Safe Harbors and Exceptions for E-Prescribing and Electronic Health Records: What Now?

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1 Safe Harbors and Exceptions for E-Prescribing and Electronic Health Records: What Now? Presenters: Benjamin T. Butler, Esq. Michael W. Paddock, Esq. BCBSA s 41 st Annual Lawyers Conference May 2, 2007 Miami, Florida

2 What s Promoting IT Pressure from payers, employers, sponsors Pay for performance Consumer choice / comparison Decrease administrative costs Quality concerns (particularly prescribing) Public health interests Bioterror defense Population dislocation (Katrina) Big market for IT vendors 2

3 What s Hindering IT Expense Change in culture Wait-and-see Perception that those bearing most cost may not be reaping most rewards (and vice versa) 10/11/06 Robert Wood Johnson Foundation Report re: implementation barriers ( Health Affairs study re: state of M.D. implementation ( AHA study re: state of hospital implementation ( continuedprogress.pdf) 3

4 Active Efforts by Blue Plans A sampling (based on published reports): E-prescribing BCBS-IL Capital BC BCBS-MA CareFirst BCBS BCBS-MI Horizon BCBS BCBS-NC Independence BC Personal/community health records BCBS-FL Health Care Service Corp. BCBS-TN WellPoint Excellus BCBS Also BCBSA/AHIP PHR standardization initiative Web-enabled physician visits BCBS Kansas City BS-CA Empire BCBS Premera BC 4

5 Why You Can t Always Give IT Away The Anti-Kickback Statute: unlawful to knowingly and willfully solicit, receive, offer, or pay any remuneration in return for or to induce a patient referral or other business payable, in whole or in part, under a Federal health care program. Stark Law: physician prohibited from making referrals to an entity for the furnishing of certain DHS reimbursable by Medicare if the physician (or immediate family member) has a direct or indirect financial relationship with that entity. 5

6 Why You Can Give IT Away Congress: MMA required CMS and OIG to promulgate new Stark exception and AKS safe harbor, respectively, related to e-prescribing technology. EHR exception/safe harbor: Purely regulatory New goal: balance F&A concerns against important national policy to promote the widespread adoption of health IT. 6

7 Why Should a Health Plan Care? Anti-Kickback Statute (42 USC 1320a-7b) Not just providers; applies to any person Not just referrals; also applies to inducement to purchase, or arrange for an item or service paid for by Medicare or Medicaid OIG: plan enrollment is an item or service Part D, Medicare/Medicaid managed care Safe harbors exist for a reason Stark Law: not likely to apply, but review of exceptions is helpful for transaction analysis 7

8 Overview of New Regulations Regulatory Exceptions under Physician Self-Referral (Stark) Law Promulgated by CMS E-prescribing Electronic health records (EHR) Regulatory Safe Harbors under Anti-Kickback Statute Promulgated by HHS OIG E-prescribing EHR 8

9 Starting Small: Stark & E-Prescribing Effective Date: Narrow exception 8 elements. They must ALL be met 1. The Donation. Nonmonetary. Hardware, software, information and training services. Used solely to receive and transmit e-prescribing info (drugs, medical supplies, DME, lab tests). No bundling software with typical office functions (billing, scheduling, admin, , contacts, etc.) Recipient can t already have IT; upgrades ok. 9

10 Starting Small: Stark & E-Prescribing 2. The Protected Donors and Recipients Hospitals Physicians already on staff Group practices Member physicians PDP Sponsors / MAOs Prescribing physicians 3. Donor s Criteria for Selecting a Recipient / Deciding How Much to Donate May not consider, directly or indirectly, the volume or value of the physician s referrals or other business generated between the parties May consider the total number of prescriptions written by that physician 10

11 Starting Small: Stark & E-Prescribing 4. E-Prescribing Standards 11 The e-prescribing program accessed via the donated items/services must meet Part D standards 5. No Limiting or Restricting Donor may not limit the item s/service s compatibility with other systems, or ability of physician to use for any patient 6. No Conditioning Physician can t require donation as condition of doing business 7. Written Agreement 8. Good Faith Donor must not have actual knowledge of, or act in reckless disregard or deliberate ignorance of, the fact that the physician possesses - or has obtained items or services equivalent to those donated

12 Sticking with Stark: the EHR Exception Broader in scope, but sunsets on elements. They must ALL be met. 1. The Donation Nonmonetary. Interoperable EHR software and directly related services. No hardware. Services: no staffing of physician offices Used predominantly to receive, transmit, and maintain EHR of entity s OR physician s patients May not be used primarily for personal / unrelated business Software must be interoperable Must have e-prescribing capability / standards 12

13 Sticking with Stark: the EHR Exception 2. The Protected Donors and Recipients DHS Entities Physicians 3. Donor s Criteria for Selecting a Recipient Same, but handy list of permissible considerations: Total # of prescriptions written by the physician Size of practice (patients, encounters, RVUs) Total # of hours that physician practices medicine Physician s overall use of automated IT in his/her practice Whether physician is a member of the donor s medical staff Level of uncompensated care provided by the physician Other reasonable and verifiable manner where referrals, business generated between parties not directly taken into account (catch all) 13

14 Sticking with Stark: the EHR Exception 4. No Limiting or Restricting same 5. No Conditioning same 6. Written Agreement same 7. Good Faith same 8. Required Co-Payments Before receipt, physician must pay 15% of the donor s cost for the items / services. Donor may not finance this payment. 9. Compliance With Other F&A Laws Federal / state laws and regulations re: billing and claims submission Federal anti-kickback statute? 14

15 Anti-Kickback Safe Harbor: E-Prescribing Nearly identical to Stark exception for E-Prescribing 8 elements. Voluntary, not mandatory. 1. The Donation Same as Stark exception 2. The Protected Donors and Recipients Hospital Physicians already on staff (same) Group practice Member prescribing professionals Group and Member : defined by Stark PDP Sponsors / MAOs network pharmacies and pharmacists; prescribing health care professionals The only difference from the Stark exception 15

16 Anti-Kickback Safe Harbor: E-Prescribing 3. Donor s Criteria for Selecting a Recipient / Deciding How Much to Donate same (no list) 4. E-Prescribing Standards same 5. No Limiting or Restricting same 6. No Conditioning same 7. Written Agreement same 8. Good Faith - same 16

17 Anti-Kickback Safe Harbor: EHRs Nearly identical to Stark exception for EHRs 9 elements. Voluntary, not mandatory. 1. The Donation same as Stark exception for EHRs 2. The Protected Donors and Recipients Donors: health plans; all individuals or entities that provide services covered by a Federal health care program and submit claims or requests for payment directly or through assignment to that program. Not pharma, device, drug or other manufacturers Recipients: any individual or entity engaged in the delivery of health care services covered by a federal health care program Very broad! 17

18 Anti-Kickback Safe Harbor: EHRs 3. Donor s Criteria for Selecting a Recipient / Deciding How Much to Donate same as Stark exception for EHR (including handy list) 4. No Limiting or Restricting same 5. No Conditioning same 6. Written Agreement same 7. Good Faith same 8. Required Co-Payments same as Stark exception for EHR (recipient must pay 15% up front) 9. No Cost Shifting Donor does not shift cost of items or services to any Federal health care program 18

19 Other Safe Harbors and Exceptions? Equipment rental Does not protect donations Personal services arrangements Use of EHR / e-prescribing program may be required via such an arrangement Payment by physicians Potentially allows for physicians to utilize plans purchasing power Non-monetary compensation Allows for provision of low-cost technology items and services 19

20 Insights From the Rulemaking Process Definition of Electronic Health Record Changed Changes to the E-prescribing exception: Contract specifies donor s cost, not value of items and services No need for physician certification re. equivalent items & services Amount or nature of items/services (in addition to receipt) cannot be a condition of doing business 20

21 Insights From the Rulemaking Process Changes to the EHR exception: Just one exception (no pre- vs. post-interoperability) Certified software is deemed interoperable Greatly expanded list of eligible donors & donees Physician pays 15% of donor s cost Contract specifies donor s cost, not value of items and services 21

22 Insights From the Rulemaking Process Changes to the EHR exception (cont.): Items/services used predominantly (not solely ) for EHR purposes Clarification re. total number of prescriptions as condition of receipt Clarification re. level of uncompensated care provided as an acceptable condition of receipt Sunset provision (December 31, 2013) (but not for e- prescribing) 22

23 Issues Raised in Preamble Discussion What degree of interoperability is sufficient? In lieu of certification, what due diligence is necessary? What is cost of homegrown software? Are three-party contracts (w/ vendor) necessary as a practical matter? Manufacturers rejected as safe harbored donors ( substantial risk of abuse) Penalties? Impact of State law? 23

24 Questions? Ben Butler (202) Mike Paddock (202)

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