August 14, 2013 COF Bi-

Monthly Call

Questions or comments?

Contact Ivy Baer: ibaer@aamc.org or

202-828-0499

OPPS –Comment Period Is NOW

Comments Due 9/6

Hospital Outpatient Services

Proposal (OPPS)

• On the hospital side, eliminate current 5 levels for clinic and ED hospital outpatient visits and replace with 3 codes:

Clinic visit

Type A ED visit (ED open 24/7)

Type B ED visit

• No distinction between new and established patients on the hospital side

• COMMENTS?

“Incident to” Proposal (PFS and

OPPS)

Codify requirement to allow “incident to” billing only for services and supplies that are furnished in accordance with applicable state law (modification to 42 CFR §410.26)

• Individual performing the services will have to meet applicable state requirements, including licensure (Medicare already requires auxiliary personnel to comply with state law)

• Will modify regulations for rural health clinics, and FQHCs to be consistent with this change

Reaction?

CMS Proposal on Payment for

IDE Devices

CMS currently has requirements that allow for Medicare payment for routine items and services related to Category A devices in some cases (decided by Medicare contractors) for Category B devices

CMS is proposing to replace the current system with 13 requirements that must be met for Category A devices and 15 requirements for Category B devices.

To read the proposed rule go to the Federal Register, July 19, 2013, pages 43342-43347:

http://www.gpo.gov/fdsys/pkg/FR-2013-07-19/pdf/2013-16547.pdf

Category A IDE Devices

Coverage for certain routine costs; no coverage for Category A device

NCD process for Category A replaced by 13 study standards:

1. Principal purpose of study: whether item or service meaningful improves health outcomes of pts who are represented by M’care-enrolled subjects [ethical]

2. Rationale for study well supported by available scientific and medical information, or intended to clarify of establish health outcomes of interventions already in common clinical use [ethical]

3. Study results are not anticipated to unjustifiably duplicate existing knowledge [ethical]

Study Standards 4-8

4. Study design methodologically appropriate; anticipated number of enrolled subjects appropriate to answer research question [ethical]

5. Study sponsored by organization of individual capable of completing it successfully [egregious misconduct]

6. Study in compliance with all applicable federal regulations at 45 CFR part 46 [egregious misconduct]

7. All aspects of study conducted according to standards set by International Committee of Medical Journal Editors [ethical]

8. Study has written protocol that clearly demonstrates adherence to standards listed here as M’carerequirements

Study Standards 9-11

9. Where appropriate, study not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. Exemption for this standard only if disease or condition being study is life threatening andpt has no other viable treatment options

10. Study registered on ClinicalTrials.gov and/or the Registry of Patient Registries (RoPR) by principal sponsor/investigator prior to enrollment of first study subject

11. Study protocol specifies method and timing of public release of outcomes, including release of all negative outcomes. Must be public w/in 24 months of end of data collection. Full report of outcomes no later than 3 years after end of data collection

Study Standards 12-13

12. Study protocol explicitly discusses subpopulations affected by item or services under investigation, particularly traditionally underrepresented groups in clinical studies.

13. Study protocol explicitly discusses how the results are or are not expected to be generalizable to subsections of the M’care population to infer whether M’care pts may benefit from the intervention

Automatic coverage for Category

A if

Automatic coverage of routine items and services and cost of investigational device if meet all 13 requirement plus:

• Study is a “pivotal study,” i.e., study designed to collect definitive evidence of safety and effectiveness of a device for a specified intended use, typically in a statistically justified number of subjects; and

• Study has a “superiority study design,” i.e., intended to demonstrate at some pre-specified level of confidence that the effect of an investigational treatment is superior to that of an active control by more than a pre-specified margin

Category B IDE Devices

For coverage, must meet same standards as Category A plus:

• Must be a pivotal study and

• Study must have a superiority study design

Process Issues

All requests must include:

• FDA approval letter

• IDE study protocol

• IRB approval letter(s)

• ClinicalTrials.gov identifier

Notification of coverage eligibility by posting IDE study title and ClincialTrials.gov registry number on CMS website and publication in Federal Register

COMMENTS?

IPPS – Final Rule

Effective 10/1/2013

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Ruling effective on date of issuance and applies to Part A i/p claims denied because admission was determined not reasonable and necessary, as long as denial was made:

• While ruling in effect

• Prior to effective date of ruling but for which timeframe to file appeal has not expired

• Prior to effective date of ruling if appeal pending

Ruling effective until final OPPS effective

ALJ Ruling – Timely Filing

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Revision to Part B inpatient payment policy:

• For claims to which ALJ ruling does not apply, if Part A claim denied as not reasonable and necessary, CMS will allow payment for all services that would have been reasonable and necessary if beneficiary has been treated as a hospital outpatient, except services specifically requiring an outpatient status

Part B Claim When Part A Denied

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If Part A claim rejected, filing for a Part B inpatient claim must be within 1 year of date of service

• CMS: Hospitals can avoid being disadvantaged by the 1 year time limit “if they bill correctly by following Medicare’s guidelines for hospital inpatient admissions.”

BUT Timely Filing Applies

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For I/P Stay (IPPS 2014 final rule)

• Need an order and certification by physician or other qualified practitioner

• Order is a required component of physician certification of medical necessity of i/p stay

• Order and certification apply to all hospital inpatient admissions

• Physician order and certification are NOT conclusive evidence that i/p stay was medically necessary; also need other documentation in medical record

• Physician order for i/p stay must be:

Present in medical record and

Supported by physician admission and progress notes

Physician Order

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For i/p stay physician must certify and recertify:

1. That the services were provided in accordance with §412.3 (new CFR section)

2. The reason for either:

a. Hospitalization of the patient for i/p medical treatment or medically required i/p diagnostic study OR

b. Special or unusual services for cost outlier cases (Subpart F of Part 412 of 42 CFR)

Certification Requirements

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• Elements of certification should be documented in medical record – use method that permits verification

• Must be a separate signed statement for eachcertification and recertification

• Must be signed and documented in medical record prior to discharge; different rules for outliers

• If information is in other provider records, such as progress notes, need not repeat but must indicate where information is to be found

More cert requirements

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• Order must be furnished at or before the time of the inpatient admission

• Certification begins with order for i/p admission

• First recert. required as of 12th day of hospitalization. Subsequent recerts at intervals established by UR committee (can by on case-by-case basis) but no less frequently than every 30 days

Timing of Order, Cert. & Recert

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• Does not substitute for a properly documented and authenticated order for inpatient admission

• Must be properly countersigned by practitioner who gave verbal order

• Subregulatory guidance on verbal orders coming

Verbal Order not Sufficient

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“There can be no uncertainty regarding the intent, decision, and recommendation by the physician (or other practitioner who can order inpatient services) to admit the beneficiary as an inpatient, and no reasonable possibility that the care could have been adequately provided in an outpatient setting.”

Order for inpatient admission must specify the admitting practitioner’s recommendation to admit “to inpatient,” “as an inpatient,” “for inpatient services,” or similar language.

What must be documented

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For an inpatient

admission

Order: Prior to or at time of admission

Certification of medical necessity: at time of order; recert. depending on LOS

Certification signed and documented in medical record prior to discharge

Preamble mentions residents and says:

• Ordering practitioner need not be responsible for patient’s inpatient care, but he or she must be knowledgeable about the patient’s hospital course, medical plan of care, and current condition

But regulation reads:

• “The order must be furnished by a qualified and licensed practitioner who has admitting privileges at the hospital as permitted by State law . . . “

What about residents?

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• Beneficiaries expected to remain in hospital for care surpassing 2 midnights after initiation of care: generally considered appropriate for i/p admission and hospital payment

• If stay less than 2 midnights, hospital services generally will be considered inappropriate unless clear documentation in medical record supporting physician’s order and expectation that beneficiary would require care over more than 2 midnights or beneficiary receiving service or procedure designated as i/p only by CMS

2 Midnight Rule

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If physician can’t reliably predict that the beneficiary requires a stay of greater than 2 midnights, physician should continue to treat beneficiary as an outpatient and admit as inpatient if and when additional information suggests a longer stay or passing of second midnight is anticipated

2 midnight rule does not create a “per se standard” but uses a benchmark to ensure uniform understanding of when an i/p admission should be ordered

2-Midnight ‘cont

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Can count time spent receiving services—even prior to admission—when determining 2-midnights

• If beneficiary spent 1 midnight in outpatient observation status or in routine recovery following outpatient surgery, 2 midnight benchmark is met if physician expects beneficiary to require an additional midnight in the hospital

• Beneficiary who has unexpected recovery during medically necessary stay should not be converted to o/p b/c at time inpatient order was written 2-midnight expectation was reasonable

When 2-midnights begins

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Procedures on OPPS inpatient-only list are always appropriately inpatient, regardless of actual time spent in hospital, so they are excluded from 2-midnight benchmark

Exclusion from 2-midnights

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Guidance will be drafted for manual instructions. A high priority.

Transfers and 2-Midnights

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