The "No Surprise Billing" Act: Why This Isn't JUST For Hospitals

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The "No Surprise Billing" Act: Why This Isn't JUST For Hospitals
The “No Surprise Billing” Act:
               Why This Isn’t JUST For
               Hospitals

               February 24, 2023

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              The Problem
              • Patient goes to an in-network hospital for a
                surgery by an in-network surgeon.
                Unbeknownst to the patient, the
                anesthesiologist is out of network.
              • The anesthesiologist bills more than the plan
                allows, leaving the patient on the hook.

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The "No Surprise Billing" Act: Why This Isn't JUST For Hospitals
The Solution
              • The No Surprises Act, Public Law 116-
                260, passed December 27, 2020.
              • A variety of state laws.
              • Like HIPAA, more restrictive state laws
                generally control.

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              The Regulatory Framework
              • Requirements Related to Surprise Billing;
                Part I, 86 Fed. Reg. 36872 (July 13,
                2021).
              • Requirements Related to Surprise Billing;
                Part II, 86 FR 55980 (October 7, 2021).

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The "No Surprise Billing" Act: Why This Isn't JUST For Hospitals
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              Lingo
              GFE: Good Faith Estimate
              IDR: Independent Dispute Resolution.
              NSA: No Surprises Act.
              OON: Out-of-Network.
              Provider: They mean physician.
              QPA: Qualified Payment Amount.

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The "No Surprise Billing" Act: Why This Isn't JUST For Hospitals
Overview: Two Rules In One?
              • Portions apply only to services provided in air
                ambulances, hospitals (including CAH) ambulatory
                surgical centers, or freestanding emergency rooms.
                The rule calls them “facilities.”
              • Applies to both the facility’s bill and the bills by medical
                professionals for services to patients at the facility.
              • This portion generally does NOT apply to services at a
                SNF or free-standing clinic.*

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              Overview: Two Rules In One?
              • Professionals/organizations that take patients to
                hospitals or ASCs have a notice requirement.
              • The second part of the rule requires a “Good Faith
                Estimates” of charges. While it also applies to
                “Facilities” the term is defined differently for this
                provision.

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The "No Surprise Billing" Act: Why This Isn't JUST For Hospitals
Key Definition: “Facilities” That
              Must Provide a GFE
          •    Facility: Health care facility (facility) means an institution (such as a
               hospital or hospital outpatient department, critical access hospital,
               ambulatory surgical center, rural health center, federally qualified health
               center, laboratory, or imaging center) in any State in which State or
               applicable local law provides for the licensing of such an institution, that
               is licensed as such an institution pursuant to such law or is approved by
               the agency of such State or locality responsible for licensing such
               institution as meeting the standards established for such licensing.

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              Overview
              • Some provisions apply to health plans,
                others apply to “facilities” and
                professionals.
              • Unfortunately, the law uses the term
                “provider” to refer to “professionals.”

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The "No Surprise Billing" Act: Why This Isn't JUST For Hospitals
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                Overview
                • Emergency Services: applies to services
                  at out-of-network hospitals and the
                  professionals providing services there.
                • Non-emergency Services: applies to
                  services by professionals at a
                  participating hospital/ASC.

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The "No Surprise Billing" Act: Why This Isn't JUST For Hospitals
Leap of Faith
               • Health plans are required to do many
                 calculations.
               • Professionals and facilities are largely at
                 their mercy.

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               Emergency Services
               • For EMTALA services, the patient should be
                 treated as if in-network. Co-pays/deductibles are
                 the same as if it was an in-network service.
               • Co-pay calculated at the lower of median rate/
                 billed charge.
               • Plans can’t use diagnosis code to determine
                 coverage.

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The "No Surprise Billing" Act: Why This Isn't JUST For Hospitals
Emergency Services
               • The “emergency” continues post-
                 stabilization until the patient can reasonably
                 transfer considering distance, patient’s
                 condition, etc.
               • The treating physician is the sole arbiter of
                 when/how far the patient may go/when
                 “emergency” ends.
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               Emergency Services
               • Limited impact on plan payment to facility/professional.
                  – If there is a state All-Payer Model agreement, it controls.
                    (MD/VT.)
                  – If state law, it controls.
                  – Otherwise, parties negotiate. Absent agreement, use dispute
                    resolution.
               • Plan must make “initial” payment on clean claim within
                 30 days.

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The "No Surprise Billing" Act: Why This Isn't JUST For Hospitals
Non-Emergency Services
               • For some non-emergency services, the
                 facility/professional can condition treatment
                 on the patient agreeing to permit balance
                 billing.
               • Patient consent is required.
               • There is a HUGE exception. Can’t seek
                 consent for “ancillary services.”
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               “Ancillary Services”
               • Items and services “related to” emergency medicine,
                 anesthesiology, pathology, radiology and neonatology.
                 (Mentions physicians and non-physician practitioners)
               • Items and services “provided by” assistants at surgery,
                 hospitalists and intensivists.
               • “Diagnostic services” such as radiology and laboratory.
               • Any item or service provided by a non-participating
                 professional if there is no participating professional who
                 could provide the service.

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The "No Surprise Billing" Act: Why This Isn't JUST For Hospitals
Independent Dispute Resolution (IDR)
               • Determines payment rate for items and services
                 when the facility or professional and plan can’t
                 agree.
               • Baseball-arbitration.
               • Presumption that QPA is the appropriate
                 amount. (The focus of NSA litigation.)

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                Ongoing Litigation
                • Texas Medical Ass’n, et al. v United States
                  Department of Health and Human Services,
                  et al.
                   – Struck portions of regulations
                     implementing the QPA as the default
                     outcome of the arbitration process
                   – Did not impact any other rulemaking
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IDR Action                                             Timeline

      Initiate open negotiation period (one party)                     30 business days, starting on the day of initial payment or notice
                                                                       of denial of payment

      Initiate IDR process (either party)                              4 business days, starting the business day after the open
                                                                       negotiation period ends

      Mutually pick IDR entity                                         3 business days after the independent dispute resolution
      *NOTE: Departments select certified independent dispute          initiation date
      resolution entity in the case of no conflict-free selection by
      parties

      Submit payment offers and additional information to certified    10 business days after the date of certified independent dispute
      independent dispute resolution entity                            resolution entity selection

      Payment determination made                                       30 business days after the date of certified independent dispute
                                                                       resolution entity selection

      Payment submitted to the applicable party                        30 business days after the payment determination
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Four Patient-facing “Forms”
                                      Standard Disclosure                         “Universal”
                                                                                  Good Faith Estimate
                                      • 42 CFR § 149.430
                                                                                  • 42 CFR § 149.610
                                      • Model form (CMS Form No. 10780)
                                                                                  • Model form (CMS Form No. 10791)

                                       Standard Notice & Consent                  Standard Notice & Consent
                                       OON Non-Emergency Services                 OON Post Stabilization Emergency
                                        •   42 CFR § 149.20                       Services
                                                                                  •   42 CFR § 149.10
                                        •   Mandatory form (CMS Form No. 10780)
                                                                                  •   Mandatory form (CMS Form No. 10780)

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               Four Patient-facing “Forms”
                                      Standard Disclosure                         “Universal”
                                                                                  Good Faith Estimate
                                      • 42 CFR § 149.430
                                                                                  • 42 CFR § 149.610
                                      • Model form (CMS Form No. 10780)
                                                                                  • Model form (CMS Form No. 10791)

                                       Standard Notice & Consent                  Standard Notice & Consent
                                       OON Non-Emergency Services                 OON Post Stabilization Emergency
                                        •   42 CFR § 149.20                       Services
                                                                                  •   42 CFR § 149.10
                                        •   Mandatory form (CMS Form No. 10780)
                                                                                  •   Mandatory form (CMS Form No. 10780)

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Model Disclosure: CMS Form No. 10780
               Hospitals, ASCs, Freestanding EDs and
               “physician or health care providers” must:
                     • Post on website.
                     • Have a sign posted prominently at the
                       location of facility or provider.
                     • 2 sided, 12-point font form provided to
                       insured patients.
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                  Must SNFs Post The Sign?
                  • Not a “facility” for this part of the rule.
                  • A “physician or health care provider” is a “physician or
                    other health care provider who is acting within the
                    scope of practice of that provider’s ciense or
                    certification under applicable State law, but does not
                    include a provider of air ambulance services.”
                  • “Physician or health care provider” would seem to be
                    people. But why the underlined phrase?

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How Many Signs Do We Need?
                  • 149.430:

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                  Do We Have To Give The
                  Notice Every Visit? Annually?
               • 149.430 requires you to “provide to
                 any individual” a copy of the notice.
               • Can notice ever be “unprovided?”

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               No. 2 – Universal Good Faith Estimate
               • This is UNIVERSAL! Applies broadly to licensed health care
                 entities.

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“Facilities” That Must Provide a
               GFE:
           •     Facility: Health care facility (facility) means an institution (such as a
                 hospital or hospital outpatient department, critical access hospital,
                 ambulatory surgical center, rural health center, federally qualified health
                 center, laboratory, or imaging center) in any State in which State or
                 applicable local law provides for the licensing of such an institution, that
                 is licensed as such an institution pursuant to such law or is approved by
                 the agency of such State or locality responsible for licensing such
                 institution as meeting the standards established for such licensing.

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               No. 2 – Universal Good Faith Estimate
               • This is UNIVERSAL! Applies broadly to licensed health care
                 entities.
               • Must provide in “clear and understandable language” the “good
                 faith estimate” of the “expect charges for providing scheduled
                 services and items.”
               • CMS Form No. 10791
                  –        Appendix 1: Right to Receive a Good Faith Estimate of Expected Charges
                           Notice.
                  –        Appendix 2: Good Faith Estimate Template.
                  –        Appendix 11: Good Faith Estimate Data Elements.

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Who Gets the Estimate?

                                  January 1, 2022                       Future

                                                        If patient is insured, the estimate will
               If patient is not using insurance, the       go to the insurance company to
                                                          inform the advanced EOB that the
               estimate goes to the patient.
                                                         company must provide the insured
                                                                         patient.

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               Who Gives the Estimate?
               Eventually one estimate generated cooperatively by all
                responsible parties:
                  • “Convening health care provider” or “convening
                    health care facility”: Whoever schedules.
                  • “Co-health care provider” or “co-health care facility”:
                    Everyone else.
                  • The 1/1/23 date has been indefinitely delayed.

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Who Is The Convenor?
               • The “convening” professional or facility is the
                 party that receives the initial estimate
                 request and who is or, in the case of a
                 request, would be responsible for scheduling
                 the primary item or service.
                                                 • 42 CFR 149.610(a)(2)(ii)

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Who Is The Convenor?
                   • The “convening” professional or facility is the
                     party that receives the initial estimate
                     request and who is or, in the case of a
                     request, would be responsible for scheduling
                     the primary item or service.
                                                     • 42 CFR 149.610(a)(2)(ii)

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               Responsibilities of Convening
               Professional or Facility
               •     Make information about the availability of requesting an estimate readily
                     available online and in accessible formats, including language of patient.
               •     “Do you plan to use insurance to pay for the visit?”
               •     If not, inform them orally and in writing of the availability of a good faith estimate
                     of expected charges.
               •     Provide an estimate if patient requests appointment, asks for estimate, or
                     inquires about costs.
               •     If there is a co-professional or co-facility, contact within one business day of
                     scheduling the appointment OR a request for an estimate.

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Co-professional or Co-facility
               (Not Enforced Yet)
               •     Provide good faith estimate to convening professional/facility no later than one business
                     day after request received from convening professional/facility.
               •     Estimate must include:
                     –        Patient name and date of birth.
                     –        Itemized list of items or services expected to be provided by the co-provider or co-facility that
                              are reasonably expected to be furnished in conjunction with the primary item or service as
                              part of the period of care.
                     –        Applicable diagnosis codes, expected service codes, and expected charges associated with
                              each listed item or service.
                     –        Name, National Provider Identifiers, and Tax Identification Numbers of the co-provider or co-
                              facility, and the State(s) and office or facility location(s) where the items or services are
                              expected to be furnished by the co-professional or co-facility.
                     –        A disclaimer that the good faith estimate is not a contract and does not require the uninsured
                              (or self-pay) individual to obtain the items or services from any of the co-professional or co-
                              facilities identified in the good faith estimate.
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               What Does the Patient’s Good Faith
               Estimate Need to Include?
               Highlights:
               •     Patient’s name, DOB, NPI, Tax ID.
               •     Diagnosis codes (ICD).
               •     Expected service codes (CPT, HCPCS, DRG, NDC).
               •     “Expected charges” associated with each listed item or service.
                        “Expected charge” means, for an item or service, “the cash pay rate or rate
                        established by a provider or facility for an uninsured (or self-pay) individual,
                        reflecting any discounts for such individuals, where the good faith estimate is
                        being provided to an uninsured (or self-pay) individual; or the amount the provider
                        or facility would expect to charge if the provider or facility intended to bill a plan or
                        issuer directly for such item or service when the good faith estimate is being
                        furnished to a plan or issuer.”
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Can I Share Price Information With
               Others?
               • Some fear of sharing pricing data is
                 overblown. Agreement on price is illegal.
                 Knowledge is not.
               • Here the law requires it.
               • How much protection does that provide?

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               When Is the Estimate Required?
               • Estimate is required if appointment is scheduled for 3 or more
                 business days in advance:
                   ‒ When the appointment is scheduled 3-9 business days out, the notice
                     must be provided within 1 business day of the date the appointment
                     was scheduled.
                   ‒ If scheduled for 10 or more business days out, the estimate must be
                     provided within 3 business days of the date the appointment was
                     scheduled.
               • Patient can also request an estimate without scheduling an
                 appointment, in which case the estimate must be provided within
                 3 business days.
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How Do We Count Business Days?
               • The government counts the day of the
                 call:
                      – Call Friday, estimate needed for visits
                        Wednesday or later.
               • Is that right? We shall see.
               • Note it is NOT hours.
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               What If the Estimate Changes?
               • Provide the uninsured (self-pay) patient a new estimate no
                 later than one business day before the appointment.
               • If change occurs less than one business day before
                 appointment is scheduled, the replacement professional or
                 facility must use the good faith estimate of expected
                 charges.

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Patient-Provider Dispute Resolution
               • Patient can use this process IF ALL 5 conditions are met:
                   – They’re uninsured or self-pay
                   – They scheduled and received the medical items or services on
                     or after January 1, 2022
                   – They have a good faith estimate from your provider or the
                     facility who provided your care
                   – They got a bill within the last 120 calendar days
                   – The difference between the good faith estimate and the bill is
                     at least $400

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                How is the $400 Calculated?
                • It is the total per “provider”.
                • The examples from the government
                  don’t make it clear if each “professional”
                  is a provider.
                • The examples don’t have one situation
                  where an estimate is LOWER than the
                  bill!
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               Important Notes
               • Estimates are considered part of medical
                 record.
               • Meeting a similar state requirement does
                 NOT meet federal requirement.
               • Reminder: Future rulemaking for insured
                 patients.
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No. 3 – Standard Notice & Consent
               • OON professionals at in-network facilities
                 cannot balance bill for non-emergency
                 services unless:
                   – They obtain the “Standard Notice & Consent”, AND
                   – The service is more than 3 hours out, AND
                   – The services are NOT ancillary services.

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               When Can Balancing Billing Protections
               Be Waived?
               • Non-emergency care.
               • Non-ancillary services.
               • Not prohibited by state law.
               • In network care is available.
               • Timing:
                   –        If appointment is scheduled at least 72 hours or more out, provide Notice & Consent at least
                            72 hours before the appointment.
                   –        If appointment is scheduled within the next 72 hours, provide Notice & Consent the same day
                            appointment is made and at least 3 hours prior to rendering the services or items.
                   –        If treatment will occur within 3 hours, patient cannot consent to be balance billed.

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What Must the Standard Notice &
                 Consent Include?
                 HHS has created a MANDATORY document (CMS Form No.
                 CMS-10780).
                      – 4 pages:
                              •        Page 1 – Notice
                              •        Pages 2 & 4 – Estimate of services
                              •        Page 3 – Consent
                      –       It CANNOT be modified (except filling in bracketed sections).
                      –       It CANNOT be attached or incorporated with other documents.
                      –       Patient MUST be able to choose to receive electronically or in paper.
                      –       Make available in 15 languages most commonly used in region.
                      –       Must include date notice provided to patient and the date AND time
                              patient signs.
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          Pages 2
          &4–
          Estimate

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How to Calculate Estimate?
               • Use definition of the “expected charge” that
                 would apply when the good faith estimate is
                 provided to a plan or issuer.
               • PROBLEM: We don’t have this guidance yet
                 from HHS and the non-enforcement position
                 does not extend to the requirement to provide a
                 good faith estimate.
                  ‒ HHS is seeking comment.
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      Page 3 – Consent

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Steps to Provide Notice & Consent
               •     Determine if you plan to balance bill.
               •     If yes, determine if waiver of protections is allowed here.
               •     Provide the notice & consent during applicable timing.
               •     Mail or email copy of the signed written notice and consent to the patient
                     (patient preference).
               •     Must retain, or ensure someone else is, a copy of the consent & notice for
                     at least 7-year period after date care provided.
               •     Notify the plan or issuer that care was provided during a visit.

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               No. 4 – Notice & Consent
               (Post Stabilization Emergency Care)
               • Generally, a nonparticipating emergency facility and
                 nonparticipating professional cannot bill patients more than
                 cost-sharing for emergency services.
               • BUT, may if 4 conditions are met.

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Condition #1
               • Attending emergency physician or treating provider
                 determines (taking into account the individual’s medical
                 condition):
                  – Patient can travel using nonmedical transportation or
                    nonemergency medical transportation.
                  – Available participating provider or facility located within a
                    reasonable travel distance.

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               Condition #2
               • Meet OON notice and consent criteria for non-
                 emergency services (42 CFR§149.420(c) through (g)).
               • PLUS
                 –        If a participating emergency facility and a nonparticipating professional,
                          notice and consent must include list of any participating professionals at the
                          facility able to provide the items and services involved and notification that
                          the patient may be referred, at their option, to such a participating provider.
                 –        If a nonparticipating emergency facility, notice must include good faith
                          estimated amount that the patient may be charged for items or services
                          provided by the nonparticipating emergency facility or nonparticipating
                          professionals with respect to the visit at such facility.

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Condition #3
               • Attending emergency physician or
                 treating provider, using appropriate
                 medical judgment, determines patient
                 can:
                  ‒ Receive the notice & consent and
                  – Provide informed consent.

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               Condition #4
               • Any additional requirements or
                 prohibitions as may be imposed under
                 state law.

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Steps to Provide OON Post Stabilization
               Emergency Care Services Notice & Consent
               •     Determine if you plan to balance bill.
               •     If yes, determine if waiver of protections is allowed here (can you meet the 4
                     conditions?).
               •     Provide the notice & consent within timing requirements.
               •     Mail or email copy of the signed written notice and consent to the patient (patient
                     preference).
               •     A participating health care facility (with respect to non-participating professional)
                     must retain copy of the consent & notice for at least 7-year period after date care
                     provided. IF the nonparticipating professional obtains the notice & consent (as
                     opposed to the facility obtaining on behalf of the professional), the professional may
                     either (1) coordinate with facility to retain it OR (2) the professional can retain it.
               •     Notify the plan or issuer that care was provided during a visit.

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               CMS Slideshow
               • https://www.cms.gov/files/document/a27
                 4577-1a-training-1-balancing-
                 billingfinal508.pdf

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Knowledge Checking The Knowledge Check

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               Knowledge Checking The Knowledge Check

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Do They Know What “Or” Means?
                •       The attending emergency physician or treating provider
                        determines that the participant, beneficiary, or enrollee is able
                        to travel using nonmedical transportation or nonemergency
                        medical transportation to an available participating provider or
                        facility located within a reasonable travel distance, taking into
                        account the individual's medical condition. The attending
                        emergency physician's or treating provider's determination is
                        binding on the facility for purposes of this requirement.
                                                                • 42 CFR 149.410(b)(1)

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               Bottom Line
               • 4 Patient facing “forms”:
                    –      Standard Disclosure.
                    –      Universal Good Faith Estimate Notice.
                    –      OON Non-emergency Services Notice & Consent.
                    –      OON Post Stabilization Emergency Care Notice & Consent.

               • Put processes in place:
                    –      Update website and physical space with Standard Disclosure.
                    –      When/how to provide Universal Good Faith Estimate.
                    –      When/how to provide OON Notices & Consents.
                    –      How to handle IDR open negotiation period.
                    –      How to handle patient-provider dispute resolution open negotiation period.

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Commonly Asked Questions

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               How to Issue a GFE When Charging a
               Flat Monthly or Annual Fee
               • Examples: Concierge services, direct primary care
               • Letter from American Academy of Family
                 Physicians, dated December 3, 2021, requested
                 HHS issue future regulations
               • Current advice: Technically required, consider
                 issuing an annual GFE

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Must GFE Be Translated?
                • Unlike the Standard Notice and
                  Consent, there is no specified number
                  of languages.
                • If the patient contests a bill, and the
                  notice wasn’t in their native tongue,
                  regs suggest they didn’t receive notice.
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                Should We Use The Model GFE?

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Does a SNF Need to Give A GFE?
               • Legal and practical answer may differ.
               • They are licensed.
               • Is the patient using insurance to pay?

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               The Hospital is OON the Dr. In-
               Network. Does NSA Apply?
               • Is it an emergency service?
               • If not, then nope!

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Must We Give GFE to Medicare
               Pts. Getting A Physical?

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               The Patient Doesn’t Want
               Their Birthdate on the GFE!
               • No provision explicitly permits the
                 patient to decline.
               • This is a patient protection measure.
                 Can the patient waive?

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How Long Must We Keep GFEs?
                 • Must provide for 6 years.
                 • Must consider it a part of the medical
                   record.
                                                • 149.610(f)

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             When Will the Rules Be Issued?!
                 • GFE requirements for insured
                   patients?
                 • Penalties! Namely, what is the exact
                   consequence of NOT issuing a GFE?
                 • Maybe May 2022????*
          *Def.’s Reply Memo in Support of Their Cross-Motion For Summary Judgment, Texas Medical Association v.
          U.S. Department of Health and Human Services (Civil Action No. 6:21-cv-00425-JDK), filed February 2, 2022,
          https://affordablecareactlitigation.files.wordpress.com/2022/02/13362908-0-79761.pdf.

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RESOURCES
               DOL Website
                     – https://www.dol.gov/agencies/ebsa/laws-
                       and-regulations/laws/no-surprises-act
               CMS Website
                     – https://www.cms.gov/nosurprises/Policies-
                       and-Resources/Overview-of-rules-fact-
                       sheets

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                                      Questions?
                                                  David Glaser
                                                  Fredrikson & Byron, P.A.
                                                  612.492.7143
                                                  dglaser@fredlaw.com

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