On October 24, 2018, Congress passed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the “SUPPORT Act”), two sections of which constitute the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”). EKRA was codified at 18 U.S.C. § 220.
Similar to the Anti-Kickback Statute, EKRA was enacted to address abusive payment arrangements but intended for the context of opioid epidemic treatment and recovery efforts. Specifically, EKRA prohibits the knowing and willful (1) solicitation or receipt of ...
California Governor Gavin Newsom’s March 30th Executive Order authorized the Department of Consumer Affairs to issue waivers of certain laws and regulations pertaining to healthcare licensees. On April 14th, the Department of Consumer Affairs issued Waiver Order 20-04, waiving certain key restrictions on physician assistants’ (“PAs’”) supervision.
The waiver order “only applies if” a PA moves to a hospital or practice setting “to assist with the COVID-19 response”; or, if no supervising physician is available to supervise the PA pursuant to a practice ...
At the request of the Medical Board of California, on April 17, 2020, the Office of the Attorney General issued California Opinion of the Attorney General No. 15-301 (“Opinion”), to formally address the meaning of the term “effective date” in Business and Professions Code section 805. 805 reports are the potentially career-changing reports filed with the Medical Board when corrective action is taken by a peer review body such as a hospital’s medical staff or a medical group to restrict or terminate a physician’s clinical privileges or employment for medical ...
On April 21, 2020, the United States Senate passed the Paycheck Protection Program and Health Care Enhancement Act (the Act). The House is expected to pass the Act and send it to the President on April 23, 2020. Broadly speaking, the Act amends the CARES Act to provide additional funding for the Paycheck Protection Program, hospitals and providers, and includes funding for coronavirus testing.
The Act provides an additional $75 billion on top of the $100 billion appropriated in the CARES Act for the Public Health and Social Services Emergency Fund of the Department of Health and Human ...
On March 28, 2020, the Centers for Medicare & Medicaid Services (“CMS”) announced that the agency would provide relief to Medicare providers and suppliers by expanding the Accelerated and Advance Payment Program for the duration of the COVID-19 public health emergency. According to CMS’ guidance, to qualify for accelerated or advance payments, the provider or supplier must:
- Have billed Medicare for claims within the prior 180 days
- Not be in bankruptcy
- Not be under active medical review or program integrity investigation
- Not have any outstanding delinquent Medicare ...
Well, not exactly. However, in an expansion of regulatory oversight, the Department of Managed Health Care (DMHC) finalized a new rule last year broadening the scope of “person[s]” required to obtain a license under the Knox-Keene Act. The new rule, 28 CCR Section 1300.49, is likely the most significant policy development in California managed care oversight since the enactment of laws governing risk bearing organizations in the late 1990s. Absent legislative or further regulatory action, any entity accepting any amount of global risk in exchange for a prepaid or periodic ...
On March 5th, the Department of Managed Health Care (DMHC) issued its first COVID-19 related All-Plan Letter (APL 20-006) regarding screening and testing. The DMHC directed all full service commercial and Medi-Cal health care service plans to immediately reduce cost-sharing to zero for all medically necessary screening and testing for COVID-19. Of note, the APL directed that health plans “ensure” provider networks are adequate to handle an increase in the need for healthcare services, including offering access to out of network services as COVID-19 cases increase. The ...
Healthcare regulatory bodies have responded to the challenges of the coronavirus by relaxing standards with which hospitals must comply. Among them, the Joint Commission (“TJC”) and DNV GL, an international accredited registrar and classification society, have issued guidance for hospitals that addresses concerns regarding the timeliness of reappointments during the declared national emergency related to COVID-19.
According to a FAQ posted under TJC’s Emergency Management Standards, TJC will permit hospitals to grant an automatic extension of the two-year ...
Many medical staffs are wondering whether they may conduct remote peer review committee meetings in the interest of supporting social distancing efforts during the COVID-19 pandemic. While it is certainly reasonable to do so, the medical staff must ensure that they have appropriate safeguards in place prior to conducting such meetings. Below we have provided the answer to some questions that may arise when deciding whether to conduct peer review meetings remotely.
Do the governing documents already allow for meetings to be conducted by telephone or video?
Medical staffs should ...
Recognizing the need to empower healthcare providers to reach those most at risk during the COVID-19 pandemic, the Department of Health and Human Services’ Office for Civil Rights recently issued a notification announcing that it will not impose penalties for noncompliance with HIPAA Rules against those healthcare entities who utilize video and voice applications to provide telehealth services.
During this national emergency, covered healthcare providers can use any non-public facing application to communicate with patients, such as Apple FaceTime, Facebook Messenger ...
In response to the outbreak of COVID-19, we are closely monitoring guidance issued by local, state and federal authorities, as well as information distributed by the Centers for Disease Control and Prevention and the World Health Organization. We are dedicated to helping clients address business disruptions, anticipate potential challenges and mitigate risk associated with irregular operations. We are available to assist in a number of core areas that may impact public agencies and businesses in this rapidly changing environment. Please visit our COVID-19 Response Team page ...
The start-up segment of our healthcare regulatory practice is focused on companies bringing digital health tools to market. As part of the efforts of the U.S. Food and Drug Administration (“FDA” or the “agency”) to clarify its regulatory stance on digital health tools, the agency released a revised guidance in 2019 entitled, Policy for Device Software Functions and Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff (the “Guidance”) ...
For more than 15 years, the process of selecting a hearing officer for a medical staff peer review proceeding has been strongly influenced by the decision in Yaqub v. Salinas Valley Memorial Healthcare System 122 Cal. App. 4th 474 (2004). That decision held that a hearing officer in a peer review proceeding was disqualified for a financial bias based upon the hearing officer's “long–standing and continuous relationship" with the hospital, which created a “possible temptation" to favor the hospital.
The court disqualified the hearing officer despite the fact that “there ...
In anticipation of its November Board meeting this past week, the Medical Board released its Medical Board Staff Report along with a long-awaited draft of the enabling regulations for its Physician Health and Wellness Program.
While the re-establishment of a Physician Health and Wellness Program is a positive development, the new Program is structured in a way which fails to encourage physicians with substance abuse problems to enter the Program voluntarily at an early stage of their addiction ...
As of January 1, 2020, when a patient (or their representative) submits a written allegation of sexual abuse or sexual misconduct to a health care entity, that entity must report the allegation to the appropriate state licensing agency (e.g., the Medical Board of California) within 15 days of receipt. (SB 425, codified at Cal. Bus. & Prof. Code Section 805.8) After making its way through the state legislature with little to no opposition from state lawmakers, California Governor Gavin Newsom signed this bill into law on October 12. The purpose of the bill was to not only accelerate the process in which state licensing boards receive notification about these serious allegations, but also to expand the types of entities that must report these events ...
The Medical Board of California (“MBC”) began this project in 2013 when it required coroners to inform it of deaths resulting from opioids. The influx of coroners’ reports triggered an intense enforcement effort by the MBC to mine the data in the CA Department of Justice’s Controlled Substance Utilization Review and Evaluation System (“CURES”) to identify physicians who prescribed for the persons identified in death certificates. The MBC has conducted a veritable deluge of formal investigations of physicians and has filed an unprecedented number of accusations based on this single source.
The U.S. Supreme Court is now in its summer recess and we anecdotally have heard of Justice “sightings” in Europe and beyond. This last session of the Court addressed many issues capturing both the political and popular imagination. Less headline-grabbing and relatively modest in length (at only nine pages) was Justice Clarence Thomas’ opinion for a unanimous Court in Cochise Consultancy, Inc. et al. v. U.S. ex rel. Hunt. (587 U.S. ____ (2019)) It directly impacts our healthcare compliance practice here at Nossaman by interpreting the statute of limitations for a False Claims Act (“FCA”) case so as to stretch it as long as possible.
On July 22, 2019, the California Supreme Court issued its long-awaited opinion in Wilson v. CNN.1 The primary question before the court concerned the application of the anti-SLAPP statute, Civil Procedure Code Section 425.16, to employment, discrimination, and retaliation claims. The factual scenario before the court involved a journalist who alleged that his employer, CNN, denied him promotions, gave him unfavorable assignments, and ultimately fired him for unlawful discriminatory and retaliatory reasons.2 The employer responded by contending that the journalist was ...
On May 7, 2019, the California Supreme Court heard oral arguments in Wilson v. Cable News Network, Inc., et al., where plaintiff was a producer at CNN who sued the media giant for employment discrimination, retaliation, wrongful termination, and defamation after he was terminated for alleged plagiarism. Wilson is of particular importance to the healthcare community, including hospitals, medical staffs, peer review committees, and practitioners, because it will impact the application of anti-SLAPP Special Motions to Strike under Civil Procedure Code Section 425.16 in suits ...
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 ...
Effective January 1, 2019, Health & Safety Code Sections 11161.5, 11162.1, and 11165 were amended to, among other things, provide 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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
This is the first installment of a two-part series on the Bipartisan Budget Act. Part II will discuss the Bipartisan Budget Act’s effect on the federal Stark Law.
Prior to adjourning for spring recess, Congress passed and the President signed into law on March 23, 2018, omnibus appropriations legislation that funds the government for the remainder of the fiscal year – through September 30. As part of the earlier negotiations to reach the budget deal, Congress passed and the President signed into law on February 9, 2018, the Bipartisan Budget Act, which included dozens of ...
Unfortunately, 2017 will most likely be remembered as the Year of Sexual Harassment. Notwithstanding that AB 1825 mandated harassment prevention training in California in 2004, the statute was amended to require training on bullying and abusive conduct in 2015 (AB 2053), and recently to require training in 2018 on gender identity, gender expression, and sexual orientation (SB 396), sexual harassment continues to permeate the work place. Given the profound impact sexual harassment has on individuals and workplaces, it is time for change.
As a new year begins, this is an ...
SynerMed, a Southern California-based physician management company, will be shutting down, per an email from its CEO earlier this month. Recently, the company had come under increasing scrutiny by health plans and California state regulators, including an investigation by the Department of Managed Health Care.
According to the company-wide email, audits conducted by health plans had found several system and control failures within medical management and other departments. Additionally, the California Department of Managed Health Care’s investigation has been publicly ...
Last Thursday, a jury in federal district court in St. Louis handed down a verdict in a False Claims Act (FCA) case that presents a laundry list of the challenges which can arise in a FCA case. This one includes kickback allegations, Stark issues, both state and federal claims, individual liability, civil-criminal cooperation, a criminal indictment (later dropped), and even family law. The defendants are neurologist, Dr. Sonjay Fonn, and his fiancee of nine years, Deborah Seeger, as well as their respective medical practice and medical device distributorship.
The verdict found ...
On January, 1, 2018, The Joint Commission’s (TJC) new and revised pain assessment and management standards go into effect for TJC accredited hospitals. The changes to the standards stem from a review commenced by The Joint Commission in 2016 to bring the preceding accreditation standards into alignment with leading practices in pain assessment and management, and the safe use of opioids. In light of these standards, hospitals and their medical staffs should review their current policies, protocols, and procedures to ensure their practices comply with the new TJC requirements.
When Covered Entities or Business Associates or their counsel analyze whether a particular disclosure of Protected Health Information (or PHI, as defined in HIPAA) is permissible, they should be sure also to analyze whether the disclosure complies with HIPAA’s Minimum Necessary Rule (MNR), which is oft forgot. This issue arises when disclosing PHI in response to subpoenas, which HIPAA permits as long as the disclosing party receives satisfactory assurances that the requesting party has made reasonable efforts to obtain a protective order or to notify the individual(s) who ...
On September 21, 2017, the Medical Board of California adopted new regulations related to the training of midwife assistants, the administration of midwife assistant training, and the requirements for approved, midwife assistant certifying organizations. The Board took this action to implement and interpret Senate Bill 408 (2015), which added new requirements and prohibitions to the Licensed Midwifery Practice Act of 1993 under Business & Professions Code § 2516.5.
SCOPE OF PRACTICE
Business and Professions Code § 2516.5(a)(1) defines midwife assistant as:
A person, who may ...
A new California law (AB 72) limits the amount that out-of-network surgeons and other health care professionals may bill patients for covered non-emergency services provided at a contracted facility, such as an ambulatory surgery center. California’s surprise medical bill law went into effect on July 1, 2017. It is intended to prevent a consumer from receiving an unexpected medical bill from a non-contracted provider as follows:
- A patient who is enrolled (Enrollee);
- In a health care service plan or health insurance policy (Plan);
- Receives health care services covered by the ...
Recently, the Medical Board of California circulated an open letter, known as a Prescriber Guidance Letter to all practitioners in California who prescribe opiates. The letter was authored by a statewide workgroup on Prescription Opioid Misuse and Overdose Prevention. The workgroup includes the Medical Board of California, the Board of Pharmacy, the California Department of Public Health, the DEA, DMV, California Department of Justice, California Health and Human Services, California Society of Addition Medicine, and California Healthcare Foundation, among others.
On May 10, 2017, the U.S. Health and Human Services Department Office for Civil Rights (OCR) announced an agreement whereby Memorial Hermann Health System (MHHS) will pay a $2.4 million penalty for releasing a patient’s name in a press release. According to the resolution agreement, in September 2015, a patient at an MHHS clinic presented an allegedly fraudulent identification card to office staff. The staff notified law enforcement and the patient was arrested. Although notification to law enforcement did not violate the HIPAA rules, it wa a violation to include the patient’s ...
In a rare move, the California Court of Appeal reversed itself and validated a California hospital’s policy of allowing healthcare workers to waive an otherwise mandatory second meal period on shifts longer than 12 hours. In reversing itself, the California Court of Appeal in Gerard v. Orange Coast Memorial Medical Center (Gerard II) held that its previous decision in Gerard v. Orange Coast Memorial Medical Center (Gerard I) [see our prior discussion re Gerard I here], partially invalidating healthcare meal waivers, was incorrect.
California Labor Code section 512(a)
A proposed rule intended to stabilize the individual and small group insurance markets was issued on February 17, 2017, only a week after the Senate confirmed Tom Price as the Secretary of the U.S. Health and Human Services Department (HHS). Although the proposed rule is intended to stabilize these markets, it may make it more difficult for individuals to obtain and maintain health insurance coverage, thereby reducing the number of people who are insured.
This is a turbulent time for American healthcare. Within weeks after the publication of the proposed rule, the American ...
The California Board of Registered Nursing (BRN) received a negative evaluation of its enforcement program in the most recent sunset review. The sunset review included a performance audit by the California State Auditor due to complaints received about the BRN’s enforcement process.
31 out of the 40 investigated consumer complaints between January 1, 2013 and June 30, 2016, were not resolved within the 18-month goal set by Consumer Affairs, potentially placing patients at additional risk. 15 of those 31 delinquent complaints took longer than 36 months to resolve. Seven of those ...
The Anti-Kickback Statute
Those in the business of providing healthcare services to Medicare and Medicaid beneficiaries are all too familiar with the federal Anti-kickback Statute (AKS). Among other dreadful sanctions, it imposes criminal penalties on those individuals or entities that knowingly and willfully offer, pay, solicit, or receive remuneration in order to induce or reward the referral of business reimbursable under federal healthcare programs. A violation of the AKS is a felony punishable by fines of up to $25,000 and imprisonment for up to five years. An offense may ...
(Updated March 11, 2017) On February 3, 2017, the Medical Board of California (MBC) published the much-anticipated 12th Edition of its Manual of Model Disciplinary Orders and Disciplinary Guidelines (Guidelines). Drafts of this latest edition had been slugging through the approval process since mid-2015.
The most notable modification is to Standard Condition #33 (Non-practice While On Probation). Under the 11th Edition, the MBC defined nonpractice as any period of time respondent is not practicing medicine in California…for at least 40 hours in a calendar month in direct ...
On January 19, 2017, the Federal Trade Commission announced a settlement which would resolve allegations that competing ophthalmologists violated federal antitrust laws when they refused to negotiate contracts with MCS Advantage, Inc. (MCS), a Medicare Advantage Plan, and Eye Management of Puerto Rico (Eye Management), MCS’s network administrator.
According to the complaint, the charges arise from an arrangement between Eye Management and MCS entered into in April, 2014. Eye Management agreed to create and manage a network of ophthalmologists to provide services to MCS enrollees and to do so at a cost savings to MCS. Eye Management planned to replace MCS’s existing contract with each individual ophthalmologist with a new contract between Eye Management and the ophthalmologist at a lower reimbursement rate. In early June 2014, Eye Management sent a proposed contract to every ophthalmologist contracted with MCS at the time. These contracts offered payments at rates that were about 10% lower, on average, than the rates under the existing contracts between MCS and each ophthalmologist.
There may be no noticeable difference between a hospital patient occupying a bed as an inpatient or one in observation status. Yet, state and federal legislators have been concerned that the difference can have important consequences for the patient. Observation care is considered by Medicare to be an outpatient service. Patients classified as outpatients in the hospital may fail to achieve a three-day inpatient stay to qualify for subsequent Medicare coverage for skilled nursing facility care. Patients in observation status may also have higher co-payments and charges for doctors’ fees and hospital services, as well as drugs.
Federal Law. The Medicare Outpatient Observation Notice (MOON) was developed to inform all Medicare beneficiaries when they are receiving observation services and are not an inpatient of the hospital. The MOON is mandated by the Notice of Observation Treatment and Implication for Care Eligibility Act (NOTICE Act), enacted in 2015. All hospitals and critical access hospitals (CAHs) are required to provide the MOON beginning no later than March 8, 2017.
On January 9, 2017, the U.S. Department of Health and Human Services, Office of Civil Rights (OCR) announced the first HIPAA enforcement action against a health care provider for failing to make a timely report of a breach of unsecured protected health information (PHI). Presence Health (Presence) agreed to pay $475,000 and implement a corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Breach Notification Rule.
The HIPAA Breach Notification Rule, 45 CFR §§ 164.400-414, requires HIPAA covered entities and ...
As the clock struck midnight on New Year’s Eve, a number of new California laws took effect. Here are three that California hospital executives need to know:
- Notice of Observation Status (SB 1076)
When a patient is being cared for in an inpatient unit of a hospital (or in an observation unit) the hospital must provide the patient with a written notice when the patient is in observation status. The notice must inform the patient that the observation care is being provided on an outpatient basis and that this may affect the patient’s health care coverage reimbursement. There are also ...
Our Health Law Ticker is a one-stop resource for everything new and noteworthy in healthcare law. We cover recent developments in healthcare legislation, healthcare reform, Medicare/Medicaid, managed care, litigation, regulatory compliance, HIPAA, privacy, peer review, medical staffs and general business operations for healthcare companies and licensed healthcare professionals.
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