Tuesday Tidbits

COVID-19 vaccine

Tuesday Tidbits

David Ermer–Congress, COVID-19, COVID-19 vaccine, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

Today the Senate invoked cloture on the compromise FY 2021 continuing resolution (HR 8337) by an 82 to 6 vote. The Senate now is in a position to pass the legislation and send it to the President for signature before the end of this federal government fiscal year, tomorrow September 30.

The Wall Street Journal reports that House Speaker Nancy Pelosi and Treasury Secretary Stephen Mnuchin have resumed discussing a compromise COVID-19 relief bill. Their discussions will continue tomorrow.

Healthcare consulting company WillisTowersWatson released a new white paper about the impact of the COVID-19 public health emergency on healthcare spending in the U.S.

Health care plan sponsors may see an unprecedented decrease in year-over-year medical costs in 2020, as system capacity shifts and fear of contracting COVID-19 in medical settings drives a significant volume of foregone and deferred care. Significant uncertainties remain however, including the course of the pandemic, the availability of effective vaccines and treatments, and changes in the health care delivery system that could impact future health care costs.

Willis Towers Watson has evaluated a set of potential future care utilization scenarios contemplating a variety of patterns of infection and care return. Across our scenarios, 2021 costs to employer plans are expected to be slightly higher (0.5% to 5.0%) than the non-pandemic baseline projection. Nevertheless, when 2020 and 2021 are combined, all scenarios show cost reductions (–2.8% to –3.8%) relative to the non-pandemic baseline. The baseline comparison from which these estimates were developed reflects projected costs for 2020 and 2021 assuming the pandemic never occurred. Employers should consider these scenarios as they budget for and measure the performance of their health care plans in the upcoming year.

Speaking of COVID-19 vaccines, the National Institutes of Health today announced that based on a separate Phase I study, the COVID-19 vaccine being jointly developed by Moderna and NIH had a positive impact on 40 older adult volunteers. This vaccine currently is in the Phase III study with a younger cohort. The separate Phase I study found that “Overall, the researchers found that “the investigational vaccine was well-tolerated in this older age group. Importantly, the immune response to the vaccine seen in older volunteers was comparable to that seen in younger age groups.” NIH is proposing that the Phase III study be expanded to include a senior cohort.

In other tidbits

  • Beckers Hospital Review reports on “13 things to know about Aetna, Anthem, Cigna, Humana and UnitedHealthcare’s virtual care strategies.” The article reminds the FEHBlog that the current end date for the federal government’s COVID-19 public health emergency technically is October 23. In all likelihood HHS will extend the deadline for another ninety days to Inauguration Day.
  • Healthcare Dive reports that “HHS has sent the Office of Management and Budget an interim final rule, called Information Blocking and the ONC Health IT Certification Program: Extension of Compliance Dates and Timeframes in Response to the COVID-19 Public Health Emergency, received on Sept. 17. ONC declined to comment on the rule. But the title implies it will extend dates identified in the sweeping information blocking provisions — notably, the looming November compliance deadline for providers — and dates for the Conditions and Maintenance of Certification provisions requiring EHR platforms to be interoperable.”

Monday Roundup

David Ermer–CDC, COVID-19, COVID-19 testing, COVID-19 vaccine, SCOTUS, Telehealth–
Photo by Sven Read on Unsplash

In COVID-19 vaccine news —

  • The American Hospital Association has a COVID-19 vaccine resources and information website.
  • PharmaManufacturing is reporting that ” Pfizer’s CEO recently stated that the company could be ready to submit data from a late-stage trial of its coronavirus vaccine by the end of October — but experts are urging the company to slow its roll. According to Bloomberg Law, more than 60 bioethicists and researchers have penned a letter asking Pfizer to delay data reporting until November.” Why not let the Food and Drug Administration do its job?

In COVID-19 rapid testing news, HHS announced today a detailed “national distribution plan for the Abbott BinaxNOW Ag Card rapid test to assist Governors’ efforts to continue to safely reopen their states. BinaxNOW is a unique testing option to provide support to K-12 teachers and students, higher education, critical infrastructure, first responders, and other priorities as governors deem fit. The BinaxNOW rapid test – the only U.S. Food and Drug Administration-authorized antigen rapid point-of-care test that does not require an instrument – is easy to use, will produce COVID-19 test results in 15 minutes, and costs $5. * * * The Federal government purchased these Abbott BinaxNOW diagnostic tests on August 27, 2020, to ensure equitable distribution of the first 150 million units – one day after an Emergency Use Authorization (EUA) was issued by the FDA to ensure they would be expeditiously distributed to vulnerable populations as quickly as possible.

In other news —

  • The Centers for Disease Control reported today about COVID-19 trends among school age children in our country. “Since March, 277,285 COVID-19 cases in children have been reported [out of seven million in total]. COVID-19 incidence among adolescents aged 12–17 years was approximately twice that in children aged 5–11 years.”
  • Healio reports on the multiple uses of telehealth beyond acute primary care. “[T]elehealth has been routinely incorporated in specialties such as psychiatry and asthma/allergy care, even prior to the COVID-19 era [‘PC”]. * * * Further, telemedicine allows for triage of patients with COVID-19 symptoms without requiring face-to-face visits to help direct next steps for testing and treatment. Telehealth can be effectively incorporated into oncology care — provided thoughtful and appropriate measures are taken.”
  • There has been a lot of press about the nomination of Judge Amy Coney Barrett to the Supreme Court following the sad occasion of Justice Ruth Bader Ginsburg’s death. It is quite likely that Judge Barrett will be sitting on the Supreme Court when the California v. Texas case is argued on November 10. Speculation is rife about this development and it is truly unfortunate that the Trump Administration is now siding with the States opposing the law’s constitutionality in the California v. Texas case. In the FEHBlog’s opinion, the position against the law’s constitutionality is a weak cup of tea. The FEHBlog is confident that the Supreme Court opted to hear the case to end this litigation in favor of the ACA’s general constitutionality. Congress obviously did not intend to render the ACA unconstitutional by zeroing out the individual mandate. The American Prospect observes

The whole legal argument [against the ACA’s constitutionality] depends on the fact that Republicans used reconciliation to pass the 2017 tax bill through the Senate with a simple majority. Due to the restrictions around reconciliation, Republicans couldn’t technically repeal the mandate in total, instead just lowering the penalty to nothing. The case effectively goes away if Congress either adds back in a penalty (even of just one cent), or just officially repeals the mandate, thereby severing it from the whole health care law.

Trying to bring back a penalty is a terrible option. The mandate is deeply unpopular, and it would be easy for Senate Republicans to oppose that move. What’s more, in the months since the mandate penalty went away, we’ve learned that it wasn’t as necessary to making the Obamacare system work as Democrats insisted in 2009 and 2010. Fully repealing the individual mandate, on the other hand, is an easy fight to win, as well as good policy. It is generally bad to have unenforced laws on the books.

Congress should take this action now by enacting an individual mandate repeal just as it repealed other ACA taxes in 2019. This is not to suggest that Congressional action is the only step that could save the law. But it would short circuit this craziness.

Midweek Update

David Ermer–Congress, COVID-19 testing, COVID-19 vaccine, HIPAA Privacy and Security Rules, Rx coverage–
Photo by Manasvita S on Unsplash

Roll Call informs us that the House of Representatives pass the compromise Fiscal Year 2021 continuing resolution (H.R. 8337) by a wide margin. The bill heads onto the Senate which is expected also to pass the bill before the end of the current fiscal year next Wednesday September 30.

In COVID-19 news —

Johnson & Johnson (J&J) has begun a 60,000-subject phase 3 assessment of its COVID-19 vaccine. The trial will enroll participants in the U.S. and other countries with a high incidence of COVID-19 with a view to generating data to support emergency use authorization early next year. * * * Unlike its rivals, J&J is evaluating the safety and efficacy of a single dose of a COVID-19 vaccine. If the one-dose regimen is successful, J&J could eliminate the logistical complexity and dropouts associated with trying to get people to return for a second shot. A one-shot regimen would also enable J&J to vaccinate 1 billion people each year. Few manufacturers of two-dose regimens can match that figure. * * *

In disclosing the start of the phase 3, J&J also called out the storage requirements of its vaccine. The candidate is expected to be stable for two years at -20°C and for upward of three months in the 2°C to 8°C range used to store many biologics. J&J said the candidate is “compatible with standard vaccine distribution channels and would not require new infrastructure to get it to the people who need it.” Pfizer’s mRNA vaccine must be kept at -70⁰C and be used within 24 hours of being thawed. Other COVID-19 vaccines have storage requirements more comparable to those of J&J’s shot.

Good news.

  • Fierce Healthcare reports that Walmart plans to use drones to deliver self-administered COVID-19 tests to single family homes within a one miles radius of one of their “pilot” stores. The recipient will need to mail the nasal sample to a lab. The gold standard will be self administered tests that can read out at home like a pregnancy test, but they are getting closer.

Fierce Healthcare also calls our attention to the fact that Optum’s latest quarterly drug pipeline report explains how health plans can prepare to cover “chimeric antigen receptor T-cell (CAR-T) therapies coming to market. CAR-T treatments for cancer are costly but are proliferating as they offer a potentially curative treatment for the disease. Through CAR-T therapy, a patient’s cells are modified in a lab and then reintroduced to the body to attack the cancer.”

The Health and Human Services Office for Civil Rights, which enforces the HIPAA Privacy and Security Rules, took another HIPAA business associate scalp today.

CHSPSC LLC, (“CHSPSC”) has agreed to pay $2,300,000 to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) and to adopt a corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules related to a breach affecting over six million people. CHSPSC provides a variety of business associate services, including IT and health information management, to hospitals and physician clinics indirectly owned by Community Health Systems, Inc., in Franklin, Tennessee.

Friday Stats and More

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, Medicare, U.S. Healthcare–

Based on the CDC’s Cases in the U.S. website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 20th through 37th weeks of this year (beginning May 14 and ending September 16; using Thursday as the first day of the week in order to facilitate this weekly update):

and here is the CDC’s latest overall weekly hospitalization rate chart for COVID-19:

Because the FEHBlog does look at his charts which are intended to show trends, he realized that new deaths chart is flat because new cases greatly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the same period (May 14 through September 16 (basically four months).

In other COVID-19 news:

  • The Wall Street Journal reports “

U.S. hospitals expect to be better prepared if a second wave of Covid-19 cases hits in coming months, doctors and administrators say, after gaining a better understanding how to triage patients, which drugs to use and what supplies are needed. When the new coronavirus first struck, beds filled up at record speed, ventilators were in short supply and proven treatments were scant. Since then, doctors say, they have developed a better understanding of who needs a ventilator and how quickly a patient can be discharged, and studies have pointed to a few drugs like the antiviral remdesivir and the steroid dexamethasone that can help

The FEHBlog heartily agrees that the country is better prepared but he believes that the Journal is assuming facts not in evidence when it speaks about a second wave because we really are still in the first wave.

  • Medscape offers an MD’s perspective on the leading COVID-19 vaccine candidates.
  • The Wall Street Journal reports that the Centers for Disease Control withdrew last month’s highly criticized advice that people who had contact with asymptomatic COVID-19 patients don’t need a COVID-19 test. “The Sept. 18 updated recommendation now says that close contacts of a person with a confirmed Covid-19 infection need a test even in the absence of symptoms. The changes were described as a clarification, rather than a revision, on the CDC website.”
  • Speaking of COVID-19 testing, Mercer Consulting offers advice on how to cover COVID-19 testing which Congress made unnecessarily complicated.

In other news,

  • Govexec.com reports that “House Democrats are preparing to vote [next week] on a six-week stopgap spending bill that would keep agencies open through Dec. 11, according to Democratic aide.” From reading the article, it looks like the continuing resolution which is not fully backed will be enacted thereby avoiding what would be the craziest government shutdown in American history.
  • Speaking of criticism, Fierce Healthcare reports that “the American Academy of Family Physicians, which represents about 135,000 physicians, said the recommendations miss the mark and skew toward virtual-only telehealth vendors and large medical systems with established telehealth infrastructure. The task force’s report doesn’t address the needs of independent practices that need guidance, support and payment advocacy, wrote Stephanie Quinn, AAFP senior vice president of advocacy, practice advancement and policy in a blog post Tuesday.” The most encouraging tele heath acceleration that the FEHBlog witnessed during the great hunker down is patients holding telehealth visits with their own doctors. That FEHBlog agrees with AAFP that this trend that should be strongly encouraged.
  • Healthcare Dive reports that “Privately insured patients pay 247% more at hospitals on average than Medicare patients for the same care, according to a new study by nonprofit think tank RAND. The study, based on 2018 data, shows the gap is increasing from 2017 and 2016, which saw disparities of 230% and 224%, respectively. If private payers had paid Medicare rates over the three-year study period, they would have saved $19.7 billion, RAND determined. The study could provide fodder for proponents of a government-run public option, a key tenet of Democratic presidential nominee Joe Biden’s healthcare agenda, which — like Medicare — would negotiate prices with hospitals and other providers.

Hey, Healthcare Dive, in contrast to health plans which do negotiate with healthcare providers Medicare imposes prices on providers. Government price fixing leads to disparities like this and it’s far from a good thing.

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, COVID-19 testing, COVID-19 vaccine, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

The FEHBlog heard on a webinar today that the House of Representatives will be releasing their FY 2021 continuing resolution tomorrow. That resolution according to press reports will be acceptable to the Senate and the White House. The FEHBlog will keep an eye out.

In COVID-19 news

  • Fierce Pharma reports that “Moderna reached human testing for its COVID-19 vaccine candidate in record time, and now with its phase 3 trial moving right along, the company is expecting efficacy data in November—likely after Pfizer and BioNTech, but before everyone else.”
  • Fierce Healthcare reports that “CVS Health is planning to double the number of its drive-thru testing sites by mid-October, the healthcare giant announced on Thursday [September 17]. CVS intends to add more than 2,000 sites at its pharmacies in the next several weeks, bringing its total to more than 4,000 nationwide. The new locations will be opened in waves, beginning with 400 new sites opening on Friday. CVS currently offers testing in 33 states and the District of Columbia.”
  • Medscape reports that “Eli Lilly and Co said on Wednesday interim trial data showed its experimental monoclonal antibody treatment reduced the need for hospitalization and emergency room visits for patients with moderate COVID-19. The company said it will discuss the interim results, which have not yet been reviewed by outside experts, with global regulators. A Lilly spokeswoman said discussions with the U.S. Food and Drug Administration are expected to range from additional clinical trials to the possibility of an emergency use authorization.”

Progress. Also a Centers for Disease Control study has confirmed an earlier Wall Street Journal report that widespread flu immunization plus continued use of social measures to prevent the spread of COVID-19 , e.g., social distancing, mask wearing, etc, should lead to an easy flu season in the United States this winter.

In other news, Healthcare Dive provides health insurer CEO insights on 2021. “Though there’s significant uncertainty around the future of the insurance industry, many remarks can be summed up in a line from Cigna CEO David Cordani: ‘We feel bullish on 2021.’ And despite the major role of government in regulating healthcare, most officials seemed agnostic on the presidential election looming in less than two months.” That is certainly encouraging.

Midweek update

David Ermer–Congress, COVID-19 vaccine, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

The Federal Times and Govexec.com report that the Senate Homeland Security and Governmental Affairs Committee postponed voting this morning on John Gibbs’ nomination to be Office of Personnel Management Director. Federal employee organizations have publicly opposed his nomination.

It occurs to the FEHBlog that OPM has not had a long acting director since Ambassador John Berry who served in that role for President Obama’s entire first term. Before Mr. Berry the OPM Directors usually lasted one Presidential term. So for the past eight years OPM has mirrored the Washington Football Team’s approach to head coaches and quarterbacks.

Healthcare Dive reports that

Cigna is rebranding its growing health services segment, including pharmacy benefit manager Express Scripts, as Evernorth, the Connecticut-based payer announced Wednesday. The new umbrella brand will encompass Express Scripts, specialty pharmacy Accredo, medical benefit manager Evicore and Cigna’s other health service product lines starting in the third quarter. The rebranding, which has been in the works for months pre-pandemic, is the next evolution of the Cigna-Express Scripts tie-up completed in late 2018, as the combined entity looks to spur more interest in its products from third parties in the industry.

The late U.S. Navy Admiral and Arctic explorer Robert Peary would be pleased.

Healthcare Dive also reports that

  • “CVS Health has struck a deal with Apple to give temporary free access for the health giant’s clients, customers and employees to Apple’s new subscription fitness service.
  • Beneficiaries enrolled in Aetna’s commercial or CVS Caremark’s prescription plans will be offered a free one-year subscription to the feature, called Apple Fitness+. A free two-month subscription will be offered to CVS Pharmacy ExtraCare members and all CVS employees after the service is launched, per Tuesday {September 15]’s release.
  • The announcement coincided with Apple’s unveiling of the subscription service, which offers virtual fitness classes. The tech giant on Tuesday also released the latest model of its Apple Watch, which includes a new blood oxygen level tracker.”

The National Committee for Quality Assurance released yesterday the final report of its Task Force on Telehealth. Here are the task force’s recommendations:

Policymakers should make permanent the following specific COVID-19 policy changes:

Lifting geographic restrictions and limitations on originating sites. Allowing telehealth for various types of clinicians and conditions. Acknowledging, as many states now do, that telehealth visits can meet requirements for establishing a clinician/patient relationship if the encounter meets appropriate care standards or unless careful analysis demonstrates that, in specific situations, a previous in-person relationship is necessary. Eliminating unnecessary restrictions on telehealth across state lines.

Policymakers should look closely at the effect of expanding prescribing authority to telehealth, as authorized by the PHE. They should evaluate what policies and guidelines could be applied to virtual prescribing to ensure patient safety and avoid adverse outcomes.

Policymakers should fully reinstate enforcement of Health Insurance Portability and Accountability Act (HIPAA) patient privacy protections that was suspended at the start of the public health emergency.

The Department of Health and Human Services and the Defense Department announced their COVID-19 vaccine distribution strategy today.

The strategic overview lays out four tasks necessary for the COVID-19 vaccine program:

  • Engage with state, tribal, territorial, and local partners, other stakeholders, and the public to communicate public health information around the vaccine and promote vaccine confidence and uptake.
  • Distribute vaccines immediately upon granting of Emergency Use Authorization/ Biologics License Application, using a transparently developed, phased allocation methodology and CDC has made vaccine recommendations.
  • Ensure safe administration of the vaccine and availability of administration supplies.
  • Monitor necessary data from the vaccination program through an information technology (IT) system capable of supporting and tracking distribution, administration, and other necessary data.

Federal News Network helpfully has created an online payroll deferral calculator for this federal employees and military members who are subject to this COVID-19 relief action.

Monday Roundup

David Ermer–Congress, COVID-19, COVID-19 testing, COVID-19 vaccine, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

Becker’s Health IT offers 20 bold health IT predictions for the next five years. Here are the FEHBlog’s favorites:

1. Joel Klein, MD. Senior Vice President and CIO of University of Maryland Medical System (Baltimore): I think at least half of all healthcare in America will be virtual within five years. There are two barriers:

• Payers. They might pay less but if they pay enough, it will be enough. If we can figure out how to solve emergency department visits with widespread, cost effective on-demand care, that will make a difference.
• ‘But I want to see my doctor.’ That might be true for some things, but the convenience factor (especially for tertiary care… especially for millennials…) once you really start doing it overwhelms most of the physical presence upsides.

Edward Lee, MD. CIO of The Permanente Federation (Oakland, Calif.): In five years, physicians will no longer need to manually document their notes into the EHR. Instead, artificial intelligence will capture all the pertinent information from the patient-physician encounter. This will enable physicians to spend quality time with their patients instead of worrying about writing their notes or placing orders in a computer system. Joy and meaning for physicians will increase, physician burnout will decrease, and above all, patient care will improve.

Michael Pfeffer, MD. Assistant Vice Chancellor and CIO of UCLA Health: Health IT will enable each patient to have a unified, interactive view of their health information regardless of place of care or type of clinical data (i.e. phenotypic, genomic, imaging). AI-based apps will help make sense of their data, taking into account social determinants of health and potential health disparities to improve health equity and health literacy. This intelligence will be paired with personal health preferences and data on health provider quality, access, pricing and satisfaction to help patients make truly informed decisions about their care.

Fierce Biotech reports that “Just under a week after it stopped its key phase 3 pandemic vaccine test [due to a safety concern], AstraZeneca and the University of Oxford have been given the green light to restart in the U.K.” What’s more

While AZ and Oxford have been highlighted as [COVID-19 vaccine] race leaders, so too have Pfizer and BioNTech, which said they now want to boost their phase 2/3 trial for one of their five mRNA vaccines, BNT162b2, from around 30,000 to 44,000.

Also over the weekend, the companies said they have asked the FDA for the extra participants in order to include a broader patient population and with plans to include adolescents as young as 16 and people with chronic, stable HIV (human immunodeficiency viruses), hepatitis C or hepatitis B infection to “provide additional safety and efficacy data.”

It said it’s on track to hit its original target of 30,000 patients this week; despite wanting more people, Pfizer said in a statement that it was still on course to deliver data by the end of next month.

CVS Health announced last week that in response to demand created by children returning to school, it has made “children age 12 years and older eligible for testing at the more than 2,000 test sites located at select CVS Pharmacy drive-thru testing locations, starting last Friday, September 11.”

In other news

  • The Washington Post reports that commuting in the Washington DC metropolitan area may not be back to normal until next summer.

Some 430 employers representing about 275,000 workers in the greater-Washington region — stretching from Baltimore to Richmond — participated in the survey conducted Aug. 10 to 28. Their responses offer a snapshot of what companies are thinking as they weigh resuming in-office operations.
A clear majority of Washington-area employers said they are adopting a phased approach to returning to the office, although many said they remain uncertain about the timing of that return. A third of the region’s employers said they don’t know whether they will have their workers back on site by next summer.

  • Govexec.com reports that “The Office of Personnel Management issued a proposed rule [today] that would enable federal agencies to appoint employees in STEM jobs, or positions on temporary or new projects or organizations, for a decade. OPM said the change would give agencies more flexibility when tackling long-term science, technology, engineering and mathematics projects and other non-permanent work. Current regulations require agencies to get special permission from OPM to keep any term employee on staff for longer than four years.” The public comment deadline is November 10, 2020.
  • The House Oversight and Reform subcommittee on government operations held a postal update hearing today. It turns out that the subcommittee’s objective was to be to call the Postmaster General’s qualifications into question. A bipartisan Postal Service Board of Governors selects the Postmaster General, rather than following the usual Presidential appointment followed by Senate confirmation route.

Thursday Miscellany

David Ermer–Congress, COVID-19 testing, COVID-19 vaccine, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

The Wall Street Journal reports that the entire Senate Republican caucus, with the exception of Sen. Rand Paul, voted for the scaled down $500 billion (is that an oxymoron?) COVID-19 relief bill, but the bill failed to receive the 60 votes necessary for cloture because the Democratic caucus lined up in opposition. So we have another political issue for the election.

Thankfully, the Congress and the White House have agreed on a continuing resolution to fund the federal government into the new federal fiscal year. The House will be holding votes next week so the FEHBlog expects that the House will pass the continuing resolution and then peace out for the campaign trail. The Senate will hang around as long as it can to approve more nominations. Following the election Congress will hold a lame duck session at which point another COVID-19 relief bill is likely to be enacted.

In healthcare news —

  • The National Academies of Sciences has a detailed web page about social determinants of health that is worth a look.
  • Humana has launched value based hearth surgery and shoulder replacement programs. “””The value-based care models are part of a portfolio of payment bundles created by Humana including a Maternity Episode-of-care Model and an Oncology Model of Care. Humana also offers a Hospital Incentive Program for acute care inpatient admissions. About 2.4 million MA members and 115,000 commercial members are enrolled in value-based models, Humana has said.”
  • Fierce Biotech reports that quick, inexpensive saliva based COVID-19 tests are being piloted at Heathrow Airport in London, England. Send the tests over here.
  • The Wall Street Journal informs us that “health experts say it’s increasingly likely that several [COVID-19] vaccines could pass muster in clinical trials and become available in phases over a period of weeks and months.”

The Centers for Disease Control and Prevention sent documents last week to state officials that lay out various scenarios, including availability of a limited number of doses of two vaccines by the end of October with more doses by the end of the year. The CDC document doesn’t name the two vaccines that could become available but describes characteristics that match those of the vaccines from Pfizer and Moderna.

Experts say multiple vaccines will be needed because no single company can make enough for the whole world. Several companies have signed contracts with the federal government to supply at least 100 million doses of each vaccine in the U.S., and are planning to produce larger global supplies.

Progress.

Midweek update

David Ermer–CDC, Congress, COVID-19 vaccine, OPM, Telehealth–
OPM Director Nominee John Gibbs (Senate video / Federal Times)

The Senate Homeland Security and Governmental Affairs Committee held a confirmation hearing for OPM Director nominee John Gibbs this afternoon. Here’s are links to Mr. Gibbs’ testimony and a Federal News Network article on the hearing. The Committee will vote on whether to advance Mr. Gibbs’ nomination to the full Senate at a business meeting scheduled for next Wednesday October 16.

The Senate Health Education Labor and Pensions Committee heard testimony today from the NIH Director Dr. Francis Collins and the U.S. Surgeon General Vice Admiral Jerome Adams on the topic of vaccines. U.S. News and World Report highlights an important segment of Dr. Collins’s appearance before the Committee.

AstraZeneca announced on Tuesday that its late-stage [COVID-19] vaccine study was being put on hold due to a “potentially unexplained illness” in one of the participants.

“With an abundance of caution at a time like this, you put a clinical hold, you investigate carefully to see if anybody else who received that vaccine, or any other vaccines, might have had a similar finding of a spinal cord problem,” Collins said.

Those who are concerned about the safety of the approval process should be reassured by the development, Collins said. “If it turns out that that is a real consequence of this vaccine and can be shown to be cause and effect then all the doses that are currently being manufactured for that will be thrown away because we do not want to issue something that is not safe,” Collins said. He added that the U.S. is investing in six vaccine candidates “because of the expectation that they won’t all work, although it would be lovely if they did.”

AstraZeneca was one of the nine drugmakers to pledge on Tuesday to uphold standards for science and safety in their pursuit of a coronavirus vaccine.

Healthcare Finance reports on America’s Health Insurance Plan comments on how health insurers can aid the COVID-19 vaccine distribution process. For example,

Insurers can use their member data to help identify which people meet the criteria to be eligible for the vaccine, according to the best available evidence. Outreach efforts must adhere to patient privacy requirements, AHIP said.

Insurers can coordinate across partners such as public health officials for data sharing regarding their members’ vaccine status, encouraging data to be shared with state or regional databases (Immunization Information Systems).

“Health insurance providers play an important role ensuring that people receive the vaccines that are recommended for them, and have experience conducting outreach to their members to inform them of the vaccines that are recommended for them and how they can get them,” AHIP said. This may include reminders to ensure they receive multiple doses of a vaccine when needed.”

The Health Affairs Blog experts offer five recommendations on how to better integrate telehealth with primary care.

RecommendationsRepresentative Open-Text Survey Responses
Harmonize the reimbursement criteria “Some insurance companies are paying less than in-person visits for telehealth visits from Day 1. Small practices, like usual, have been left to themselves for the most part.”“Primary care is extremely challenging with the constant change in protocols, the uncertainty and enormously confusing insurance schemes.”
Create billing codes or payment models for the additional work required to offer telehealth “Insurance companies not reimbursing telephone visits at a rate that supports the level of work done on a telephone visit.”“Elderly patients have no access or are unable to access virtual – more work, have to teach them how to take BP, some hard of hearing, etc.”“I am more stressed out doing telehealth, as we spend time to fix internet, video, and voice. There are calling issues, so it’s more time consuming.”
Provide coverage for at-home monitoring devices “I need blood pressure cuffs and glucometers covered by insurance for home monitoring.” “I will do tele health… provided patients have equipment.”“Patients lack thermometers, blood pressure cuffs, and pulse oximeters.”
Incentivize the development of and access to, patient- and provider-centered telehealth technology “Telehealth information technology platform is NOT user friendly.”“Difficult to properly diagnose with telehealth. Have been using photos from patients to supplement but still not really sufficient.”“Our patients are low-income with language barriers. Requiring third party interpreter by speaker phone takes extra time and reduces quality of care.”
Review, revise, and communicate telehealth malpractice policies  “I am not going to practice telehealth; it is not reliable and may increase malpractice cases.”“I’m very concerned about being sued for managing the patients over telehealth especially since many are requesting opioids.”“Malpractice premiums are a major barrier for telehealth.”

Source: Authors’ analyses of data from surveys administered to primary care providers in New York City from April to July 2020.

Weekend update

David Ermer–Congress, COVID-19, COVID-19 vaccine, U.S. Healthcare, Uncategorized–
Photo by Dane Deaner on Unsplash

The FEHBlog hopes that all of his readers are enjoying the Labor Day Weekend. The FEHBlog whose home state Maryland was removed from the COVID-19 travel ban list for New York, New Jersey and Connecticut last month skedaddled up to the Nutmeg State to visit family and friends. He is headed back to his Bethesda hacienda inside the Capital Beltway tomorrow morning.

The House of Representatives and the Senate have full committee schedules in the week ahead. The Senate will also engage in floor business this week while the House will not resume floor votes until next week.

The FEHBlog was pleased to read this Wall Street Journal report that

Several drug makers developing Covid-19 vaccines plan to issue a public pledge not to seek government approval until the shots have proven to be safe and effective, an unusual joint move among rivals that comes as they work to address concerns over a rush to mass vaccination.

A draft of the joint statement, still being finalized by companies including Pfizer Inc., PFE -0.11% Johnson & Johnson JNJ -0.64% and Moderna Inc. MRNA -3.45% and reviewed by The Wall Street Journal, commits to making the safety and well-being of vaccinated people the companies’ priority. The vaccine makers would also pledge to adhere to high scientific and ethical standards in the conduct of clinical studies and in the manufacturing processes.

As President Reagan would say trust but verify.

Health Payer Intelligence provides a 2020 perspective on health plan network centers of excellence. Centers of excellence generally are payer designated facilities that have worthy track records in costly surgeries like transplants. The article explains how payers have branched out this approach to other medical specialties:

Payers can boost their quality of care by working with a COE with particular specialty care providers. For example, Premera Blue Cross recently expanded its own COE strategy in order to improve its quality of care for radiology. Previously, radiology was not part of Premera Blue Cross’s COE strategy, but the payer recognized the need for better quality of care around this service.

“Establishing COEs around the highest quality radiology practices ensures patients are on the most direct treatment path back to health and reduces the high costs associated with misdiagnoses, which are surprisingly common,” explained the press release. At least a third of MRIs and CT scans produce erroneous diagnoses, the release stated.

Healthcare Dive reports that MEDPAC, a nonpartisan legislative branch agency that provides the U.S. Congress with analysis and policy advice on the Medicare program, has concluded that COVID-19 cash from the federal government saved most hospitals from the bleakest financial forecasts made last April. MEDPAC “Commissioners at Thursday’s meeting commended the administration for the speed of getting loans and grants out the door to providers, but said it was time for an in-depth review to make sure the money went to where it was needed most.”

Federal News Network provides an update on the Administration’s plan on the President’s payroll tax deferral program.

All active-duty military members as well as federal civilian employees will be subject to the president’s upcoming payroll tax deferral, a senior administration official told Federal News Network Friday evening.

The president’s payroll tax deferral, which the administration said all payroll providers will launch in unison later this month, has left federal employees, their unions and members of Congress scrambling this week for more details about the policy and its impact on the workforce.

The changes in payroll tax deductions are temporary, and federal employees will have to pay back deferred taxes starting in January. They’ll have until April to do so before penalties and interest may accrue, the IRS has said.

The FEHBlog congratulates OPM’s “Human Resources Solutions because its “USA Staffing® Onboarding platform is the winner of the 2020 Igniting Innovation Awards, hosted by the American Council for Technology and Industry Advisory Council (ACT-IAC). The awards recognize groundbreaking technologies that enhance services for citizens and government operations. USA Staffing Onboarding won with 68% of the vote. * * * Designed to efficiently onboard new hires in ordinary times, this fully online, automated solution proved instrumental in helping Federal agencies adapt to COVID-19.”