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Concierge Medicine: Key Legal Considerations Complying with Medicare Regulations, Insurance Laws and the Anti-Kickback Statute. Texas Health Law Conference October 15, 2012. David W. Hilgers, JD [email protected] Brown McCarroll, L.L.P. Robert M. Portman, JD, MPP

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Texas health law conference october 15 2012

Concierge Medicine:Key Legal ConsiderationsComplying with Medicare Regulations, Insurance Laws and the Anti-Kickback Statute

Texas Health Law Conference

October 15, 2012

David W. Hilgers, JD

[email protected]

Brown McCarroll, L.L.P.

Robert M. Portman, JD, MPP

[email protected]

Powers Pyles Sutter & Verville, PC


Road map

Road Map

  • Overview of Concierge Medicine and Models

  • Federal Legal Issues

  • State Law and Private Insurance Issues

  • Contracting Issues

  • Valuation Issues


Concierge care

Concierge Care

  • a/k/a “boutique” or “retainer” medicine

  • Reasons for development

    • lower reimbursement

    • payment denials, delays

    • rising malpractice premiums

    • greater liability risk/regulatory burdens

    • increasing overhead/paperwork

    • higher patient loads


Concierge care1

Concierge Care

  • Positive outcomes

    • Personal care

    • Professional satisfaction

    • May make preventative care affordable and accessible

    • Looks a lot like a family medical home


Concierge care2

Concierge Care

  • Common Characteristics

    • Primary care

    • Fixed monthly or annual fee

    • Limited number of patients—300-800

    • Special services/attention

    • Greater physician access

    • Plan of care

    • Amenities

    • Must pay retainer to receive any services


Services provided

Services Provided

  • Typical Services/Amenities

    • priority/extended/Sat. appointments

    • nicer, less crowded waiting rooms

    • 24/7 pager/email/cell phone access

    • house calls/visits to specialists

    • preventive/wellness care

    • telephone/email consultations

    • Prescription/claims assistance


Services provided1

Services Provided

  • Premium Services

    • Unlimited appointments

    • Same day appointments

    • All physician office services covered

    • Transportation

    • Spa-like amenities (bathrobes/slippers)

    • “free” x-rays


Practice models

Practice Models

  • Non-participation (no insurance)/all preventive and primary care (which can include specialists)

  • Participation (accepts insurance)/retainer only covers non-covered services

  • Participation/amenities only


Practice models1

Practice Models

  • Variations

    • Hybrid – concierge and non-concierge services within

      same practice

    • Direct Care – retainer plus high deductible insurance

    • Bifurcated corporate structure

    • Franchise/Practice Management

    • Direct non-physician ownership – only in states with

      weak corporate practice of medicine laws


Practice models2

Practice Models

  • Key Decisions

    • Participation vs. Non-participation

    • All concierge vs. hybrid

    • What services included in the fee

    • What fees to charge

    • Size of patient panel

    • Independent practice or affiliate with franchise or management company


The numbers

The Numbers

  • 750-2,000 doctors

  • 200,000 patients

  • Retainer fees ranging from $600-30,000

  • 100-500 patients

  • Concierge practices in most states

  • All but 11 states have concierge practices (per 2010

    MedPAC report)


Concierge care examples

Concierge Care Examples

  • MD2 – www.md2.com Portland based

    • Does not accept insurance

    • Will franchise for $75k plus 5% royalty

    • Goal is to create international network of similar practices


Concierge care examples1

Concierge Care Examples

  • MDVIP – http://www.mdvip.com/

    • Boca Raton based closed model

    • Starbucks approach – over 450 physician affiliates in 32 states

    • $1500-1800 annual fee

    • 600 patients per physician

    • Does accept insurance

    • Will franchise turn-key operation for percentage of franchisee’s concierge fees

    • Franchisee keeps all insurance reimbursements


Concierge care examples2

Concierge Care Examples

  • Personal Physician Health Care, LLC/PCwww.personalphysicians.net

    • Boston based/closed model

    • Dual corporate structure – LLC and PC

    • PC accepts Medicare/private insurance

    • LLC provides concierge services

      • $5,000 per patient

      • 300 patients per physician


Concierge care examples3

Concierge Care Examples

  • Health Access RI

    • Network of independent medical practices

    • Monthly membership fee of $25-30 per month

    • Per visit fee of $5-10

    • Provides primary care services

    • Does not accept insurance


Concierge care examples4

Concierge Care Examples

  • Qliance Medical Management, Inc.

    • Seattle-based “Direct Care” – retainer for concierge

      services backed up by high deductible insurance

    • Funded by venture capital and other investors

    • Shows growing interest of venture capital firms in direct care model

    • Monthly fee of $39-79 for unlimited preventive and

      primary care


Concierge care examples5

Concierge Care Examples

  • Other Examples

    • SignatureMD – Arizona, California, Georgia, Indiana, Missouri, Montana, New York, Oklahoma, Pennsylvania and Washington D.C

    • Concierge Choice Physicians (National)

    • PartnerMD – Virginia


Concierge medicine key legal considerations best practices to comply with medicare regulations

Concierge Medicine: Key Legal Considerations Best Practices to Comply with Medicare Regulations


Concierge medicine under medicare

Concierge Medicine Under Medicare

  • Secretary of HHS, 2002:

    • Physicians participating in Medicare can charge patients a special fee to provide services that are not covered by Medicare

  • 2002 – Congress sent letter to HHS and OIG

    • Alleged that fees charged by MDVIP violated

      Medicare limiting charge rules and false claims act

  • HHS response did not call practices illegal as long as charges were for non-covered services

  • Cautioned that physicians entering arrangements should seek legal counsel


Medicare reimbursement issues

Medicare Reimbursement Issues

  • Participating physicians

    • Physician accepts assignment

    • Medicare pays physicians 80% of fee schedule

      directly

    • Physician bills patient co-payment of 20%

    • 80% plus 20% is payment in full

  • Non-participating physicians

    • Patients pay physician directly

    • Patients seek reimbursement from Medicare

    • Limiting charge 115% of Medicare


Medicare reimbursement issues1

Medicare Reimbursement Issues

  • OptingOut

    • Physician has private agreement with Medicare

      beneficiary and Medicare is not billed by

      physician or patient for any services provided by

      physician

  • Review Medicare’s Opt-Out rules carefully

    • Be certain to properly opt out before billing any

      patients

    • Failure to properly “opt-out” renders any contracts

      entered into with Medicare beneficiaries void and

      nullifies the physician’s decision to opt-out


Medicare reimbursement issues2

Medicare Reimbursement Issues

  • Physicians who opt-out may not receive ANY

    remuneration from Medicare, including sharing in practice income where other practice physicians have not opted out for two years

    • Other physicians in practice are not required to

      opt-out

  • Recognize that opt-out is for two years


Medicare prohibition

Medicare Prohibition

  • Physicians cannot charge patients for services already covered by Medicare

    • Applies to participating and non-participating

      physicians

  • Violation of assignment agreement and carries civil money penalties

  • Opt-out physicians are not subject to rule


Medicare coverage issues

Medicare Coverage Issues

  • What does practice bill patient for?

  • Medicare prohibits billing patients for covered services beyond limiting charges

  • Unclear distinction between “covered” and “not-covered”


Covered services

Covered Services

  • Generally, routine photocopying, routine overhead (including malpractice insurance costs, heating, lighting, staff salaries, etc), supplies, rent, continued education or certification fees

  • Malpractice fees


Covered service

Covered Service?

  • Annual Wellness Physical

    • Medicare covers annual wellness visit

    • Is it the same as an annual physical?

  • Many screening tests now covered

    • But, covered under specific intervals: cardiology screen every 5 years, pap smears 24 months, colonscopy 10 years

    • Women’s health issues: screening pap tests, pelvic exams, and mammography

    • Medicare enrolled physicians with retainer practices must clearly be certain they are well aware of current Medicare coverage guidelines


Non covered services

Non-Covered Services

  • Same day appointments

  • Cell phone access

  • Email consultations/texting

  • Lectures to patients on wellness

  • Claims facilitation

  • Home visits

  • Access that has been explicitly expanded in measurable

    ways

  • Is this enough??


Non covered services1

Non-Covered Services

  • Additional or extra-ordinary services

    • CDs, booklets, or pamphlets prepared by the physician regarding the patient’s health, well-being, or a plan to achieve either

    • Testing or treatment that is explicitly not covered by Medicare

    • Any other services which provide a genuine value and which are not part of a patient’s covered service

    • Is the retainer fair market value for the services?


Government pronouncements

Government Pronouncements

  • 2004 – OIG Alert to physicians about added

    charges for covered services

  • 2004 OIG settlement with physician for Personal

    Health Care Medical Care Contract with $600

    annual fee because some covered services were included in the contract services

  • 2007 OIG settlement for over $100,000 with

    physician in North Carolina allegedly violating

    Civil Money Penalty Law for violating assignment agreement


Oig roadmap for new physicians avoiding medicare fraud and abuse

OIG Roadmap for New Physicians: Avoiding Medicare Fraud and Abuse

  • OIG education materials to teach physicians

  • Issued in 2011

  • Specifically discusses “’boutique, concierge, retainer’” practices

    • Explains that can’t get paid a second time for a Medicare covered service

    • IMPORTANT – Explicitly states that it is legal to charge for service not covered by Medicare

    • Access fees or administrative fees are not allowed where they are to obtain Medicare covered services


Oig roadmap for new physicians avoiding medicare fraud and abuse1

OIG Roadmap for New Physicians: Avoiding Medicare Fraud and Abuse

  • Alleged violation of assignment agreement because SOME of the services were already covered by Medicare

  • Legality of agreement turns on what additional fees cover


Oig roadmap for new physicians avoiding medicare fraud and abuse2

OIG Roadmap for New Physicians: Avoiding Medicare Fraud and Abuse

  • Specifically notes CMP settlement

    • Physician paid $107,000 to resolve allegations of

      charging patients annual fee for Medicare covered services

    • Fee covered

      • Annual physical, same or next-day appointments, dedicated support personnel, around the clock physician availability, prescription facilitation, expedited and coordinated referrals, and other amenities at the physician’s discretion


Potential fraud and abuse issues

Potential Fraud and Abuse Issues

  • When dealing with Concierge Practice Management Companies be sensitive to:

    • State Fee Splitting Prohibition: prevent a physician from sharing any part of their fees with a third-party without the third-party performing certain substantive services

      • e.g., often payments are appropriate, but need to be tied to the value of the services

    • Potential kickback issues for marketing; see Advisory Opinion 10-23 (November 4, 2010)

    • Amenities as inducements that violate antikickback rules


Prognosis for concierge care after the aca

Prognosis for Concierge Care After the ACA

  • Primary care doctors at a premium

    • Many more patients

    • Primary care can opt for the better paying practice methodologies

  • ACO’s—Can concierge doctors be participating providers if they are seeing Medicare patients.


Aca and concierge care

ACA and Concierge Care

  • ACA Expanded Medicare Covered Services

    • Prevention Plans

    • Annual Wellness visits

  • Potential Limitations on DME and other prescriptions

  • Will Medicare restrictions be expanded to exchange policies.

  • Family Medical Homes


Guidelines for contracting with patients

Guidelines for Contracting with Patients

  • AMA Ethical Guidelines

    • AMA acknowledges that retainer contracts enhance patient choice and pluralism in the delivery and financing of health care.

    • However, AMA is concerned that a proliferation of retainer practices might “threaten access to care”

    • The AMA provides that retainer contracts:

      • Be entered into without duress, with full disclosure (including any knowledge the physician has regarding the patient’s insurance coverage)


Guidelines for contracting with patients1

Guidelines for Contracting with Patients

  • AMA Ethical Guidelines

    • The AMA provides that retainer contracts:

      • Must be cancelable without financial penalty or “undue inconvenience”

      • Cannot promise “more or better diagnostic and therapeutic services”

        • a guideline which conflicts with the physician’s obligation to provide “more” in return for non-covered service fees

      • In sum, AMA cautions against a physician’s use unfair persuasion in the contracting process and emphasizes the need to uphold quality of care standards for both retainer and non-retainer patients alike


Guidelines for contracting with patients2

Guidelines for Contracting with Patients

  • Where a physician runs a “dual” practice (serving both retainer and non-retainer patients) they must provide the same level of diagnostic and therapeutic service to both

  • Physician must facilitate transfer of patients to other physicians where necessary, or, if no other physicians are available, they must continue to treat them

  • Contracts should clearly and specifically describe all “non-covered” services and physicians must always be honest in their insurance or other payor billings


Guidelines for contracting with patients3

Guidelines for Contracting with Patients

  • For Medicare beneficiaries

    • Contracts with beneficiaries must be available for

      inspection (although not necessarily filed with CMS)

    • Missed appointment fees may be charged, but you must charge all patients the same at the same rate

    • Never bill a patient for services covered by Medicare


Concierge medicine key legal considerations state laws private insurance contracting issues

Concierge Medicine:Key Legal Considerations State LawsPrivate InsuranceContracting Issues


State insurance law

State Insurance Law

  • Unlicensed insurance companies?

    • Practices that provide health care services for fixed, prepaid fee may be health plans under state insurance laws (e.g., Knox-Keene Act in California)

    • No other entity in chain of treatment/payment to accept risk/subject to state regulation (e.g., reserve requirements)

    • If practice goes under, patients left high & dry

      • Ex.: Washington medical group offered their own insurance plan that was put in state receivership


State insurance laws

State Insurance Laws

  • State Limitations on Concierge Medicine

    • West Virginia – Determined that a physician providing care for a flat fee was operating as an unlicensed insurer.

    • Maryland-2008 warning of insurance concerns

    • New Jersey – Warned that NJ physicians serving on HMO or PPO panels could not require a concierge fee, because it discriminates against HMO and PPO patients.

    • New York – Issued an informal warning against double billing for services already covered by private insurance.

      • Reoccurring Issue: Which services are covered and which are not?


State insurance laws1

State Insurance Laws

  • Positive State Trends

    • WVA legislature has pilot program allowing physicians/health

      clinics to charge prepaid fee for primary care and preventive

      services

    • Florida – Found that MDVIP did not require an insurance

      license because the concierge fees were not considered

      insurance.

    • Massachusetts – Found that Personal Physicians Healthcare

      did not violate state insurance laws, and the state licensing

      board for physicians also found that the concierge model was

      legal.


Other state laws

Other State Laws

  • Abandonment

    • Concierge docs must be careful in how they

      drop patients who do not become members

    • Must provide adequate written notice and

      appropriate referrals

    • Do not leave patients in unstable condition;

      provide transition care

    • Check state law


Other state laws1

Other State Laws

  • Corporate Practice of Medicine

    • For franchise/practice management models, physicians must control medical decision-making

  • Anti-kickback (all payor)/Fee Splitting

    • Will affect franchise or practice management fees

  • Franchise Laws

    • Check to see if state franchise laws apply if franchise/practice management model is chosen


Private insurance

Private Insurance

  • Balance Billing and Nondiscrimination

    • Most provider agreements and some state insurance laws preclude balance billing of covered patients for covered services

    • Key is to show these are not covered services

      • However it is not always easy to distinguish what is a covered service and what is not.

        • Examples: 24/7 doctor availability, physical examinations, and coordination of care with specialists

    • Notice to patients

    • Nondiscrimination issue


Private insurance1

Negative Reactions

Premera Blue Cross in

Washington and Blue Shield of

Rochester: extra fees violate

balanced billing and non-

discrimination laws

Harvard Pilgrim Health Care in

Mass: no longer contracts with

physician groups that charge

access fees

Cigna and United Healthcare in

Florida and Texas: physician

concierge care practices no longer qualify for their networks

Positive Reactions

Regence Blue Shield in

Washington: extras fees okay as

long as for noncovered services

BCBS of Mass: will contract

with concierge practices as long

as they notify patients of nature

of practice and fee structure

Private Insurance


Contracting issues

Contracting Issues

  • Business Entity-Practice Contracts

    • If franchise/practice management model

      chosen, business entity will need to enter into

      contracts with participating medical practices

    • Contract will specify whether business entity or practice will collect retainer fees

    • Practice receives license to use entity’s name and logo


Contracting issues1

Contracting Issues

  • Patient Contracts – should contain:

    • Services covered by the subscription fee

    • What services/costs are not covered and any out-of-pocket costs

    • Whether the physician accepts Medicare/private insurance

    • When the retainer fee is payable/refundable

    • When services covered by Medicare or private insurance will be billed or collected

    • How much practice will charge for services not covered by retainer fee


Contracting issues2

Contracting Issues

  • Patient Contracts

    • Contract should specify duration of membership and

      whether it automatically renews or patient must affirmatively renew

    • Patient should be able to terminate without financial

      penalties or excessive inconvenience

    • Patient must be able to understand the contract and

      sign it voluntarily – practice staff assistance

    • Contract should not make exaggerated claims about the

      quality of care


Tips to reduce legal risk

Tips to Reduce Legal Risk

  • Charge retainer fees only for noncovered medical services

  • Take proper steps to transfer nonparticipating patients to other competent physicians

  • Fully inform patients which services are covered by the annual fee, which are covered by insurance, and which will require additional out-of-pocket payments by the patient


Tips to reduce legal risk1

Tips to Reduce Legal Risk

  • Follow carefully rules for opting out of Medicare as well as the termination provisions in agreements with managed care and other insurers

  • For those who do not opt out of Medicare or private insurance, do not require insured patients to pay a retainer fee as a condition of receiving covered services

  • To avoid bumping up against state insurance laws, do not offer all necessary medical services in exchange for a fixed, prepaid fee; rather provide clearly defined services for retainer fee


Texas health law conference october 15 2012

Concierge Medicine:

Key Legal Considerations

Fair Market Value Considerations

Between Practice & Patient

and

Between Concierge Company & Practice


Case study 1 practice patient

Case Study 1: Practice & Patient

  • Determine FMV of Concierge Medicine Program Annual Patient Fee

    • Facts to Consider

      • Program Offering & Patient Benefits

        • Wellness Program with Annual Visit

          • Wellness Plan

          • Metabolic Panel, Heart Health, Diabetes Prevention

          • Respiratory Health, Bone Density, Sleep, Vision, Hearing

          • Comprehensive Risk Factor Analysis

          • Comprehensive Lab Test Program

          • 24/7 access to personal doctor, same day appointments, access to network of physicians when traveling & access to nationally renowned specialists


Case study 1 practice patient1

Case Study 1: Practice & Patient

  • What to Consider when Determining FMV

    • Internal Information

      • All Promotional Literature

      • Membership Application & Agreement

      • Encounter Forms

      • Physician Curricula Vitae

      • Annual Visit CPT Codes & Description of Services with Time Estimates for Provision of Services

      • Does Medicare Reimburse for Service?


Case study1 practice patient

Case Study1: Practice & Patient

  • External Sources of Information

    • The Centers for Medicare & Medicaid Services (“CMS”)

    • Physician Fee Schedule (“PFS”)

    • The Frank Cohen Group Advanced Healthcare Analytics

    • Sinaiko Healthcare Consulting’s Proprietary Paid Claims Database

    • American Medical Group Association: 2010 Medical Group Compensation and Financial Survey (“AMGA Compensation Survey”);

    • Medical Group Management Association: 2010 Physician Compensation and Productivity Survey (the “MGMA Survey”);

    • Sullivan Cotter and Associates: 2010 Physician Compensation and Productivity Survey (the “2010 SCA Survey”); and

    • Economic Research Institute Salary Assessor (“ERI Survey”).


Case study 1 practice patient2

Case Study 1: Practice & Patient

  • Approaches to Value

    • Income – Not Relevant

    • Cost – Relevant

    • Market – Relevant


Case study 1 practice patient3

Case Study 1: Practice & Patient

  • Cost Approach

    • Use Considered Surveys to Determine Physician Compensation per FTE

    • Adjust for Time Difference between Valuation Date and Survey Date

    • Add Benefits

    • Determine Hourly Rate & Apply to High & Low Time Estimates

    • Use PFS to Determine wRVU & tRVU per CPT

    • Calculate Compensation per wRVU & tRVU & Apply to wRVU & tRVU per CPT


Case study 1 practice patient4

Case Study 1: Practice & Patient

  • Results of Cost Approach Analysis

    • Hourly Compensation Rates


Case study 1 practice patient5

Case Study 1: Practice & Patient

  • Results of Cost Approach Analysis

    • Total Compensation per wRVU & tRVU


Case study 1 practice patient6

Case Study 1: Practice & Patient

  • Results of Cost Approach Analysis

    • Total Compensation for Annual Wellness Visit


Case study 1 practice patient7

Case Study 1: Practice & Patient

  • Market Approach

    • Reviewed Data by Frank Cohen Group

      • National Average Charge Data per CPT

      • Average Charge per CPT for Internal Medicine Specialty

      • Average Charge per CPT for Family Practitioners

    • Reviewed Sinaiko Proprietary Paid Claims Database

      • Commercial Payor Reimbursement by CPT and location (physician office)

    • For Lab Tests CMS Clinical Lab Fee Schedule


Case study 1 practice patient8

Case Study 1: Practice & Patient

  • Analysis Summary

    • Cost approach approximates the physician compensation received in clinical practice for provision of the services absent any other benefit available to the patients in concierge program.

    • Family practice and internal medicine doctors generally earn more for specialized services such as those provided in the concierge program. The cost approach which looked at weighted average compensation per hour and compensation per wRVU and tRVU across all procedures does not adequately capture the complexity and specialized nature of the concierge services.

    • The market approach approximates what the physicians would charge for the provision of comparable procedures to those offered. Does not consider the added benefits received by patients in the concierge program.


Case study 1 practice patient9

Case Study 1: Practice & Patient

  • Conclusion


Case study 2 concierge company practice

Case Study 2: Concierge Company & Practice

  • Determine FMV of Fee Concierge Medicine Company Charges Physician Practice

    • Facts to Consider

      • AKS Statute of Primary Importance – depends on whether physician is seeing patients participating in federal programs

      • State anti-kickback and fee-splitting laws may also be implicated


Case study 2 concierge company practice1

Case Study 2: Concierge Company & Practice

  • Approaches to Value

    • Income – Not Relevant

    • Cost – Relevant

    • Market – Relevant


Case study 2 concierge company practice2

Case Study 2: Concierge Company & Practice

  • What to Consider when Determining FMV

    • Internal Information

      • All Promotional Literature

      • Agreement Between Physician Practice & Company

        • Length of Time

        • Right to Cancel

        • Rights & Responsibilities of Parties to Agreement

      • What Services Does Company Provide to Physicians

      • Staff Providing Services

        • Level of Professional

      • Cost to Provide the Services


Case study 2 concierge company practice3

Case Study 2: Concierge Company & Practice

  • External Sources of Information

    • What Companies Providing Similar Marketing Services to Non-Physicians are Charging Clients

      • Reasonable Markup or Gross Margin for Marketing Companies

    • Franchise Fees for Non-Medical Arrangements

    • Perhaps a Licensing Fee or Royalty Rate for use of a Trade-name

    • Points One Cost/Market Hybrid Approach

    • Points Two & Three Market Approach


Case study 2 concierge company practice4

Case Study 2: Concierge Company & Practice

  • Results of Analysis

    • Review and Reconcile Cost Approach Information

    • Review and Reconcile Market Approach Info

    • Reconcile Two Approaches

    • Conclusion as to FMV of Fee


David w hilgers

David W. Hilgers

David W. Hilgers is a Partner at Brown McCarroll, L.L.P. and is a member of the firm’s Health Care Law Section.  He has practiced law for more than thirty-five years.  His primary focus is on health care, corporate, and administrative law.  Mr. Hilgers represents health care providers, including physicians, dentists, health systems, managed care organizations, long-term care facilities, multi-specialty groups, hospitals, hospital districts, and community mental health and mental retardation centers.

David W. Hilgers

Brown McCarroll, L.L.P.

111 Congress Avenue, Suite 1400

Austin, Texas 78701

512-472-5456 Main

202-703-5739 Direct

[email protected]


Robert m portman

Robert M. Portman

Robert M. Portman is a principal in the law firm of Powers Pyles Sutter and Verville PC in Washington, DC. Mr. Portman concentrates his practice in health and association law, focusing on certification law, administrative law, antitrust law, litigation, transactions, election and lobbying law, and legislation and regulation in the health care field. He represents a wide range of non-profit health care organizations including a large number of national professional societies, trade associations, other health

care associations, voluntary health organizations and certification bodies, as well as numerous individual physicians, physician practice groups and other health care providers.

Robert M. Portman

Powers Pyles Sutter & Verville PC

1501 M Street NW Seventh Floor Washington, DC 20005

202-466-6550 Main

202-872-6756 Direct

[email protected]


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