waiving co-pays, offering freebies, and other traps for providers

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Waiving Copays, Offering Freebies, and Other Traps for Providers Kim Stanger (4-14)

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Page 1: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Waiving Copays, Offering Freebies, and Other Traps for Providers

Kim Stanger(4-14)

Page 2: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

OverviewKey Fraud and Abuse Laws Anti-Kickback Statute

(“AKS”) Ethics in Physician

Referrals Act (“Stark”) Civil Monetary Penalties

Law (“CMPL”) State laws

Common Problem Situations Free or discounted items to

patients Waiving copays Writing off bills Prompt pay discounts Paying patient premiums Free screenings or tests Free transportation Gifts or perks to providers Professional courtesies Gainsharing

Page 3: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Preliminaries

Written materials– Copy of .ppt slides– OIG Roadmap for New Physicians: Avoiding Medicare and

Medicaid Fraud and Abuse– OIG Supplemental Compliance Program Guidance for Hospitals– OIG Special Advisory Bulletin: Offering Gifts and Other

Inducements to Beneficiaries– OIG, Hospital Discounts to Patients Who Cannot Afford to Pay

Their Bills Written materials are available per the webinar instructions or contact

me at [email protected]. The program will be recorded and available for download at

www.hhhealthlawblog.com. Submit questions per Web-Ex “chat” function or contact me at

[email protected].

Page 4: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Preliminaries

This is an overview of some relevant federal laws. Additional laws may apply

– Federal laws– State laws

Application may depend on specific facts.– govt v. private payors

We’re going to be moving fast.– Written materials will provide more detail.

This presentation is for educational purposes only.– It does not constitute legal advice.– It does not create and attorney-client relationship.

Page 5: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Anti-Kickback Statute(42 USC 1320a-7b)

Regulations at 42 CFR 1001.952

Page 6: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Anti-Kickback Statute

Cannot knowingly and willfully offer, pay, solicit or receive remuneration to induce referrals for items or services covered by govt program unless transaction fits within a regulatory safe harbor.

(42 USC 1320a-7b(b)) Anti-Kickback Statute applies if one purpose of the

remuneration is to induce referrals even if there are other legitimate purposes.

(U.S. v.Greber, 760 F.2d 68 (3d Cir. 1985)).

Page 7: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Anti-Kickback Statute

Penalties – 5 years in prison– $25,000 criminal fine– $50,000 administrative penalty– 3x damages– Exclusion from Medicare/Medicaid

(42 USC 1320a-7b(b); 42 CFR 1003.102) Anti-Kickback violation = False Claims Act violation

– Lower standard of proof– Subject to False Claims Act penalties– Subject to qui tam suit.– Obligated to repay govt.

(42 USC 1320a-7a(a)(7)) OIG Self-Disclosure Protocol: minimum $50,000 settlement.

Page 8: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Anti-Kickback Statute

Anytime you want to:• Give anything to induce or reward

referrals, or• Do any deal with a referral source.

Page 9: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Ethics in Patient Referrals Act (“Stark”) (42 USC 1395nn)

Regulations at 42 CFR 411.350-.389

Page 10: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Stark

If a physician (or their family member) has a financial relationship with an entity:– The physician may not refer patients to that

entity for designated health services, and– The entity may not bill Medicare for such

designated health servicesunless arrangement is structured to fit within a regulatory safe harbor.

(42 CFR 411.353)

Page 11: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Stark

Penalties– No payment for services provided per improper referral.– Repayment of payments improperly received within 60

days.– Civil penalties.

$15,000 per claim submitted $100,000 per scheme

(42 CFR 411.353, 1001.102(a)(5), and 1001.103(b)) May also constitute Anti-Kickback Statute violation May trigger False Claims Act.

Page 12: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

StarkApplies to referrals by a physician to entities with which physician (or their family member) has a financial relationship. Physician =

– MDs– DOs– Oral surgeons– Dentists– Podiatrists– Optometrists– Chiropractors

(42 CFR 411.351)

Family member =– Spouse– Parent, child– Sibling– Stepparent, stepchild,

stepsibling– Grandparent,

grandchild– In-law

Page 13: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Stark

Applies to referrals for designated health services (“DHS”) payable in whole or part by Medicare.– Inpatient and outpatient hospital services– Outpatient prescription drugs– Clinical laboratory services– Physical, occupational, or speech therapy– Home health services– Radiology and certain imaging services– Radiation therapy and supplies– Durable medical equipment and supplies– Parenteral and enteral nutrients, equipment, and supplies– Prosthetics and orthotics

CMS website lists some of the affected CPT codes.(42 CFR 411.351)

Page 14: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Civil Monetary Penalties Law(42 USC 1320a-7a)

Page 15: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Civil Monetary Penalties Law

Prohibits certain specified conduct, including:– Submitting false or fraudulent claims.– Offering, soliciting, giving or receiving remuneration to

induce referrals (i.e., kickbacks).– Offering inducements to program beneficiaries if know

or should know that remuneration is likely to influence beneficiary to order or receive items or services payable by federal or state programs from a particular provider.

– Offering inducements to physicians to limit services.– Submitting claims for services ordered by, or contracting

with, an excluded entity.– Failing to report and repay an overpayment.

(42 USC 1320a-7a; 42 CFR 1003.102)

Page 16: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Civil Monetary Penalties Law

Penalties vary depending on conduct, but generally range from:– $2,000 to $50,000 fines– 3x amount claimed– Denial of payment– Repayment of amounts improperly paid– Exclusion from govt programs

CMPL violations may also violate:– False Claims Act– Anti-Kickback Statute– Stark

Page 17: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Remember State Laws

Page 18: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Common State Laws

Anti-kickback statutes– Prohibits paying for referrals.

Mini-Stark laws– Prohibit referrals to entities with which the provider has

an ownership or other financial relationship. Fee splitting statutes

– Provider splits fees with others. Laws prohibiting paying cappers, providing

rebates, etc.

Page 19: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Free or Discounted Items or Services to Patients

Page 20: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Free or Discounted Items or Services to Patients May include:

– Advertising or marketing campaigns that include free or discounted items.

– Free services, especially when tied to other services that are payable by govt payors.

– Gift cards or other rewards for referrals.– “Thank you” gifts.

Page 21: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Free or Discounted Items or Services to Patients Free or discounted items or services (i.e., less than fair

market value) =– Remuneration.– May induce patient to receive services.

May violate:– AKS if “one purpose” is to induce referrals for items or

services payable by federal healthcare programs.– CMPL if likely to induce beneficiary to receive items or

services payable by govt programs.– Stark, if offered to referring physicians or family

members.– State laws.

Page 22: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Free or Discounted Items or Services to Patients May offer free or discounted items to govt beneficiaries if: Remuneration is not likely to influence the beneficiary to

order or receive items or services payable by federal or state health care program.(42 USC 1320a-7a(5))

Item or service is of low value, i.e., – Each item or service is less than $10, and– Aggregate is less than $50 per patient per year.

(OIG Bulletin, Offering Gifts and Inducements to Beneficiaries (8/02); 66 FR 24410-11)

Page 23: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Free or Discounted Items or Services to Patients CMPL defines “remuneration” to exclude:

– Incentives to promote delivery of preventative care.– Payments meeting AKS safe harbor.– Any other remuneration that promotes access to care

and poses a low risk of harm to patients and federal health care programs.

– Retailer coupons, rebates or rewards offered to public.– Certain other situations.

(42 USC 1320a-7a(i); 42 CFR 1003.101)

Page 24: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Free or Discounted Items or Services to Patients May offer items to govt beneficiaries if not “remuneration”. Free or discounted items satisfy the following:

– Good faith determination that beneficiary has financial need or after reasonable collection efforts have failed;

– Not offered as part of any advertisement or solicitation;– Not tied to provision of other federal program business;

and – Reasonable connection between item or service and

medical care of beneficiary.(42 CFR 1320a-7a(i); 42 CFR 1003.101; see also OIG Bulletin, Hospital Discounts Offered to Patients Who Cannot Afford to Pay Their Hospital Bills)

Page 25: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Free or Discounted Items or Services to Patients May offer items to govt beneficiaries if not “remuneration”. Item fits within an AKS safe harbor.

– 42 CFR 1001.952(h): Discounts. Item or service promotes access to care and poses low risk

of harm to patients or federal program.– Adv. Op. 11-16: OIG concluded it would not seek sanctions

based on non-profit entity’s provision of transportation, lodging and meal assistance to patients and their family where, among other things: Program not advertised in advance. Costs not claimed on cost report. Public benefit offered through program.

(42 CFR 1320a-7a(i); 42 CFR 1001.101)

Page 26: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Free or Discounted Items or Services to Patients May offer items to govt beneficiaries if not “remuneration”. Incentives to promote certain types of preventative care

payable by Medicare or state program if:– Prenatal service or post-natal well-baby visit, or a service

described in the U.S. Preventive Services Task Force’s Guide to Clinical Preventive Services.

– Not tied (directly or indirectly) to provision of other services payable by Medicare or a state program.

– Not cash instrument or convertible cash.– Value of inducement not disproportionately large in relation to

value of the preventative care service or future health care costs that will be prevented.

(42 CFR 1320a-7a(i); 42 CFR 1003.101; Adv. Op. 12-21)

Page 27: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Free or Discounted Items or Services to Patients CMPL does not prohibit an independent entity (e.g.,

charity) from providing free or discounted items or services to beneficiaries.

Providers could fund the items or services provided by third party so long as:– The independent entity makes an independent

determination of need, and– Beneficiary’s receipt of remuneration does not depend,

directly or indirectly, on the beneficiary’s use of a particular provider.

(OIG Bulletin, Gifts to Beneficiaries)

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Waiving or Discounting Copays and Deductibles

Page 29: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Waiving or Discounting Copays or DeductiblesWhat’s the big deal? Medicare typically pays 80% of reasonable charge, which is

based on provider’s customary and actual charges. “A provider … who routinely waives Medicare copayments or deductibles is misstating its actual charges…”

“[I]f patients are required to pay [a] portion of their care, they will be better health care consumers, and select items or services because they are medically needed, rather than simply because they are free. Ultimately, if Medicare pays more for an item or service than it should, or if it pays for unnecessary items or services, there are less Medicare funds available to pay for truly needed services.”

(OIG Fraud Alert, Routine Waiver of Copayments or Deductibles) Same considerations apply to private insurers.

Page 30: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Waiving or Discounting Copays or Deductibles Waiving or discounting copays or deductibles =

– Remuneration.– May induce patient to receive services.

May violate:– AKS if “one purpose” is to induce referrals for items or

services payable by federal healthcare programs.– CMPL if likely to induce beneficiary to receive items or

services payable by federal or state healthcare programs.

– Stark, if offered to referring physicians or family members.

– Private insurance contracts.

Page 31: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Waiving or Discounting Copays or Deductibles Red flag situations

– Advertising no copay or deductible. “Medicare accepted as payment in full” “No out of pocket expenses” “Insurance only billing”.

– Routine use of “financial hardship” forms without Good faith attempt to collect Determination of financial need.

– Collection of copays only if patient has Medigap coverage.

(OIG Fraud Alert, Routine Waiver of Copayments or Deductibles)

Page 32: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Waiving or Discounting Copays or Deductibles May waive or discount govt copays or deductibles if: Not offered as part of any advertisement or solicitation; Do not routinely waive copays or deductibles; and Waive or discount after

– good faith determination that the beneficiary is in financial need, or

– unable to collect after reasonable collection efforts.(42 USC 1320a-7a(i)(6); 42 CFR 1003.101; see also Adv. Op. 12-16) Document factors such as local cost of living; patient’s

income, assets and expenses; patient’s family size; scope and extent of bills.

Page 33: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Waiving or Discounting Copays or Deductibles May waive or discount govt copays if satisfy AKS safe harbor. Hospital inpatient stay paid under PPS.

– Waived amounts cannot be claimed as bad debt or shifted to any other payors.

– Offered without regard to the reason for admission, length of stay, or DRG.

– Waiver may not be made as part of any agreement with third party payer with limited exceptions.

FQHC or other health care facility under any Public Health Services Grant.

(42 CFR 1001.952(k))

Page 34: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Waiving or Discounting Copays or Deductibles But waiving copays may violate other provisions. Physician or family member of physician

– May violate Stark if physician refers designated health services unless transaction fits within safe harbor.

Referral source– May violate AKS if one purpose is to induce referrals for

federal program business unless fit within safe harbor. Private pay patients

– May violate managed care contracts.– May violate state laws prohibiting kickbacks, rebates, or

fee splitting.

Page 35: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Writing Off Bills

Page 36: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Writing Off Bills

Free or discounted items or services (i.e., less than fair market value) =– Remuneration.– May induce patient to receive future services.

May violate:– AKS if “one purpose” is to induce referrals for items or

services payable by federal healthcare programs.– CMPL if likely to induce beneficiary to receive items or

services payable by govt programs.– Stark, if offered to referring physicians or family

members.– State laws.

Page 37: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Writing Off Bills

The key: document legitimate purpose, i.e., not intent to generate referrals!– Resolution of legitimate dispute or settlement of claim.– Unsuccessful attempts to collect.– Financial need.– Other

Page 38: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Writing Off Bills

Under AKS, may waive or discount copays if satisfy “waiver of copay” safe harbor.– Hospital inpatient stay paid under PPS.

Waived amounts cannot be claimed as bad debt or shifted to any other payors;

Offered without regard to the reason for admission, length of stay, or DRG; and

Waiver may not be made as part of any agreement with third party payer with limited exceptions.

– FQHC or other health care facility under any Public Health Services Grant.

(42 CFR 1001.952(k))

Page 39: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Writing Off Bills

Under CMPL, may waive or discount beneficiary’s bills if:– Good faith determination that beneficiary has financial

need or after reasonable collection efforts have failed;– Not offered as part of any advertisement or solicitation;– Not tied to provision of other federal program business;

and – Reasonable connection between item or service and

medical care of beneficiary.(42 CFR 1320a-7a(i); 42 CFR 1003.101; see also OIG Bulletin, Hospital Discounts Offered to Patients Who Cannot Afford to Pay Their Hospital Bills)

Page 40: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Writing Off Bills

OIG suggests that hospitals (and presumably other providers) should:– Have a reasonable set of financial guidelines based on

objective criteria that documents real financial need.– Recheck patient’s eligibility at reasonable intervals to

ensure they still have financial need.– Document determination of financial need.

(OIG Bulletin, Hospital Discounts Offered to Patients Who Cannot Afford to Pay Their Hospital Bills)

Page 41: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Writing Off Bills

Writing off entire bill is less risky than writing off copays and deductibles.– If no third party billed, third party payor likely does not

care.– If write off only copay or deductible, beware:

Private payor contracts. AKS and CMPL.

If patient is a referring physician or family member of a referring physician, beware Stark.

Page 42: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Prompt Pay Discounts

Page 43: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Prompt Pay Discounts

Discounted items or services (i.e., less than fair market value) =– Remuneration.– May induce patient to receive future services.

May violate:– AKS if “one purpose” is to induce referrals for items or

services payable by federal healthcare programs.– CMPL if likely to induce beneficiary to receive items or

services payable by govt programs.– Stark, if offered to referring physicians or family members.– State laws.– Payor contracts re “usual charges”.

Page 44: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Prompt Pay Discounts

OIG has approved prompt pay discounts for govt beneficiaries if: – Amount of discount relates to avoided collection costs.– Offered to all patients for all services without regard to

patient’s reason for admission, length of stay, or DRG.– Not advertised so as to solicit business.– Notified private payors of program.– Costs not passed to Medicare, Medicaid or other

payors.(56 FR 35952; Adv. Op. 08-3)

Beware Stark, state laws, and private payor contracts.

Page 45: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Prompt Pay Discounts

Private payor issues– Generally cannot discount copays and deductibles

without violating managed care contracts unless payor agrees.

– May adversely affect “usual and customary charges” and payor’s reimbursement under contract.

– Payors may claim the benefit of the discount if the insurer pays within the relevant time.

Check your payor contract or contact your private payors.

Page 46: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Paying Patient’s Insurance Premiums

Page 47: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Paying Patient’s Insurance Premiums Free or discounted items or services (i.e., less than fair

market value) =– Remuneration.– May induce patient to receive future services.

May violate:– AKS if “one purpose” is to induce referrals for items or

services payable by “federal healthcare programs.”– CMPL if likely to induce beneficiary to receive items or

services payable by govt programs from a particular provider, but not simply to enroll. (See Adv. Op. 13-16)

– Stark, if paid for referring physicians or family members.– Tax exempt status laws.– Payor contracts.– State laws.

Page 48: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Paying Patient’s Insurance Premiums If paying Medicare Part B, C or D premiums:

– AKS implicated.– OIG approved plan’s payment of Part B premiums for

ESRD patients where: Patients are already receiving the services, so unlikely to

induce services that might not otherwise be received. No inappropriate patient steering to particular providers. Patients are not coerced into enrolling in Part B. Certain protections built in to protect Medicare program

from additional costs.– OIG cautioned that it might reach different result in other

circumstances.(Adv. Op. 13-16; see also Adv. Op. 01-15)

Page 49: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Paying Patient’s Insurance Premiums If paying premiums for participation in health insurance

exchange:– “HHS has significant concerns with this practice because it

could skew the insurance risk pool and create an unlevel playing field in the Marketplaces. HHS discourages this practice and encourages issuers to reject such third party payments. HHS intends to monitor this practice and to take appropriate action, if necessary.” (HHS Letter dated 11/4/13).

– Letter does not apply to: Indian tribes and govt grant programs. Payments made by private non-profit foundation based on

defined criteria based on financial status that does not consider health status and payment covers entire year.

(HHS Letter dated 2/7/14; 79 FR 15240)

Page 50: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Paying Patient’s Insurance Premiums If paying private insurance premiums (e.g.,

COBRA or other coverage):– Probably does not implicate AKS or CMPL unless it is

tied to or induces referrals for services payable by govt programs.

– COBRA regulations contemplate that COBRA premiums may be paid by third party.

– Check state laws and payor contracts. But stay tuned—this is a developing area of the

law.

Page 51: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Free Tests or Screening

Page 52: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Free Tests or Screening

Free or discounted items or services (i.e., less than fair market value) =– Remuneration.– May induce patient to receive services.

May violate:– AKS if “one purpose” is to induce referrals for items or

services payable by federal healthcare programs.– CMPL if likely to induce beneficiary to receive items or

services payable by govt programs.– Stark, if offered to referring physicians or family

members.– State laws.

Page 53: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Free Tests or Screening

OIG has approved free screening services or tests (e.g., free blood pressure check by hospital) where:– Not conditioned on the use of any items or services

from any particular provider.– Patient not directed to any particular provider.– Patient not offered any special discounts or follow-up

services.– If test shows abnormal results, visitor is advised to see

his or her own health care professional.(Adv. Op. 09-11)

Advisory Opinions are not binding, but provide guidance.

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Free Transportation

Page 55: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Free Transportation

Free or discounted items or services (i.e., less than fair market value) =– Remuneration.– May induce patient to receive services.

May violate:– AKS if “one purpose” is to induce referrals for items or

services payable by federal healthcare programs.– CMPL if likely to induce beneficiary to receive items or

services payable by govt programs.– Stark, if offered to referring physicians or family

members.– State laws.

Page 56: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Free Transportation

OIG has approved free transportation programs where, among other things:– Program open to all eligible patients; not selectively

limited to targeted beneficiary populations.– Type of transportation is reasonable (i.e., no limousine).– Travel is local to physicians’ offices.– Public transportation and parking is limited.– Cost of program would not be claimed on cost report or

shifted to a federal program.(Adv. Op. 11-02; see also OIG Bulletin, Gifts to Beneficiaries)

Advisory Opinions are not binding, but provide guidance.

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Gifts or Perks to Providers or Other Referral Sources

Page 58: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Gifts or Perks to Providers or Other Referral Sources May include offering, soliciting, giving or receiving:

– Gifts, e.g., “thank you” or appreciation gifts.– Free items or services, e.g., meals, CME, travel, space,

equipment, etc.– Discounted items or services, i.e., less than fair market

value.– Perks.– Business opportunities.– Practice or expense subsidies.– Payments for services not performed.– Payments for unnecessary services.

Page 59: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Gifts or Perks to Providers or Other Referral Sources Free or discounted items or services (i.e., less than fair

market value) =– Remuneration.– May be inducement for referrals.

May violate:– AKS if “one purpose” is to induce referrals for items or

services payable by federal healthcare programs.– CMPL if AKS is violated.– Stark, if offered to referring physicians or family

members.– State laws.

Page 60: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Gifts or Perks to Providers or Other Referral Sources Lower risk if entity receiving gift does not refer

items or services payable by federal healthcare programs.– Stark, AKS and CMPL generally apply to referrals for

items or services payable by govt programs. But no guarantee…

– OIG has cautioned that carving out federal programs from specific transaction may not protect the parties if there are other referrals for federal programs between parties.

– May violate state laws.

Page 61: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Gifts or Perks to Providers or Other Referral Sources AKS contains safe harbors for certain transactions if satisfy

all associated conditions, e.g., – Certain discounts offered by certain buyers or sellers.– Waiver of copays and deductibles for hospital inpatient

stays or services at FQHC.– Practitioner recruitment.– OB malpractice subsidy.– Electronic health records items and services.– Ambulance replenishing.– Certain items offered to health centers.(42 CFR 1001.952)

But beware Stark, CMPL, or state law.

Page 62: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Gifts or Perks to Providers or Other Referral Sources Stark contains safe harbors for certain transactions with

physicians if satisfy all associated conditions, e.g., – Non-monetary compensation less than $300+/year. – Incidental benefits to medical staff members.– Professional courtesy.– Physician recruitment.– Physician retention.– OB malpractice subsidy.– Compliance training.– Electronic health records items and services.(42 CFR 411.357(k))

But beware AKS, CMPL, or state law.

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Professional Courtesy

Page 64: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Professional Courtesy Free or discounted items or services (i.e., less than fair

market value) =– Remuneration.– May induce referrals for services.

May violate:– AKS if “one purpose” is to induce referrals for items or

services payable by federal healthcare programs.– CMPL if violates AKS or is likely to induce beneficiary to

receive items or services payable by govt programs.– Stark, if offered to referring physicians or family

members.– Private payor contracts if waive copays– State laws.

Page 65: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Professional Courtesy

Stark contains safe harbor for courtesies offered to physicians or their family members if:– Practice has formal medical staff.– Written policy approved in advance.– Offered to all physicians in service area regardless of

referrals.– Not offered to govt beneficiaries unless showing of

financial need.– Does not violate AKS.(42 CFR 411.357(s); 72 FR 51064)

But beware AKS, CMPL, state laws, and private payor contracts.

Page 66: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Professional Courtesy

Especially beware waiving copays, deductibles or engaging in “insurance only” billing.– See prior discussion.

Offering free items or services to employees may implicate tax or employee benefit laws.– Benefits to employees are usually taxable.– May be structured to fit within employee benefit plan,

but may be subject to ERISA or similar laws.

Page 67: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Gainsharing or Other Cost Saving Programs

Page 68: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Gainsharing or Other Cost Saving ProgramsWhat’s the big deal? When govt changed to prospective payment system

(DRGs), – Payment for hospital episode of care was capped

despite costs involved in care.– Govt concerned that hospitals would create incentives

to reduce costs by reducing or limiting services. Congress: “We must not tolerate hospitals paying

physicians to reduce or limit services to the elderly.”(OIG Bulletin, Gainsharing Arrangements)

Page 69: Waiving Co-Pays, Offering Freebies, and Other Traps for Providers

Gainsharing or Other Cost Saving Programs Hospital or CAH cannot knowingly make a payment,

directly or indirectly, to a physician as an inducement to reduce or limit services provided to Medicare or Medicaid beneficiaries who are under the direct care of the physician.– Includes “gainsharing” programs.

Physician cannot knowingly accept such a payment. Penalties:

– $2000 for each individual with respect to whom payment made.

– Any other penalty allowed by law.(42 USC 1320a-7a(b)(1); 42 CFR 1003.102)

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Gainsharing or Other Cost Saving Programs “[A]ny hospital incentive plan that encourages physicians

through payments to reduce or limit clinical services directly or indirectly violates the statute.” – Payment need not be tied to actual diminution in care so

long as the hospital knows that the payment may influence physician to reduce or limit services. 

– No requirement that payment be tied to a specific patient or a reduction in medically necessary care.

(OIG Bulletin, Gainsharing Arrangements) Does not apply Medicare or Medicaid risk-based managed

care contracts and Medicare Advantage plans, which are governed by different statute.(Adv. Op. 12-22 at n.20)

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Gainsharing or Other Cost Saving Programs Gainsharing = arrangement in which a hospital gives

physician a percentage or share of any reduction in the hospital’s cost for patient care attributable in part to the physicians’ efforts, i.e., physician shares in cost savings.(OIG Bulletin, Gainsharing Arrangements)

OIG concerned about “(i) stinting on patient care, (ii) ‘cherry picking’ healthy patients and steering sicker (and more costly) patients to hospitals that do not offer such arrangements; (iii) payments to induce patient referrals; and (iv) unfair competition among hospitals offering incentive compensation programs to foster physician loyalty and to attract more referrals.”(Adv. Op. 12-22)

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Gainsharing or Other Cost Saving Programs OIG has periodically approved gainsharing in advisory

opinions if certain safeguards included, e.g., – Proposed plan does not adversely affect patient care. – Quality evaluated by third party.– Low risk that incentive will lead physicians to provide

medically inappropriate care.– Payments limited in duration and amount.– Payments not tied to referrals or other suspect actions.

(See, e.g., Adv. Op. 12-22) OIG advisory opinions do not apply to Stark.

– CMS proposed Stark exception, but was not finalized. CMS/OIG have issued interim rule waiving CMPL and

Stark for ACOs.

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Action Items

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Action Items

Identify existing remunerative relationships with referral sources (e.g., providers, facilities, vendors, beneficiaries).– Contracts (employment, independent contractors, purchasing,

management, etc.).– Group compensation structures.– Leases (space, equipment, etc.).– Subsidies or loans.– Joint ventures or partnerships.– Free or discounted items or services (e.g., use of space,

equipment, personnel or resources; professional courtesies; insurance; gifts or perks; advertising; etc.).

– Marketing programs.– Financial policies.

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Action Items

Review relationships for compliance with statute or exception, including:– No improper intent to induce referrals.– Written contract that is current and signed by parties.– Compliance with terms of contract.

Parties providing required services. Documentation confirming that services provided.

– Fair market value.– Compensation not based on volume or value of referrals.– Arrangement is commercially reasonable and serves

legitimate business purpose.

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Action Items

Implement method to track and monitor relationships with referral sources for compliance.– Central repository for contracts or deals.– Method to track contract termination dates.– Process for confirming compliance before payments to

or receipt of payments from referral sources.– Require review and approval by compliance officer,

attorney or other qualified individual. Contracts. Joint transactions with referral sources. Benefits or perks to referral sources. Marketing or advertising.

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Action Items Ensure your compliance policies address fraud and abuse

laws. (See, e.g., OIG Supplemental Hospital Compliance Program Guidance, 70 FR 4858 (2005)).

Train key personnel regarding compliance.– Administration.– Compliance officers and committees.– Human resources.– Physician relations and medical staff officers.– Marketing / public relations.– Governing board members.– Purchasing.– Accounts payable.

Document training.

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Don’t do this!

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Additional Resources

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https://oig.hhs.gov/compliance/

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OIG Website

Compliance 101 series OIG Compliance Program Guidance

– OIG Supplemental Compliance Program Guidance for Hospitals, 70 FR at 4863-69

– OIG Compliance Program Guidance for Physicians Advisory Opinions Special Fraud Alerts Fraud Bulletins Letters Other materials

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Questions?

Kim C. StangerHolland & Hart LLP

[email protected](208) 383-3913