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 ...
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 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 ...
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 ...
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 ...
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 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.
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