MSSNY eNews: April 28, 2021 – Department of Health on Guidance Johnson & Johnson Vaccine
NYS DOH Guidance Regarding Use of the Johnson & Johnson COVID-19 Vaccine
Following a thorough safety review, including two meetings of the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP), the U.S. Food and Drug Administration (FDA) and the CDC have determined that the recommended pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the U.S. should be lifted and use of the vaccine should resume.
ACIP voted to reaffirm its original, pre-pause recommendation that “the Janssen COVID-19 vaccine is recommended for persons 18 years of age and older in the U.S. population under the FDA’s Emergency Use Authorization” without any limitations by age, sex or other risk factors.
PLEASE REVIEW FOR IMPORTANT DETAILS: FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review. Key points from the FDA and CDC regarding this vaccine following a 10-day pause include:
- Use of the Janssen COVID-19 Vaccine should be resumed in the United States.
- The FDA and CDC have confidence that this vaccine is safe and effective in preventing COVID-19.
- The FDA has determined that the available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.
- At this time, the available data suggest that the chance of thrombosis-thrombocytopenia syndrome (TTS) occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk.
The FDA and Janssen have agreed on a warning about thrombosis and thrombocytopenia which will be added to the Janssen COVID-19 vaccine’s Emergency Use Authorization (EUA), and the CDC has created a handout for vaccine recipients about this adverse event.
Health care providers administering the vaccine and vaccine recipients or caregivers should review the Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Fact Sheet for Recipients and Caregivers, which have been revised to include information about the risk of this syndrome, which has occurred in a very small number of people who have received the Janssen COVID-19 Vaccine.
The Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Fact Sheet for Recipients and Caregivers, have been revised to include information about the risk of this syndrome, which has occurred in a very small number of people who have received the Janssen COVID-19 Vaccine. These new documents MUST be used and are attached and linked above. Please DISCARD any previous versions.
If you currently have Janssen (Johnson & Johnson) COVID-19 vaccine in stock, you may begin to use it immediately. NYS expects to receive notification from the CDC of a small allocation of this vaccine on Tuesday to be ordered and shipped to providers next week. For providers enrolled in the New York State (outside of NYC) COVID-19 vaccination program, please submit a weekly planning request by 5:00 PM on Monday, April 26 if you are interested in being considered to receive an allocation of this vaccine next week.
- ACIP Meeting Agenda April 23, 2021 (cdc.gov)
- ACIP April 23, 2021 Presentation Slides | Immunization Practices | CDC
April 26 Statements from Governor Cuomo And New York State Health Commissioner Dr. Howard Zucker Regarding Resuming Johnson & Johnson Vaccinations
Statement from Governor Andrew M. Cuomo:
“World-renowned public health experts from the federal government and our own independent state task force have reviewed the data and reaffirmed that the use of the Johnson & Johnson vaccine can resume. The state of New York will resume administration of this vaccine at all of our state-run sites effective immediately. The vaccine is the weapon that will win the war against COVID and allow everyone to resume normalcy, and we have three proven vaccines at our disposal. I urge every New Yorker to take whichever one is available to them first. The sooner we all get vaccinated, the sooner we can put the long COVID nightmare behind us once and for all.”
Statement from State Health Commissioner Dr. Howard Zucker:
“Yesterday evening, following a thorough safety review, the CDC and FDA lifted the recommended pause on the COVID-19 Johnson & Johnson vaccine and said that the United States can resume the use of the vaccine for adults, 18 years of age and older. Following discussions with New York State’s Clinical Advisory Task Force and Governor Cuomo, I recommend that New York State accept the federal recommendations and resume Johnson & Johnson vaccinations effective immediately. “The data has shown the vaccine’s known benefits far outweigh the potential and extremely rare risks, but we urge anyone with questions about the COVID-19 vaccines to speak with their healthcare provider.
We will continue to communicate regular updates and guidance from the federal government to providers and the general public about the Johnson & Johnson vaccine and all vaccines on the market.We encourage all New Yorkers to get whichever vaccine is available to them, as quickly as possible, so we can finally defeat this virus and continue our path towards fully reopening our communities and economy.”
Impact of Pandemic on Spending and Use of Medicare Physician Services
A recent report from the AMA summarized impacts of the COVID-19 pandemic on the spending and use of Medicare physician services through the first half of 2020. That report found that spending declined as much as 57% in April of 2020. Key findings include:
- The recovery in use of Medicare physician services continued but spending was still 8% less than expected at the end of September 2020.
- In total, spending from the start of the pandemic through September was $11.5 billion or 16% below expected.
- Telehealth accounted for 5.2% of Medicare physician spending from July to September of 2020, down from a peak of over 16% of spending in April 2020.
- Use of telehealth continues to be largely concentrated in a handful of service categories including established patient office visits, telephone calls, and mental health services.
Northwell Cardiologist Named American Heart Association’s 2021 Physician of the Year
The American Heart Association has named Stacey E. Rosen, MD, a cardiologist with Northwell Health for 26 years, as Physician of the Year, the organization’s highest honor given to a practicing cardiologist who has made outstanding achievements in the field of cardiology. Dr. Rosen is senior vice president for the Katz Institute for Women’s Health, where she oversees the development and coordination of a comprehensive and integrated approach to women’s health services at Northwell Health.
In this role her mission is focused primarily on the elimination of health care disparities through comprehensive clinical programs, gender-based research, community partnerships and education. As a practicing cardiologist, Dr. Rosen previously served as chief of cardiology at LIJ Medical Center and associate chair of cardiology at Northwell Health.
Seven-Day Case Average Down 74.9 Percent from Pandemic Peak and 12 Other COVID Stats from CDC
One-third of U.S. adults were fully vaccinated against COVID-19 as of April 22, and more than half had received at least one dose, according to the CDC’s COVID Data Tracker Weekly Review published April 23.
Thirteen statistics to know:
1. The U.S. had administered more than 218.9 million total vaccine doses as of April 22.
2. About 135.8 million people have received at least one dose — representing 40.9 percent of the total U.S. population, and more than 89.2 million people have gotten both doses, about 26.9 percent of the population.
3. The seven-day average number of COVID-19 vaccines administered daily was 2.9 million as of April 15, a 12 percent decrease from the previous week’s average.
4. The nation’s current seven-day case average is 62,596, a 10.1 percent decrease from the previous week’s average.
5. The seven-day case average is down 74.9 percent from the pandemic’s peak seven-day average of 249,436 on Jan. 8.
6. Based on an analysis of specimens collected through March 27, the CDC estimates 44.7 percent of U.S. COVID-19 cases are caused by the U.K. variant B.1.1.7.
7. The P.1 variant first found in Brazil is estimated to account for 1.5 percent of all cases, and the B.1.351 variant first identified in South Africa comprises 0.7 percent of all cases.
8. The nation’s seven-day average test volume for the week of April 9-15 was 1.2 million, up 1.6 percent from the prior week’s average.
9. The seven-day average for percent positivity from tests is 5.2 percent, down 5.4 percent from the previous week.
New hospital admissions
10. The current seven-day hospitalization average for April 14-20 is 5,631, up 1.6 percent from the previous week’s average.
11. The seven-day hospitalization average marks a 65.9 percent decrease from the peak seven-day average of 16,521 admissions reported Jan. 9.
12. The current seven-day death average is 691, down 3.7 percent from the previous week’s average. Some historical deaths have been excluded from these counts, the CDC said.
13. Overall, the seven-day death average has decreased 80 percent since peaking at 3,457 deaths Jan. 13.
Guidance for New York State COVID-19 Vaccination Program
All individuals that reside, study, or work in New York 16 years of age and older are eligible to be vaccinated in New York State. All providers enrolled in the NYS vaccine program may vaccinate any eligible individual. Effective April 19, Executive Order 202.102 eliminated the enhanced civil penalty for failure of a provider to administer its allocated COVID-19 vaccine within seven days of receipt. The elimination of this enhanced penalty is intended to give all providers flexibility in scheduling vaccination appointments if they need more than seven days to use a vaccine allocation. This flexibility is being given to providers at a time where the State has vaccinated more than half the adult population with at least one dose and demand for the vaccine begins to steady.
While the enhanced civil penalty has been eliminated, performance, throughput, effort, and effective administration of vaccines by providers will continue to be key factors in making future vaccine allocation decisions, along with equity, access, and regional positivity rates. All vaccine providers in New York State, including those located in the City of New York and those participating in federal programs, must follow New York State Department of Health (NYSDOH) guidance and directives, including the requirement to report to the NYS COVID-Vaccine Tracker on Mondays and Thursdays.
Do You Know an Outstanding Physician? MSSNY Now Accepting Nominations for the Albion O. Bernstein, MD Award
“…the physician, surgeon or scientist who shall have made the most widely beneficial discovery or developed the most useful method in medicine, surgery or in the prevention of disease in the twelve months prior to December 2020.”
This award was endowed by the late Morris J. Bernstein in memory of his son, a physician who died in an accident while answering a hospital call in November, 1940.
The $2,000 award will be presented to the recipient during a MSSNY Council Meeting.
Nominations must be submitted on an official application form and must include the nominator’s narrative description of the significance of the candidate’s achievements as well as the candidate’s curriculum vitae, including a list of publications or other contributions.
Deadline for applications is June 9, 2021. To request an application, please contact:
Committee on Continuing Medical Education
Miriam Hardin, PhD, Manager, Continuing Medical Education
Medical Society of the State of New York
99 Washington Avenue, Suite 408
Albany, NY 12210
Accelerated and Advanced Payment (AAP) Nettings/Offsets Across Organization Affiliations
CMS has implemented a change to begin netting/offsetting provider money across affiliated provider within the same Tax ID Number and across workloads within a single organization. The CMS change brings consistency to all Medicare contractors regarding netting across organization affiliations.
Definition of Affiliated Providers:
Affiliated providers are providers that share the same Tax ID number across multiple Provider Transaction Access Numbers (PTANs). It’s important to know that CMS policy is recouping based on the Tax ID number rather than the PTAN. CMS instructs contractors to use the Tax ID to get the recoupment of the advanced payment regardless of which PTAN actually received the payment. We are asking you to collaborate with all affiliated providers under one Tax ID number.
If you are part of a group, you did not receive an AAP, and you see the recoupment on your remittance advice; reach out to your other group providers to determine which PTAN received the AAP.
Any or each related provider (same Tax ID) to the PTAN that received the AAP will each offset 25% of the total Remittance Advice (RA) amount. Any affiliate PTANs will offset 25% of their remaining amount on their RA after any regular AR or ERS offsets are made.
If you have additional questions, attend NGSMedicare Part B webinar on April 29, 2021, from 10:00 a.m. to 11:00 a.m. EST.
NYS DOH COVID-19 Update: Thursday, April 29th at 1 – 2 PM
To accommodate the large number of participants, find the webinar streaming via YouTube Live (and available for viewing immediately thereafter) on the NYSDOH COVID website for providers:https://coronavirus.health.ny.gov/weekly-healthcare-provider-update
Audio number and code: 844-512-2950 Access code 1556908#
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Date Posted: 03/23/21 Applications Due: 04/06/21 Vacancy ID: 85272
|Agency||Health, Department of|
|Title||Health Program Director 2 -TBD|
|Occupational Category||Other Professional Careers|
|Bargaining Unit||M/C – Management / Confidential (Unrepresented)|
|Salary Range||From $122092 to $154253 Annually|
|Jurisdictional Class||Non-competitive Class|
Hours Per Week
|Compressed workweek allowed?||No|
|Street Address||CCH; Division of Family Health
Corning Tower, ESP
|Minimum Qualifications||Twelve years of professional level work experience, three of which must have included managerial, decision-making and/or oversight responsibilities for a major health-related program or in the direction of a major administrative function of a large health-related organization. A bachelor’s degree may be substituted for four years of the general professional experience.
Twelve or more years of progressively responsible administrative experience in programs that improve perinatal health, child and/or adolescent health, early care, and learning, and/or sexual violence prevention, including four years of managerial, decision-making, and/or program direction. Seven years of this experience would also include fiscal management, policy making and oversight responsibilities, and statewide supervision of professional level staff. The preferred candidate would be familiar with representing departmental interests and serving as a spokesperson and liaison to Executive staff, and have experience working with other state and federal governmental programs. Experience with second-level professional supervision as well as strong oral and written communication skills is also desired. A master’s degree in an appropriate field may substitute an additional one year of the general professional experience, not to exceed a maximum of five years total allowable educational Please refer to full listing