Health

Monkeypox vax outages & bureaucracy impedes healthcare providers – Los Angeles Blade

LOS ANGELES – Frustrations are mounting as the campaign to vaccinate people against infection of the monkeypox virus is derailed by a critical supply shortage of vaccine doses with added bureaucratic obstacles in getting financial reimbursement to the healthcare providers and clinics dispensing the vaccine.

The Los Angeles County Department of Public Health has nearly exhausted its limited supplies of the JYNNEOS and is anticipating resupply, but has paused its County-wide pre-registration link on its website, putting off scheduling new vaccine appointments.

In one notable example, Public Health’s Monkeypox Vaccination Pop-Up Clinic at the West Hollywood Library exhausted its supply of the vaccine on Friday and ceased operations. According to a press release from West Hollywood city officials, more doses of vaccine are anticipated to be delivered by the federal government in the coming days, on a date to be determined. Once supply is reestablished, then operations will resume for the Pop-Up Clinic.

Exacerbating the crisis, the Centers for Disease Control and Prevention on Friday reported that the number of confirmed cases of the monkeypox virus has doubled in the past two weeks escalating to 11,177.

In Los Angeles County, the County Health Department said that the county’s monkeypox profile is similar to the national case load increase as the disease spreads.

Complicating the issue, in an action taken earlier this week, Michelle Baass, the Director
of the California Department of Health Care Services, (DHCS) announced that Medi-Cal will only reimburse Federally Qualified Health Centers (FQHCs) for monkeypox vaccine administration when provided during a face-to-face visit with a provider.

Reacting to Baass’ decision, a group of 17 healthcare providers for the LGBTQ community in California sent a letter to Director Baass expressing deep concerns regarding the seemingly arbitrary move, which ran counter to the history of state efforts during the coronavirus pandemic.

In the letter [embedded below] the signatories representing the 17 organizations stated:

This decision will significantly hamper the ability of FQHCs to respond to the monkeypox outbreak with the speed and urgency it requires and flies in the face of Governor Newsom’s declared State of Emergency.

As health care providers who serve a significant percentage of low-income LGBTQ+ Californians, we believe this decision is a flagrant example of institutionalized homophobia and we urge the department to reverse course immediately. Monkeypox vaccine administration by FQHCs should be reimbursed in the same way as COVID-19 vaccines.”

The letter also stated:

Regrettably, DHCS’ announcement this week will only make it harder for many of our most
vulnerable LGBTQ+ Medi-Cal patients to be vaccinated. In the FQHC setting, monkeypox
vaccines are generally administered outside of a primary care visit by a non-billable provider.
This allows us to vaccinate a significantly greater number of patients on a daily basis
.

Forcing Medi-Cal patients to have a face-to-face visit with a primary care provider will dramatically slow our current vaccination effort and make it even harder to control the current outbreak. In the time it takes for one individual to have their vitals taken and engage in a face-to-face visit with a primary care provider, FQHCs have the ability to vaccinate 15-20 people. DHCS’ policy makes absolutely no sense from a public health perspective and it screams of discrimination.

Anthony Cava, a spokesman for the California Department of Health Care Services, responded to the Blade’s inquiry over the facts of the letter laid out by the Healthcare provider signatories. However Cava ignored the implications of homophobia and discrimination specified in the letter:

“In response to the monkeypox public health emergency, the Department of Health Care Services (DHCS) appreciates the tremendous effort, focus, and compassion that our clinic partners are bringing to the important work of combatting this virus in their communities. Their hard work and dedication make them critical partners in our response.

DHCS is committed to working with the Centers for Medicare & Medicaid Services (CMS) to respond to monkeypox. DHCS will broadly seek federal approval to reimburse vaccine administration and applicable laboratory testing at 100 percent of the Medicare rate, once established. As part of this request, DHCS will seek federal approval to reimburse Federally Qualified Health Centers (FQHC), and similarly situated clinics that are paid an all-inclusive rate, the vaccine administration fee for vaccine-only visits, consistent with how we are reimbursing for COVID-19 vaccine-only visits. The requested federal approvals will also include reimbursement for vaccine administration performed by non-clinic providers.

At this time, DHCS has not yet received federal guidance regarding reimbursement policies for the administration of the monkeypox vaccine. However, DHCS has communicated with CMS about the urgent need for clarity. Pending the release of such guidance, we informed FQHC providers that we will reimburse them for care provided, which may include the administration of the vaccine if it is done as part of a clinic visit that includes addressing this virus.”

Aaron Fox, the Director of Government Relations for the Los Angeles LGBT Center responded to the DHCS statement:

“Our community cannot wait for DHCS and CMS to continue talking. We must have action on this yesterday and we are in a Public Health crisis and government bureaucracy and inaction is unacceptable and will only result in increased suffering in our community,” Fox told the Blade in a phone call late Friday.

Fox added that his perception of the government response is that while the Biden-Administration and California have declared a Public Health Emergency, in terms of immediate action taken thus far it is little more than saying, “oh look there’s a house on fire,” but neglecting to dial 911 and get the fire dept rolling.

The Blade also had a conversation by phone late Friday with Jim Mangia, President and CEO of St. John’s Community Health, a network of community clinics in the greater Los Angeles region:

“While I applaud the spirit of the DHCS response, however, spirit alone will not stop this outbreak. DHCS has the power to make decisions about reimbursement rates and services allowable under Medi-Cal so they can set an interim rate for monkey-pox administration at the same rate it was set under COVID-19. I’ll note though that it took DHCS over a year to reimburse clinics for the COVID-19 community clinic programs. We urge them to do the right thing now before its too late.”

At a federal level, this last week on Tuesday, as part of a decision by Secretary of Health & Human Services Xavier Becerra to issue a determination under Section 564 of the Federal Food, Drug and Cosmetic Act to justify emergency use authorization of vaccines, the FDA also ordered a new vaccine approach.

This would change injections of the JYNNEOS vaccine from the subcutaneous route (delivery of the vaccine under the fat layer underneath the skin) to the intradermal route (delivery of the vaccine into the layer of skin just underneath the top layer).

This would allow for healthcare providers to squeeze five doses out of what used to be just one dose, which the FDA said should increase the number of vaccine doses in the national stockpile from 441,000 to more than 2.2 million.

In a letter first obtained by the Washington Post and later by the Blade, [embedded below] Paul Chaplin the President & CEO of Bavarian Nordic A/S, the sole manufacturer of the JYNNEOS Monkeypox vaccine expressed grave misgivings over HHS Secretary Becerra’s plan to dilute the dosage.

“Bavarian Nordic (BN) is dedicated to assisting Governments around the globe to control the current monkeypox outbreak and is fully supportive of dose-sparing approaches, such as delaying the second vaccination. However, we do have some reservations on the ID approach, due to the very limited safety data available,” Chaplin wrote.

Addressing both the reimbursement issues raised by the community clinic networks as well as the supply chain issues, California State Senator Scott Wiener told the Blade in an email,

“The Administration has been a strong partner in our effort to fight monkeypox, and we’re working closely and collaboratively to ensure our response is as effective as possible. I’m confident we’ll be able to resolve this issue.”

Wiener (D-San Francisco) was appointed by California Senate President Pro Tem Toni Atkins (D-San Diego) to chair the newly-formed State Senate Select Committee on Monkeypox. Also appointed as members of the committee are Senators Susan Eggman (D-Stockton), John Laird (D-Santa Cruz), Rosilicie Ochoa Bogh (R-Yucaipa), Lena Gonzalez (D-Long Beach), and Richard Pan (D-Sacramento).

LADPH reported Friday that the total Monkeypox / Orthopox Confirmed Cases were 797 which
included Long Beach and Pasadena
which have separate independent health departments.

Los Angeles County (excl. Long Beach and Pasadena) 753
Long Beach 36
Pasadena 8

Long Beach data as of August 11, 2022 at 12:00 AM.
Pasadena data as of August 10, 2022 at 5:30 PM.

CDC Monkeypox data table for August 12, 2022, 11,177 total cases:

Location Cases
Alabama 30
Alaska 2
Arizona 170
Arkansas 15
California 1,945
Colorado 111
Connecticut 59
Delaware 8
District Of Columbia 328
Florida 1,085
Georgia 851
Hawaii 12
Idaho 9
Illinois 771
Indiana 78
Iowa 15
Kansas 3
Kentucky 11
Louisiana 103
Maine 3
Maryland 275
Massachusetts 202
Michigan 92
Minnesota 66
Mississippi 11
Missouri 20
Montana 2
Nebraska 15
Nevada 74
New Hampshire 15
New Jersey 293
New Mexico 16
New York 2,295
North Carolina 138
North Dakota 2
Ohio 89
Oklahoma 12
Oregon 95
Pennsylvania 298
Puerto Rico 48
Rhode Island 31
South Carolina 60
South Dakota 2
Tennessee 67
Texas 815
Utah 69
Vermont 2
Virginia 175
Washington 251
West Virginia 4
Wisconsin 31
Wyoming 0