Source: https://www.thehealthlawticker.com/
Timestamp: 2019-04-25 16:52:02+00:00

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A Civil Investigative Demand, often referred to as a “CID,” is a pre-litigation mechanism used to collect information and evidence for use in civil false claims act and other investigations. CIDs are typically lengthy documents, broadly drafted, invasive, and even frightening. In the past decade since the passage of the Fraud Enforcement and Recovery Act of 2009, CIDs have been issued at exponentially higher rates than in years past, and have become more comprehensive and more aggressive.
While this post will focus on Department of Justice CIDs in federal health care cases, CIDs are available in other cases and to other agencies, including state agencies. Some can have unique rules and deadlines. Recipients of any CID should consult with counsel immediately upon receipt.
The federal False Claims Act is codified at 31 U.S.C. § 3729, et seq. Health care false claims act cases can be brought by relators – whistleblowers – as qui tam matters. Alternatively, false claims act investigations can be initiated by the Department of Justice without a relator. In either instance, the Department of Justice uses CIDs as part of its investigation. CIDs are available to the government to request sworn responses to interrogatories, to request documents, and to interview or depose witnesses and persons of interest. Statutory authority for a CID, and other applicable provisions and guidelines, are found at 31 U.S.C. § 3733.
If a false claims act investigation is initiated by a whistleblower’s qui tam lawsuit, the CID recipient will not know that, nor know who the whistleblower is for quite some time. Relator-initiated qui tam actions are filed under seal and then kept under seal until a court order lifting the seal is entered. This can sometimes be years after the matter was filed. Nevertheless, the subject matter of the investigation and its potential targets are sometimes discernable from the CID and from subsequent interactions with government agents and lawyers.
Not every recipient of a CID is a direct target of government scrutiny. Some are third party witnesses, or persons of interest who will turn out not to be targets. Some, however, are targets from the outset. Still others will become targets after the production of the requested data, depending on what that data reveals.
Most CIDs are very broadly drafted. They typically span many years and contain phrases such as “all documents related to…” The expense of compliance, and the dedication of resources that must be made for proper compliance, both monetary and labor, cannot be overstated. Selective or partial compliance is not an option. Non-compliance is a serious violation. Notwithstanding that, there are some limited bases on which to challenge a CID in court, including the burden presented by compliance, or the seeking of records already within the government’s possession, or the relevance of what is being sought, or even assertions of abuse of the process. Generally, a legal challenge to a CID may result in a judicial narrowing of its scope, but it will rarely obviate the need for compliance altogether.
Any person or entity in receipt of a CID would be wise to contact experienced counsel without delay. Counsel’s early, regular, and ongoing dialogue with the government is critical to demonstrating good faith, managing compliance and managing the government’s expectations. Reasonable prosecutors and agents are often receptive and even appreciative of counsel’s communications. Counsel can often negotiate and narrow the scope of the production, negotiate compliance deadlines, and communicate protocols for the collection and production of responsive items. Counsel can also help ensure the CID recipient takes the extremely important step of placing a “hold” on all data, which includes measures for preservation of data, and implementing a stay on normal back up and destruction processes. Counsel can ensure that documents which should not be produced for legal reasons are not produced. Here, issues to consider include whether documents are protected by privileges such as the attorney-client privilege; and whether there are items that – though responsive – should be flagged for internal preparation. Experienced counsel can also ensure that in any subsequent interviews or depositions, the protections and privileges of attorney-client communications are not waived, and that interviewees are advised regarding their Fifth Amendment rights should the need arise.
Items to be searched, preserved, and produced in response to a CID range from the obvious to the not-so-obvious. Emails in all folders including archived folders are a good beginning. Paper files, files in storage, and written correspondence are also key, but the breadth of a necessary search and response goes deeper. Voice mails, recorded calls, text messages, marketing materials, even social media posts, and messages might be responsive.
After CID compliance, a CID recipient may hear nothing for quite some time. The government will be hard at work behind the scenes, however, evaluating all of the information it has received from a variety of sources and determining whether to intervene in an existing qui tam matter if one has been filed. Settlements might be in negotiation and decisions may be made about whom to charge, and for what. If, in the meantime, the CID recipient comes across materials not previously produced that are responsive, the obligation to produce is a continuing one, and such matters should be brought to counsel’s attention immediately.
The day a CID is dropped on one’s desk is a stressful one. Taking quick and decisive action, including hiring experienced counsel, can help ensure everyone gets through the process as painlessly as possible.
The statutory amendments established the way in which the prescription forms must be printed, the various features that the prescription forms must include, and the way in which the dispenser of controlled substances must report the serial number to the Controlled Substance Utilization Review and Evaluation System (CURES) system. However, the amendments did not provide any grace period within which prescribers could bring themselves into compliance.
As a result, prescribers who waited too long to order the new prescription forms found themselves on January 1, 2019 without any valid prescription forms, causing delays in filling prescriptions for controlled substances.
On March 11, 2019, Governor Newsom signed AB 149, which took effect immediately and addressed the problem of noncompliant prescription forms.
The bill provides that the Department of Justice establish a date no later than January 1, 2020 for prescription forms to be printed bearing uniquely serialized numbers. The bill further provides that the requirement for a prescriber to use a prescription form with a uniquely serialized number will not take effect until January 1, 2021, at the earliest, and that the date may be extended as much as six months if the Department of Justice finds that there are an inadequate number of prescription forms bearing uniquely serialized numbers.
AB 149 thus provides a substantial extension of time for both the production and use of prescription forms bearing uniquely serialized numbers.
It is well-documented that California is facing a shortage of primary care providers. The Californians most affected by these shortfalls are largely low-income, Latino, African American, and Native American and located in rural areas as well as in California’s largest and fastest-growing regions—the Inland Empire, Los Angeles, and the San Joaquin Valley. Newly-proposed legislation aims to address this problem by permitting California’s nurse practitioners to practice under certain conditions without physician supervision.
Assembly Bill 890 was introduced by Assemblymember Jim Wood (D-Santa Rosa), Chair of the Assembly Health Committee, and co-authored by five Assemblymembers and four Senators on both sides of the aisle. Among the co-authors are Cecilia Aguiar-Curry (D-Winters), member of the Assembly Health Committee; Jeff Stone, (R-Temecula) Vice Chair of the Senate Health Committee; and Connie Leyva (D-Chino), member of the Senate Health Committee.
The bill, which amends Section 2837.1 of the Business & Professions Code (a section of The Nursing Practice Act), would expand nurse practitioner education and revise scope of practice regulations so that nurse practitioners could practice without physician supervision after a transitional period of collaboration with a physician or experienced nurse practitioner. Specifically, the bill would authorize a certified nurse practitioner to practice without the supervision of a physician if the nurse practitioner meets specified requirements, including having practiced under the supervision of a physician and surgeon for an unspecified number of hours (to be determined by the Board of Registered Nursing). The bill also would authorize a nurse practitioner to perform additional specified functions, including ordering and interpreting diagnostic procedures, certifying disability, and prescribing, dispensing, and administering controlled substances. Because the bill would expand the scope of a crime (a violation of the Nursing Practice Act is a misdemeanor), the bill would impose a state-mandated local program under the Commission on State Mandates to review and assess alleged violations.
Full practice authority for nurse practitioners would result in cost savings to Californians from reduced avoidable emergency department stays and hospitalizations, and the lower costs of retail clinic use and primary care.
Removing scope of practice restrictions would increase the growth rate of nurse practitioner supply by 25 percent. Between 2010 and 2017, California’s NP supply grew 39 percent; with full practice authority, the growth rate would have been 49 percent, and the state would have 1,500 NPs more than it does today.
If full practice authority is achieved by 2020, there would be nearly 50,000 fewer revisits to emergency departments for ambulatory sensitive conditions, resulting in cost savings of more than $58 million per year.
Currently regulations promulgated by the Board of Registered Nursing under present statutory provisions require nurse practitioners to collaborate with physicians to develop standardized procedures—written authorization to perform certain medical functions not otherwise part of a nurse practitioner’s scope of practice2. There are no requirements in those regulations regarding the physical proximity of the supervising physician to the nurse practitioner—supervision could be done remotely. However, the physician is still legally responsible for the nurse practitioner’s practice, and is expected to determine the appropriate level of supervision, communicate regularly with the nurse practitioner, and oversee quality of care.
Opponents of the bill say nurse practitioners lack the training needed to practice on their own, arguing that online coursework is not as effective as the in-person medical education received by physicians, and that nurse practitioners have fewer hours of actual patient contact than physicians. The bill’s proponents point out that this concern creates a double standard between nurses and physicians because there is a mix of online and in-person programs offered by medical schools, which has been deemed sufficient for a physician and surgeon license.
If this bill passes, California would join 22 other states3 and the District of Columbia in allowing nurse practitioners to practice and prescribe without physician supervision or collaboration, as specified. Doing so, the bill’s proponents state, would not only be cost-effective, but would expand access to care for the state’s most vulnerable populations.
2Title 16, Code of California Regulations, Section 1485 (Scope of Practice).
3Alaska, Arizona, Colorado, Connecticut, District of Columbia, Hawaii, Idaho, Iowa, Maine, Maryland, Minnesota, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Dakota, Oregon, Rhode Island, South Dakota, Vermont, Washington, and Wyoming.
In a decision affecting California hospitals, medical groups, medical staffs, and physicians, the California First District Court of Appeal has concluded that a physician’s notice and hearing rights apply to situations where a hospital directs a medical group of a “closed” department to remove a physician from the hospital schedule.
In 2011, California Department of Public Health conducted an unannounced survey and placed the hospital in “immediate jeopardy” upon finding numerous deficiencies attributed to one of East Bay Group’s anesthesiologists, Dr. Economy. At hospital administration’s direction, East Bay Group removed Dr. Economy from the schedule pending further investigation. In the weeks that followed, the medical staff peer review committees reviewed the issue and recommended to East Bay Group that Dr. Economy complete a continuing education course through Physician Assessment and Clinical Education (PACE) program prior to returning to clinical practice. Dr. Economy did not receive an opportunity to meet with any medical staff peer review committees to discuss the matter.
Dr. Economy eventually completed the PACE program and returned to practice. After being alerted by the pharmacy manager of problems with Dr. Economy’s chart, hospital administration contacted East Bay Group and asked them to “address the issue immediately.” Dr. Economy once again was taken off the anesthesia schedule and asked by East Bay Group to resign. When he refused, they terminated his employment.
Dr. Economy thereafter filed a complaint alleging the hospital had violated his right to notice and a hearing under Business & Professions Code § 809 and his common-law right to fair procedure. He also filed suit against East Bay Group, which were resolved on summary judgment or settled prior to trial.
In finding that the hospital violated Dr. Economy’s common law and statutory due process rights, the trial court rejected the hospital’s contention that the Easy Bay Group made the decision to suspend and terminate Dr. Economy’s employment – not the hospital – and therefore, no hearing right had been triggered. The court found the hospital’s approach untenable, as it would effectively allow a hospital to avoid complying with the notice and hearing requirements of 805 and 809 simply by relying on its contracts with third-party employers as a way to terminate the services of physicians. Rather, the court found that the “request” for Dr. Economy to be removed from the hospital schedule, first temporarily and then permanently, was the functional equivalent of a decision to suspend and later revoke his clinical privileges.
While the court in Economy focused on removal of a physician for competency reasons, which plainly met the definition of “medical disciplinary cause or reason,” it remains to be seen how a court would respond if a hospital directs a medical group to remove a physician when the jeopardy to quality of care is not as obvious, such as when the physician engages in behavior that does not align with the professionalism standards of the hospital.
Medical staffs, as well as other peer review bodies, should also analyze their Bylaws to ensure they reflect the hearing rights afforded to physicians restricted from practicing for a medical disciplinary cause or reason in a similar situation. This case also serves as an important reminder for medical staffs and hospitals to assure that they meet their own peer review and fair hearing obligations, rather than relying on the actions of a medical group.
Hospitals and medical groups should review their current contracts to determine whether their contracts run afoul of Economy or Business & Professions Code § 809.6 (prohibiting the waiver of hearing rights by contract). As an example, since the court equated the removal of a physician to a summary suspension, hospitals should consider whether similar contractual language allowing removal for “an act or omission that jeopardizes the quality of care provided to hospital’s patients” is moot and should be replaced with language mirroring the standards for summary suspensions (i.e., when the failure to take such action may result in an imminent danger to the health of any individual).
In a decision that facilitates flexible staffing practices for healthcare employers, the California Supreme Court recently held that healthcare workers can legally waive a second meal period when they work shifts longer than 12 hours. Gerard v. Orange Coast Mem’l Med. Ctr., 430 P.3d 1226 (Cal. 2018). The high court’s decision finally and conclusively resolves a contentious and technical dispute over labor enactments that had been the subject of several prior appellate rulings. See our prior discussion re Gerard II here.
Plaintiff healthcare workers alleged that their hospital employer had violated California Labor Code section 512(a) by allowing waivers of second meal periods when they worked shifts longer than 12 hours.
In Gerard, the high court resolved this conflict by affirming the validity of Wage Order No. 5 and holding that it did not violate the Labor Code. To reach that decision, the Court’s opinion wades through a morass of legislative and administrative provisions, as well as the prior appellate decision and an intervening statutory amendment. To reiterate, the core dispute was between, on the one hand, Labor Code section 512(a) which expressly allows voluntary waivers of second meal periods for employees who works shifts of 8 but no more than 12 hours and, on the other hand, Section 11(D) of Wage Order No. 5 which creates an express exception for healthcare employees that allows such waivers, even if the employee works more than 12 hours.
Inappropriate prescribing resulting in harm to patients and a probationary period of five years or more.
The notification must provide details of the practitioner’s probation status, the length of the probation, the probation end date, all practice restrictions placed on the practitioner by the licensing board, the board’s telephone number, and an explanation of how the patient can find further information about the probation. Such patient notice is required regardless of whether the probation is the result of an administrative hearing in front of an administrative law judge, or a stipulated settlement between the practitioner and the Medical Board of California without any findings of fact or admissions of guilt.
Although such information has long been publicly available on licensing board websites, this new law will require a practitioner on probation to obtain a signed copy of the disclosure prior to each patient’s first visit following the effective date of the practitioner’s probation. Exceptions to the disclosure requirement exist for specific situations where a disclosure prior to treatment is not feasible (e.g., unscheduled urgent care or emergency room visits).
Although similar bills had been introduced in prior years, key to the passage of SB 1448 was the testimony of survivors of physician sexual assault, including athletes who had recently testified against Olympic team doctor, Larry Nassar.
The new law, which amends various provisions of the Business and Professions Code, will apply to physicians, osteopaths, naturopathic doctors, chiropractors, podiatrists and acupuncturists. The full text of the law is available at the California Legislature’s website.
There is a host of new, ever changing, and conflicting guidelines from a multitude of regulators and academic societies. This evolving and uncertain landscape is making the life of a practicing pain physician in the midst of today’s nationwide opiate epidemic…painful.
2. Treat the 2014 MBC Guidelines as Dictating the Standard of Care (i.e. rules you must follow) – Deviations from these Guidelines must be justified and documented.
1 This blog post is not intended to constitute specific legal advice, and it is not a substitute for advice from qualified counsel. The information on this website is general in nature and may not pertain to your specific circumstances.
The CURES consult and the PAR must be completed in the 24-hour period, or the previous business day, before prescribing, ordering, administering, or furnishing a controlled substance, unless an exception applies.
Thereafter, practitioners must consult CURES before subsequently prescribing a controlled substance, if the consult was previously exempt, and at least once every four months, if the controlled substance remains a part of the patient’s treatment plan.
Professional licensing boards have the authority to audit CURES activity to ensure compliance. Failure to comply could result in disciplinary proceedings against a practitioner’s license.
2. In the emergency department of a general acute care hospital, and the controlled substance does not exceed a non-refillable seven-day supply.
4. The patient is receiving hospice care.
The Medical Board of California has issued CURES Mandatory Consultation FAQs, located here.
1 This requirement does not apply to veterinarians or pharmacists.
On Friday, June 22, 2018, a Florida Appeals Court handed down its decision in Omulepu v. Department of Health Board of Medicine. The case involved a doctor’s appeal from a decision by the Florida Department of Health, Board of Medicine to revoke a plastic surgeon’s right to practice medicine. The main issue on appeal was the effect of the doctor’s invocation of his Fifth Amendment right not to incriminate himself.
In criminal proceedings, a defendant’s invocation of his Fifth Amendment privilege cannot be used against him. Juries are instructed in criminal cases that they cannot draw any inference from a defendant’s refusal to testify. Indeed, jury selection in a criminal case often focuses on ensuring a jury can and will follow this important safeguard.
But the issues are less cut and dried in the civil and administrative contexts. Generally in civil cases, invocation of the Fifth Amendment results in an adverse inference against the invoker. See Baxter v. Palmigiano, 425 U.S. 308 (1976), and its progeny. To be sure, as warned in the concurring opinion in Omulepu, this is an inference only. It must be combined with other evidence for a sustainable result and cannot serve as the sole basis for a verdict or decision. But the inference is a powerful one nonetheless.
In Omulepu, the doctor claimed no such inference should have been permitted in his license revocation proceeding. The Florida appeals court disagreed, and noting the existence of other evidence against the doctor, deemed the adverse inference both proper and probative.
Omulepu serves as a reminder to doctors facing administrative hearings and board suspensions, and lawyers counseling them, to factor carefully the pros and cons of an invocation of the Fifth Amendment. Often, the overarching concerns leading a doctor to invoke his right are simply too great, no matter the adverse inference or its consequences. But at the margins, there may be reasons to take 5 before taking the Fifth, and game out the consequences first.

References: § 3729
 § 3733
 § 809
 § 809
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