Tag: 2021 News

A new study from the Workers Compensation Research Institute examines the effects of must-access prescription drug monitoring programs (PDMPs) and recent regulations limiting the duration of initial opioid prescriptions on various outcomes for workers with work-related injuries.

“The policies examined were part of an extensive effort by stakeholders at local, state, and national levels to address potential excessive opioid prescribing and opioid abuse,” said John Ruser, president and CEO of WCRI. “Must-access PDMPs reduced the amount of opioids prescribed to workers without changing the likelihood that workers had any opioid prescriptions.”

The study, Effects of Opioid-Related Policies on Opioid Utilization, Nature of Medical Care, and Duration of Disability, explores how policies limiting access to opioid prescriptions contributed to changes in opioid utilization and how they altered other medical care related to the management of pain. The study estimates the effects of state-level opioid policies by comparing outcomes in states that adopted the policies relative to states that did not, while accounting for other factors that could have influenced changes in opioid utilization and the other outcomes studied.

In California, the prescription drug monitoring program is called Controlled Substance Utilization Review and Evaluation System (CURES). CURES is a database of Schedule II, Schedule III, Schedule IV and Schedule V controlled substance prescriptions dispensed in California. Section 11165.4 of the Health and Safety Code, sets forth the requirements for mandatory consultation of CURES.

The following are among the study’s findings:

– – Must-access PDMPs reduced the amount of opioids prescribed by 12 percent in the first year.
– – Regulations limiting duration of initial opioid prescriptions resulted in a 19 percent decrease in the amount of opioids among claims with opioids.
– – For most injuries, there was little evidence that workers increased the use of other types of care due to must-access PDMPs. However, for neurologic spine pain cases, the policies resulted in an increase in the number of non-opioid pain medications and an increase in whether workers had interventional pain management services.
– – Must-access PDMPs and limits on initial prescriptions had little impact on the duration of temporary disability benefits captured within 12 months after an injury.

The analysis includes information for workers injured between October 1, 2009, and March 31, 2018, in 33 states: Alabama, Arizona, Arkansas, California, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Jersey, New Mexico, New York, North Carolina, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, and Wisconsin. These states represent 85 percent of benefits paid in 2017.

The authors of this study are David Neumark and Bogdan Savych. To learn more about this study or to download a copy, visit https://www.wcrinet.org/reports/effects-of-opioid-related-policies-on-opioid-utilization-nature-of-medical-care-and-duration-of-disability.

Three years ago, pharma giant Pfizer paid $24 million to settle federal allegations that it was paying kickbacks and inflating sales by reimbursing Medicare patients for out-of-pocket medication costs.

By making prohibitively expensive medicine essentially free for patients, the company induced them to use Pfizer drugs even as the price of one of those medicines, covered by Medicare and Medicaid, soared 44% to $225,000 a year, the Justice Department alleged.

Now, Kaiser Health News reports that Pfizer is suing the federal authorities to legalize essentially the same practice it was accused of three years ago – a fighting response to a federal crackdown that has resulted in a dozen drug companies being accused of similar practices.

A Pfizer win could cost taxpayers billions of dollars and erase an important control on pharma marketing after decades of regulatory erosion and soaring drug prices, say health policy analysts. A federal judge’s ruling is expected any day.

“If this is legal for Pfizer, Pfizer will not be the only pharmaceutical company to use this, and there will effectively be a gold rush,” government lawyer Jacob Lillywhite said in oral arguments last month.

Pfizer’s legal argument “is aggressive,” said Chris Robertson, a professor of health law at Boston University. “But I think they’ve got such a political tailwind behind them” because of pocketbook pain over prescription medicine – even though it’s caused by pharma manufacturers. Pfizer’s message, “‘We’re just trying to help people afford their drugs,’ is pretty attractive,” he said.

That’s not all that’s working in Pfizer’s favor. Courts and regulations have been moving pharma’s way since the Food and Drug Administration allowed limited TV drug ads in the 1980s. Other companies of all kinds also have gained free speech rights allowing aggressive marketing and political influence that would have been unthinkable decades ago, legal scholars say.

Among other court arguments, Pfizer initially claimed that current regulation violates its speech protections under the First Amendment, essentially saying it should be allowed to communicate freely with third-party charities to direct patient assistance.

“It’s infuriating to realize that, as outlandish as they seem, these types of claims are finding a good deal of traction before many courts,” said Michelle Mello, a professor of law and medicine at Stanford University. “Drug companies are surely aware that the judicial trend has been toward more expansive recognition of commercial speech rights.”

Pfizer’s lawsuit, in the Southern District of New York, seeks a judge’s permission to directly reimburse patient expenses for two of its heart-failure drugs each costing $225,000 a year. An outside administrator would use Pfizer contributions to cover Medicare copays, deductibles and coinsurance for those drugs, which otherwise would cost patients about $13,000 a year.

Letting pharma companies put money directly into patients’ pockets to pay for their own expensive medicines “does induce people to get a specific product” instead of shopping for a cheaper or more effective alternative, said Stacie Dusetzina, an associate professor of health policy at Vanderbilt University. “It’s kind of the definition of a kickback.”

Government rule-makers have warned against such payments since the launch of Medicare’s Part D drug benefit in 2006. Drug companies routinely help privately insured patients with cost sharing through coupons and other means, but private carriers can negotiate the overall price.

Because Congress gave Medicare no control over prescription drug prices, having patients share at least part of the cost is the only economic force guarding against unlimited price hikes and industry profits at taxpayer expense.

At the same time, however, regulators have allowed the industry to help patients with copays by routing money through outside charities – but only as long as the charities are “bona fide, independent” organizations that don’t match drugmaker money with specific drugs.

Several charities have blatantly violated that rule in recent years by colluding with pharma companies to subsidize particular drugs, the Justice Department has alleged. A dozen companies have paid more than $1 billion to settle allegations of kickback violations.

The Labor Commissioner’s Office cited three El Super grocery stores in Southern California for failing to provide or delaying supplemental paid sick leave (SPSL) or other benefits to 95 workers impacted by COVID-19. Some of the workers were forced to work while sick, others were told to apply for unemployment while quarantining or in isolation, while others waited months to be paid.

The citations were issued to Bodega Latina Corporation, a Delaware corporation doing business as El Super with 52 stores in California. The following locations in Los Angeles and San Bernardino counties were cited:

– – 1100 W Slauson Avenue, Los Angeles 90044
– – 10721 Atlantic Avenue, Lynwood 90262
– – 14590 Bear Valley Road # 28, Victorville 92395

The 2021 SPSL, which went into effect on March 29 and is retroactive to January 1, 2021, requires that California workers are provided up to two weeks of supplemental paid sick leave if they are affected by COVID-19. Among the key updates in the legislation, leave time also applies to attending a COVID-19 vaccine appointment and recovering from symptoms related to the vaccine.

The law is in effect until September 30, 2021. Small businesses employing 25 or fewer workers are exempt from the law but may offer supplemental paid sick leave and receive a federal tax credit, if eligible.

The Labor Commissioner’s Office opened an investigation on September 9, 2020 after receiving complaints from workers and a referral from the United Food and Commercial Workers International Union representing grocery store workers.

The investigators determined the employer did not consistently inform workers of their rights to SPSL if impacted by COVID-19. In some instances, sick workers were told to come to work until they received their test results even when they had COVID-19 symptoms. To cover isolation time, workers were in some cases told to apply for unemployment or disability. Moreover, many were denied time off to isolate, even though members of their household had tested positive. Some workers were never paid for their time off due to COVID-19.

The citations include $114,741.67 in wages, damages and interest for failing to provide leave under 2020 COVID-19 SPSL for food sector workers (Labor Code § 248), and $14,894.66 in wages, damages and interest for failing to provide leave under 2021 COVID-19 SPSL for employers with 26 or more employees (Labor Code § 248.2). In addition, $318,200 was assessed in penalties for nonpayment or late payment of SPSL (Labor Code § 246(n)).

Anyone who currently works or has worked at El Super who believes their employer refused to provide paid sick leave or COVID-19 supplemental paid sick leave as required by law is encouraged to call the Labor Commissioner’s Office confidential Paid Sick Leave Hotline at (855-526-7775) and leave their contact information. All workers can also call the Labor Commissioner’s Office to ask questions or get more information on how to file a wage claim for paid sick leave at 833-LCO-INFO (833-526-4636).

The Centers for Disease Control and Prevention (CDC) is set on Tuesday to recommend masks for vaccinated people indoors under certain circumstances.

“Federal officials met on Sunday night to review new evidence that may have prompted the reversal,” the report continued. “The new guidance would mark a sharp turnabout from the agency’s position since May that vaccinated people do not need to wear masks in most indoor spaces.

New cases of COVID-19 are popping up in San Francisco and elsewhere in the Bay Area in what local media is calling “clearly a fourth wave of the pandemic”, and everyone is clearly anxious and exhausted.

The latest surge in new cases arrived swiftly over the last two weeks, with the numbers in San Francisco still fairly low in the first days of July. The city was averaging 12.6 new cases per day in the month of June, and that rose to an average of 39 per day in the week after the July Fourth holiday. Now, SF’s seven-day average, as of Sunday (with a couple of days of delay in the health department’s reporting of numbers), was 147 new cases per day. 218 new infections were tallied in SF on Sunday alone, with 196 the previous day, which compares to days in mid-January when we were in the midst of the winter surge. July 20 also saw 215 new cases.

There has not been a day with over 200 new cases in San Francisco since the first week of February.

The number of hospitalized COVID patients has also risen sharply in SF in the last two weeks, rising from 24 on July 1 to 61 as of Saturday, according to state data.

UCSF’s Dr. Bob Wachter tweeted a lengthy thread Sunday about the current surge and the precautions he plans to take. He notes that everything they are seeing at UCSF points to the ongoing efficacy of the vaccines, but now 77% of cases they are seeing through routine testing of many patients are among the vaccinated, the chances of encountering the virus in public are much higher in SF now than a month ago. Based on internal data about asymptomatic cases, Wachter says you now have a 1 in 50 chance of encountering an asymptomatic COVID infection while out in the city, compared to about 1 in 1000 back in June.

California Gov. Gavin Newsom announced Monday that his state will be the first in the nation to impose a vaccine mandate on state employees and healthcare workers, requiring they show proof of vaccination or submit to regular tests.

California will also be requiring health care settings to verify that workers are fully vaccinated or tested regularly. Unvaccinated workers will be subject to at least weekly COVID-19 testing and will be required to wear appropriate PPE. This requirement also applies to high-risk congregate settings like adult and senior residential facilities, homeless shelters and jails.

The new policy for state workers will take effect August 2 and testing will be phased in over the next few weeks. The new policy for health care workers and congregate facilities will take effect on August 9, and health care facilities will have until August 23 to come into full compliance.

Interface Rehab, headquartered and operating in Orange County, has agreed to pay $2 million to resolve allegations that it violated the False Claims Act by causing the submission of claims to Medicare for rehabilitation therapy services that were not reasonable or necessary.

The settlement resolves allegations that, from January 1, 2006, through October 10, 2014, the Placentia-based Interface knowingly submitted or caused the submission of false claims for medically unreasonable and unnecessary “Ultra High” levels of rehabilitation therapy for Medicare Part A residents at 11 Skilled Nursing Facilities.

These facilities include Colonial Care Center, Covina Rehabilitation Center, Crenshaw Nursing Home, Green Acres Lodge, Imperial Care Center, Laurel Convalescent Hospital, Live Oak Rehabilitation Center, Longwood Manor Convalescent Hospital, Monterey Care Center, San Gabriel Convalescent Center, and Whittier Pacific Care Center.

In July 2020, the Department of Justice announced that Longwood Management Corporation and 27 affiliated skilled nursing facilities agreed to pay $16.7 million to the United States to resolve allegations that they violated the False Claims Act by submitting false claims to Medicare for rehabilitation therapy services that were not reasonable or necessary.

This newly announced  settlement resolves Interface’s role in that alleged conduct.

During the relevant time period, Medicare reimbursed skilled nursing facilities at a daily rate that reflected the skilled therapy and nursing needs of qualifying patients. The greater the patient’s needs, the higher the level of Medicare reimbursement. The highest level of Medicare reimbursement for skilled nursing facilities was for “Ultra High” therapy patients, who required a minimum of 720 minutes of skilled therapy from two therapy disciplines (e.g., physical, occupational, or speech therapy), one of which had to be provided five days a week.

The United States contends that Interface pressured therapists to increase the amount of therapy provided to patients in order to meet pre-planned targets for Medicare revenue. These alleged targets could only be achieved by billing for a high percentage of patients at the “Ultra High” level without regard to patients’ individualized needs.

This civil settlement includes the resolution of claims brought under the qui tam or whistleblower provisions of the False Claims Act by Keith Pennetti, a former Director of Rehab at Interface. Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. Mr. Pennetti, will receive $360,000 of the settlement proceeds. The qui tam case is captioned United States ex rel. Pennetti v. Interface Rehab, et al., No. CV-14-4133 (C.D. Cal.).

The claims resolved by the settlement are allegations only and there has been no determination of liability.