More Time for Serialized Prescription Forms

Effective January 1, 2019, Health & Safety Code Sections 11161.5, 11162.1, and 11165 were amended to, among other things, provided that the Department of Justice implement a system by which prescription forms for controlled substance prescriptions should each have “a uniquely serialized number.”

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 that 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.

Is There A Nurse Practitioner In the House? Doctor Supervision Not Required Under Certain Conditions With New Proposed Legislation

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.

A report by the private-sector California Future Health Workforce Commission1, of which Assemblymember Wood is a member, makes the following statements:

  • 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.


1California Future Health Workforce Commission, Final Report, February 2019
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.

$3.8 Million Awarded to Physician Serves as Important Reminder About Fair Hearing Rights

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 Economy v. Sutter East Bay Hospitals, Sutter Hospital operated a closed anesthesia department pursuant to a contract with East Bay Anesthesiology Medical Group (“East Bay Group”).  The exclusive contract required all physicians providing anesthesia services at the hospital to be employed by East Bay Group.  The contract also permitted the hospital to require East Bay Group to immediately remove from the schedule any of the anesthesiologists who performed “an act or omission that jeopardizes the quality of care provided to [the] hospital’s patients.”

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.

The trial court entered judgment in favor of Dr. Economy, finding that the action taken by the hospital in removing him from the anesthesia schedule was indisputably for a medical disciplinary cause or reason, and constituted a summary suspension of Dr. Economy’s right to exercise his privileges and use the facilities of the hospital.  Dr. Economy received an award $3,867,122 in damages for past and future income, emotional distress, and “tax neutralization.”

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.

The Court of Appeal upheld the trial court’s decision.  Furthermore, the Court of Appeal rejected the hospital’s argument that Dr. Economy had no entitlement to lost wages since he had not shown he would have been exonerated at a peer review hearing.  Relying on a case involving a civil service employment case, the court determined that even if Dr. Economy would not have prevailed, he still would have been “entitled to back pay for the period during which the discipline was invalid.”  (See Skelly v. State Personnel Board (1975) 15 Cal.3d 194, holding that civil service employees held a property interest in the continuation of their employment which is protected by due process.)

Despite siding with the Plaintiff on most issues, the court ruled for the hospital in rejecting Dr. Economy’s claim for attorney fees under Business & Professions Code § 809.9, finding that the hospital’s defense of the litigation could not be found to be “frivolous, unreasonable, without foundation, or in bad faith” as the evidence supported their factual assertions, and the hospital’s argument that it had no duty to prepare an 805 report had “some support.”

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).

Hold the Pickle—and the Meal Break: California Supreme Court Holds That Healthcare Workers May Voluntarily Waive Second Meal Period Even When Shifts Last More Than 12 Hours

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.

Defendant employer argued that such waivers were expressly allowed by Section 11(D) of Industrial Welfare Commission Wage Order No. 5, which creates an exception allowing healthcare employees to voluntarily waive the second meal period on shifts over 12 hours. (Nothing in the Gerard case addressed the first meal period requirement, also set forth in section 512(a), which mandates a meal period of at least 30 minutes for an employee who works more than five hours per day.)

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.

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New California Law Will Require Practitioners to Disclose Probation to Their Patients

On September 19, 2018, Governor Jerry Brown signed into law the “Patient’s Right to Know Act of 2018” (SB 1448), which will require practitioners to notify their patients when they are placed on probation on or after July 1, 2019 for the following offenses:

  • The commission of any act of sexual abuse, misconduct, or relations with a patient or client;
  • Drug or alcohol abuse directly resulting in harm to patients or to the extent that such use impairs the ability of the practitioner to practice safely;
  • Criminal conviction directly involving harm to patient health; or
  • 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.

Avoiding Medical Board Discipline when Prescribing Opiates

Business People Carrying Tips Word - White Background - 3D Rendering

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.

Here are 10 tips to help you avoid Medical Board discipline when prescribing opiates:1

1.  Don’t Prescribe Opiates Unless…

  • The patient has exhausted all reasonable alternatives
  • There is medical indication
    – Recently documented objective evidence of/consistent with patient’s pain complaints
  • You have conducted a comprehensive history, initial exam, imaging, UDT’s, CURES, ORT’s, have a signed pain contract, and have provided informed consent

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.

3.  Use a Team Approach

  • Include other professionals
    – Addictionologist/Pain Psychologist
    – Residential/Inpatient Detox
    – Physiatrist
    – Physical therapist
    – Psychiatrists (for psych medications)
    – Sleep Specialist
  • Document
    – Referrals
    – Patient Declinations/Refusals of Recommended Care or
    – Consultation
    – Communications with other providers
    – Plan of action based upon other providers’ recommendations

4.  Pay Attention to the Red Flags and Take the Following Precautions

  • Use opioid risk tools
  • Use screening questionnaires
  • Train your staff to pick up signs of abuse
  • Correct your staff if they miss a sign
  • Never dismiss calls from pharmacists, or insurance plans with questions about prescriptions
  • Beware of treating one patient differently than you treat all other patients
  • Do not ignore risk factors for history of abuse/addiction
  • Do not excuse failures solely because patient claims are not feasible

5.  Document, Document, Document, Including:

  • Patient questionnaires, pain scores, vitals, patient chief complaints for each visit
  • Make sure to have a pain contract signed & in chart
  • Physical exam for each new complaint
  • Treatment plan and objectives at each visit; document projected end point/re-eval point
  • Description of relief from pain medications on each body part, at each visit
  • Instructions & advisements
  • Beware of templates!

6.  Use CURES When2 …New patient

  • Reason for suspicion
  • Request for early fill
  • Changing medications
  • Patient has new complaint
  • If patient has any compliance issue with pain contract (and you decide not to discharge patient or stop writing prescriptions)
  • Document: Consistent with Pain Contract/ Inconsistent with Pain Contract/Questionable

7.  Conduct Drug Testing on Regular Basis

  • For all new patients
  • Anytime reason for suspicion:
    – Request for early fill
  • Anytime changing medications
  • Anytime patient has new complaint
  • Multiple times per year
    – Quarterly for every patient
  • Minimum 1x/year
  • Document: Consistent with Prescribed Medications/ Inconsistent/Questionable

8.  Only Use Electronic Prescriptions

9.  Audit Your Own Charts

10.  Keep Current on Regulations and News


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.

2 As of October 2, 2018, any physician who prescribes Controlled Substances to a patient will be required to check CURES before the first time and at least quarterly (Health & Safety Code §11165.4)

Mandatory CURES Use Begins October 2, 2018

Blue Pills and Pill Bottle in the shape of a Question Mark.Starting October 2, 2018, health care practitioners authorized to prescribe, order, administer, or furnish a controlled substance must query, or consult, the Controlled Substance Utilization Review and Evaluation System (CURES) database and run a Patient Activity Report (PAR) on each patient the first time the patient is prescribed, ordered, or administered a Schedule II-IV controlled substance. “First time” is defined as the initial occurrence in which a health care practitioner intends to prescribe, order, administer, or furnish a controlled substance to a patient and has not previously prescribed a controlled substance to the patient. (Health and Safety Code (HSC), § 11165.4(a)(1)(B).)

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.

Health care practitioners required to consult CURES include1:

  • Allopathic or Osteopathic Surgeon
  • Certified Nurse Midwife (Furnishing)
  • Dentist
  • Naturopathic Doctor
  • Nurse Practitioner (Furnishing)
  • Optometrist
  • Physician Assistant
  • Podiatrist

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.

Exemptions

A health care practitioner is exempt from consulting the CURES database before prescribing, ordering, administering, or furnishing a controlled substance in any of the following circumstances:

1.  While the patient is admitted to, or during an emergency transfer between a

2.  In the emergency department of a general acute care hospital, and the controlled substance does not exceed a non-refillable seven-day supply.

3.  As part of a patient’s treatment for a surgical procedure, and the controlled substance does not exceed a non-refillable five-day supply when a surgical procedure is performed at a

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.

Take 5 before Taking the Fifth

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.

 

 

 

2018 Bipartisan Budget Act Revises Stark Law Regulations – Part II

This is the second installment of a two-part series on the Bipartisan Budget Act. Part I discussed the Bipartisan Budget Act’s effect on Medicare Advantage health plans.

The Bipartisan Budget Act of 2018 (the “Act”), signed into law on February 9, 2018, contains an amendment that should cause physicians and healthcare providers to take note. Section 50404 of the Act, titled “Modernizing the Application of the Stark Rule under Medicare,” codifies recent Centers for Medicare and Medicaid Services (“CMS”) regulations and corresponding preamble that went into effect on January 1, 2016 (“2016 Final Rule”). These new provisions provide greater authority to the Secretary of Health and Human Services to grant waivers or exceptions under the law.

BRIEF BACKGROUND ON THE STARK LAW

The Stark Law prohibits a physician from referring Medicare patients for certain “designated health services” (“DHS”) to DHS providers if the physician (or an immediate family member) has a direct or indirect financial relationship with the DHS provider, unless one or more exceptions apply to the arrangement. The Stark Law also prohibits DHS providers from submitting claims to Medicare if the service was provided as a result of a prohibited referral.   Additionally, the Stark Law mandates that all entities furnishing services for which payment may be made under Medicare submit information on their reportable financial relationships to CMS or to the OIG.

Over the last few decades, the federal government and many state governments have increasingly scrutinized the financial relationships between health care facilities and physicians who refer patients or business to them.  Such relationships are prone to fraud and abuse because a physician may be more likely to make unnecessary referrals or otherwise over-utilize services if the relationship monetarily incentivizes him or her to do so.  Over-utilization not only results in higher costs to patients and payors, but also may adversely affect patient care.

THE ACT EASES STARK LAW REQUIREMENTS

Previously, arrangements between physicians and providers that were well-structured to comply with the Stark Law’s substantive requirements have nevertheless failed on technicalities—not being written or signed by the parties. With the passing of this Act, Congress aims to ease some of the burdens imposed by these technical requirements and, in turn, lower the instances of over-payments and self-reporting of violations to the government.

Specifically, the Act revised the Stark Law to indicate the following:

  1. The Writing Requirement. The writing requirement of various Stark Law compensation exceptions can be satisfied “by a collection of documents, including contemporaneous documents evidencing the course of conduct between the parties involved.” Previously, CMS had only indicated in a preamble to the 2016 Final Rule that a collection of documents could be relied upon to meet the writing requirement. This was not set forth in regulatory text. Now that this language is in the Stark Law statute, physicians and providers can more comfortably rely on a collection of documents to satisfy the exceptions’ requirements (such as appointment letters, time cards, pay stubs, copies of checks, etc.) to evidence a course of conduct between the parties, rather than formal written contracts.
  2. The Signature Requirement. If parties to an arrangement do not obtain the required signatures before the compensation arrangement is effective, they may do so within 90 consecutive calendar days immediately following the date on which the compensation arrangement became noncompliant (without regard to whether any referrals occur or compensation is paid during such 90-day period) and the compensation arrangement otherwise complies with all criteria of the applicable exception. This 90-day grace period is available for use only once every three years with respect to the same referring physician. This statutory language now aligns with the regulatory language in the 2016 Final Rule.
  3. Holdover Leases for Office Space, Rental of Equipment, and Personal Services Arrangements. Congress additionally offers relief for expired lease and personal services arrangements, providing that they may indefinitely meet the applicable Stark Law exceptions if the immediately preceding arrangement (a) expired after a term of at least one year, (b) met all the requirements of the exception when it expired, (c) continues on the same terms and conditions as the immediately preceding arrangement, and (d) continues to satisfy the conditions of the applicable exception. The corresponding regulatory language was updated in the 2016 Final Rule, which previously only permitted holdovers for up to six months.

Please see Part I of our installment which pertains to Medicare Advantage health plans.

 

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