Posts in Healthcare.
DOJ Broadly Applies New Kickback Law Beyond Its Original Opioid-Related Purpose

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 ...

Paycheck Protection Program and Health Care Enhancement Act

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 ...

CMS Expands the Accelerated and Advance Payment Program in Response to COVID-19

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 ...
Providers Permitted to Use Video Chat Applications During COVID-19 Pandemic

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 ...

Posted in COVID-19, Healthcare
Supporting Businesses in the Wake of the COVID-19 Outbreak

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 ...

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Is It the End of Yaqub for Hearing Officer Selection?

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 ...

California Health Care Entities Required to Report Patient Allegations of Sexual Abuse or Misconduct

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 ...

Death Certificate Project: A Dragnet!

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.

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 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 ...

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 ...

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 ...

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.

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).[1] 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.

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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