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 ...
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 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.
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) requires that two meal periods be provided for any employee working shifts longer than 12 hours. However, Industrial Welfare Commission (IWC) Wage Order No. 5 carves out an exception to this requirement for employees in the healthcare industry. The Wage Order permits healthcare employees to waive one of their two meal periods on shifts longer than 8 hours even when their shift exceeds twelve hours.
In Gerard I, the Court found that IWC Wage Order No. 5 was partially invalid to the extent it authorized second meal break waivers by healthcare workers on shifts longer than 12 hours. Thus, Gerard I invalidated these meal period waivers. In response to the uncertainty created by Gerard I, Governor Brown signed SB 327 as an emergency measure on October 5, 2015, effective immediately. Although SB 327 confirmed that employees in the healthcare industry who worked shifts longer than eight hours could voluntarily waive their right to one of their two meal periods, even where shifts lasted longer than 12 hours, it only affected meal period waivers entered into on or after October 5, 2015. Now, as a result of Gerard II, healthcare employers in California will not face retroactive liability if they used such waivers prior to October 5, 2015.
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 Health Care Act (AHCA) was introduced in the U.S. House of Representatives to repeal and replace key provisions of the Affordable Care Act (ACA) and make significant changes to federal funding for Medicaid. On Friday, March 24, House Speaker Paul Ryan pulled the bill before a vote. In the aftermath of the bill’s withdrawal, President Trump predicted that if it were left in place, ObamaCare would explode. As recently as Sunday, April 2, however, the President tweeted that talks of repeal and replace of the ACA were ongoing and would continue until a deal was struck. On Tuesday, April 4, House Speaker Paul Ryan said Republican lawmakers are having productive talks on a new healthcare reform bill.
This on again, off again, action to attack the ACA leaves a great deal of uncertainty for healthcare providers. That uncertainty is compounded by regulatory action that will affect the ACA in ways less visible to the public. Apparently, Secretary Price is well aware of HHS' options to make regulatory changes. According to the Chicago Tribune, he remarked during the House Appropriations Committee hearing on his agency’s proposed budget that "[f]ourteen hundred and forty-two times the ACA said 'the secretary shall' or 'the secretary may.'
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 15 complaints took longer than 48 months to resolve, six of which included allegations of patient harm resulting from a nurse’s actions.
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 also result in the imposition of civil monetary penalties, government program exclusion, and liability under the federal False Claims Act. The U.S. Department of Health and Human Services (HHS) has the authority, however, to protect certain provider arrangements and payment practices under the AKS. To that end, HHS has established safe harbors in various areas. While compliance with a safe harbor is not mandatory, healthcare providers and others may voluntarily seek to comply with safe harbors so that they may have substantial assurance that their business practices do not violate the AKS.
A New Safe Harbor
On January 20, 2017, a new safe harbor became available for local transportation services furnished by healthcare providers to Medicare and Medicaid beneficiaries.  The safe harbor protects an offer of free or discounted local transportation services when paid for by an eligible entity. An eligible entity may be a direct provider of healthcare services or one that arranges for the provision of healthcare services to patients, such as a health plan or clinically integrated network. The definition of an eligible entity excludes organizations that primarily supply healthcare items rather than services, such as a durable medical equipment suppliers or pharmacies. However, entities that primarily provide services, but also provide items, such as a hospital, may provide patients with transportation to the hospital for items or services provided by the hospital (such as for obtaining items at the hospital’s on-site pharmacy).
The safe harbor is available for two types of transportation. First, the safe harbor protects an offer to provide transportation of an established patient to or from an eligible entity for medically necessary items or services. An established patient is a person who has contacted the eligible entity to schedule an appointment or had a previous appointment with the eligible entity furnishing the transportation.
Second, the safe harbor protects certain types of shuttle services that are generally available to the public, as well as patients on a non-discriminatory basis.
(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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