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H1N1 Information:

Click Here to Read the memo from Bob England, MD to providers about H1N1 distribution- Nov. 3, 2009

From: PHPIO – PHSX

Sent: Friday, October 23, 2009 10:14 AM

Subject: UPDATE from Dr. Bob update re: H1N1 vaccine distribution\allocation

October 23, 2009

Dear Colleagues,

I have a lot of information for you this time.  I’ll do a brief vaccine supply update, tell you about our first vaccine events open to the public (but still only for the highest risk groups) that will occur this Saturday, warn you about a potential news story, give you a heads-up about calls that you’ll be getting from us, and tell you how to get info from us as this goes along.

Vaccine Supply

Since I wrote you last week, we received no allocation last Thursday, Friday, or this Monday.  Tuesday and Wednesday this week, we were allowed to order a total of 46,200 doses, as shown in the table below (which shows everything right from the beginning).  We don’t know whether we’ll be able to order any more today, or when this supply chain will become more reliable.

With this latest vaccine, we have finally begun to direct some to family practitioners.  The largest 116 practices (all those who said in their enrollment that they had more than 600 pts in all high-risk categories) have vaccine on the way.  Most of you have only 100 doses coming, although some of the larger practices will receive 200 or 300, all of it in multi-dose vials.

Meanwhile, small additional amounts (averaging ~200 doses each) of multi-dose vial injectable vaccine have gone to hospitals to continue vaccinating health care workers.  We reserved just 300 doses of live attenuated and 300 doses of multi-dose vial vaccine for school nurses and other school health workers.

We will be sending 13,400 doses to pharmacies, primarily for health care workers who don’t work in hospitals.  As soon as it’s in place, we’ll notify the health care community to send one employee to their local retail pharmacy with a Rx for enough doses for the office staff.  Still nothing yet for many private providers, none for our own immunization clinics or WIC clinics, just a dribble for health care workers, and very few of you have been ordered any resupply.

Below is the allocation chart, to date:

We do not receive confirmation of shipment or delivery, but it’s a safe bet that none of what was ordered this week, and not all from last week, have yet been delivered.

Moving forward with public vaccination events

Despite the small supply, we simply must move forward with some public vaccination.  No one without a provider, or anyone whose provider chose not to participate, or anyone, whose provider has not yet been supplied, has yet had any opportunity to be vaccinated.  We had recently allocated vaccine to Mollen Clinics for the first school-based events, and this vaccine arrived faster than most.  Thus, we had vaccine that would potentially sit for more than a week waiting for the first school events, slated to begin November 2.  Adding to those small amounts that some of you have returned adds up to ~51,000 doses of mixed types.

Tomorrow (Saturday, October 24), our Maricopa County Childhood Immunization clinics and our private partners, Mollen Immunization Clinics, CIGNA Healthcare, and Scottsdale HealthCare Osborn Medical Center will be holding numerous small public clinics scattered as broadly across the county as we could arrange.  Mollen Clinics has generously shared their already delivered vaccine supply with the other private partners involved, as well as agreed to host most of these sites themselves.  In addition, they are gambling that we can refill their supply to start the school clinics within a week.  Meanwhile, with less than a day’s notice, CIGNA agreed to use some of their clinic sites and have called in staff who were not scheduled to work.  And Scottsdale Health Care was the first to commit to opening a public clinic despite their limited vaccine supplies.

All told, we’re going to have ~50 sites running with nearly 52,000 doses available, all of it directed toward young children < 5 yrs of age, older children with underlying health conditions, pregnant women, and those living with or caring for infants < 6 mo of age.

Wish us luck.

Anticipated Arizona Republic story

A reporter with the Republic has filed a public records request for the list of all providers in Maricopa County who enrolled to receive vaccine, what you’ve ordered, and what you’ve been allocated.  If you’re not familiar with public records requests, anything we have that is not legally confidential is fair game for the media to request.  I will likely have to release this information later today.

I am well aware that very few of you would be comfortable having that information about your practice made public.  I have had extensive conversations with the reporter about the potential damage that would result from divulging the list.  Most of you ordered only enough for your own patients, and you haven’t yet received enough even for them.  The last thing you need is to have people “doctor shopping,” jamming your phone lines looking for vaccine.  Those of you who chose to prioritize your vaccine to your most vulnerable patients first are to be commended, and you don’t need your other patients calling for vaccine that has already been used up.

I know (believe?) that the reporter understands these issues, and she assures me that she will not publish the entire list in print or on line.  Once the paper has the list, however, they are legally free to use it however they see fit.  The reporter will be calling several of you, probably both those who have received vaccine, and those who have not, seeking quotes about the process so far.  You are, of course, free to say anything you want.

If I exchange any written correspondence with the paper about this, I’ll copy all of you.

Calls from us

Starting next week, you’ll get calls from Maricopa County Research & Reporting, asking how much vaccine you’ve received, how much you’ve used.  For those of you who didn’t complete a provider agreement with the Arizona Dept of Health Services (ADHS), we’ve been receiving the vaccine for you and reshipping it to you.  That means that we’re on the hook for reporting to ADHS the statistics on whom you are vaccinating, so there are a few extra questions for you.  Estimates are perfectly acceptable.

Besides required reporting, we’ll use this to begin restocking some of you as soon as we can.

Getting info from us

I sincerely apologize for the extra headaches that this process has caused you.  We had expected that the supply would have been smoother and made many of your questions moot.  Since that’s not the case, here’s how to get answers from us most efficiently:

Questions re: your vaccine order or other professional questions:  602-747-7111

For your patients to call with general questions:  1-877-764-2670

I am grateful for the continued good will shown by so many of you in this response.  Thank you for helping our community to weather the pandemic.  As always, more info to follow.

–Bob

Bob England, MD, MPH

Director

Maricopa County Dept of Public Health

FDA NEWS RELEASE

For Immediate Release: Oct. 19, 2009

Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Approves Seasonal Influenza Vaccine Fluarix for Pediatric Use

The U.S. Food and Drug Administration today approved use of the seasonal influenza vaccine Fluarix for children ages 3 years to 17 years. Previously, this vaccine, which contains inactivated (killed) influenza A and B viruses, had been approved for use in adults, ages 18 years and older.

The safety and effectiveness of Fluarix for use in children ages 3 years and older is documented by  a U.S. study comparing 2,115 children who received Fluarix with 1,210 children who received Fluzone, a different influenza vaccine already licensed by the FDA for use in children ages 6 months and older. Study results showed that children 3 years and older vaccinated with Fluarix and Fluzone produced similar amounts of antibodies in the blood at levels considered likely to be protective against seasonal influenza.

Fluarix is a seasonal influenza vaccine not intended to protect against the 2009 H1N1 influenza virus.

“This approval of an additional seasonal influenza vaccine for children provides help in protecting them against influenza,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research. “Children are very vulnerable to the influenza virus and are more likely to be hospitalized for associated problems.”

With today’s approval, there are now four companies approved by the FDA to manufacture seasonal influenza vaccine for use in children.

Influenza is far more dangerous than the common cold for children, who often require medical care, especially if they are younger than 5 years. It is best to vaccinate children each fall, but vaccination also can occur in the winter months when influenza season often peaks.

Common adverse events experienced after administration of Fluarix are typical of those for flu shots and include pain, redness, and swelling at the injection site as well as irritability, loss of appetite, and drowsiness.

Because Fluarix contains a small amount of egg protein, it should not be administered to anyone allergic to eggs or egg products.

Fluarix is manufactured by GlaxoSmithKline Biologicals of Dresden, Germany.

For more information:

FDA Web site on Influenza Virus Vaccine Safety and Availability
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm110288.htm

Q & A About H1N1 Vaccine:

My office has received its first shipment of H1N1 Live Attenuated Influenza Vaccine (LAIV).  Should I give these first doses only to high risk patients?

It depends on what you mean by high risk.   LAIV should only be given to healthy people 2 years through 49 years.  LAIV should not be given to people who have underlying medical problems or who are pregnant.  However, you can get the maximal early impact from LAIV by targeting the healthy people who receive LAIV so that the medically high risk patients are also protected.  This would include prioritizing these early doses of  LAIV to healthy people ages 2-49 years old who are household contacts of children under 6 months old, household contacts of pregnant women, close contacts of medically high risk people, children ages 2-4 years old, and health care workers.

If patients have already tested positive for Influenza A by the rapid swab in the office (and since presumably all these infections are currently H1N1), should these patients still get the H1N1 vaccine?

The CDC recommendations are that if you don’t know for sure that it was H1N1 influenza, you should go ahead and eventually give H1N1 vaccine to those patients anyway, just to be on the safe side.  That being said, the ones who recently had documented influenza A infection or influenza-like illnesses have likely had H1N1 infection and would be immune.  Therefore, in the early days of H1N1 vaccine distribution, people who have not had influenza-like illnesses may be more likely to need H1N1 vaccination than those who have had recent influenza-like illnesses.

Can a shot of seasonal influenza vaccine and a nasal spray of H1N1 Live Attenuated Influenza Vaccine (LAIV) be given simultaneously?

Yes.  Most influenza vaccines can be given at the same time.  A seasonal influenza shot and nasal spray H1N1 vaccine can be given simultaneously.  A seasonal influenza nasal spray vaccine and a H1N1 influenza shot can be given simultaneously.  Seasonal and H1N1 influenza shots can also be given simultaneously.  HOWEVER, it is NOT recommended to give both seasonal and H1N1 nasal spray influenza vaccines at the same time.   If both influenza vaccines were to be given in the nasal spray formulation, they should be separated by at least 28 days.

Can a patient get seasonal influenza and/or H1N1 influenza infection twice in the same season?

One would not expect to get 2009 H1N1 influenza infection more than once.  In terms of seasonal influenza, there are three circulating strains:  H1N1 seasonal, H3N2 seasonal, and influenza B…so you could get sick with several different influenza strains in a season.  The H1N1 influenza vaccine does not protect against the strains in the seasonal influenza vaccine, and the seasonal influenza vaccine does not protect against the H1N1 influenza virus.  Therefore, it is important to get both influenza vaccines.

What should I do if I want to give influenza vaccines to infants (6 months and older) or pregnant patients, but the only influenza vaccine that is available is in multidose vials with thimerosal?  Do I have to defer influenza vaccination until I can get thimerosal-free vaccine for them?

CDC says “The risks for severe illness from influenza virus infection are elevated among both young children and pregnant women, and vaccination has been demonstrated to reduce the risk for severe influenza illness and subsequent medical complications. In contrast, no scientifically conclusive evidence has demonstrated harm from exposure to vaccine containing thimerosal preservative. For these reasons, persons recommended to receive TIV may receive any age- and risk factor–appropriate vaccine preparation, depending on availability.”  [MMWR July 31, 2009, P. 18]

Currently 2009 H1N1 influenza is widely circulating.  Arizona has already had thirty deaths from 2009 H1N1 influenza virus; seven of these deaths were in children.  Therefore, physicians can counsel patients that the risks from H1N1 infection are much higher than the possible risks from theoretical and unproven concerns about thimerosal.   This same principle applies for seasonal influenza vaccines.  Thimerosal-containing H1N1 influenza vaccines can be safely offered to any patient aged 6 months and older.

Further references for Information about 2009 Influenza Vaccines

MMWR August 28, 2009. Use of Influenza A (H1N1) 2009 Monovalent Vaccine http://www.cdc.gov/mmwr/PDF/rr/rr5810.pdf

MMWR July 31, 2009.  Prevention and Control of Seasonal Influenza with Vaccines http://www.cdc.gov/mmwr/PDF/rr/rr5808.pdf

Get Paid for H1N1 Vaccine Admin:

• UnitedHealthcare is asking physicians to submit the CPT vaccine administration code appropriate to patient age, route of administration and number of vaccines administered. In addition, physicians must submit CPT code 90663 for the vaccine itself and indicate an amount of $0.01. The federal government is providing the vaccine free of charge, but some claims clearinghouse systems will reject CPT codes with a $0 charge.
• CIGNA is asking physicians to bill for the administration of H1N1 flu vaccines using the new G9141 HCPCS code.
• Aetna wants physicians to use age-appropriate CPT codes — 90465-90468 for children or 90471-90474 for adults. Use of the G9141 HCPCS code also is permissible.
• Humana prefers that physicians use the HCPCS G9141 code when filing a claim for administration of the H1N1 vaccine.
• Because of the large number of Blue Cross Blue Shield companies, the AAFP cannot give definitive instructions for these payers. If physicians have questions about H1N1 vaccine administration payment, they should contact their local BCBS plan.
• WellPoint and Wellpoint’s subsidiary, Anthem, have not released instructions to physicians regarding administration of the H1N1 vaccine.
• Medicare wants physicians to bill for administration of the H1N1 vaccine using the HCPCS G9141 code. Payment will be the same as for administration of the seasonal influenza vaccine. More information about CMS’ H1N1 vaccine payments is available in a recent MLN Matters.

New Law Impacts H1N1 Vaccine admin:

A law was passed last year by the Arizona legislature, with the support of the AzAFP and the Arizona Department of Health Services, with a flu pandemic in mind. This new legislation allows physicians to prescribe antimicrobial medication as post exposure prophylaxis to a contact of a person diagnosed with a communicable disease, without conducting a physical examination or having an established doctor-patient relationship. This is a significant tool that can assist family physicians in preventing influenza in family members of those with influenza and should be considered when these family members have conditions that place them at high risk for complications from influenza. The CDC recommends that PEP antiviral medication be considered in these situations. The CDC guidance can be found at: http://www.cdc.gov/h1n1flu/recommendations.htm

A.R.S. 32-1401(27)(ss)(v): Prescribing, dispensing or furnishing a prescription medication or a prescription-only device as defined in section 32-1901 to a person unless the licensee first conducts a physical examination of that person or has previously established a doctor-patient relationship. This subdivision does not apply to: PRESCRIPTIONS WRITTEN OR ANTIMICROBIALS DISPENSED TO A CONTACT AS DEFINED IN SECTION 36-661 WHO IS BELIEVED TO HAVE HAD SIGNIFICANT EXPOSURE RISK AS DEFINED IN SECTION 36-661 WITH ANOTHER PERSON WHO HAS BEEN DIAGNOSED  WITH A COMMUNICABLE DISEASE AS DEFINED IN SECTION 36-661 BY THE PRESCRIBING OR DISPENSING PHYSICIAN.