This article examines the difficulties faced by medical staff peer review committees and compliance departments in quickly identifying and coordinating with each other to address False Claims Act exposure for alleged medically unnecessary or substandard care.

Introduction

The medical staff and the compliance department should be natural allies who work together to ensure quality care is provided in the hospital and that the hospital is well prepared to refund any payment for unnecessary care, and possibly also care that is so substandard as to be worthless or tantamount to no services at all.¹ Concerns about loss of peer review privilege and immunity, however, can create barriers that fundamentally limit the ability of the medical staff to fully cooperate with the compliance department. As a result, peer review information is not regularly incorporated into the compliance process, and the reverse is also true.

False Claims Act² (“FCA”) liability for medically unnecessary or substandard hospital care challenges the traditional separation of medical staff and compliance functions. The federal government continues to view medically unnecessary or substandard care as a basis for government health care payment decisions and potential enforcement under the FCA.³ Providers who hoped that the government would temper its drive to identify fraud and abuse during the pandemic need only review the Department of Justice’s September 17, 2021, release announcing that “National Health Care Fraud Enforcement Action Results in Charges Involving over $1.4 Billion in Alleged Losses”⁴ to be reminded of the government’s continued commitment. The government, to support charges for unnecessary or substandard care, will often issue a Civil Investigative Demand⁵ (“CID”) that seeks medical staff peer review documents and information. Medical staffs may be surprised that they will have to turn over peer review documents to federal investigators.

The Medical Staff Must Be Actively Engaged in the Culture of Compliance

The federal government, in its ongoing effort to move from fee-for-service care, has refocused its efforts on quality of care measures that incentivize providers to deliver effective, safe, efficient, patient-centered, equitable, and timely care.⁶ Hospitals are expected to develop and implement a formal health care compliance program.⁷ One of the compliance program’s many directives is ensuring quality of care in the hospital.⁸ In its compliance program guidance, the Office of Inspector General of the federal Department of Health and Human Services (“HHS”) has cautioned that hospital compliance programs must include processes for ensuring that the services provided are medically necessary and the care is high-quality.⁹ The compliance department is also responsible for responding to detected deficiencies, limiting government overpayments, and for ensuring that the hospital refunds improper payments when identified.¹⁰

The government’s position on the consequences for failure to provide quality care continues to evolve. The federal government used to address quality through corrective action plans and potential exclusion from Medicare for egregious quality of care concerns.¹¹ Now, the government continues to actively target unnecessary and substandard care under the FCA.¹² FCA liability requires that a provider, such as a hospital or physician, knowingly submit a false claim to the federal government, such as a claim for Medicare or Medicaid services.¹³ Knowledge, deliberate ignorance, or reckless disregard of falsity is all that is required to establish intent under the FCA – specific intent to break the law is not.¹⁴

One of the most significant weapons in the government’s arsenal when evaluating substandard or unnecessary care under the FCA is the “60-Day Repayment Rule.”¹⁵ This law requires providers report and repay identified overpayments from Medicare or Medicaid within 60 days or, if applicable, the date when any corresponding cost report is due, whichever is later. An overpayment has not been “identified” under the 60- day rule until a provider has or should have, through “reasonable diligence,” quantified the overpayment. If a provider or supplier receives “credible information” of a potential overpayment, it may not ignore the information or it may be deemed to have acted in deliberate ignorance of the overpayment and could be held liable under the FCA.

What constitutes “credible information” is a fact-specific inquiry. Credible information could arise from many sources, including hospital acquired condition,¹⁶ a sentinel event, a patient safety event that results in death, permanent harm, or severe temporary harm, quality of care complaints, random medical review audits, malpractice cases, compliance hot-line complaints, or a whistleblower. The government has even alleged a false claim violation where there were differing medical judgments as to the care provided, but this argument was not upheld on appeal.¹⁷ Some of the most valuable information when determining the existence of an overpayment arising from unnecessary or substandard care is found in protected peer review materials. The hospital’s position will be difficult to defend if the peer review process should have alerted the hospital to improper physician care, but the concern was ignored by the medical staff, or the care was deemed unnecessary or substandard, but was never communicated to the hospital compliance department for repayment.¹⁸

What are the Consequences?

FCA penalties are significant. FCA violations entitle the government to three times its damages and a penalty for each violation. Each claim for care, and for hospitals each claim can include each line item in the bill that is problematic, is a separate violation. FCA penalties increase each year with inflation and the current range is $11,803 to $23,607 per violation.¹⁹ The payment to settle FCA claims for unnecessary care can be substantial. For example, a Florida cardiologist paid $6.75 million to resolve an allegation that from January 1, 2013 through December 31, 2019, he submitted false claims for unnecessary ablations and vein stent procedures.²⁰ In 2019, Sanford Health entities agreed to pay $20.25 million to settle FCA allegations regarding unnecessary spine surgeries.²¹ Recently, in May 2021, the University of Miami agreed to pay $22 million to settle claims involving unnecessary laboratory tests.²²

Why is Coordination Difficult?

While the compliance department has some responsibility for quality of care under the hospital-approved compliance plan, the hospital’s board usually delegates the primary operational responsibility to the medical staff, who ensures quality through various quality improvement and peer review processes that are mandated by state licensing laws,²³ Medicare Conditions of Participation,²⁴ and accreditation requirements, including The Joint Commission.²⁵ The state peer review privilege, sometimes referred to as the quality improvement privilege, protects this process and decision making and is the main impediment to full coordination between the medical staff and compliance programs in evaluation of substandard care. Even when the compliance department needs to fully investigate concerns that could lead to an obligation to refund an overpayment, medical staffs are justifiably reluctant to provide full access into the medical staff review process and decision making due to concerns that the peer review privilege could be waived through such disclosures.

State Peer Review Privilege

All 50 states and the District of Columbia have adopted some form of peer review privilege that grants immunity to those who participate in the peer review process in good faith, and confidentiality and evidentiary protection for documents collected and maintained on behalf of a peer review committee.²⁶ The scope of and conditions for protection are specific to the statutory language adopted by each state and must be carefully evaluated.²⁷ There is no generally recognized evidentiary privilege for compliance activities.

As with most evidentiary privileges, the scope of the peer review privilege is construed narrowly.²⁸ The statutory process must be carefully followed to maintain confidentiality and immunity. While courts do not usually overturn factual determinations of the peer review committee, the court may reject the privilege or immunity protections if the regulatory requirements have not been fully implemented and followed.²⁹ For example, a key requirement for peer review privilege and confidentiality is that the information was gathered on behalf of and maintained by a peer review committee.³⁰ Medical records, billing information, and complaints originating with the compliance department would not be protected under the peer review privilege, even if provided to a peer review committee.

Peer review statutes usually contain exceptions that further limit their scope. In some states complaints and incident reports are protected and in others they are not.³¹ Documents requested in a criminal proceeding are not generally protected.³² A provider whose privileges were restricted or terminated can, in a civil matter, obtain, and introduce into evidence peer review documents and information about the provider, but not other providers.³³ Facts are not protected, so an independent investigation about the care provided can be conducted by opposing counsel and medical records can be reviewed, provided the disclosure and use complies with HIPAA.³⁴

Waiver of the peer review privilege is difficult in most states and some states even require written waiver signed by an authorized agent of the hospital to waive the privilege.³⁵ However, under some state statutes, waiver can occur inadvertently. For example, once protected peer review documents and information are disclosed outside of the peer review committee process, those outside documents and the information are no longer subject to the peer review protection, even if the same documents, when maintained by the peer review committee, remain protected.³⁶ As a result, the medical staff could potentially lose the state peer review privilege if protected peer review information is shared with the compliance department.

Limited Federal Protection of Peer Review and Quality Documents

Perhaps to the surprise of most medical staffs, most peer review information is not protected in federal proceedings and investigations.³⁷ Similar to the legislatures of most states, Congress recognized the value of providing immunity from liability for good faith engagement in peer review when it adopted the Federal Health Care Quality Improvement Act (“HCQIA”). Immunity extends to anyone who participates in the professional review action, including members of a professional review body and their staffs who take actions in good faith which adversely affect the clinical privileges of a physician or dentist.³⁸ However, Congress did not include confidentiality or evidentiary protection for information provided to or maintained by the professional review body within HCQIA.³⁹ The courts have generally reasoned that the failure to add confidentiality protections is evidence that no federal privilege exists.⁴⁰

Congress subsequently adopted the Patient Safety and Quality Improvement Act of 2005 (“PSQIA”) and offered limited protections for a small category of quality improvement documents.⁴¹ The PSQIA provides broad privilege and confidentiality protections for information reported to, developed by, or analyzed by a Patient Safety Organization (“PSO”)⁴² as part of the cooperative analysis of patient safety events.⁴³ A PSO is an external entity to the hospital and must receive the document for the PSQIA privilege to apply. For medical staff purposes, the PSQIA has limited usefulness as most of the information gathered for and maintained by a peer review committee is internal, will not be shared with a PSO, and will not be protected in federal proceedings. This includes government investigations under the FCA.⁴⁴

The majority of federal district courts continue to decline to recognize a broader peer review privilege.⁴⁵ Medical staffs should not be misled by the few federal districts that have provided protection to peer review materials.⁴⁶ Those cases are unique and isolated. Nearly all jurisdictions will deny protection in anti-trust and discrimination matters.⁴⁷ The courts reason that in these matters it is the peer review process that is at issue and the plaintiff or the government cannot prove their case without access to the peer review information. The courts conclude that the broader need to stop alleged problematic behavior through enforcement overrides any justification that may exist to protect the peer review documents and process.⁴⁸ For the same reasons, even in districts where courts have recognized a limited privilege for peer review materials, the privilege is unlikely to be available in an FCA matter that involves standard of care concerns.

While federal courts may not recognize a peer review privilege and will require disclosure to federal government investigators, most courts recognize the value of the privilege and are willing to protect the hospital’s interest through other means, such as protective orders, confidentiality agreements, and in some instances, in camera review of documents. An in camera review is when a judge reviews the privileged documents privately in their chambers and not in the courtroom, which is almost always open to the public, including journalists and malpractice attorneys. Thus, in camera review may help reduce the risk that peer review records disclosed in federal proceedings or investigations are readily available to malpractice plaintiffs through a request for court or government investigation records. ⁴⁹ Experienced legal counsel will have this at the top of mind when negotiating the production of peer review records and testimony in response to a Civil Investigative Demand.

Promoting Medical Staff and Compliance Coordination on Substandard Care FCA Matters Using the Attorney-Client Privilege

The attorney-client privilege and attorney work product doctrine are two of the strongest legal protections from disclosure, and when used appropriately can provide an avenue for the medical staff and compliance departments to evaluate FCA risk of potential medically unnecessary or substandard care. The attorney-client privilege is recognized under state and federal law and preserves the confidentiality of communications between attorneys and their clients. It requires communication made in confidence between an attorney and a client for the purpose of seeking or providing legal advice.⁵⁰

The attorney work product doctrine, also recognized under state and federal law, protects written and oral materials prepared by or for an attorney in the course of legal representation.⁵¹ The work product doctrine is similar to the peer review privilege in that it can work to protect the information and documents derived from an attorney’s investigation necessary to support the attorney’s legal advice. For example, an attorney can engage an expert to help inform legal decisions and the non-testifying expert’s report would be protected from discovery as attorney work product.⁵²

As an illustration, let’s assume that the medical staff receives a complaint that its highest volume cardiovascular surgeon is performing unnecessary procedures, which raises many peer review and FCA concerns. The medical staff should immediately consult with the hospital’s attorney to determine the best means to move forward. The attorney can help identify whether a billing concern exists and the compliance department should be involved. The consultation will be covered by the attorney-client privilege and potentially the peer review privilege.⁵³ Where appropriate, the attorney could consult with the compliance department as part of an attorney-directed investigation and provide legal advice. Those discussions would be covered by the attorney-client privilege and any documents generated as part of the inquiry would be attorney work product. Careful steps should be taken to memorialize the attorney’s direction of the compliance personnel in order to secure this protection.

The attorney and medical staff should also discuss engagement of experts, if necessary. The medical staff may in many circumstances engage experts directly for peer review purposes. However, where a FCA concern has arisen, any experts should be engaged by the attorney to ensure attorneywork product protection. The attorney work product protection will allow the attorney to collaborate with the expert, the medical staff, and compliance teams to refine areas of focus and to work through drafts of opinions to ensure consistency and that questions necessary for effective medical staff peer review and for hospital compliance activities are answered. For example, the expert may need to address whether the physician’s care met the standard in the community or hospital, i.e., was negligent, or if the care was unnecessary and potentially subject to FCA liability. The medical staff and attorney should decide before the expert is engaged whether the expert will be engaged through the attorney in order to assert attorney work product privilege. The presence of an attorney cannot bring an existing expert report within the scope of the work product privilege.

Attorneys and the medical staff should also keep in mind that the final expert reports will likely be used by the medical staff to support a peer review decision and if that decision is adverse, only the peer review privilege, and not the attorney work product doctrine, will likely protect the final report. If the peer review privilege is the only protection available, the report will be discoverable in an FCA investigation.⁵⁴ Importantly, the final report would also likely be used to defend the hospital’s actions, including findings of no wrongdoing or calculations of overpayment, so special care should be taken in their preparation.

Considerations to Implement to Improve Coordination

Improved processes should be developed to focus on early identification of standard of care concerns, early coordination across medical staff, compliance, and legal departments, and on maintaining available evidentiary privileges and protections. The medical staff and compliance processes should continue to be managed separately to limit loss of the state peer review privileges. Medical staff leadership should be reminded of the importance of fully participating in the culture of compliance and the implications of the failure to do so. Compliance training for the medical staff should emphasize that substandard care concerns should not be ignored, especially if long-term trends or multiple claims are possible.

The hospital should consider designating at least one organizational leader with visibility into both compliance and medical staff activities, ideally general counsel or someone authorized to work directly with legal counsel, to help ensure that matters are identified and handled appropriately. The organization’s legal counsel can be critical to managing the interplays between compliance and the medical staff and initiating a process that helps best ensure confidentiality and evidentiary privileges are maintained, whether based on peer review or the attorney-client relationship. The attorney should involve the compliance department when substandard or unnecessary care could lead to an overpayment to leverage billing expertise and to help ensure compliance with payer repayment timelines.

The medical staff should also consult with an attorney when experts are engaged to determine if the expert should be engaged through the attorney, thereby protecting the expert opinion under the attorney work product doctrine. If not, the expert should be engaged by the peer review committee, thereby providing peer review protection for the expert opinion. Finally, the medical staff and compliance departments should understand that regardless of the protections asserted, there is a possibility that the discussions and documents can be discovered in litigation, and all expert opinions, reports, and minutes should be drafted with potential disclosure in mind.

Summary

The federal government’s use of the FCA to punish substandard care puts hospitals, their medical staffs, and compliance departments between the proverbial “rock and a hard place.” The medical staff may be surprised that the hospital will likely have to produce peer review information in response to federal requests. Once the information is produced, the federal government will evaluate whether the medical staff identified or should have identified substandard care and whether the hospital took appropriate action, including issuance of refunds of any government payment for the care. If a refund was not made, the hospital may be exposed to substantial FCA liability.

As a result, quality of care issues in the hospital, whether identified through compliance channels or the medical staff peer review process, will require some coordination. The level of coordination depends on the severity of the issue. Appropriate coordination is best achieved when medical staffs work carefully to integrate peer review with compliance, with legal counsel’s guidance. Appropriate procedures can help improve coordination and reduce the risk of FCA liability and other liabilities arising from unnecessary or substandard care. Coordination can also help maintain evidentiary privileges and protections and limit the potential discovery of information gathered and documents created as part of the evaluation.

1 In some rare cases, the government also pursues FCA claims where they consider the care to be so substandard as to be worthless or tantamount to no services at all. See, e.g., In re Genesis Health Ventures, Inc., 112 Fed. App’x 140, 143 (3d Cir. 2004); See also, U.S. ex. rel. Taylor v. Comhar, Inc., Case 2:16-cv-01218-GAM Document 32 Filed 08/30/21 (memorandum in support of order to dismiss FCA claim that alleged negligence resulting in only diminished value as opposed to rendering the care worthless).

2 False Claims Act, 31 U.S.C. §§ 3729–33. The investigation may not be limited to Medicare and Medicaid but may also include public or private health care benefit programs under 18 U.S.C. §§ 1035, 1347.

3 The federal government may also be interested in peer review documents and information while investigating non-compliance with the Emergency Medical Treatment and Labor Act (“EMTALA”), 42 U.S.C. § 1395dd; Health Insurance Portability and Accountability Act (“HIPAA”), 42 U.S.C. § 1320d-6); Food, Drug, and Cosmetic Act 21 U.S.C. §§ 331, 333; and Research Misconduct, 42 C.F.R. Part 93.

4 National Health Care Fraud Enforcement Action Results in Charges Involving over $1.4 Billion in Alleged Losses, U.S. Dep’t of Just., Friday, (Sept. 17, 2021), https://www.justice.gov/opa/pr/national-health-carefraud-enforcement-action-results-charges-involving-over-14-billion.

5 31 U.S. Code § 3733.

6 See Quality Measures, CMS (Feb. 11, 2020), https://www.cms.gov/Medicare/Quality-Initiatives-PatientAssessment-Instruments/QualityMeasures; Patient Protection and Affordable Care Act, 42 U.S.C. § 18001 et seq.; Quality Initiatives, CMS (Nov. 17, 2019), https://www.cms.gov/Medicare/Quality-InitiativesPatient-Assessment-Instruments/QualityInitiativesGenInfo.

7 OIG Compliance Guidance for Hospitals, 63 Fed. Reg. 8981 (Feb. 23, 1998); OIG Supplemental Compliance Program Guidance for Hospitals, 70 Fed. Reg. 4858 (Jan. 31, 2005).

8 See “Driving for Quality in Acute Care: A Board of Directors Dashboard”—Government-Industry Roundtable, Dep’t Health and Human Servs., https://oig.hhs.gov/documents/compliance-guidance/811/ RoundtableAcuteCare.pdf.

9 Publication of the OIG Compliance Program Guidance for Hospitals, 63 Fed. Reg. 8987 (Feb. 23, 1998), supplemented at OIG Supplemental Compliance Program Guidance for Hospitals, 70 Fed. Reg. 4858 (Jan. 31, 2005).

10 Id.

11 The OIG may impose permissive exclusions of providers who provide unnecessary or substandard services. 42 U.S.C. § 1320a-7(6).

12 Orlando Cardiologist Pays $6.75 Million to Resolve Allegations of Performing Unnecessary Medical Procedures, U.S. Dep’t of Just. (Sept. 15, 2021), https://www.justice.gov/opa/pr/orlando-cardiologistpays-675-million-resolve-allegations-performing-unnecessary-medical (unnecessary ablations and vein stent procedures); SavaSeniorCare LLC Agrees to Pay $11.2 Million to Resolve False Claims Act Allegations, U.S. Dep’t of Just. (May 21, 2021), https://www.justice.gov/opa/pr/savaseniorcare-llc-agrees-pay-112- million-resolve-false-claims-act-allegations.

13 False Claims Act, 31 U.S.C. §§ 3729–33.

14 Id. at § 3729(b)(1)(B).

15 42 USC § 1320a-7k(d).

16 CMS has identified 14 categories of Hospital Acquired Conditions for which payment will not be made. See 79 Fed. Reg. 49854, 49876-49880 (Aug. 22, 2014).

17 United States v. Aseracare, Inc., 938 F.3d 1278 (11th Cir. 2019) (that a mere difference in medical judgment cannot rise to a false statement under the False Claims Act).

18 The medical staff must also be aware of potential for retaliation against anyone who may have filed a complaint or raised a concern about alleged unnecessary or substandard care. 31 U.S.C. § 3730(h): “Any employee, contractor, or agent shall be entitled to all relief necessary to make that employee, contractor, or agent whole, if that employee, contractor, or agent is discharged, demoted, suspended, threatened, harassed, or in any other manner discriminated against in the terms and conditions of employment because of lawful acts done by the employee, contractor, agent or associated others in furtherance of an action under this section or other efforts to stop 1 or more violations of this subchapter.” 31 U.S.C. § 3730(h)(1). Penalties include two times back payment, plus interest, special damages and costs, plus attorney fees. Id. at § 3730(h)(2). State or municipal owned hospitals may also be subject to state-based employee retaliation penalties.

19 Civil Monetary Penalty Inflation Adjustment, 86 Fed. Reg. 2005 (Jan. 11, 2021).

20 Orlando Cardiologist Pays $6.75 Million to Resolve Allegations of Performing Unnecessary Medical Procedures, U.S. Dep’t of Just. (Sept. 15, 2021), https://www. justice.gov/opa/pr/orlando-cardiologist-pays-675-million-resolve-allegations-performing-unnecessary-medical.

21 Sanford Health Entities to Pay $20.25 Million to Settle False Claims Act Allegations Regarding Kickbacks and Unnecessary Spinal Surgeries, U.S. Dep’t of Just. (Oct. 28, 2019), https://www.justice.gov/opa/pr/sanford-health-entities-pay-2025-million-settle-false-claims-act-allegations-regarding.

22 University of Miami to Pay $22 Million to Settle Claims Involving Medically Unnecessary Laboratory Tests and Fraudulent Billing Practices, U.S. Dep’t of Just. (May 10, 2021), https://www.justice.gov/usao-sdfl/pr/university-miami-pay-22-million-settle-claims-involving-medically-unnecessary.

23 E.g., RCW 70.41.200 (Washington State requires as a conditions of licensure that hospitals to implement a comprehensive quality improvement program).

24 42 C.F.R. §§ 482.21, 482.22.

25 Medical Staff Standards, Joint Commission at 4.40, 4.45 and 8.01.01.

26 For example, RCW 4.24.250, 70.41.200 and 43.70.510; Tex. Occ. Code § 160.007; Mo. Rev. Stat. § 537.035; Ohio Rev. Code §§ 2305.25 et seq.; N.C. Gen. Stat. § 131E-95(B); 735 Ill. Comp. Stat. 5/8-2101.

27 For example, Washington State has three statutes that provide a peer review or quality improvement privilege: RCW 4.24.250 (broad application to peer review committees), RCW 70.41.200 (applies to hospital quality improvement activities), and RCW 43.70.510 (applies to non-hospitals, professional societies and organizations, health insurers and health maintenance organizations and health care provider groups of more than five providers). Each statute has its own terms and conditions that must be satisfied for privilege and immunity.

28 United States v. Nixon, 418 U.S. 683, 710 (1974); see also, Fellows v. Moynihan, 175 Wn. 2d 641, 285 P.3d 864 (2012).

29 Adcox v. Children’s Orthopedic Hosp. and Med. Ctr., 123 Wn. 2d 15, 864 P.2d 921 (1993) (holding records of investigation were not privileged as they were not created for a “regularly constituted” quality review committee).

30 Id.

31 See Tunca v. Painter, 980 N.E.2d 1132 (Ill. App. Ct. 2012) (holding that 735 Ill. Comp. Stat. 5/8-2101 does not protect information obtained after a medical incident but before the peer review process formally begins, nor does this information transform into privileged information when reported to the committee); but see RCW 70.41.200 (specifically protecting complaints and incident reports).

32 See RCW 70.41.200(3) (“Quality improvement documents and information are not subject to review, or disclosure [] or discovery or introduction into evidence in any civil action . . . ”).

33 Id.

34 In California, the names of the peer review committee members are privileged, Willits v. Superior Court, 20 Cal. App. 4th 90, 97 (1993), but any committee member can voluntarily waive the privilege, West Covina Hosp. v. Superior Court, 718 P.2d 119, 41 Cal. 3d 846 (1986).

35 In re Christus Santa Rosa Healthcare Corp., No. 04-20-00327-CV, 2020 WL 5215058 (Tex. App. Sept. 2, 2020), no pet.

36 Yocabet v. UPMC Presbyterian, 2015 Pa. Super. 132 (June 5, 2015) (holding that board minutes discussing peer review directed by an attorney could be covered by the attorney-client privilege and the peer review privilege and remanded the documents for in-camera review and that documents disclosed to the Department of Health during its investigation were no longer privileged); but see RCW 70.41.200(7) (maintaining privilege for documents disclosed to Department of Health or accreditation organization in connection with the inspection and review of hospitals); Fox v. Kramer, 22 Cal. 4th 531 (2000) (holding that disclosure of peer review materials to the Department of Health Services for investigative purposes does not constitute a waiver).

37 Wilcox v. Arpaio, 753 F.3d 872 (9th Cir. 2014) (federal law of privilege applies to federal question claims and pendent state law claims); Virmani v. Novant Health, Inc., 259 F.3d 284 (4th Cir. 2003) (declining to recognize peer review privilege in federal proceedings); Johnson v. Nyack Hosp., 169 F.R.D. 550 (S.D.N.Y. 1996) (refusing to recognize New York and New Jersey peer review protection in federal discrimination claim).

38 42 USC § 11101 et seq. The immunity does not extend to review of allied health professionals.

39 Id.

40 Virmani, 259 F.3d 284.

41 42 U.S.C. § 299b-21 et seq.; see also 42 C.F.R. § 483.75(h) (providing limited protection for long term care facility quality assurance and performance).

42 A PSO must be certified and listed by the Secretary of the Department of Health and Human Services. 42 U.S.C. § 299b-24.

43 42 U.S.C. § 299b-21.

44 United States ex rel. Wollman v. Gen. Hosp., Inc., et al., Case No. 1:15-cv-11890-ADB (Nov. 3, 2020).

45 Teasdale v. Marin Gen. Hosp., 138 F.R.D. 691, 694 (N.D. Cal. 1991) (“Congress spoke loudly with its silence in not including a privilege against discovery of peer review materials in the HCQIA”); accord In re Administrative Subpoena Blue Cross Blue Shield of Mass., Inc., 400 F. Supp. 2d 386, 390–91 (D. Mass. 2005).

46 Tep v. Southcoast Hosps. Grp., Inc., No. 13-11887-LTS, 2014 WL 6873137 (D. Mass. Dec. 4, 2014) (upholding privilege after determining that estate of deceased patient’s EMTALA violation claims were intertwined with state malpractice claims).

47 Mem’l Hosp. v. Shadur, 664 F.2d 1058 (7th Cir. 1981).

48 Adkins v. Christie, 488 F.3d 1324 (11th Cir. 2007).

49 But see In re Pac. Pictures Corp., 679 F.3d 1121 (9th Cir. 2012) (confidentiality agreement with the government did not prevent waiver).

50 The client, rather than the lawyer, holds the privilege and can waive the privilege at any time. There are a few notable exceptions, including if the client initiates a communication for the purpose of committing a crime or fraud or the disclosure is necessary to prevent death or serious injury. United States v. White, 970 F.2d 328 (7th Cir. 1992); Swidler & Berlin v. United States, 524 U.S. 399 (1998).

51 Fed. R. Civ. P. 26(b)(3); Hickman v. Taylor, 329 U.S. 495 (1947); United States v. Nobles, 422 U.S. 225 (1975) (applies to both civil and criminal cases). A limited exception for substantial need or undue hardship make documents available.

52 The expert opinion and information provided to the expert will be available if the expert is a witness in a legal proceeding.

53 Yocabet v. UPMC Presbyterian, 119 A.3d 1012 (Pa. Super. 2015) (court found that both attorney-client privilege and peer review privilege could apply to board minutes).

54 Documents provided to the expert whose opinion is used in litigation may not be protected by the attorney-client privilege or work product doctrine and are generally discoverable and must be carefully evaluated. But see Mullins v. Tompkins, 15 So. 3d 789 (Fla. 1st DCA 2009) (holding that facts and opinions used by experts are discoverable).