以臨床決策輔助警示(CDS alerts)「促使」醫師開立特定藥品——美商Practice Fusion以新台幣43億元與美國司法部達成和解

◎ 顧長芸(中央研究院法律學研究所)

*本文經授權轉載自中研院法律所資訊法中心,2020/04/14發佈
*本研究感謝中央研究院「資料安全研發及人才培育計畫」及「中央研究院法律學研究所資訊法中心」支持

Photo by Michael Longmire on Unsplash

電子病歷(Electronic Health Record,後稱EHR)軟體商Practice Fusion,因收受某藥廠(Pharma Co. X)報酬,以其EHR系統中的CDS alerts (Clinical Decision Support alerts, 臨床決策輔助警示),「促使」醫師採取開立ERO(Extended Release Opioid, 緩釋型鴉片類藥物),增加某藥廠ERO銷量,遭控違反反回扣法(Anti-Kickback Status, 42 U.S.C. §1320a-7(b))。今年1月27日,Practice Fusion與佛蒙特轄區聯邦檢察官(United States Attorney’s Office for the District of Vermont)達成刑事緩起訴協議(Deferred Prosecution Agreement)與民事和解協議(Settlement Agreement),其罰金總計為1億4千5百萬美元(約台幣43億8千萬元)。依DOJ新聞稿(U.S. Department of Justice, Press Release),此為美國第一個EHR軟體商遭到刑事調查之案件,且其罰款金額為該聯邦轄區史上最高。

美國FDA(U.S. Food and Drug Administration)CDSS草稿指令(CDS Software, Draft Guidance 2019)指出,CDS一詞可用於多種範圍,而其主要功能為對醫護專業人員(Health Care Professionals)與病患,提供知識與個人特殊資訊(person-specific information),並於適當時機智能地(intellectually)過濾與呈現這些資訊,以提升健康與醫療照護。依美國FDASIA(Food and Drug Administration Safety and Innovation Act)之Health IT Report 2014,CDS範圍包括給予醫護人員與病患的電腦警示或提醒、臨床指引、特殊症狀指令集(condition-specific order sets)、焦點病患資料與摘要、文件模板、診斷輔助(diagnosis support)和脈絡相關參考資訊(contextual relevant reference information)等多種不同的工具(tools)。技術上,依美國國家衛生資訊科技協調辦公室(Office of the National Coordinator for Health Information Technology, ONC)說明,CDS為一複雜的衛生資訊科技組件(health IT component),需要可計算的(computable)生物醫學資訊、個人特定資料、以及一推論或推斷之機制(mechanism)用來結合知識與資料,以產生並呈現出有助於臨床醫師正在給予照護時之資訊;大多數CDS之應用為EHR系統之部分,但也有個別的CDS系統。

依緩起訴協議(附件Exhibit B:Information),Practice Fusion提供數十萬名美國醫師免費使用其EHR軟體,每月替上百萬名病患提供醫療服務。Practice Fusion與某藥廠於2013年開始討論使用Pain CDS alerts以提升該藥廠ERO藥品銷量的計畫;雙方於2015年簽訂合約並共同設計Pain CDS內容,包括疼痛指數(pain score)、簡易疼痛量表(brief pain inventory)、後續照護選項、Pain CDS的設計邏輯等。某藥廠於2016年3月支付近美金96萬元(約台幣2千8百萬元),作為換取置入Pain CDS alerts的代價,Pain CDS alerts並於同年7月正式上線。依緩起訴協議(附件Exhibit C:Statement of Facts)Practice Fusion內部評估,使用Pain CDS alerts可讓某藥廠增加2,777名病患並獲得約850萬至1100萬美元(約新台幣2億5千萬至3億3千萬元)的營收。Pain CDS於2016年7月至2019年4月間,共提出超過2億3千萬次的Pain CDS alerts。

依緩起訴協議(附件Exhibit B:Information),Practice Fusion EHR系統的基本CDS alerts運作方式,是在醫師進行診斷治療的「當下」,以訊息的方式,提醒醫師有關特殊個人健康資訊與病患情況,並提供醫師應考量之特殊臨床資訊、採取特殊檢驗與評估、或應完成的特定文件。Pain CDS alerts的設計,主要針對具有慢性疼痛但未曾使用過鴉片類止痛藥物的病患(opioid naïve patient),以及有使用IRO(Immediate Release Opioid)之病患,提出警示;其具有三種不同功能提示。第一種提示是鼓勵醫師記錄病患疼痛指數;第二種提示是建議醫師使用簡易疼痛量表,紀錄被診斷為慢性疼痛患者,或於前三個月具有兩種以上疼痛、且其疼痛指數達到4分(1至10分標準)以上之病患;簡易疼痛量表將使醫師專注於病患疼痛的症狀,且提出一連串關於病患疼痛的嚴重程度與影響之問題,由病患自述其24小時內的疼痛症狀。第三種提示,則提醒醫師應建立治療病患疼痛的後續追蹤計畫,此警示僅出現於近四個月內病患自述超過兩次等級4以上之疼痛者,或有慢性疼痛且已完成簡易疼痛量表者;後續追蹤計畫以下拉式選單的方式表列可能的物理治療與藥物選項,而ERO便與其他治療選項並列。依據緩起訴協議(附件Exhibit C:Statement of Facts),Practice Fusion在Pain CDS alerts實際上線四個月後的內部分析,接收到Pain CDS alerts的醫師,的確比未接收者,每月增加4800至6300件的疼痛照護計畫,開立更多ERO處方,並有效促使醫師由IRO改為ERO處方。

依緩起訴協議(附件Exhibit B:Information),基於ERO藥品有部分或全部是由聯邦或州政府透過保險所支付,例如聯邦醫療保險(Medicare)、聯邦醫療補助(Medicaid)或軍人保險(TRICARE),屬於聯邦健康照護計畫(Federal health care program)範圍:Practice Fusion知情並自願地索取或收到某藥廠之報酬,以換取推薦購買或訂購某商品或物品之安排,而其為由聯邦照護計畫支付全部或部分,故違反聯邦反回扣法,並且基於為兩人以上向美國政府進行共謀或詐欺,同時觸犯共謀罪(18 U.S. Code §371)。同時,依和解協議,Practice Fusion被指控與多家藥廠達成共計14件之CDS alerts協議,導致自2014年4月至2019年4月期間,使用該軟體開立之ERO處方並申請聯邦照護計畫支付者,與另使用Practice Fusion不合格EHR軟體而申請EHR獎勵計畫(EHR Incentive Payment Programs)之醫師,皆做出虛假陳述(false claims)。依緩起訴協議,除支付刑事與民事罰款外,Practice Fusion須承認其錯誤行為且自行公告於網站,於三年內完全配合檢察官相關調查,實施CDS遵守計畫(Compliance Program),並接受監督組織(Oversight Organization)之查核。

本案引起筆者注意的,並非軟體商收取回扣之犯罪行為,而是緩起訴協議中軟體商以CDS alerts影響醫師的「方式」。R. H. Thaler與C. R. Sunstein將「Nudge」(輕推)定義為「選擇架構(choice architecture)的任何面向,以可預期的方式改變人們的行為,而無需禁止其任何選擇或是顯著地改變其經濟誘因(economic incentives)」。本案軟體商透過CDS alerts「輕推」醫師採取特殊行為,而緩起訴協議(附件Exhibit C:Statement of Facts)更形容該CDS alerts可「影響(influence)醫師並誘導(induce)開立ERO」,且就其實際結果而言,此方法確實對醫師產生影響。儘管,該軟體商於本案並未因此「輕推之設計」觸犯法律,但,透過本案我們似乎可以去思考這樣一個問題:軟體商透過軟體或演算法而造成的「輕推」行為,在為不當目的而設計,且造成當事人或他人不利後果的情況下,是否,軟體商須為此方式負起相應程度之法律責任?換言之,物理世界中的「教唆」、「煽動」、「引誘」等共犯罪責,在數位世界中,當軟體商可透過軟體設計而產生相同效果的時候,是否也應追究其責任?


資料來源

  • U.S. Department of Justice. Electronic Health Records Vendor to Pay Largest Criminal Fine in Vermont History and A Total of $145 Million to Resolve Criminal and Civil Investigation.(Jan 27, 2020. Press Release, Deferred Prosecution Agreement and Settlement Agreement)(https://www.justice.gov/usao-vt/pr/electronic-health-records-vendor-pay-largest-criminal-fine-vermont-history-and-total-145
  • Official Website of The Office of the National Coordinator for Health Information Technology(ONC), Clinical Decision Support. https://www.healthit.gov/topic/safety/clinical-decision-support
  • U.S. Food & Drug Administration. Clinical Decision Support Software: Draft Guidance for Industry and Food and Drug Administration Staff. (Sep. 27, 2019)
  • Christopher Brown. Opioid Case Spotlights Use of AI for Health-Care Fraud. (Bloomberg Law, Jan. 29, 2020)
  • Brian Mann. Health Care Software Firm Fined $145M in Opioid Scheme With Drug Companies. (NPR, Feb. 1, 2020)
  • Rujul Desai, Stefanie Doebler, Anna Kraus and Shanya J. Dingle. Electronic Health Record Company Settles Department of Justice Kickback Probe. (Covington & Burling LLP. Feb.26, 2020)
  • Jack Murtha. After a $145 Million Opioid Kickback Settlement, Can We Trust Our Doctors? (Filter Magazine, Jan.31, 2020)
  • Mike Spector and Tom Hals. Exclusive: OxyContin maker Purdue is ‘Pharma Co X’ in U.S. opioid kickback probe-sources. (Reuters, Jan. 29, 2020)
  • Eliser Reuter. Practice Fusion Allegedly Weaponized EHRs in Kickback Scheme. (MedCity News, Jan. 28, 2020)
  • Jaclyn Jaeger. Practice Fusion To Overhaul Compliance After $145M Kickback Resolution. (Compliance Week, Feb. 6, 2020)
  • Mary Inman, Esq. and Anne Hayes Hartman, Esq.. EHR Vendor Settles Landmark Case Alleging Acceptance of Kickbacks from pharma Company to Steer Opioid Prescriptions. (RAC monitor, Mar.4, 2020)
  • Jackie Drees. Allscripts Agrees to $145M Settlement Over Practice Fusion HIPAA, meaningful use investigation. (Backer’s Hospital Review, Aug. 9, 2019)
  • Rocco Maglio. Tech Talk: Software Company Punished for Pushing Opioids.  (Hernando Sun, Mar. 3, 2020)
  • Ted Anderson. S.F-based Practice Fusion Inc. Admits to Opioid Kickback Scheme. (San Francisco Business Times, Jan. 28, 2020)
  • Heather Landi. Practice Fusion to Pay $145M Settlement for Taking Kickbacks Aimed at Increasing Opioid Prescriptions. (Fierce Healthcare, Jan. 27, 2020)
  • Katyanna Quach. SF Tech Biz Forks Out $146m in Fines, Settlements after Painkiller Makers Bribed It to Design Medical Software that Pushed Opioids to Patients.(The Register UK, Jan. 31, 2020)
  • Vanessa Szalapski. $145 Million Settlement Shows the Depth of Government’s Effort to Combat Opioid Crisis And Its Interest In Fraud Actions Against Electronic Health Records Companies.(Dorsey & Whitney LLP, Mar. 5, 2020)
  • Mark Hayward. Opioid Maker Allegedly Paid Kickbacks to Access Electronic Health Records. (Union Leader, Feb. 3, 2020)
  • Matthew Rozsa. Oxycontin Makers Gave Kickbacks to Medical Software Company that Pushed Doctors to Prescribe Opioids. (Salon, Jan. 30, 2020)
  • Janice Hopkins Tanne. US Electronic Records Company Fined $145 Million for Pushing Doctors to Prescribe Opioids. (BMJ, Jan. 31, 2020)
  • Elizabeth Murray. Vermont U.S. Attorney’s Office: Health Records Vendor will Pay $145 Million in Kickback Scheme. (Burlington Free Press, Jan. 28, 2020)
  • Susan Morse. Allscripts Pays $145 Million to Settle Practice Fusion Civil and Criminal Investigation.(Healthcare IT News, Aug. 09, 2020)
  • Enid Montasgue. Electronic Health Records Need an Ethical Turn-Up. (Scientific American Blog Network, Mar. 24, 2020)
  • Kim Lyons. Your Doctor’s Computer May Have Suggested Opioids Because Drugmakers Paid to Tweak the Software, DOJ says. (The Verge, Jan. 31, 2020)
  • Robert Dillard. Electronic Health Records Company Practice Fusion Inc. to Pay $145 Million After Admitting to Opioid Prescriptions Kickback Scheme. (Docwire News, Jan.30, 2020)