The Health Law Ticker

COVID-19 accelerated the trend of physician employment with hospitals, with recent data showing that nearly 70 percent of physicians are employed by hospitals or hospital-affiliated foundations or groups.  While physician integration improves quality of care and clinical efficiency, it also blurs the separation of responsibilities between the medical staff and the employer.  This can create headaches for stakeholders who want to address physician performance issues. … 

California’s Department of Health Care Services (DHCS) is in the final stages of establishing new Medical Loss Ratio (MLR) requirements in Medi-Cal Managed Care. Most significantly, the guidelines specify that the MLR program, which previously applied to Medi-Cal managed care plans, will now also apply to certain of their subcontractors, including risk-bearing providers. … 

A recent California First District Court of Appeal (“Court”) decision, Futterman v. Kaiser Foundation Health Plan, Inc., (“Futterman”) has shed light on potential liabilities for noncompliance with the State’s mental health parity requirements.[1]

As background, the COVID-19 pandemic served as a catalyst for increasing already soaring behavioral health care demand, by intensifying mental health and substance use conditions across the country. In a 2020 survey by the California Health Care Foundation, Californians ranked mental health treatment as their top ...

May 11, 2023 marked a milestone in the pandemic response with the expiration of the federal COVID-19 Public Health Emergency (PHE). The expiration of the PHE marks an end to the wide-reaching efforts undertaken by the federal government through emergency declarations, congressional and regulatory actions that provided flexibilities for the healthcare industry to ensure continuous delivery of health services during the PHE. As the Centers for Medicare & Medicaid Services (CMS) explained, while some of these changes are extended or made permanent, others are not. Medicare ...

A recent survey found that the average wait time for a new patient to see a physician in 15 of the largest cities in the U.S. was 26 days, up from 24.1 days in 2017. Timely access to health care providers has long been an issue, but appears to be worsening in certain geographies and provider types. Until recently, timely access to care was regulated at the state level; however, in April, the Centers for Medicare & Medicaid Services (CMS) unveiled its proposed rule to address the issue. The Notice of Proposed Rulemaking Managed Care Access, Finance, and Quality (CMS-2439-P) (NPRM) only ...

Parties in peer review hearings can present a wide range of relevant evidence, regardless of its admissibility in a court of law.  But California has passed a new “apology law” that modifies that standard, erecting a potential hurdle for medical staffs to admit relevant evidence against practitioners in peer review hearings.

Under California law, statements, writings, or benevolent gestures expressing sympathy or a general sense of benevolence relating to the pain, suffering, or death of a person involved in an accident are inadmissible in civil trials.  (Evid. Code, § 1160.)  ...

It’s no secret that patients from marginalized groups experience lower quality health care.  Acknowledging its role in closing the health care disparity gap, the Joint Commission recently announced new and revised requirements to reduce health care disparities in accredited facilities.  For medical staffs, the new accreditation standard provides an opportunity to lead the fight against health care disparities.

Medical literature over the past twenty years confirms the persistence of health care disparities.  In August 2021, the Journal of the American Medical Association ...

Given California’s shortage of primary care providers, nurse practitioners (“NPs”) are increasingly being asked to fill gaps in provider coverage.  With that background, Governor Newsom signed Assembly Bill 890 (“AB 890”) into law in 2020.  AB 890 allows NPs to practice with expanded independence under certain conditions.  Although nearly two years have passed since AB 890 was enacted, regulatory and legislative delay have prevented full implementation of the law.

But that’s expected to change soon.  The Board of Registered Nursing anticipates the law will be fully ...

As healthcare grows increasingly complex, delivery structures continue to evolve.  A popular arrangement is the “Friendly PC” model, where large medical groups are backed by private equity or health system investment and administrative support.  But courts and lawmakers have become concerned that certain Friendly PC arrangements encroach on physician autonomy and violate the century-old prohibition on the corporate practice of medicine (“CPOM”).  A recent lawsuit—American Academy of Emergency Medicine Physician Group, Inc. v. Envision Healthcare Corporation ...

For various reasons, a medical group may decide that it is time to sell their practice. This could be due to reduced reimbursements, increased operational complexities or the desire to “cash out” and retire. When considering a sale, practice leadership should take the following steps to ensure maximum benefit to the physicians in the practice …

As the COVID-19 vaccine rollout continues, and the rate of newly recorded infections is starting to decline, many California counties are moving to less restrictive tiers and lifting restrictions applicable to the business environment. A hot topic for many employers has been developing COVID-19 protocols and vaccine requirements for employees returning to corporate office buildings. (See “Can a Healthcare Provider Require Employees to Take a COVID-19 Vaccine?” for protocol guidelines.) Some healthcare businesses that utilize both traditional office space and medical ...

Congress and the Biden Administration are grappling with an economic stimulus bill that will touch many segments of American life, including health care, if it passes in the Senate. This has many clients wondering what impact the Biden Administration will have on the healthcare sector from a regulatory perspective. Early indications point to a focus on four issues that continue to resound: the Affordable Care Act (“ACA”), COVID-19-related regulatory relief, lowering prescription drug prices and restricting the occurrence of surprise billing … 

In response to public health restrictions ordered by county health departments and the resulting disruption of local business, a number of California cities are exploring whether or not to create their own health departments. While city health departments were common in California during the 1800s and early 1900s, most cities deferred this governmental function to the better-equipped county … 

Faced with an ongoing public health emergency that threatens to overload healthcare systems, many states, including California, have developed or revisited their crisis care guidelines to address a potential COVID-19 patient surge. Many of these provide a framework, guided by ethical principles and a commitment to treating patients with equity, for hospitals, county health departments and healthcare providers to plan for the potential allocation of critical care resources (such as ventilators) should they become scarce … 

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 ...

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), partially invalidating healthcare meal waivers, was incorrect.

California Labor Code section 512(a) requires that two meal periods be provided for any ...

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 12^th 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.