Medical marijuana growers, labs file lawsuit against 2-lab rule

A new rule in Pennsylvania requiring cannabis growers to use different labs to test their products at the harvesting and final stages is on hold as the case is litigated in Commonwealth Court.

In early March, a group of cannabis growers and labs went to court to block the rule, saying its immediate implementation would have the result of voiding existing contracts and creating other problems.

The plaintiffs in the case are Green Analytics North LLC, doing business as Steep Hill PA; Hanging Gardens LLC; Pennsylvania Medical Solutions LLC; Curaleaf PA LLC; AES Compassionate Care LLC; Standard Farms LLC; and Parea BioSciences LLC.

Harrisburg attorney Judith Cassel, who is among those representing the plaintiffs, explained in an email that the state Department of Health developed temporary regulations for the medical marijuana program in 2017, permitting “each grower/processor to contract with a lab of their choice for testing at both of these stages.”

On March 4, the department released new, permanent regulations, mandating that one laboratory be used to test at the harvest stage and another at the final stage.

In their filing to block the two-lab rule, the plaintiffs argued that it throws a spanner into the existing system, effectively freezing the production and sale of medical cannabis, creating shortages and increased prices.

The permanent rules had been voted on and approved last October by the body that regulates the medical marijuana program in Pennsylvania. One of the reasons given by the state to defend the two-lab rule is it would better protect the public from contaminants.

Asked for a response from the Health Department, a spokesman from its press office released the following statement: “The department does not comment on pending litigation.” Its website did note that the two-lab reg is not being enforced as court action plays out.

The requirement strips “50% of the business away from a lab that previously performed testing for a grower/processor at both stages,” Cassel said. “And grower/processors lose the continuity and cost savings they achieve with using a single lab for both testing stages.”

The extra costs incurred will at least partly be passed on to patients, she said.

“The other potential harm is that production on products could be halted or less safe, which will also lead to negative impacts on patients.”

Cassel, of the firm Hawke McKeon & Sniscak LP, said the Department of Health “admits that there is no problem in Pennsylvania for which this regulation is aimed. And DOH has not justified its implementation of this regulation. In addition to not providing any rationale for the promulgation of this regulation, DOH has not provided any guidance as to its use. In other words, what if these two laboratories get two different results, which is likely since the two laboratories use different processes, different equipment, and different personnel and are testing two completely different products? … DOH doesn’t bother explaining what will happen when the inevitable discrepancies occur.”

She asked: “Will there be a third test required and would all three laboratories get different results? Does the product get destroyed? If the product is getting stalled or destroyed, that will mean less product in the market, which translates to higher prices again.”

The plaintiffs are challenging the rule legally on three counts, Cassel explained: that it is beyond DOH’s enabling statute, the regulation is an abdication of DOH regulatory responsibility, and the regulation violates the Constitution’s (state and federal) contract clause.

Both parties have been ordered by Commonwealth Court to file applications for summary relief. If neither wins, she said, “then the issues will go to full litigation.”

Oral arguments before the full court (en banc) are scheduled for May 10.

Paula Wolf is a freelance writer

Pa. long-term care facilities receive nearly $12 million investment from DOH

To help long-term care facilities build resilience to sustain quality care as the population ages, the Department of Health (DOH) announced plans to distribute approximately $11.7 million in federal Centers for Disease Control (CDC) funding. 

Acting Secretary of Health and Pennsylvania Physician General Dr. Denise Johnson said in a statement the investments will contribute to the long-range success of facilities that care for Pennsylvania’s most vulnerable residents. 

“These funds will be invested in key areas including workforce development, staff retention, and infrastructure developments that support infection prevention control and emergency preparedness.” 

The “Long-Term Care Quality Investment Pilot Request for Applications (RFA)” is open to skilled nursing facilities (SNFs), personal care homes (PCHs), assisted living facilities (ALFs), and intermediate care facilities (ICFs). Facilities must be enrolled by Dec. 9 in the state’s LCT RISE program’s quality improvement work initiative to be eligible to receive funding. 

Philadelphia facilities are not eligible for this funding, as the Philadelphia Department of Public Health received its own funding. The application deadline is 1:30 p.m. on Dec. 31, 2022. Funds are anticipated to be awarded in the second quarter of 2023. 

Long-term care facilities receive sizeable investment from DOH

To help long-term care facilities provide quality care as the population ages, the Department of Health (DOH) announced plans Tuesday to distribute approximately $11.7 million in federal Centers for Disease Control (CDC). 

The “Long-Term Care Quality Investment Pilot RFA” Request for Applications is open to skilled nursing facilities (SNFs), personal care homes (PCHs), assisted living facilities (ALFs), and intermediate care facilities (ICFs). 

“We want to make investments that will contribute to the long-range success of facilities that care for some of our most vulnerable residents,” Acting Secretary of Health and Pennsylvania Physician General Dr. Denise Johnson said. “These funds will be invested in key areas including workforce development, staff retention and infrastructure developments that support infection prevention control and emergency preparedness.” 

Facilities must be enrolled by Dec. 9 in the state’s LTC RISE program’s quality improvement work initiative to be considered eligible to receive funding. The funding deadline is 1:30 p.m. on Dec. 31, 2022. Funds are anticipated to be awarded in the second quarter of 2023.

Department of Health announces proposed rulemaking for Pennsylvania’s long-term care facilities

The Pennsylvania Department of Health (DOH) is holding a public comment period for a package of proposed nursing home regulations for new construction, alterations and renovations of skilled nursing facilities.

If the new rulemaking is approved, the department would adopt the 2018 edition of the Facility Guidelines Institute’s (FGI) Guidelines for Design and Construction of Residential Health, Care and Support Facilities as the minimum standard for alterations, renovations or construction plans.

The guidelines are updated every four years and are considered a gold standard for the planning, designing and construction of health care facilities, according to a bulletin by the DOH.

Facilities would not need to immediately update their facilities to fall in line with the new FGI Guidelines, which the department says would impose an undue burden on Pennsylvania’s long-term care facilities. Instead, the guidelines would only be in effect for facilities performing new alterations, renovations or construction.

“A facility completing new alterations, renovations or construction is already assuming the costs for those alterations, renovations or construction,” wrote the department in the bulletin. “Therefore, requiring compliance with the FGI Guidelines would be considered costs already planned for by the facility, and no different than costs for complying with other physical environment standards, local municipality codes or the like.”

The proposed changes to Pennsylvania’s regulations are the second in a series of five planned waves of regulation updates by the DOH. They are the first changes of their kind to the department’s long-term care nursing facilities regulations since 1999.

In its first proposed rulemaking, the department looked to expand the adoption of a number of federal requirements in order to make the state’s requirements more consistent with what is expected nationally.

To create these regulation updates, the DOH has worked with a long-term care work group (LTC Work Group) consisting of relevant stakeholders from local organizations such as Landis Communities, Leading Age, Pennsylvania Home Care Associations are more.

“The Wolf Administration is looking at long-term care in a comprehensive manner and we are committed to getting the proposed updated regulations through the regulatory review process by the end of 2022,” said Acting Secretary of Health Alison Beam. “Skilled nursing facility regulations have not been updated in nearly 25 years. Given the magnitude and importance of the regulations for more than 72,000 nursing home residents and their families, publishing the proposed updates in a series of separate, smaller packages will allow each section the opportunity for appropriate feedback during the public comment period.”

Nearly half of Pennsylvanians vaccinated, COVID-related hospitalizations down

51.9% of Pennsylvania’s eligible population have received their first dose of the COVID-19 vaccine as of May 7, according to the Centers for Disease Control and Prevention. More than 43% are fully vaccinated.

The state currently ranks fifth in the nation for total doses administered.

The trend in the 14-day moving average of hospitalized patients per day is starting to come down, after peaking at 2,661 patients. The number is slightly below what it was at the height of the spring 2020 peak of 2,751 on May 3, 2020.

There were 2,986 additional positive cases of COVID-19 as of May 7, bringing the statewide total to 1,169,678, the department of health reports. There are 2,047 individuals hospitalized with COVID-19. Of that number, 448 patients are in the intensive care unit. Most of the patients hospitalized are 65 or older, as are most of the deaths.

More data is available here.

Gov. Tom Wolf lifts all COVID restrictions except mask wearing on Memorial Day

Pennsylvania will lift all COVID-19 restrictions except the order to wear a mask in public on Memorial Day, the Wolf administration announced.

The decision to no longer restrict capacity on restaurants, bars or indoor and outdoor gatherings on May 31 was made in partnership with the state’s COVID-19 Vaccine Joint Task Force.

Pennsylvanians will continue to be required to wear masks until 70% of Pennsylvanians age 18 and older are fully vaccinated, according to the commonwealth. Fully vaccinated individuals are not required to wear masks in certain situations, however, according to the Centers for Disease Control and Prevention.  More details on masking for those already vaccinated can be found here.

“As more Pennsylvania adults get vaccinated and guidance from the CDC evolves, we can continue to move forward with our reopening efforts,” said Alison Beam, acting secretary for the Pennsylvania Department of Health in a statement. “I encourage Pennsylvanians to take the critical steps needed to put this pandemic behind us by getting vaccinated, follow through with both doses if you receive the Moderna or Pfizer vaccines, and continue to take steps like masking, frequent hand washing and sanitizing and social distancing.”

The mitigation updates will not prevent municipalities and school districts from ​continuing and implementing stricter mitigation efforts.

For Pennsylvania restaurants and hotels, the news is a relief, according to John Longstreet, president and CEO of the Pennsylvania Restaurant and Lodging Association.

“The PRLA welcomes Governor Wolf’s announcement to loosen mitigation standards as vaccination rates continue to rise and positive cases decline,” Longstreet said. “As a major economic driver throughout the Commonwealth, the hospitality industry needs further support to regain a sense of normalcy to attract its workforce, retain a consistent customer base and meet ever-changing mitigation standards.”

All Pennsylvanians ages 16 and older are eligible to schedule a COVID-19 vaccine. The provider map is available on the Department of Health’s website. Pennsylvanians with questions about the vaccination process can call the Department of Health hotline at 1-877-724-3258.

Senior home restrictions to continue into green phase

Nursing homes, personal care homes and other long-term care providers in the green phase of the state’s reopening plan will continue to have ongoing restrictions for at least 28 days after transitioning to green, according to the Pennsylvania departments of Health and human Services.

The Wolf Administration announced on Friday that it will continue to enforce visitation restrictions on long-term and congregate care facilities to help prevent further outbreaks among Pennsylvania’s most vulnerable populations.

The Department of Health initially issued COVID-19 guidance to facilities on March 18, which included regulations related to visitor limitations and personnel restrictions.

While hospitals in green counties may begin to allow limited visitations, the state plans to continue to enforce regulations at senior care facilities for what could be longer than the initial 28 days announced on Friday, said Teresa Miller, secretary of the Department of Human Services (DOH).

“We must remain vigilant and be deliberate about our actions even as we begin to reopen,” Miller said. “Green does not mean all clear for anyone, and COVID-19 is still a threat, especially for those who are medically fragile and vulnerable. This virus is not gone, and mitigation efforts are still necessary to keep people safe.”

Miller added that that the DOH understands how difficult and isolating the restrictions can be for residents of long-term care facilities and their families and have issued a number of recommendations for families trying to keep in touch with their loved ones.

The department asks facilities to promote that their residents arrange meetings with family and friends through a window or glass door, use software like FaceTime, Skype, Zoom meetings and Facebook Messenger and communicate through phone calls, emails and virtual assistant technology like Amazon’s Alexa or Google Home.

DOH mask mandate allows for homemade masks

A statewide order compelling employers to require all employees and customers to wear masks in their facilities will not be postponed despite a lack of available supplies.

Pennsylvania Health Secretary Dr. Rachel Levine signed the order on April 15. The requirement goes into effect on Sunday. Failure to comply could result in fines and citations.

It is unclear how aggressively the state’s departments will enforce the order. In a phone call with press on Thursday, Gov. Tom Wolf referred to the order as a set of guidelines when asked if the order would be enforced by the Pennsylvania State Police.

“Businesses are responsible for ensuring that customers abide by the protocols pertaining to customers, and the appropriate enforcement agencies are responsible for ensuring that employers abide by the protocols pertaining to employers and employees,” said Elizabeth Rementer, deputy press secretary for the Office of the Governor. “Law enforcement has been tasked with ensuring that businesses are aware that the order exists and notifying businesses that a complaint of noncompliance was received.”

During a press conference on Thursday, Levine said she would not delay the start date past April 19 for any industry.

“We recommend that if someone comes to a retailer or a grocery store and doesn’t have a mask, that they be asked to go back home and get a mask,” Levine said. “If the store has extra masks they can certainly give one and that would be great.”

The Department of Health has since released further guidance on the order, noting that masks can be obtained or made by employers or employees but must be approved by the employer in accordance with department guidelines.

Masks can be non-medical-grade and when masks aren’t available, the department also recommends using a scarf or bandana.

Levine’s order also specifies that if an employee contracts COVID-19, businesses must implement temperature screenings before employees can enter the business prior. When asked what a business should do if they purchase no-contact thermometers that cannot be delivered before Sunday, Levine said they can reach out to the department for support.

Pa. announces continued efforts as cases of coronavirus rise

This weekend, Pennsylvania’s number of positive cases of COVID-19 rose to 63 as the Department of Health found the first positive cases in the midstate.

Positive cases of the coronavirus continue to rise in Pennsylvania, which prompted Governor Tom Wolf to close all Pennsylvania k-12 schools, urge non-essential businesses in Bucks, Chester, Delaware and Montgomery counties to close and order all restaurants in Allegheny and the four previously mentioned counties to close their dine-in facilities.

“Non-essential” businesses include community and recreation centers, spas, casinos, concert venues, shopping malls and more. The state has not yet announced if it will be expanding this guidance to other counties in the commonwealth.

As of Sunday afternoon, the state has 63 confirmed cases of COVID-19. While a majority of cases are based in the regions around Philadelphia, with 24 counts in Montgomery alone, the virus’ effects have now been felt in central Pennsylvania, where five positive cases were found over the weekend.

The state Department of Health also noted on Sunday that it documented its first case in Lehigh County.

In total, there have been 446 patients who have been tested or are in the process of being tested, 205 who tested negative and 183 samples still awaiting processing.

“While we anticipate that there will be more Pennsylvanians with COVID-19 in the coming days and weeks, it is important for residents to know the commonwealth is prepared and to be prepared themselves,” Dr. Levine said.

The state will be announcing more cases this week during its scheduled daily meetings at the capital.