David Winkle Bill Boling Meredith Mlynar [email protected] [email protected] [email protected] Regulatory Challenges and Opportunities for Georgia’s

David Winkle Bill Boling Meredith [email protected] [email protected] [email protected]

Regulatory Challenges and Opportunities for Regulatory Challenges and Opportunities for Georgia’s Rural Hospitals:Georgia’s Rural Hospitals:

Anti-Kickback Law & Safe Harbors Anti-Kickback Law & Safe Harbors Stark Law & ExceptionsStark Law & Exceptions

April 27, 2007April 27, 2007

© 2006 Powell Goldstein LLP. All Rights Reserved.

2

What’s the Big Deal?What’s the Big Deal?

Physician financial relationships with hospitals and other health care providers to which they refer patients are heavily regulated under federal and state law

If these relationships are improperly structured, documented or implemented, these laws can subject a hospital, its management and the physicians to civil, administrative and criminal penalties

3

Federal Anti-Kickback StatuteFederal Anti-Kickback Statute

Prohibits a person or entity from knowingly and willfully offering, paying, soliciting or receiving any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind, with the intent to induce referrals for federal health care program reimbursable items or services

Can implicate immediate family members

4


The statute applies to physician – hospital financial relationships of all types, including common arrangements:

Service and supply contracts

Ancillary services

Imaging

Equipment

Leases (space, equipment)

Ambulatory surgery centers

5

Federal Anti-Kickback StatuteFederal Anti-Kickback Statute Criminal Penalties

$25,000

Five years’ imprisonment

Civil Money Penalties

$10,000 per item or service

3 times amount claimed for each item or service

Exclusion

Federal and State healthcare programs

False Claims Act Liability

Treble damages; penalties

6


“Safe Harbors” protect conduct that otherwise

might be found to violate the statute

The conduct or arrangement must fully satisfy

all of the safe harbor’s conditions to claim safe

harbor protection from sanctions

Safe harbor conditions are detailed, narrow,

and difficult to satisfy consistent with common

business practices

7


Safe Harbors commonly relied upon in hospital-physician arrangements:

Personal services/management contracts

Physician Recruitment

Employment

Space leases and equipment leases

Electronic Health Records (EHR) & E-Prescribing *NEW*

Certain investment interests: “small entity”

Investments in Ambulatory Surgery Centers

8


Services/Management Agreement Safe Harbor

Written agreement signed by the parties; must be at least for a one-year term

Services are specified; terms are commercially reasonable

Aggregate compensation is set in advance, is FMV, and is not related to the volume or value of referrals or business otherwise generated between the parties

Percentage, “per-click” or “per service” fees are not protected, but not specifically prohibited

If services provided on part-time basis, agreement specifies the exact schedule, length and charge for such services; time logs must be maintained

9

Federal Anti-Kickback StatuteFederal Anti-Kickback StatutePhysician Recruitment Safe Harbor

Safe harbor protection limited to recruitment into a health professional shortage area (HPSA) (Document community need if not a HPSA)

Written agreement; benefits not exceeding 3 years

At least 75 percent of revenues of new practice must be from new patients

No requirement to make referrals to or practice exclusively at hospital; physician to treat federal patients in non-discriminatory manner

Benefits may not vary with referrals or be provided to any other person or entity in a position to make or influence referrals to hospital

10


Employment Exception/Safe Harbor

Anti-Kickback statutory exception and safe harbor

protect amounts paid by an employer to a bona fide

employee

“Employee” defined with reference to IRS guidelines

11


Space and Equipment Lease Safe Harbor

Written lease signed by the parties; at least a one-year term

Aggregate rent set in advance, is FMV, and not determined in a manner that takes into account the volume or value of referrals or business otherwise generated by the parties

No adjustment for proximity to referral sources

Percentage, “per click” or “per use” rent not protected

Aggregate space/equipment leased must not exceed commercially reasonable business purpose of Lessee/Tenant

12

Summary: General Anti-Summary: General Anti-Kickback Problem AreasKickback Problem Areas

Offering terms or returns based on referrals

Loans to investors for capital

Investors have little or no risk

No legitimate business purpose; No “Value Added”

Departure from contract terms

Service fees not FMV

Payments Changed to Reflect Referrals

Increased Program Costs

Overutilization

Quality of Care Compromised

Rewards for limiting or withholding of care

Patient Choice Restricted

13

Stark LawStark Law

Stark law prohibits a physician from making referrals for Medicare/Medicaid designated health services (“DHS”) to an entity with which the physician (or a member of the physician’s immediate family) has a financial relationship

Strict Liability: No intent or knowledge necessary

DHS includes inpatient and outpatient hospital services

Financial relationships covered by Stark law can be:

A direct or indirect ownership interest, or

A direct or indirect compensation arrangement

14

Stark LawStark Law

Stark Law’s prohibition is absolute:

If the financial relationship exists and no exception

applies, the physician may not refer patients to the

entity (in the case of a hospital for inpatient or

outpatient hospital services or other designated

health services)

If the financial relationship exists, no exception is met,

and a referral is made, the hospital may not bill for

the services it provides as a result of that referral

15

Stark LawStark Law

If the hospital bills for its services pursuant to an illegal referral, it must refund the entire amount of the payment

If the hospital fails to properly refund illegally billed amounts, the hospital is subject to:

A fine of $15,000 per item billed

Exclusion from the Medicare program

Stark law violation may give rise to liability under the False Claims Act

Treble damages, penalties (apply to each transaction)

16

Stark LawStark Law

Exceptions related to compensation arrangements

Personal services agreements

Fair market value compensation

Indirect compensation

Physician recruitment

Employment

Space and equipment leases

EHR & E-Prescribing *NEW*

17

Stark LawStark LawService contracts, space/equipment leases,

FMV compensation:

Exceptions have requirements similar to those under the Federal Anti-Kickback Safe Harbors:

Contracts in writing, signed, at least one year term

All services/space/items must be covered by the written contract

Commercially reasonable and necessary for legitimate business

Does not violate the Anti-Kickback Statute or other law

Compensation must be:

Fair market value

Set in advance

Unrelated to volume or value of referrals or other business generated between the parties

18

Stark LawStark LawIndirect Compensation Arrangement

Exception

Any unbroken chain of financial relationships (whether ownership or compensation) may link hospital and physicians in an “indirect compensation” arrangement

Exception allowed if:

Compensation to physician is FMV for items/services actually provided

Compensation is unrelated to volume or value of referrals to or other business generated with the hospital

Set out in writing that specifies services covered by arrangement

Does not violate the Anti-Kickback Statute or any laws on billing and claims submission

19

Stark LawStark LawRecruitment Exception

Protects payments to physician to induce physician to relocate practice to the area served by the hospital and become a member of the medical staff

Must be in writing, no condition that physician refer to hospital and payments cannot be based on volume or value of actual or anticipated referrals

Physician must be allowed to establish privileges at and refer to other entities (unless recruited for employment)

Physician must either (i) move practice at least 25 miles, or (ii) derive at least 75 percent of revenues from new patients (physicians in practice for less than one year not subject to these requirements)

20

Stark LawStark LawRecruitment Exception

If recruitment payments are made to group which physician joins:

Written agreement must be signed by group

Payments flow straight through to physician except for actual costs incurred by group in recruiting physician

If income guarantee, overhead allocated to physician must be limited to incremental cost increase attributable to that physician

Practice may not impose additional practice restrictions on physician

Payments must not take into account referrals to hospital from group

21

Stark LawStark LawEmployment Exception

Protects payments by hospital to physician with bona fide employment relationship for identifiable services

Employment compensation must be fair market value and not determined in a manner that takes into account referrals to the employer

Productivity bonuses are permitted based on services personally performed by physician. Use Relative Value Unit (RVU) method; that is, measure of productivity of provider, which reflects time to perform service, technical skill and mental effort of provider.

Cannot bonus on volume of ancillaries ordered

Agreement would be commercially reasonable even if no referrals were made to employer

22

Summary: Stark Problem Summary: Stark Problem AreasAreas

Complex Business Arrangements: Failure to Bring Every Payment, Financial Relationship under an Exception

Agreement Not in Writing; Written Agreement Lapsed

Departure from Contract Terms

Compensation not FMV

Compensation not set in advance

Compensation Tied to Referrals, Business Generated between the Parties

No Bona Fide Business Purpose

23

Georgia Self-Referral LawGeorgia Self-Referral Law

Applies referral prohibitions similar to Stark law to relationships between hospitals and other health care providers, including physicians

Unlike Stark law, applies only to ownership (equity) interests (not compensation [salary] interests)

Unlike Stark law, applies to all payors

Broad exception for referrals for services performed by referring physician or by member of referring physician’s group practice, and for referrals made to a hospital by a physician holding medical staff privileges

Requires notice of ownership interest to patients

24

A Positive OutlookA Positive Outlook

Many opportunities

remain despite

stringent regulation

and enforcement

25

Hospital-Physician Integration Hospital-Physician Integration Models Models

Can help rural hospitals stay in compliance under these statutes, especially those centered on:

Recruitment

Employment

Personal Services

Medical Directorships

Co-Management

Leasing Arrangements

Equipment, Space, Property

26

EmploymentEmployment

Regulatory issues turn in part on how

physicians become employees of the hospital

Recruitment

Acquisition of existing physician practices

Community Need

Primary care vs. specialists

Coverage

27


Recruitment

Recruit as hospital employee

Satisfy employment exception and safe harbor

Recruit to join existing physician practice

Satisfy recruitment exception and, if possible, safe harbor

Document community need for physicians in that specialty

No recruitment benefits to pay overhead of physician practice

No restrictions on establishing privileges or referring elsewhere

28


Acquisition of existing practice/Stark law

Acquisition of practice/isolated transaction exception

(requires that subsequent financial arrangements satisfy

Stark exception)

Employment exception

Applies only to employment compensation

Places limits on productivity bonuses

If doctors maintain investment interests, must satisfy:

Personally-performed services exception

In-office ancillary services exception

Practice must satisfy the Stark definition of “group practice” to fall under

these exceptions

29

EmploymentEmploymentAcquisition of existing practice/Anti-

Kickback Statute

Purchase of medical practices have been treated as kickbacks (safe harbor extremely limited)

Purchase must be FMV, legitimate business purpose, arms length

Pay for hard assets, value of ongoing business, covenants not to compete, exclusive dealing arrangements and patient lists/records; not goodwill

Do not require seller to refer to hospital

Ensure post-purchase compensation to seller is reasonable with no incentives for referrals

30

Leasing ArrangementsLeasing Arrangements

Hospital may affiliate with physicians through various leasing arrangements

Medical office buildings and other real estate

Equipment

Service lines (imaging, outpatient surgery, cardiac lab, physical therapy)

Likely issues: Commercially reasonable business purpose; short-term leases; FMV; rental that varies with clinical income, referrals, or other business

31

Leasing ArrangementsLeasing Arrangements

Space, Real Property Leases: Stark law

Space lease exceptions available

May be indirect compensation relationship

Space, Real Property Leases: Anti-kickback statute

Lease safe harbor

“Per use” rent payments do not qualify for safe harbor protection

Contractual joint venture?

32

Leasing ArrangementsLeasing ArrangementsEquipment Leases: Stark law

Equipment lease exceptions available

May be indirect compensation relationships

Leased service lines must be structured to comply with in-office ancillary services exception and other reimbursement regulations for lessee to be eligible to bill for services

Can compensate on “per use” or “per click” basis

Equipment Leases: Anti-kickback statute

Lease safe harbor

“Per use” rent payments may not qualify for safe harbor protection

Contractual joint venture?

33

Electronic Health Records Electronic Health Records & E-Prescribing& E-Prescribing

New Federal Exceptions

On August 8, 2006, both the Centers for Medicare &

Medicaid Services and the Office of the Inspector

General of the Department of Health and Human

Services published final rules providing for

exceptions from Stark and safe-harbors under the

Anti-Kickback law.

34

New CMS Stark ExceptionsNew CMS Stark Exceptions

The new CMS final rule contains two

exceptions to Stark:

Hospitals may provide technology to

support EHRs; and

Hospitals may provide e-prescribing

technology

35

EHR Stark ExceptionEHR Stark Exception

Hospitals furnishing designated health services may provide “software or information technology and training services” to a physician so long as the technology is used “predominantly to create, maintain, transmit or receive” EHRs.

The arrangement must also comply with the anti-kickback law.

36


Technology covered under the exception:

Software meeting certain conditions;

Interfaces and translation software;

Rights, licenses and intellectual property related to EHR software;

Connectivity services;

Clinical support and information services related to patient care;

Maintenance services;

Secure messaging; and

Training and support services.

HARDWARE IS NOT COVERED

37


In donating technology to physicians,

hospitals may not take referral volume or

value into consideration in choosing who

receives the technology.

Hospitals may, however, use criteria not

directly related to the value or volume of

referrals in choosing recipients.

38


In choosing recipients for EHR technology,

hospitals may consider:

Total number of prescriptions written;

Size of medical practice;

Physician’s overall use of technology; or

Other reasonable and verifiable criteria not related

to volume or value of referrals.

39

EHR Stark Exception EHR Stark Exception

Additional conditions:

Donated items cannot be the “equivalent” of items the physician already has;

The arrangement must be detailed in a written agreement;

The physician must pay 15% of the donor’s costs;

Hospital may not disable or limit interoperability functions that the technology may have;

Hospital may not limit the kinds of patients for whom the technology is used;

Donation must include an e-prescribing function.

40

E-prescribing Stark ExceptionE-prescribing Stark Exception

Under the final rule, hospitals may provide

e-prescribing items and services to:

Members of their medical staffs;

Practices and their physician members;

Medicare Part D Prescription Drug Plan sponsors;

Medicare Advantage organizations.

41

E-prescribing Stark ExceptionE-prescribing Stark Exception

The e-prescribing exception contains limitations similar to

those discussed with the EHR exception:

Items must be used solely to receive and transmit electronic

prescription information;

Items must not be equivalent to items the recipient already has;

Donor may not limit or disable interoperability functions the

technology may have;

Donor may not consider volume or value of referrals in deciding who

receives the technology;

Arrangement must be in writing

42

OIG Safe HarborsOIG Safe Harbors

On the same day that CMS published its

Stark exceptions for EHR technology and e-

prescribing, the OIG published safe harbors

for similar EHR and e-prescribing items.

The Anti-Kickback safe harbors closely

reflect the Stark exceptions previously

discussed

43

EHR Anti-Kickback EHR Anti-Kickback Safe HarborSafe Harbor

EHR safe harbor allows hospitals to

provide “software or information

technology and training services” to:

Physicians

Individuals

Organizations

44

EHR Anti-KickbackEHR Anti-KickbackSafe HarborSafe Harbor

Donation must be used “predominantly to

create, maintain, transmit or receive” EHRs.

The covered technology closely reflects that

under the Stark Exception.

Broad range of protected donors – those

who provide health services covered by a

federal health program.

45

E-prescribing Anti-KickbackE-prescribing Anti-KickbackSafe HarborSafe Harbor

Similar to e-prescribing exception under Stark.

Hospitals may give items and services relating to

e-prescribing to members of their medical staffs.

Other potential donors and recipients:

Group practices and their members;

Medicare Part D Prescription Drug Plan Sponsors

Medicare Advantage organizations.

46

Certification RequiredCertification Required

Under both Stark and Anti-kickback, interoperability of EHR items must be certified by a recognized body

The Certification Commission for Healthcare Information Technology (CCHIT) is the first group to be designated a Recognized Certification Body (RCB) by HHS

HHS hopes CCHIT’s seal of approval will accelerate adoption of health IT products by removing uncertainty about the technical capabilities of the products, and thereby limiting the risk associated with investing in health IT for health care providers

CCHIT has certified 59 EHR products so far, consistent with published criteria

47

Reasons for Move to National Reasons for Move to National Electronic Medical Record GridElectronic Medical Record Grid

According to Rand Corp study, EMR system creates an estimate annual administrative cost savings of $81 billion a year and $346 billion annual savings from a more efficient practice of medicine.

Sept. 2006 – National Academies of Medicine reported: “Medicare payment System encourages volume rather than efficiency and quality.”

According to the Advisory Board (study by Penn. Healthcare Council) in-hospital-acquired infections resulted in an average additional cost of all hospital-acquired infections of $60,678.

48

• According to Reinertsen Group (the 100,000 Lives Campaign): Doctors’ treatment helps their patients only 55% of the time, with serious harm 1% of the time. Hospital’s care is defective 10% of time, resulting in over 200,000 annual deaths

• Tenet’s recent corporate integrity agreement requires quality initiatives based upon evidence-based medicine

• The federal government’s goals of rapid EMR adoption are: (1) improve quality and reducing errors by connecting patients’ healthcare information across all practices settings, (2) measure and report outcomes, and pay for outcomes to realign financial incentives of healthcare.

49

Federal ResponseFederal Response

• By Executive order, President has adopted a 10 year plan to create EMR infrastructure and created office of National Coordinator for Health Information Technology

• Four federal contracts have been entered into: (1) establish IT standards and harmonization; (2) establish compliance certification; (3) establish privacy and security standards; (4) design national health information network

• August 22, 2006 – Executive order directing federal agencies that administer federal healthcare programs to increase price and quality transparency by January 1, 2007

◦ Require providers of federally financed healthcare adopt quality – measurement tools and uniform standards for health IT

◦ Require adoption of EMR and interoperability

50

National ePrescribing Patient National ePrescribing Patient Safety Initiative (NEPSI)Safety Initiative (NEPSI)

Formed by a coalition of some of the nation’s largest technology and healthcare companies

Will provide free e-prescribing software (“eRxNOW”) to EVERY physician in America

eRxNow generates secure electronic prescriptions that can be sent computer-to-computer or via fax to 55,000 retail pharmacies

Includes instant “harmful interactions” check & real-time notification of insurance formulary status from payors

One Atlantic Center

Fourteenth Floor

1201 West Peachtree Street, NW

Atlanta, GA 30309

Tel. 404.572.6600

Fax. 404.572.6999

901 New York Avenue, NW

Third Floor

Washington, DC 20001

Tel. 202.347.0066

Fax. 202.624.7222

2200 Ross Avenue

Suite 3200

Dallas, TX 75201

Tel. 214.721.8000

Fax. 214.721.8100

www.pogolaw.com

A t l a n t a▪ W a s h i n g t o n ▪ Dallas

© 2006 Powell Goldstein LLP. All Rights Reserved.

David [email protected]

Bill [email protected]

Meredith [email protected]

OUTPATIENT IMAGING

Proposed Lease Transaction For 3 + 2 Year Term

Total Equipment Cost $3,587,465

Equity $1,076,240

Percent Financed by Venture 70%

Amount Finance $2,511,226

Assumed LLC Borrowing Interest Rate 7.75%

Annual Debt Service (3 years only) $1,028,250

Lease Term (Years) 3 + 2

Annual Lease Payment (3 years) $1,198,190

(2 years) $444,996

Residual Value of Equipment (3 years) $896,866

(5 years) $358,746

Estimated annual IRR for Investors (3 years) 15%

(Cash on Cash Return) = IRR (5 years) 17%

64 Slice

Projected Lease Transaction for 3 + 2 Year Term

Terms with Financial Institution

Total Equipment Cost $1,910,000

Equity – 30% $ 573,000

Amount Finance – 70% $1,337,000

Assumed LLC Borrowing Interest Rate 6.21%

Annual Debt Service (3 years only) $ 487,097

Terms with Leasing Company

Lease Term (Years) 3 + 2

Annual Lease Payment (3 years) $637,928

(2 years) $248,318

Residual Value of Equipment (3 years) $477,500

(5 years) $191,000

Estimated annual IRR for Investors (3 years) 15% (5 years) 14%

THE OFFERINGTHE OFFERING

Total Investment Units 500

Maximum Units Available 495

Minimum Units Per Investor 5

Maximum Units Per Investor 10

Unit Price $1,146

Minimum Unit (5) Commitment: $5,730

Maximum Unit (10) Commitment: $11,460

C A R D I O V A S C U L A R M A N A G E M E N T S E R V I C E S A G R E E M E N T

M A N A G E M E N T S E R V I C E S

A d m i n i s t r a t i v e K n o w s , u n d e r s t a n d s , i n c o r p o r a t e s , a n d d e m o n s t r a t e s t h e S R H S p h i l o s o p h y , m i s s i o n , v i s i o n , a n d v a l u e s i n b e h a v i o r s , p r a c t i c e , a n d d e c i s i o n s . 1 . P r o v i d e l e a d e r s h i p a n d m o t i v a t e c a r d i a c p h y s i c i a n s t o s u p p o r t a c o m m o n v i s i o n a n d f u n c t i o n a s a n

i n t e g r a t e d t e a m . 2 . D e v e l o p a s t r a t e g i c p l a n f o r t h e H o s p i t a l c a r d i o v a s c u l a r p r o g r a m t h a t i n c l u d e s :

• V i s i o n o f t h e p r o g r a m s / s e r v i c e s t o b e o f f e r e d ; • E n h a n c e m e n t o f g e o g r a p h i c d i s t r i b u t i o n o f h e a l t h c a r e s e r v i c e s ; a n d • C l i n i c a l B u s i n e s s D e v e l o p m e n t p l a n .

3 . M o n i t o r t h e i m p l e m e n t a t i o n o f t h e s t r a t e g i c p l a n ; d e v e l o p a c t i o n p l a n s f o r a r e a s o f t a r g e t s h o r t f a l l .

4 . G u i d e t h e d e v e l o p m e n t o f a c o m m u n i c a t i o n s t r u c t u r e f o r o t h e r c a r d i o v a s c u l a r c l i n i c i a n s i n v o l v e d i n t h e c a r d i o v a s c u l a r p r o g r a m .

5 . W o r k w i t h t h e H o s p i t a l l e a d e r s h i p t o i d e n t i f y p h y s i c i a n p r a c t i c e n e e d w i t h i n t h e c a r d i o v a s c u l a r p r o g r a m .

6 . E v a l u a t e c u r r e n t c l i n i c a l o f f e r i n g s r e l a t e d t o c u r r e n t a n d p r o p o s e d c o m m u n i t y n e e d o p p o r t u n i t i e s a n d e v i d e n c e b a s e d m e d i c i n e .

7 . P a r t i c i p a t e a s n e e d e d i n r e g i o n a l d e v e l o p m e n t a c t i v i t i e s .

8 . M e e t w i t h r e f e r r a l p h y s i c i a n s p e r i o d i c a l l y t o s o l i c i t i n p u t f r o m r e f e r r a l p h y s i c i a n s a s t o t h e o p e r a t i o n s o f t h e c a r d i o v a s c u l a r p r o g r a m .

9 . M o n i t o r p a t i e n t s , r e f e r r a l p h y s i c i a n s a n d p a y e r s a t i s f a c t i o n r e s u l t s ; w o r k i n c o n j u n c t i o n w i t h t h e H o s p i t a l 's M a n a g i n g D i r e c t o r a n d o t h e r m e d i c a l l e a d e r s t o d e v e l o p a n d i m p l e m e n t c o r r e c t i v e a c t i o n p l a n s a n d p r o c e s s i m p r o v e m e n t .

1 0 . D e v e l o p a n n u a l p l a n f o r p r o g r a m i m p r o v e m e n t s f o r a p p r o v a l b y t h e H o s p i t a l l e a d e r s h i p . P h y s i c i a n a n d C o m m u n i t y R e l a t i o n s 1 . S t r e n g t h e n t h e m a r k e t p r e s e n c e t h r o u g h m a r k e t i n g o f t h e H o s p i t a l c a r d i o v a s c u l a r p r o g r a m t o

c o m m u n i t y , p a y e r m a r k e t a n d o t h e r p r o v i d e r s .

2 . E s t a b l i s h q u a r t e r l y m e e t i n g s w i t h r e f e r r i n g p h y s i c i a n s r e g a r d i n g a c c e s s a n d s a t i s f a c t i o n . R e p o r t r e s u l t s t o H o s p i t a l l e a d e r s h i p s e m i - a n n u a l l y .

3 . P a r t i c i p a t e i n t h e e d u c a t i o n o f l a y c o m m u n i t y r e g a r d i n g r i s k f a c t o r s a n d b e h a v i o r s f o r c a r d i o v a s c u l a r d i s e a s e .

4 . P a r t i c i p a t e i n d e v e l o p i n g a n d i m p l e m e n t i n g s t r a t e g i e s f o r e f f e c t i v e r e l a t i o n s h i p s b e t w e e n c a r d i a c p h y s i c i a n s a n d o t h e r c o m m u n i t y p h y s i c i a n s .

5 . A c t i v e l y p r o m o t e t h e H o s p i t a l c a r d i o v a s c u l a r p r o g r a m i n o u t r e a c h a r e a s i n c l u d i n g p a r t i c i p a t i n g i n e d u c a t i o n a l s e m i n a r s / l e c t u r e s , p e r s o n a l v i s i t a t i o n s t o a r e a p h y s i c i a n s a n d h o s p i t a l s , e t c .

6 . P a r t i c i p a t e i n t h e a n n u a l m a r k e t a s s e s s m e n t p r o c e s s t o i d e n t i f y o p p o r t u n i t i e s f o r i n c r e a s e d m a r k e t s h a r e .

7 . A s s i s t i n i n t e r f a c i n g w i t h p a y e r m a r k e t t o v a l i d a t e n e e d s a n d r e v i s e p r o g r a m a n d p a c k a g e s e r v i c e s b a s e d o n c o n s u m e r n e e d s .

8 . A s s i s t i n c o m p l e t i n g w r i t t e n a n d v e r b a l r e s p o n s e s t o m a n a g e d c a r e r e q u e s t f o r p r o p o s a l s ( R F P s ) .

C l i n i c a l O p e r a t i o n s M a n a g e m e n t 1 . P a r t i c i p a t e i n p r o g r a m o p e r a t i o n s t e a m s w i t h i n t h e c o - m a n a g e m e n t s t r u c t u r e t o e n g a g e

p h y s i c i a n s i n t h e d a i l y o p e r a t i o n a l m a n a g e m e n t .

2 . I n c o n j u n c t i o n w i t h t h e H o s p i t a l 's M a n a g i n g D i r e c t o r a n d p h y s i c i a n s w i t h i n t h e p r o g r a m : • E v a l u a t e o p e r a t i o n a l p r o c e s s e s f o r o p p o r t u n i t i e s i n s e r v i c e a n d e f f i c i e n c y

i m p r o v e m e n t i n c l u d i n g c o s t a n d q u a l i t y • A n n u a l l y d e v e l o p , i m p l e m e n t a n d m o n i t o r t h e a c t i o n p l a n s f o r p r o c e s s

i m p r o v e m e n t • D e v e l o p , i m p l e m e n t , a n d m o n i t o r c l i n i c a l s t a n d a r d s o f p r a c t i c e b a s e d o n e v i d e n c e

b a s e d m e d i c i n e • D e v e l o p , i m p l e m e n t a n d m o n i t o r s t a n d a r d s f o r r e s o u r c e u t i l i z a t i o n b y D R G

a n d / o r d i a g n o s i s • P a r t i c i p a t e i n c o s t b e n e f i t a n a l y s i s f o r p r o p o s e d c l i n i c a l p r o c e s s i m p r o v e m e n t

c h a n g e s • A s s i s t w i t h t h e p r e p a r a t i o n a n d m o n i t o r i n g o f t h e a n n u a l b u d g e t s • M a i n t a i n c o m p l i a n c e w i t h a l l a p p l i c a b l e J C A H O a n d D e p a r t m e n t o f H e a l t h

r e g u l a t i o n s 3 . M o n i t o r p h y s i c i a n c o m p l i a n c e w i t h e s t a b l i s h e d c l i n i c a l p r a c t i c e g u i d e l i n e s a n d d e v e l o p

q u a r t e r l y r e p o r t t o t h e c a r d i o v a s c u l a r p r o g r a m c o m m i t t e e s .

4 . A s s i s t i n t h e c o o r d i n a t i o n o f a n d a t t e n d t e a m " c a r e c o n f e r e n c e s " t o p r o v i d e c o n c u r r e n t r e v i e w o f p a t i e n t c a r e a n d d e v e l o p a n d i m p l e m e n t a c t i o n p l a n s f o r i d e n t i f i e d i s s u e s .

5 . C o o r d i n a t e q u a l i t y r e v i e w a c t i v i t i e s r e l a t i v e t o a r r a n g i n g f o r r e v i e w a n d a c t i o n a s a p p r o p r i a t e o n c o m p l i c a t i o n s e x p e r i e n c e d a n d / o r s i t u a t i o n i d e n t i f i e d i n c l u d i n g h o l d i n g C a r d i o l o g y D e p a r t m e n t q u a l i t y i m p r o v e m e n t m o n t h l y m e e t i n g s w i t h t h e H o s p i t a l l e a d e r s h i p , m e d i c a l s t a f f a n d c l i n i c a l m a n a g e r s / c o o r d i n a t o r s t o r e v i e w p a t i e n t c h a r t s .

6 . G u i d e t h e d e v e l o p m e n t a n d m o n i t o r i n g o f a p p r o p r i a t e p h y s i c i a n c r e d e n t i a l i n g c r i t e r i a f o r t h e c a r d i o v a s c u l a r p r o g r a m . C r i t e r i a t o i n c l u d e p r i m a r y e d u c a t i o n , b o a r d c e r t i f i c a t i o n o r e l i g i b i l i t y r e q u i r e m e n t s , c u r r e n t l i c e n s u r e , r e l e v a n t t r a i n i n g o r e x p e r i e n c e , c o n t i n u i n g e d u c a t i o n , c l i n i c a l o u t c o m e s t a n d a r d s ( c u r r e n t c o m p e t e n c e ) , v o l u m e c r i t e r i a w h e r e a p p r o p r i a t e , a n d p e e r r e c o m m e n d a t i o n s .

7 . D e v e l o p a n d m o n i t o r b e d m a n a g e m e n t s y s t e m s i n c l u d i n g a d m i s s i o n a n d d i s c h a r g e c r i t e r i a f o r u s e o f t e l e m e t r y b e d s .

8 . W o r k w i t h M e d i c a l R e c o r d s s t a f f t o e n s u r e a d e q u a t e p h y s i c i a n d o c u m e n t a t i o n f o r a c c u r a t e c o d i n g .

9 . S e r v e a s t h e r e s o u r c e i n t h e r e s o l u t i o n o f p e r f o r m a n c e a n d / o r p e r s o n a l i t y i s s u e s r e l a t e d t o t h e c l i n i c a l c a r e t e a m .

1 0 . A s s i s t w i t h c o n f l i c t r e s o l u t i o n o f i s s u e s r a i s e d r e g a r d i n g p r o g r a m o p e r a t i o n s a n d / o r m a n a g e m e n t .

1 1 . P a r t i c i p a t e i n t h e p r o c e s s t o e v a l u a t e n e w t e c h n o l o g y i n c l u d i n g i t s i m p a c t o n s a f e t y , e f f i c a c y a n d e f f i c i e n c y o f c a r e .

1 2 . W o r k w i t h p h y s i c i a n s t o e n s u r e p a r t i c i p a t i o n , t i m e l i n e s s o f t a s k s a n d c o m p l e t i o n o f a s s i g n e d t a s k s .

CARDIOVASCULAR MANAGEMENT SERVICES AGREEMENTPERFORMANCE GOALS AND STANDARDS

Co-Management Agreement Quality Bonus Indicators

NA1.41.361.32

Appropriate documentation of severity of illness; impacts external measures

Appropriate case mix for all patients within the service lineCase mix index for MDC 5

General

$15,500 $17,500$17,500 $19,000$18,500 $20,000Single: $19,500Dual: $21,000

Acquisition costs to national benchmarksAcquisition cost per defibrillator

Defibrillator implant cost per case

1.51.5National Cardiovascular Data Registry (ACC)Utilization of procedure areas

Average number of lab visits per admission

2.82.8National Cardiovascular Data Registry (ACC)Utilization of procedure areasLength of stay

Electrophysiology

98%% of patients with antibiotic administered 1 hour pre-operatively

Prophylactic antibiotic within 1 hour of surgical procedures

90%IHl Surgical Infection Rate Reduction Plan

% of patients with serum glucose less than or equal to 200 mg/dL intro-operatively and during the first 48 hours postoperatively

Percent of patients with perioperative glucose controlVascular

92%90%85%82%JCAHO Core MeasureMeasurement of LVF through ultrasound or other means during hospital stay

Left ventricular function assessment

95%90%85%80%JCAHO Core MeasureLVEF <40%, med prescribed at discharge of documentation med not indicatedACE/ARB at discharge

44.24.74.8Fiscal managementAMLOS 5.2 GMLOS 4.1ALOS for DRG 127

CHF

81.8% <90 minutes90%15%44%CMSDoor to PCI; door to thrombolyticsDoor to PCI time for STEMI

95%95%94%93%JCAHO Core Measuredischarge of documentation medBeta Blacker at discharge

99%98%97%97%JCAHO Core MeasureMed prescribed at discharge of documentation med not indicatedASA at discharge

95%92%75%58%JCAHO Core MeasureMed prescribed at discharge of documentation med not indicatedACE/ARB at discharge

AMI

$7,800$8,000$8,250$9,028Fiscal managementBudget cost per interventional caseBudget cost per case

NA <0.5% <1%0%Post PCI complications -preventable errors% of PCI with complication codesAdverse events

75% 124;25% 125

60% 124; 40% 125

55% 124; 45% 125

48% 124; 52% 125

Case mix for diagnostic caths measures accurate documentation of patient severity%of IP caths in each DRGDRG Ratio - 124/125Interventional

Cardiology

National Benchmark Stretch Target BaselineRationaleDefinitionIndicatorProgram

Documents

David Winkle Bill Boling Meredith Mlynar [email protected] [email protected] [email protected] Regulatory Challenges and Opportunities for Georgia’s