accomplished so far.
    As we continue to work to maintain flexibility and efficiency 
throughout the Medicare and Medicaid programs, we would like to 
continue our national conversation about improvements that can be made 
to the health care delivery system that reduce unnecessary burdens for 
clinicians, providers, and patients and their families. Through these 
efforts, we aim to increase quality of care, lower costs, improve 
program integrity, and make the health care system more effective, 
simple, and accessible. For these reasons, we are seeking comments on 
additional opportunities for improvement through this RFI.

II. Solicitation of Public Comments

    We invite the public to submit ideas for regulatory, subregulatory, 
policy, practice, and procedural changes to better accomplish these 
goals. Specifically, we are soliciting new ideas not conveyed during 
our first RFI on this matter and innovative ideas that may help broaden 
perspectives about potential solutions. Ideas may include, but are not 
limited to:
     Modification or streamlining of reporting requirements, 
documentation requirements, or processes to monitor compliance to CMS 
rules and regulations;
     Aligning of Medicare, Medicaid and other payer coding, 
payment and documentation requirements, and processes;
     Enabling of operational flexibility, feedback mechanisms, 
and data sharing that would enhance patient care, support the 
clinician-patient relationship, and facilitate individual preferences; 
and
     New recommendations regarding when and how CMS issues 
regulations and policies and how CMS can simplify rules and policies 
for beneficiaries, clinicians, and providers.
    We are particularly interested in recommendations on how CMS could:
     Improve the accessibility and presentation of CMS 
requirements for quality reporting, coverage, documentation, or prior-
authorization;
     Address specific policies or requirements that are overly 
burdensome, not achievable, or cause unintended consequences in a rural 
setting;
     Clarify or simplify regulations or operations that pose 
challenges for beneficiaries dually enrolled in both Medicare and 
Medicaid and those who care for such beneficiaries; and
     Simplify beneficiary enrollment and eligibility 
determination across programs.
    We are requesting respondents provide complete, clear, and concise 
comments that include, where practicable, data and specific examples.

III. Collection of Information Requirements

    Please note, this is a request for information (RFI) only. In 
accordance with the implementing regulations of the Paperwork Reduction 
Act of 1995 (PRA), specifically 5 CFR 1320.3(h)(4), this general 
solicitation is exempt from the PRA. Facts or opinions submitted in 
response to general solicitations of comments from the public, 
published in the Federal Register or other publications, regardless of 
the form or format thereof, provided that no person is required to 
supply specific information pertaining to the commenter, other than 
that necessary for self-identification, as a condition of the agency's 
full consideration, are not generally considered information 
collections and therefore not subject to the PRA.
    We note that this is a RFI only. This RFI is issued solely for 
information and planning purposes; it does not constitute a Request for 
Proposal (RFP), applications, proposal abstracts, or quotations. This 
RFI does not commit the U.S. Government to contract for any supplies or 
services or make a grant award. Further, we are not seeking proposals 
through this RFI and will not accept unsolicited proposals. Responders 
are advised that the U.S. Government will not pay for any information 
or administrative costs incurred in response to this RFI; all costs 
associated with responding to this RFI will be solely at the interested 
party's expense. We note that not responding to this RFI does not 
preclude participation in any future procurement, if conducted. It is 
the responsibility of the potential responders to monitor this RFI

[[Page 27072]]

announcement for additional information pertaining to this request. In 
addition, we note that CMS will not respond to questions about the 
policy issues raised in this RFI.
    We will actively consider all input as we develop future regulatory 
proposals or future subregulatory policy guidance. We may or may not 
choose to contact individual responders. Such communications would be 
for the sole purpose of clarifying statements in the responders' 
written responses. Contractor support personnel may be used to review 
responses to this RFI. Responses to this notice are not offers and 
cannot be accepted by the Government to form a binding contract or 
issue a grant. Information obtained as a result of this RFI may be used 
by the Government for program planning on a non-attribution basis. 
Respondents should not include any information that might be considered 
proprietary or confidential. This RFI should not be construed as a 
commitment or authorization to incur cost for which reimbursement would 
be required or sought. All submissions become U.S. Government property 
and will not be returned. In addition, we may publically post the 
public comments received, or a summary of those public comments.

    Dated: April 22, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
    Dated: June 3, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.

Appendix: Patients over Paperwork Sample Accomplishments

    The following is a sample of CMS accomplishments reducing 
unnecessary administrative burden in response to input from 
clinicians, providers, beneficiaries, and other stakeholders. For 
more Patients over Paperwork highlights, visit https://www.cms.gov/About-CMS/story-page/patients-over-paperwork.html.

Reducing Regulatory Burden

     Removed data elements from the Outcomes and Assessment 
Information Set (OASIS) assessment instrument.
     Removed the inpatient admission order documentation 
requirement in an effort to reduce duplicative documentation 
requirements at the time of admission.
     Removed the requirement that certification/
recertification statements detail where in the medical record the 
required information can be found.
     Established the innovative new classification system, 
the Patient Driven Payment Model (PDPM), that ties skilled nursing 
facility payments to patients' conditions and care needs rather than 
volume of services provided, and simplifies complicated paperwork 
requirements for performing patient assessments by significantly 
reducing reporting burden.
     Eliminated the requirement that certifying physicians 
estimate how much longer skilled services are required when 
recertifying the need for continued home health care.
     Proposed giving facilities the flexibility to review 
their emergency program every 2 years, or more often at their own 
discretion, in order to best address their individual needs.
     Proposed allowing multi-hospital systems to have 
unified and integrated Quality Assessment and Performance 
Improvement (QAPI) and unified infection control programs for all of 
its member hospitals.
     Published a proposed rule to streamline Medicaid & CHIP 
managed care regulation.
     Issued Medicare Advantage (MA) and the prescription 
drug benefit program (Part D) final rule that promotes innovation, 
empowers patients and providers to make healthcare decisions, and 
includes burden-reducing provisions.

Simplifying Documentation Requirements

     Changed policy to allow a teaching physician to rely on 
medical student documentation and verify it rather than re-
documenting the evaluation and management (E&M) service, and 
explained that the physician's signature and date is acceptable 
verification of the medical student's documentation.
     Provided an exception so that physicians acting as 
suppliers do not need to write orders to themselves.
     Simplified the requirements for preliminary/verbal 
Durable Medical Equipment, Prosthetics, Orthotics, and Supplies 
(DMEPOS) orders: Suppliers may dispense most items of DMEPOS based 
on a verbal order or preliminary written order from the treating 
physician.
     Clarified DMEPOS written order prior to delivery date 
requirements: If the written order is dated the day of or prior to 
delivery, there is no need for affirmative documentation of it being 
``received''.
     Clarified that a supplier can use the discharge date as 
the date of service if mailing 1 or 2 days before discharge.
     Released a newly revised Skilled Nursing Facility 
Advanced Beneficiary Notice (SNFABN) with concise instructions and 
no longer using the 5 denial letters and Notice of Exclusion from 
Medicare Benefits--SNF.

Focusing on Meaningful Measures

     Our Meaningful Measures initiative is centered on 
holding providers accountable for patient health outcomes, safe and 
efficient care, and making sure the measure sets providers are asked 
to report on are meaningful to patients and clinicians alike.
     Reduced the burden of reporting quality measures in 
MIPS with a focus on reporting through electronic means and 
incentivizing the use of clinical registries.

Improving Operational Efficiencies and Interoperability

     In implementing the Quality Payment Program (QPP), 
established a consolidated data submission experience for the 
different performance categories of the Merit-based Incentive 
Payment System (MIPS) so that clinicians no longer need to submit 
data in multiple systems as under the legacy programs (the Physician 
Quality Reporting System (PQRS) and the Medicare Electronic Health 
Record (EHR) Incentive Program).
     Refocused the Medicare EHR Incentive Program (now 
called the Promoting Interoperability Program) on interoperability, 
emphasizing exchange of health information between patients and 
providers.
     Implemented changes resulting in faster processing of 
state requests to make program or benefit changes to their Medicaid 
program through the state plan amendment (SPA) and section 1915 
waiver review process.

Enhancing Transparency and Consistency

    Made significant changes to the Medicare Program Integrity 
Manual Chapter 13 to improve transparency in the Local Coverage 
Determination process. The manual includes instructions, policies 
and procedures for Medicare Administrative Contractors (MAC) that 
administer the Medicare program in different regions of the country, 
as well as guidance for stakeholder engagement in the process.

Offering Burden-Reducing Flexibilities in Payment Model Demonstrations

     In the Bundled Payments for Care Improvement Advanced 
(BPCI Advanced) model, CMS issued the Post-Discharge Home Visit 
Payment Policy waiver which allows for certain services to be 
delivered in the eligible model beneficiary's home by auxiliary 
personnel under the general supervision of a participating 
practitioner.
     In the Next Generation Accountable Care Organization 
(Next Gen ACO) model, CMS issued the Telehealth Expansion waiver 
which allows for eligible model beneficiaries to receive Telehealth 
services in their home.

[FR Doc. 2019-12215 Filed 6-6-19; 11:15 am]
 BILLING CODE 4120-01-P