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Virginia Telehealth Summit
Telehealth Legal and Regulatory Issues
               Greg Billings
     Senior Government Relations Director

Center for Telehealth and e-Health Law
               Washington, DC
Objectives


• Telehealth Licensure State Statutes
• Internet Prescribing
• Telehealth Private Payer State
  Statues
• Credentialing and Privileging of
  Telehealth Providers
CTeL | Thursday, March 18, 2010
Licensure Overview
•    Under U.S. law, states are allowed to monitor the practice of
     professionals within their boundaries.

      – Through licensure, State medical boards are responsible for
        regulating physicians and other health care providers within
        their own state.

      – Licensure is the process by which a state government
        validates a health care provider’s credentials and deems the
        provider competent to practice medicine.

      – Licensure, as it applies to telemedicine, refers to:
           “Issues surrounding the regulations of physicians and
            other health care providers who practice telemedicine
            between health care facilities in different states.”
            (Reid, A Telemedicine Primer)

CTeL | Thursday, March 18, 2010
What to Consider When Practicing
           Telemedicine…
• Jurisdiction
   – Where is the patient located?
        A majority of State Medical Boards maintain
         that jurisdictional authority is attached to the
         patient.
   – Where is the physician located?
   – Does the physician hold other medical licenses?
• Licensure Laws
   – Licensure laws vary among states.
   – Review each individual state’s licensure statutes
     before practicing telemedicine.
CTeL | Thursday, March 18, 2010
Types of Licensure
• Full Medical Licensure for Telemedicine
   – 36 states/territories require telemedicine providers to
     obtain a full medical license.
        To obtain a full license, a telehealth provider may
         need to meet the following requirements:
                » Pay licensure fees;
                » Pass additional oral and written
                   examinations; and/or
                » Travel for interviews.
• Exceptions
   – Direct Consultation
   – Limited Encounters
   – Limited Time
CTeL | Thursday, March 18, 2010
Types of Licensure (cont’d)
• Special/Telemedicine License
   – There are 11 states and 1 territory that grant
     telemedicine providers special/telemedicine licenses,
     they are:
        AL, GU, LA, MN, MT, NV, NM, OH, OK, OR, TN, and TX.
   – These states may require other conditions:
        Maintain a full medical license in another state;
        No ethics violations;
        Not have an in-state office;
        May only practice telemedicine in an ER situation;
        Limited time or “occasionally;” and/or
        Volunteer services.

CTeL | Thursday, March 18, 2010
Licensure Through Exception
 •    7 states (HI, LA, MD, MS, MO, WA and WV) grant telemedicine
      providers the opportunity to practice telemedicine through a
      “licensure exception.”

 •    These state licensure statutes exempt telemedicine providers
      from being required to obtain a full or special/telemedicine
      license to administer telemedicine, as long as some conditions
      are met, such as:
             Maintain a full medical license in another state;
             No ethics violations;
             Not have an in-state office;
             May only practice telemedicine in an ER situation;
             Limited time or “occasionally;” and/or
             Volunteer services.
       – Note: Conditions vary among states. If a physician does not meet the
         state’s specific conditions, it is equivalent to the physician practicing
         without a license.

CTeL | Thursday, March 18, 2010
Licensure Laws for
                      KY, NC, TN, and WV
• States that boarder Virginia:

      – Kentucky : Full medical licensure required.
      – North Carolina: Full medical licensure required.
      – Tennessee: Board has authority to grant a limited
        purpose/ restricted license.
      – West Virginia: Licensure reciprocity will be granted to
        those applicants coming from states whose licensure
        laws are similar to those of the state of West Virginia. If
        licensure laws are less stringent than West Virginia’s,
        then full medical licensure will be required.


CTeL | Thursday, March 18, 2010
Consultation versus Practicing

• Can the lines be blurred between consultation
  and practicing?
   – Consulting physician to primary physician at
      the same “level.”
   – Consulting physician at different level than
      primary physician.
• Can the lines be crossed so that a consultation is
  actually practicing medicine without being
  licensed in that state?


CTeL | Thursday, March 18, 2010
Prescribing Medication through
               Telehealth
• Nearly all states require a bona-fide doctor-patient
  relationship in order to prescribe medication.
• Online Medical questionnaires :
   – 5 states specifically forbid online questionnaires.
         HI, ID, IN, MN and SC
   – 22 states follow FSMB guidelines medical
      questionnaires—TN, KY, WV, NC.
   – 24 states have no language on medical questionnaires.
         VA is one of those 24 states.
• Defining “bona-fide” doctor patient relationship is the
  challenge.
   – Is a physical, “touch the patient” examination required?


CTeL | Thursday, March 18, 2010
Prescribing Medication through
               Telehealth
• Federation of State Medical Boards:
   – Relationship is established when physician
     agrees to undertake diagnosis and treatment
     of patient.
   – Patient agrees, regardless of a personal
     encounter.
   – Treatment, including prescription, based
     solely on online questionnaire or consultation
     does not constitute an acceptable standard of
     care.

CTeL | Thursday, March 18, 2010
Prescribing Medication through
                Telehealth
• American Medical Association Guidelines:
   – Reliable medical history and perform physical
     exam;
   – Have sufficient dialogue – treatment and risks;
   – Follow up to assess outcome;
   – Maintain contemporaneous medical record; and
   – Include electronic prescription info in record.
• Exceptions:
   – Consultation with another physician; and,
   – On-call or cross-coverage situations.

 CTeL | Thursday, March 18, 2010
Telehealth Private Payer Statutes

• U.S. Department of Commerce estimates 64.4%
  of America’s health care is insured through
  private payers.
• Assumption that private payers resist
  telemedicine coverage.
• AMD Telemedicine Study found 38 programs in
  25 states receive private payer reimbursement.
• Over 100 private payers currently reimburse for
  telemedicine.
• 10 States have Private Payer statutes: CA, CO, HI,
  KY, LA, ME, NH, OK, OR, TX.

CTeL | Thursday, March 18, 2010
Medicare Reimbursement

• Checklists found at www.ctel.org under
  “Reimbursement.”
• Reimbursement for facility and professional fees
• Federally designated rural Health Professional.
  Shortage Area (HPSA); in county not included in
  a Metropolitan Statistical Area; or from a Federal
  telemedicine demonstration project.
• Only certain CPT codes eligible.
• Encounter involved interactive audio and video
  telecommunications.

CTeL | Thursday, March 18, 2010
Medicare Reimbursement

• Eligible Practitioners:
   – Physician
   – Nurse practitioner
   – Physician assistant
   – Nurse midwife
   – Clinical nurse specialist
   – Clinical psychologist
   – Clinical social worker
   – Registered dietician or nutrition professional

CTeL | Thursday, March 18, 2010
Medicare Reimbursement
• Originating Sites:
   – Physician’s office
   – Critical access hospital
   – Federally qualified health center
   – Hospital
   – Rural Health Clinic
   – Hospital-based or CAH-based renal dialysis
     center
   – Skilled nursing facility
   – Community mental health center

CTeL | Thursday, March 18, 2010
JC Guidelines Since 2004

• Joint Credentialing (JC) hospitals accept
  credentialing from other JC facilities.
• JC hospitals OK unless audited by state or the
  Center for Medicare & Medicaid Services (CMS).




CTeL | Thursday, March 18, 2010
Impact of CMS Credential/Privileging
             Requirements on Telehealth

• Denial of credentialing and privileging by proxy
  potentially has a more significant impact than
  licensure.
• Licensure impedes interstate practice of
  telemedicine.
• Requiring credentialing and privileging of all
  telehealth providers impacts the delivery of all
  telehealth services.
• Some argue the CMS position will have a more
  crippling effect on telehealth than licensure.

CTeL | Thursday, March 18, 2010
Case Study: Legislative Fix for
       Credentialing/Privileging by Proxy

• Legislation in Washington seems “far away.”
• Take you through an attempt to fix the CMS
  position on credentialing and privileging by
  proxy.
• “Sausage making”:
   – Not always pretty.
   – Goal may not always be evident.
• In this case, objective to preserve credentialing
  and privileging by proxy under controlled
  circumstances.
CTeL | Thursday, March 18, 2010
Telehealth Action Plan

• Began initiative in December 2008
   – Conducted Credentialing Survey.
   – Met with Representative Mike Thompson (D-
     CA) staff on H.R.2068 Medicare Telehealth
     Enhancement Act of 2009.
      – 13 important telehealth and remote
        monitoring provisions.




CTeL | Thursday, March 18, 2010
H.R.2068 Introduced on 4/23/09


• Gave option of credentialing by proxy between JC
  hospitals.

• Did NOT Include Privileging.

• Did NOT include interpretative services.

• Included reference to “Joint Commission.”




CTeL | Thursday, March 18, 2010
Ways and Means Committee Markup

• Staff changes in Representative Thompson's
  office.
• CBO gave credentialing a “no cost score.”
• Included in Ways and Means bill.
• "We'll send it to CMS, but . . ."




CTeL | Thursday, March 18, 2010
TLI Letter to Secretary Sebelius

• Signed by 300 telehealth stakeholders.

• “We need a solution.”

• Strategy – Get OAT and HRSA at the table.




CTeL | Thursday, March 18, 2010
Letter from CMS

• Need to protect the patient.
• Hold hospitals accountable by requiring
  credentialing and privileging at the originating
  site.
• Included language on critical access hospitals.




CTeL | Thursday, March 18, 2010
JC enters the picture

• Deeming authority expired July 2010.

• August – In process of submitting application.

• Two outstanding issues – One is telehealth.




CTeL | Thursday, March 18, 2010
JC Strategy Clear

• Proceed with application.
• Work for a legislative fix.




CTeL | Thursday, March 18, 2010
Born: TLI, JC, ATA Coalition

• Began amendment strategy.
• Deficiencies with Way and Means legislation:
         Did NOT cover privileging;
         Did NOT cover interpretative services
         ie: teleradiology or telecardiology; and
         Did NOT cover small hospitals.



CTeL | Thursday, March 18, 2010
Next step

• Worked on modified legislation.

• Rep. Thompson's message:

      – “Very long call with CMS.“

• Willing to put credentialing in a certification
  letter.
• Vehemently opposed to including privileging.
• If privileging was pressed, all could be lost.

CTeL | Thursday, March 18, 2010
CMS Offer Came in Writing

• Rejected.

• Not a lot of trust between CMS and telehealth.

• Did NOT include privileging.

• Did NOT include interpretive services.




CTeL | Thursday, March 18, 2010
Senate
•    Senator Tom Udall introduced S. 2741, the Rural Telemedicine
     Enhancing Community Health (TECH) Act of 2009.

•    Number of telehealth provisions.

•    Credentialing and Privileging:
      • Directs CMS to develop workable standards, and
      • Holds facilities harmless for using proxy process while
         standard are being drafted.

•    Tried to get Udall language included in Senate bill.




CTeL | Thursday, March 18, 2010
Next Steps: Administration

• Continual Congressional Involvement.
• Involvement of high-level officials in the Obama
  Administration:
   – “This CMS guideline will impact telehealth as
     we know it today.”
   – Does the administration want this to happen
     on it’s watch?




CTeL | Thursday, March 18, 2010
Next Steps: Congress

• House:
   – Congressman Thompson to introduce new
     legislation.
• Senate:
   – Senator Udall’s credentialing and privileging
     language to be offered to other Senate bills.
• Congressional involvement
   – Meetings with CMS.



CTeL | Thursday, March 18, 2010
Data Needed!

• Compiling information on the impact of CMS
  position on credentialing and privileging by
  proxy:
   – Cost numbers: what will it cost to credential
     and privilege all telehealth providers?
   – Will your program be adversely impacted?
     Specifically, how?
   – Examples of how remote
     credentialing/privileging helped patient care.


CTeL | Thursday, March 18, 2010
Contact for more information

• Greg Billings
   – Senior Government Relations Director
     Center for Telehealth and e-Health Law
     Washington, DC
     Phone:202-230-5104
     E-mail: Greg.Billings@DBR.com




CTeL | Thursday, March 18, 2010

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Billings

  • 1. Virginia Telehealth Summit Telehealth Legal and Regulatory Issues Greg Billings Senior Government Relations Director Center for Telehealth and e-Health Law Washington, DC
  • 2. Objectives • Telehealth Licensure State Statutes • Internet Prescribing • Telehealth Private Payer State Statues • Credentialing and Privileging of Telehealth Providers CTeL | Thursday, March 18, 2010
  • 3. Licensure Overview • Under U.S. law, states are allowed to monitor the practice of professionals within their boundaries. – Through licensure, State medical boards are responsible for regulating physicians and other health care providers within their own state. – Licensure is the process by which a state government validates a health care provider’s credentials and deems the provider competent to practice medicine. – Licensure, as it applies to telemedicine, refers to:  “Issues surrounding the regulations of physicians and other health care providers who practice telemedicine between health care facilities in different states.” (Reid, A Telemedicine Primer) CTeL | Thursday, March 18, 2010
  • 4. What to Consider When Practicing Telemedicine… • Jurisdiction – Where is the patient located?  A majority of State Medical Boards maintain that jurisdictional authority is attached to the patient. – Where is the physician located? – Does the physician hold other medical licenses? • Licensure Laws – Licensure laws vary among states. – Review each individual state’s licensure statutes before practicing telemedicine. CTeL | Thursday, March 18, 2010
  • 5. Types of Licensure • Full Medical Licensure for Telemedicine – 36 states/territories require telemedicine providers to obtain a full medical license.  To obtain a full license, a telehealth provider may need to meet the following requirements: » Pay licensure fees; » Pass additional oral and written examinations; and/or » Travel for interviews. • Exceptions – Direct Consultation – Limited Encounters – Limited Time CTeL | Thursday, March 18, 2010
  • 6. Types of Licensure (cont’d) • Special/Telemedicine License – There are 11 states and 1 territory that grant telemedicine providers special/telemedicine licenses, they are:  AL, GU, LA, MN, MT, NV, NM, OH, OK, OR, TN, and TX. – These states may require other conditions:  Maintain a full medical license in another state;  No ethics violations;  Not have an in-state office;  May only practice telemedicine in an ER situation;  Limited time or “occasionally;” and/or  Volunteer services. CTeL | Thursday, March 18, 2010
  • 7. Licensure Through Exception • 7 states (HI, LA, MD, MS, MO, WA and WV) grant telemedicine providers the opportunity to practice telemedicine through a “licensure exception.” • These state licensure statutes exempt telemedicine providers from being required to obtain a full or special/telemedicine license to administer telemedicine, as long as some conditions are met, such as:  Maintain a full medical license in another state;  No ethics violations;  Not have an in-state office;  May only practice telemedicine in an ER situation;  Limited time or “occasionally;” and/or  Volunteer services. – Note: Conditions vary among states. If a physician does not meet the state’s specific conditions, it is equivalent to the physician practicing without a license. CTeL | Thursday, March 18, 2010
  • 8. Licensure Laws for KY, NC, TN, and WV • States that boarder Virginia: – Kentucky : Full medical licensure required. – North Carolina: Full medical licensure required. – Tennessee: Board has authority to grant a limited purpose/ restricted license. – West Virginia: Licensure reciprocity will be granted to those applicants coming from states whose licensure laws are similar to those of the state of West Virginia. If licensure laws are less stringent than West Virginia’s, then full medical licensure will be required. CTeL | Thursday, March 18, 2010
  • 9. Consultation versus Practicing • Can the lines be blurred between consultation and practicing? – Consulting physician to primary physician at the same “level.” – Consulting physician at different level than primary physician. • Can the lines be crossed so that a consultation is actually practicing medicine without being licensed in that state? CTeL | Thursday, March 18, 2010
  • 10. Prescribing Medication through Telehealth • Nearly all states require a bona-fide doctor-patient relationship in order to prescribe medication. • Online Medical questionnaires : – 5 states specifically forbid online questionnaires.  HI, ID, IN, MN and SC – 22 states follow FSMB guidelines medical questionnaires—TN, KY, WV, NC. – 24 states have no language on medical questionnaires.  VA is one of those 24 states. • Defining “bona-fide” doctor patient relationship is the challenge. – Is a physical, “touch the patient” examination required? CTeL | Thursday, March 18, 2010
  • 11. Prescribing Medication through Telehealth • Federation of State Medical Boards: – Relationship is established when physician agrees to undertake diagnosis and treatment of patient. – Patient agrees, regardless of a personal encounter. – Treatment, including prescription, based solely on online questionnaire or consultation does not constitute an acceptable standard of care. CTeL | Thursday, March 18, 2010
  • 12. Prescribing Medication through Telehealth • American Medical Association Guidelines: – Reliable medical history and perform physical exam; – Have sufficient dialogue – treatment and risks; – Follow up to assess outcome; – Maintain contemporaneous medical record; and – Include electronic prescription info in record. • Exceptions: – Consultation with another physician; and, – On-call or cross-coverage situations. CTeL | Thursday, March 18, 2010
  • 13. Telehealth Private Payer Statutes • U.S. Department of Commerce estimates 64.4% of America’s health care is insured through private payers. • Assumption that private payers resist telemedicine coverage. • AMD Telemedicine Study found 38 programs in 25 states receive private payer reimbursement. • Over 100 private payers currently reimburse for telemedicine. • 10 States have Private Payer statutes: CA, CO, HI, KY, LA, ME, NH, OK, OR, TX. CTeL | Thursday, March 18, 2010
  • 14. Medicare Reimbursement • Checklists found at www.ctel.org under “Reimbursement.” • Reimbursement for facility and professional fees • Federally designated rural Health Professional. Shortage Area (HPSA); in county not included in a Metropolitan Statistical Area; or from a Federal telemedicine demonstration project. • Only certain CPT codes eligible. • Encounter involved interactive audio and video telecommunications. CTeL | Thursday, March 18, 2010
  • 15. Medicare Reimbursement • Eligible Practitioners: – Physician – Nurse practitioner – Physician assistant – Nurse midwife – Clinical nurse specialist – Clinical psychologist – Clinical social worker – Registered dietician or nutrition professional CTeL | Thursday, March 18, 2010
  • 16. Medicare Reimbursement • Originating Sites: – Physician’s office – Critical access hospital – Federally qualified health center – Hospital – Rural Health Clinic – Hospital-based or CAH-based renal dialysis center – Skilled nursing facility – Community mental health center CTeL | Thursday, March 18, 2010
  • 17. JC Guidelines Since 2004 • Joint Credentialing (JC) hospitals accept credentialing from other JC facilities. • JC hospitals OK unless audited by state or the Center for Medicare & Medicaid Services (CMS). CTeL | Thursday, March 18, 2010
  • 18. Impact of CMS Credential/Privileging Requirements on Telehealth • Denial of credentialing and privileging by proxy potentially has a more significant impact than licensure. • Licensure impedes interstate practice of telemedicine. • Requiring credentialing and privileging of all telehealth providers impacts the delivery of all telehealth services. • Some argue the CMS position will have a more crippling effect on telehealth than licensure. CTeL | Thursday, March 18, 2010
  • 19. Case Study: Legislative Fix for Credentialing/Privileging by Proxy • Legislation in Washington seems “far away.” • Take you through an attempt to fix the CMS position on credentialing and privileging by proxy. • “Sausage making”: – Not always pretty. – Goal may not always be evident. • In this case, objective to preserve credentialing and privileging by proxy under controlled circumstances. CTeL | Thursday, March 18, 2010
  • 20. Telehealth Action Plan • Began initiative in December 2008 – Conducted Credentialing Survey. – Met with Representative Mike Thompson (D- CA) staff on H.R.2068 Medicare Telehealth Enhancement Act of 2009. – 13 important telehealth and remote monitoring provisions. CTeL | Thursday, March 18, 2010
  • 21. H.R.2068 Introduced on 4/23/09 • Gave option of credentialing by proxy between JC hospitals. • Did NOT Include Privileging. • Did NOT include interpretative services. • Included reference to “Joint Commission.” CTeL | Thursday, March 18, 2010
  • 22. Ways and Means Committee Markup • Staff changes in Representative Thompson's office. • CBO gave credentialing a “no cost score.” • Included in Ways and Means bill. • "We'll send it to CMS, but . . ." CTeL | Thursday, March 18, 2010
  • 23. TLI Letter to Secretary Sebelius • Signed by 300 telehealth stakeholders. • “We need a solution.” • Strategy – Get OAT and HRSA at the table. CTeL | Thursday, March 18, 2010
  • 24. Letter from CMS • Need to protect the patient. • Hold hospitals accountable by requiring credentialing and privileging at the originating site. • Included language on critical access hospitals. CTeL | Thursday, March 18, 2010
  • 25. JC enters the picture • Deeming authority expired July 2010. • August – In process of submitting application. • Two outstanding issues – One is telehealth. CTeL | Thursday, March 18, 2010
  • 26. JC Strategy Clear • Proceed with application. • Work for a legislative fix. CTeL | Thursday, March 18, 2010
  • 27. Born: TLI, JC, ATA Coalition • Began amendment strategy. • Deficiencies with Way and Means legislation: Did NOT cover privileging; Did NOT cover interpretative services ie: teleradiology or telecardiology; and Did NOT cover small hospitals. CTeL | Thursday, March 18, 2010
  • 28. Next step • Worked on modified legislation. • Rep. Thompson's message: – “Very long call with CMS.“ • Willing to put credentialing in a certification letter. • Vehemently opposed to including privileging. • If privileging was pressed, all could be lost. CTeL | Thursday, March 18, 2010
  • 29. CMS Offer Came in Writing • Rejected. • Not a lot of trust between CMS and telehealth. • Did NOT include privileging. • Did NOT include interpretive services. CTeL | Thursday, March 18, 2010
  • 30. Senate • Senator Tom Udall introduced S. 2741, the Rural Telemedicine Enhancing Community Health (TECH) Act of 2009. • Number of telehealth provisions. • Credentialing and Privileging: • Directs CMS to develop workable standards, and • Holds facilities harmless for using proxy process while standard are being drafted. • Tried to get Udall language included in Senate bill. CTeL | Thursday, March 18, 2010
  • 31. Next Steps: Administration • Continual Congressional Involvement. • Involvement of high-level officials in the Obama Administration: – “This CMS guideline will impact telehealth as we know it today.” – Does the administration want this to happen on it’s watch? CTeL | Thursday, March 18, 2010
  • 32. Next Steps: Congress • House: – Congressman Thompson to introduce new legislation. • Senate: – Senator Udall’s credentialing and privileging language to be offered to other Senate bills. • Congressional involvement – Meetings with CMS. CTeL | Thursday, March 18, 2010
  • 33. Data Needed! • Compiling information on the impact of CMS position on credentialing and privileging by proxy: – Cost numbers: what will it cost to credential and privilege all telehealth providers? – Will your program be adversely impacted? Specifically, how? – Examples of how remote credentialing/privileging helped patient care. CTeL | Thursday, March 18, 2010
  • 34. Contact for more information • Greg Billings – Senior Government Relations Director Center for Telehealth and e-Health Law Washington, DC Phone:202-230-5104 E-mail: Greg.Billings@DBR.com CTeL | Thursday, March 18, 2010