Management and Structural Analysis of Health Care Organizations: Objectives:

35Journal of Health Care Compliance — July–August 2019 35

Health care attorney Laura F. Fryan works with health care providers,

hospitals, health plans, and health care companies to solve complex problems

and to facilitate transactions, includ- ing joint ventures, leasing of physician practices, and the buying and selling

of hospitals, physician groups, and other health care-related entities. She

advises clients on HIPAA, Stark, and anti-kickback compliance, vendor

agreements and employment con- tracts, overpayments and government

investigations, reimbursement from commercial and government payors, facility bylaws and peer review plans,

and state and federal licensing.

Patient Visits lAuRA f. fRyAn

Going Viral: Not Always a Good Thing

Medical Facilities Should Address Patient Recordings and Photography and Implement a Suitable Policy

Remember when the passenger on an overbooked United Airlines flight was forcibly removed from the plane and videos of the incident went viral on social media? Viral videos are made in an instant, but the impressions they leave can be long-lasting, and this is only one example of the power of a video recording.

In this day and age, the widespread use of record- ings, photography, and even live-streaming poses a significant concern to many businesses, including med- ical practices, hospitals, and other health care facilities. Multiple news stories in recent years—including a man who recorded audio of physicians making derogatory remarks during his colonoscopy and a woman who recorded audio of physicians disparaging her race and physical appearance during an abdominal surgery— have highlighted the need for practitioners to address patient recordings during office visits and procedures. This article will discuss patient- and visitor-initiated recording and photography during a medical visit and ways practitioners can proactively address this emerg- ing issue.

Points to PondeR State recording laws are the first place to look to deter- mine whether patient recording or photography is permissible. Many states, including Ohio, allow the recording of a conversation if one participant consents to the recording. In practical terms, this means that a person recording a conversation does not need to have the consent of anyone else that is part of the conversa- tion. Thus, a patient or visitor can record a physician or other staff member at a medical practice without anyone else’s consent. Unfortunately, it can be difficult to pre- vent a patient or visitor from recording audio or video or taking photographs. If asked, however, physicians and

Journal of Health Care Compliance — July–August 201936

Patient Visits

staff members have the right to say no to a recording or picture.

to PRohiBit oR PeRMit? Ultimately, the decision to prohibit or per- mit recordings and photography is up to the medical practice or facility, though it is important to develop policies and pro- cedures ahead of time to ensure that phy- sicians and staff respond to recording situations appropriately. These are a few considerations for each side of the coin.

Prohibit All Patient Recordings and Pictures

There are advantages to having a bright- line approach. For example, prohibiting all recordings and photography means less of a risk that other, nonrecording (and non- consenting) patients are inadvertently recorded or photographed. Additionally, a bright-line policy accompanied by a signed patient acknowledgement of that policy could help limit or mitigate provider liabil- ity arising from in-office patient recordings.

There are also several drawbacks to an absolute ban on patient recording and photography. First, when a patient refuses to comply, there are no good options from a business or patient-relationship per- spective. Patient refusal to comply with an anti-recording and photography pol- icy is often resolved with isolation of the patient within the facility, removal from the premises, or removal from the prac- tice. In other words, providers should be mindful of the ways an anti-recording and photography policy may undermine efforts to ensure patient comfort and develop trust during a visit. Second, since it is impossible to prevent patients or visi- tors from using less conspicuous means to record a visit, providers lose the chance to have more control over the recording or photograph—a matter discussed in more detail later in this article.

Implementing an anti-recording and photography policy should include posting

a statement about the prohibition in prom- inent places and preparing personnel to politely address recording situations and answer any questions patients or visitors may have about why recordings and pho- tography are prohibited. An anti-recording and photography policy also should con- tain appropriate procedures for address- ing refusal to comply; some facilities even have patients read and sign an acknowl- edgment notifying them that recordings and photography are not permitted. These policies and procedures can help alleviate the surprise or distress patients, visitors, or medical personnel might experience as the result of an anti-video recording and photography policy.

Regulate Patient Recording/Photos With more patients seeking to record vis- its, now may be the time to embrace the value of recordings and regulate this prac- tice effectively. Allowing patients to record or photograph their visits can contribute to patient peace of mind, and the increased transparency of the medical practice can help build trust between physicians and patients. Implementing permissive patient recording and photography regulations can result in more control over the process by practitioners and facilities. In addition to having patients sign an acknowledgment of the policy, some offices include a release that expressly waives patient claims result- ing from subsequent dissemination and use of the recording or photograph. By regulat- ing instead of prohibiting patient record- ing and photography, a medical practice or facility can gain more control over the recording process, thereby gaining more control over the recording itself.

Of course, permitting patient record- ings and photographs is not without risks. As previously mentioned, allow- ing patient recordings and photographs means that there is an ever-present risk that other, nonconsenting patients may

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Journal of Health Care Compliance — July–August 2019 47

12. Id. 13. Id. at 9. 14. Id. 15. Id. 16. Id. 17. Id. 18. Id. at 37. 19. 45 C.F.R. § 160.10. 20. Id. at 29. 21. Id. 22. Id. 23. Id. at 22. 24. Id. 25. In fact, the updated Code’s definition of “Medical

Technology” acknowledges this increasing com- plexity. Both the current and updated Codes refer- ence specific examples in the definition, including implantables, surgical devices, and noninvasive reagents, instrumentation, and/or software. The updated Code also includes, however, a reference to digital technology and software platforms that aid in the monitoring, diagnosing, and treating of patients, and a general definition not present in the current Code, which references “medical devices and products, technologies, digital and software platforms, and related services, solutions, and therapies used to diagnose, treat, monitor, manage, and alleviate health conditions and disabilities.” Code at 6.

26. Id. at 12. 27. Id. 28. Id. at 13. 29. Meske Testimony at 5 (referencing a settlement with

multiple hip and knee device manufacturers). 30. Id. at 14. 31. Id. at 13-14. 32. Id. 33. Id. 34. Id. 35. Id. at 26. 36. Id. at 15. 37. Id. at 16. 38. Id. at 17. 39. Id. at 16. 40. Id. at 20. 41. Id. at 21. 42. See Prior Code at 10; Code at 33. 43. Id. 44. Id. 45. 42 U.S.C. § 1320a-7a(a). 46. 31 U.S.C. §§ 3729-3733. 47. 42 U.S.C. § 1320a-7b(b). 48. See e.g., United States v. Nagelvoort, 856 F.3d 1117

(7th Cir. 2017); United States v. McClatchey, 217 F.3d 823 (10th Cir. 2000); United States v. Davis, 132 F.3d 1092 (5th Cir. 1998); United States v. Kats, 871 F.2d

105 (9th Cir. 1989); United States v. Greber, 760 F.2d 68 (3d Cir. 1985), cert. denied, 474 U.S. 988 (1985).

49. U.S. Public Law 111-148, March 23, 2010, § 6402(f)(2). A violation of the AKS is a felony and may be punished by fines of up to $100,000 and/or impris- onment for up to 10 years. In addition, the federal government may impose civil monetary penalties of up to $100,000 per kickback and damages calcu- lated at three times the amount of the remuneration and exclude violators from participation in federal health care programs. Furthermore, violations of the AKS also may expose an individual or entity to liability under the federal False Claims Act, includ- ing via qui tam action, for knowingly presenting, or causing to be presented, to the government a false or fraudulent claim for payment or approval, which imposes penalties of not less than $11,181 and not more than $22,363 per claim, plus three times the amount of damages that the government sustains because of the submission of the false claim.

50. 42 C.F.R. § 1001.952(d). 51. OIG, Medicare and State Health Care Programs:

Fraud and Abuse; Clarification of the Initial OIG Safe Harbor Provisions and Establishment of Additional Safe Harbor Provisions Under the Anti-Kickback Statute, 64 Fed. Reg. 63518, 63526 (Nov. 19, 1999).

52. OIG, Compliance Guidance for Pharmaceutical Manufacturers, 68 Fed. Reg. 23731 (May 5, 2003).

53. Id. at 23742. 54. OIG, Compliance Program Guidance for Hospitals,

63 Fed. Reg. 8987 (Feb. 23, 1998); Supplemental Compliance Program Guidance, 70 Fed. Reg. 4858 (Jan. 31, 2005).

55. OIG, Compliance Guidance for Individual and Small Group Physician Practices, 65 Fed. Reg. 59,434 (Oct. 5, 2000).

56. 68 Fed. Reg. at 23,738. 57. 68 Fed. Reg. at 23734; 70 Fed. Reg. 4864. 58. OIG, Roadmap for New Physicians: Avoiding

Medicare and Medicaid Fraud and Abuse, available at oig.hhs.gov/compliance/physician-education/ roadmap_web_version.pdf.

59. Id. at 22. The OIG further warns physicians (in bold type): “If your contribution is your ability to prescribe a drug or use a medical device or refer your patients for particular services or supplies, the proposed con- sulting arrangement likely is one you should avoid as it could violate fraud and abuse laws.” Id. at 23.

60. Id. at 25. 61. Id. 62. Provisions of the Code that have not changed

from the current version include Educational & Patient Benefit Items; Clinical Studies and Research Arrangements (though now in narrative form rather than only in the “Frequently Asked Questions”); Prohibition on Gifts; Prohibition on Entertainment & Recreation; Travel & Lodging; and Venue. While we have not included these areas of the Code in this summary, HCPs should ensure that any arrange- ments with companies are compliant with these guidelines as well.

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Journal of Health Care Compliance — July–August 201948

programs], to prevent any of them from implement- ing their own laws that authorize the use, distribu- tion, possession, or cultivation of medical marijuana.” Consolidated Appropriations Act, 2019, Pub. L. No. 116-6, § 537, available at www.govtrack.us/congress/ bills/116/hr21/text.

9. See United States v. McIntosh, 833 F.3d 1163 (9th Cir. 2016). Three caveats are important to note. First, the Ninth Circuit’s decision may be persuasive for, but is not binding on, other federal appellate courts. Therefore, another appellate circuit court could interpret the Rohrabacher provision’s scope differ- ently, although district courts in other circuits have adopted the Ninth Circuit’s interpretation. Second, most courts considering the issue have decided that the criminal defendant, not the government, has the burden to prove strict compliance with state law. See United States v. McIntosh, No. 14-cr-00016 (N.D. Cal. Mar. 20, 2017); United States v. Daleman, No. 1:11- CR-00385, 2017 WL 1256743 (E.D. Cal. Feb. 17, 2017); United States v. Gentile, No. 1:12-cr-00360, 2017 WL 1437532 (E.D. Cal. Apr. 24, 2017); but see United States v. Samp, No. 16-cr-20263, 2017 WL 1164453 (E.D. Mich. Mar. 29, 2017) (burden of proof on govern- ment). Third, the Ninth Circuit noted in the McIntosh opinion that the Rohrabacher provision protects against prosecution only while the provision is in place; if it were not continued at any point, the DOJ could prosecute any past conduct within the statute of limitations. McIntosh, 833 F.3d at 1179 n.5. see also United States of Am. v. Marin All. for Med. Marijuana, 139 F. Supp. 3d 1039 (N.D. Cal. 2015), appeal dis- missed No. 15-17486 (9th Cir. Apr. 12, 2016).

10. See supra n.8. 11. SAFE Banking Act of 2019. H.R. 1595, 116th Cong.

§ 1 (2019), www.congress.gov/bill/116th-congress/ house-bill/1595.

12. Strengthening the Tenth Amendment Through Entrusting States Act, H.R. 2093, 116th Cong. § 1 (2019), available at www.congress.gov/bill/ 116th-congress/house-bill/2093/text.

13. Kyle Jaeger, Top Congressional Democrats Announce Bill To Federally Deschedule Marijuana, marijuana moment (May 9, 2019), www.marijuanamoment.net/ top-congressional-democrats-announce-bill-to- federally-deschedule-marijuana/.

14. See Rick Schettino, Marijuana Freedom and Opportunity Act introduced to federally decriminalize cannabis, www.potnetwork.com/news/marijuana- freedom-and-opportunity-act-introduced-federally- decriminalize-cannabis.

15. 42 C.F.R. § 482.25. 16. Durkin M., Medical marijuana . . . in the hospital? As

states legalize marijuana, hospitals develop policies on inpatient use. ACP Hospitalist. January 2017.

acphospitalist.org/archives/2017/01/marijuana- policies-hospital.htm.

17. Minnesota Hospital Associate, Medical Cannabis Template Policy (June 17, 2015), available at www. mnhospitals.org/Portals/0/Documents/patient- safety/MedCannabis/Medical%20Cannabis%20 Documentation.pdf.

18. Washington Health Care Association, Draft Medical Marijuana Policy, available at www.whca.org/files/ 2013/04/sample-medical-marijuana-policy.pdf.

19. As previously stated, entities that are only involved in the medical side of the cannabis industry have federal protection under the Joyce Amendment (previously the Rohrabacher-Farr Amendment), which prevents the DOJ from spending money to prosecute those in strict compliance with state medical cannabis laws. This does not apply to the FDA, which is not restricted in this fashion.

20. See supra n.2. 21. Statement from FDA Commissioner Scott Gottlieb,

M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compound, dated Dec. 20, 2018, available at www.fda.gov/NewsEvents/ Newsroom/PressAnnouncements/ucm628988.htm.

22. Id. 23. Links to Gottlieb’s prepared testimony and to a

video of the committee hearing can be found here: www.appropriations.senate.gov/hearings/review-of- the-fy2020-budget-request-for-the-fda. Even though Gottlieb has stated multiple times that congressional action would be needed for a speedy solution, con- gressional observers believe that the current 116th Congress is not likely to act on CBD regulation.

24. Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products, available at www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm635048.htm.

25. The Health Insurance Portability and Accountability Act of 1996. Pub. L. 104-191. Stat. 1936; 45 C.F.R. Part 160 and Subparts A and E of Part 164.

26. 45 C.F.R. § 160.103. 27. A health care provider means a provider of medical

or health services (as defined in Section 1861(s) or Section 1861(u) of the Social Security Act) and any other person or organization who furnishes, bills, or is paid for health care in the normal course of busi- ness. 45 C.F.R. § 160.103.

28. HIPAA-covered transactions include the follow- ing types of information transmission: (1) health care claims or equivalent encounter information; (2) health care payment and remittance advice; (3) coordination of benefits; (4) health care claim status; (5) enrollment and disenrollment in a health plan; (6) eligibility for a health plan; (7) health plan premium payments; (8) referral certification and authorization; (9) first report of injury; (10) health

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