A health care provider based in Centennial was suspended from providing COVID-19 vaccinations after the state public health department found “multiple occurrences of storage and handling issues” and discovered that the facility was charging some patients a fee, according to the department.

Compliance staff with the Colorado Department of Public Health and Environment identified unaccounted-for doses due to “missing and/or inaccurate documentation,” along with “significant vaccine wastage, which is often a sign of poor inventory management,” said a statement from the Colorado State Joint Information Center, which takes questions for the health department.

The main violations at Health Now Family Practice were the providing of vaccine doses outside of recommended storage conditions, past a vial’s puncture shelf life of 12 hours or past a beyond-use date, the statement to Colorado Community Media said.

The facility had also inadvertently given certain types of vaccine doses to people in the wrong age groups, the joint information center said.

“Upon inspection, Health Now Medical’s records showed two instances of vaccines inadvertently given to inappropriate ages: one 12 year old patient received the Pfizer vaccine formulated for 5-11 year olds, and one 5 year old received the Pfizer vaccine formulated for persons 12 and older,” the statement said. 

The health department also discovered the facility was charging some patients a fee for COVID-19 vaccination, the statement said.

“Collecting an administration fee from patients for COVID-19 vaccine is a violation of the CDC COVID-19 Provider agreement and federal COVID-19 vaccine billing requirements,” the statement said. “Health Now Family Practice was also billing health plans, which is allowable under the CDC provider agreement.”

The health department “has reported these violations of federal billing requirements to the Division of Homeland Security, Office of Inspector General, and Health Now Family Practice may face additional disciplinary actions as a result of their investigation,” the statement added.

Some should be revaccinated, state says

A website for Health Now Family Practice lists an address of 9137 E. Mineral Circle in Centennial. A news release from the health department identified the business as Health Now Medical LLC, operating as Health Now Family Practice.

Due to the storage and handling issues, roughly 68 Pfizer COVID vaccine doses administered at Health Now Family Practice were considered invalid, and the patients that received them need to be revaccinated, according to another news release. 

Asked how many people were vaccinated with those doses, the information center said 48 total patients should be revaccinated.

According to an April 12 news release, Health Now Family Practice was to contact affected patients directly with the following information about revaccination:

• Patients who received one invalid dose at Health Now Family Practice should be revaccinated with one valid dose. They should receive their repeat dose from another COVID vaccine provider as soon as possible.

• Patients who received two invalid doses at Health Now Family Practice should repeat both doses. They should receive their first repeat dose from another COVID vaccine provider as soon as possible.

• For some patients, it may be best to wait eight weeks after the invalid dose before getting revaccinated. Boys and men aged 12 to 39 may be at higher risk of a rare side effect called myocarditis if they get revaccinated before eight weeks have passed.

Talking with a health care provider can help people learn more about their “individual risk factors” and whether it’s best to wait before getting revaccinated, the release said.

Myocarditis is an inflammation of the heart muscle. A recent study found that “the risk for cardiac complications was significantly higher after (COVID-19) infection than after mRNA COVID-19 vaccination for both males and females in all age groups.”

The study looked at cases including myocarditis and another condition called pericarditis.

The study was released in April in the Morbidity and Mortality Weekly Report under the U.S. Department of Health and Human Services. See the study at tinyurl.com/CardiacCOVIDstudy.

See other studies on that topic in Nature Medicine at tinyurl.com/NatureCardiacStudy and from the American Medical Association at tinyurl.com/JAMAcardiacstudy.

“The severity of cases of myocarditis and pericarditis can vary. For the cases reported after mRNA COVID-19 vaccination, most who presented to medical care have responded well to medications and rest and felt better quickly,” the information center’s statement said.

See more information about reported vaccine side effects at tinyurl.com/VaccineSideEffectNumbers.

State oversight role

The state suspended Health Now Family Practice from participation in the federal Centers for Disease Control and Prevention’s COVID-19 Vaccination Program, an April 8 news release said.

The health department suspended the facility for not meeting the standards required by the CDC and the federal Food and Drug Administration, or FDA, for “safe and effective COVID-19 vaccine administration,” the health department said in a news release.

That means Health Now Family Practice may not order or administer COVID vaccines as long as the facility is under suspension. The suspension also prevents it from receiving COVID vaccines from another enrolled vaccine provider, according to the information center.

Health care providers may be reinstated into the COVID vaccination program if they address all compliance issues identified during site visits. Reinstatement into the COVID vaccination program is not guaranteed and “is at the discretion” of the health department, according to the information center.

Health Now Family Practice is an independent private practice with one clinic location, according to the information center.

The health department’s staff conduct oversight on health care providers. To be approved for enrollment as a new COVID vaccine provider, a “virtual enrollment site visit” must be completed, and the health care provider must submit certain documentation, according to the information center.

The health department “also conducts compliance site visits, informal observations, or investigations, in conjunction with local public health agencies periodically and as necessary,” the information center said in the statement.

The health department also suspended Pueblo-based VitalPoint Urgent Care from the COVID vaccination program, effective Nov. 19, according to a news release at the time.