Monthly Archives: August 2022

Covering COVID-19 is a daily Poynter briefing of story ideas about the coronavirus and other timely topics for journalists, written by senior faculty Al Tompkins. Sign up here to have it delivered to your inbox every weekday morning.

The Walgreens drug store chain posts the results of the COVID-19 tests it oversees, and the picture is grim. More than a third of the tests are positive and some states have seen a spike of 25% in the last week. Click on the map, which is linked to an interactive for each state.

Screnshots, Walgreens COVID-19 Index

The answer is yes and no. In all of the 60 or so years that monkeypox has infected people, it has not been spread by sexual contact. But that is one way that it is spreading now. The World Health Organization last week advised men to consider reducing their sexual partners for the moment. The WHO says 98% of the monkeypox cases detected since May have been among gay, bisexual and other men who have sex with men.

But the WHOs warning also shows that monkeypox is not only transmitted through sexual contact, so to call it an STD might lead people to believe there is no danger if they are not having sex with an infected person. The WHO says among the ways the virus can be transmitted are:

In recent days you have heard about the vaccine being used to fight the spread of monkeypox being the same vaccine used to fight smallpox. That might be disconcerting considering that smallpox killed one in three people it infected. Smallpox was extremely infectious.

Monkeypox is different from smallpox. It is rarely deadly. But the smallpox vaccine protected people against a related orthopoxvirus infection that we call monkeypox. Four decades ago, most countries that had a smallpox problem stopped delivering smallpox vaccines as the infection was eradicated. That means that now, monkeypox has an opportunity to make a comeback, as viruses sometimes do.

Vox explains that there are smallpox vaccines in U.S. storage called ACAM2000 that are not likely to be used unless monkeypox presents a much larger problem:

Public health leaders are weighing significant trade-offs: While using the USs stockpiles of smallpox vaccines might seem like an easy fix to this scary situation, the decision is much thornier than it appears. ACAM2000s potentially concerning side effects, the complex way it has to be administered, and limits on who can safely receive the vaccine seriously complicate the risk-benefit calculation around using it.

Health officials arent likely to make ACAM2000 widely available unless something big about the monkeypox outbreak changes. Heres why.

ACAM2000s best feature right now is its availability: 100 million-odd doses of the vaccine are currently sitting on the shelves at the US Strategic National Stockpile, largely untouched.

But it comes with a long list of contingencies, among them its unwieldy administration.

The FDA explains the not very comforting way that smallpox vaccines are administered:

ACAM2000 cannot cause smallpox; it does not contain the smallpox virus, but rather the live vaccinia virus not dead virus like many other vaccines. For this reason, attentively caring for the vaccination site is important to prevent the virus from spreading from the vaccination site to other parts of the body, or to other people.

ACAM2000 is administered differently than the typical shot associated with most vaccinations. A two-pronged stainless steel (or bifurcated) needle is dipped into the vaccine solution and the skin is pricked several times in the upper arm with a droplet of the vaccine. The virus begins growing at the injection site causing a localized infection or pock to form.

A red, itchy sore spot at the site of the vaccination within 3-4 days is an indicator that the vaccination was successful; that is, there is a take. A blister develops at the vaccination site and then dries up forming a scab that falls off in the third week, leaving a small scar. The vaccine stimulates a persons immune system to develop antibodies and cells in the blood and elsewhere that can then help the body fight off a real smallpox infection if exposure to smallpox ever occurs.

ACAM2000 is also not safe for immunocompromised people. And sometimes the vaccination does not take on the first try.

You might ask why the U.S. government keeps 100 million doses of vaccine on hand for a virus that was eradicated decades ago. The answer, the FDA says, is as a defense against smallpox being used as a biological weapon.

The Wall Street Journal zeroed in on the way Americans are shopping for bargains:

One way they are doing so is by relying more ondollar and discount stores for groceries. Average spending on grocery products at discount chains increased 71% from October 2021 to June 2022, according to analytics firm InMarket. Over that time period, spending on the same items in grocery stores decreased by 5%. Many large consumer brandsincluding WalmartandUnileverattest that theirprices arent going down anytime soon.

Other households are buying in bulk or making do without items they never used to think twice about spending money on. Sams Club membership income was up 10.5% year-over-year, according to parent company Walmarts May earnings call.

Consumer-products giantProcter & Gamble Co. just posted its largest sales gain in 16 years. Still, the companyis predicting its slowest sales growthin years as consumers cut back on household staples like the companys Tide detergent and Pampers diapers.

The WSJ story profiled some families that are cutting back on how much shampoo their kids use, shutting off nightlights to save electricity, wearing less makeup and using some products past their expiration dates.

These are the kinds of stories that make me want to listen to my mother tell me how her family made it through the Great Depression. I bet we could learn a lot from hearing those stories today.

There may soon be a day when before you go in for your colonoscopy you will not be drinking a gallon of awful-tasting liquid, but instead you will take a handful of pills and drink water.

The New York Times tells us:

In what experts believe could end the dread that keeps many people from this important screening the Food and Drug Administration approved a regimen of pills, Sutab, that studies showworks just as well as the liquid solutions without the vile flavor. Its a 24-tablet regimen: 12 pills the day before and 12 the next day, several hours before the procedure.

Patients still must drink lots of water, a total of 48 ounces the first day and another 48 ounces the next day. But at least plain water is tasteless.

The thing that is great about Sutab is that it takes the issue of the taste away, says Douglas K. Rex, distinguished professor emeritus of medicine at the Indiana University School of Medicine.

Youre still going to have to sit on the toilet, but not having to drink something that tastes awful is a big advantage.

Besides skin cancers, colon cancer is the third most common kind of cancer in the U.S., with 106,180 new cases expected this year. Anything that cuts down on the excuses people have not to get tested is a good thing.

The New York Times observed:

Owning an ice cream truck used to be a lucrative proposition, but for some, the expenses have become untenable: The diesel that powers the trucks has topped $7 a gallon, vanilla ice cream costs $13 a gallon and a 25-pound box of sprinkles now goes for about $60, double what it cost a year ago.

Though no organization appears to have hard figures on just how many ice-cream trucks are currently working the streets of New York City, some owners said they would likely leave the business in the next few years. Its a sentiment that is felt nationwide, where mobile ice-cream vendors face higher costs for city permits and registration, and hefty competition from other ice cream businesses, said Steve Christensen, the executive director of theNorth American Ice Cream Association.

The ice cream truck, he said, is unfortunately becoming a thing of the past.

New delivery methods, through third-party apps or ghost kitchens, are proliferating. Brick-and-mortar scoop shops are focusing on offering a fun experience, he said, and serve dozens more flavors than a traditional ice cream truck can, driving lines away from these vehicles.

New York City store clerks say it is not uncommon to see four shoplifting episodes per evening shift in one store as people steal food and other supplies.

(Twitter)

Well be back tomorrow with a new edition of Covering COVID-19. Sign up here to get it delivered right to your inbox.

Al Tompkins is senior faculty at Poynter. He can be reached at atompkins@poynter.org or on Twitter, @atompkins.

Originally posted here:

More than a third of COVID-19 tests done at Walgreens are positive - Poynter

The Centers for Medicare & Medicaid Services (CMS) recently issued the Medicare Physician Fee Schedule (PFS) proposed rule for calendar year (CY) 2023,[1] which clarified the timeline for increased COVID-19 vaccine administration fees and coverage of monoclonal antibody (mAb) products for the remainder of the public health emergency (PHE) and into the future.

The CY 2023 PFS proposed rule will become effective in 2023, and the deadline for public comment is September 6, 2022.

More broadly, CMS has reiterated that its goal for CY 2023 includes program expansions that create a more equitable health care system by providing better accessibility, quality, affordability, and innovation.[2] CMSs CY 2023 PFS proposed rule highlights the federal agencys goals to promote broad and timely access to both COVID-19 vaccines and mAb products.[3]

This Insight highlights four Medicare coverage and payment changes related to COVID-19 vaccines and mAb products in the CY 2023 PFS proposed rule and provides key takeaways for the commercialization of preventive vaccines and mAb products in the near future.

Under the Coronavirus Aid, Relief, and Economic Security (CARES) Act, COVID-19 was added to the vaccine coverage benefit under Part B of the Medicare program.[4] In its CY 2022 PFS final rule,[5] CMS established payments under Part B for COVID-19 vaccine administration at $40 per dose while existing preventive vaccines, such as pneumococcal, influenza, and Hepatitis B (HBV), remained at a payment rate of $30.[6]

CMS continues its efforts to establish payment for vaccine administration for the long-term in the CY 2023 PFS proposed rule. Through 2021, vaccine administration payment rates for pneumococcal, influenza, or HBV vaccines were established using a crosswalk for similar services paid under the PFS. In its CY 2022 PFS final rule, CMS responded to commenters concerns that the codes were improperly linked and did not reflect the unique costs of administering vaccines. Therefore, CMS finalized administration fees for non-COVID-19 vaccines (pneumococcal, influenza, and HBV) at $30, while establishing a $40 administration fee for COVID-19 vaccines.

CMS now proposes to update the payment for Part B vaccine administration by making adjustments to reflect cost differences for the geographic locality.[7]

CMS also proposes to continue the $40 administration fee for COVID-19. The agency anticipates vaccinating providers will continue to experience rising costs associated with staffing, scheduling, and reporting requirements as the number of patients increases, especially as boosters remain an important tool in the COVID-19 response. While CMS previously intended to maintain increased payment for COVID-19 vaccine administration through the end of the PHE, it has determined this transition will occur on January 1 in the year following the termination of the March 27, 2020, Emergency Use Authorization Declaration (EUA Declaration). The payment rate for COVID-19 vaccine administration will then be set at a rate that aligns with other Part B preventive vaccine administration payment rates, which are currently at $30.[8]

In June 2021, CMS announced an add-on payment with a national rate of $35 for COVID-19 vaccine in-home (at-home) administration, bringing the national average for at-home COVID-19 vaccine administration payments to $75 per dose ($40 for the COVID-19 vaccine administration and an additional $35 for administration in the home). By August 2021, CMS had expanded the circumstance for when the add-on payment was available, allowing providers and suppliers who administered the COVID-19 vaccine at a patients home to bill Medicare. These policies were established to ensure beneficiaries received access to COVID-19 vaccines during the PHE.

After hearing multiple requests from commenters to extend the add-on payment past the PHE, CMS acknowledged in the CY 2022 PFS final rule that the costs of at-home COVID-19 vaccine administration would not diminish immediately after the PHE, thereby stating that it would allow the $35 add-on payment to continue until the end of the calendar year of the PHE. CMSs CY 2023 PFS proposed rule suggests the continuation of the additional $35 payment for at-home vaccination beyond the PHE, which allows the agency to maintain expanded COVID-19 vaccine access for vulnerable housebound beneficiaries. The CY 2023 PFS proposed rule also underscores the agencys need to better understand COVID-19 vaccine inaccessibility barriers in the Medicare population.[9]

While the CY 2023 PFS proposed rule provides a continuation of the additional $35 payment for at-home COVID-19 vaccine administration, it does not include other preventive vaccines. CMS requests comments related to the inclusion of other Part B preventive vaccines (such as pneumococcal, influenza, and HBV).

Once COVID-19 mAb products for treatment and post-exposure prophylaxis were granted EUAs, CMSs CY 2022 PFS final rule finalized coverage and payment for COVID-19 mAb products under the Part B vaccine benefit. Notably, this determination absolved beneficiaries of cost-sharing responsibility for both the mAb product and its administration.

The payment for administration of mAb products for treatment or post-exposure prophylaxis under Part B ranges between $150.50 and $750.00. CMS intends to continue coverage under the Part B vaccine benefit at these reimbursement levels until the EUA Declaration is terminated. In the year following termination of the EUA Declaration, CMS intends to then transition coverage of these products to ordinary system coverage for complex biological products under Part B.

Following the CY 2022 PFS final rule, a mAb product was granted an EUA for use as pre-exposure prophylaxis prevention of COVID-19. Although the CMS policies regarding coverage of COVID-19 mAb products did not address mAb products used for prevention of COVID-19, the agency covered and paid for them without subjecting patients to out-of-pocket costs.

CMS proposes to continue coverage of preventive mAb products under the Part B vaccine benefit beyond the termination of the EUA Declaration, so long as a product has market authorization. CMS also proposes to maintain the current payment amounts for administration for pre-exposure prophylaxis mAb products under Part B of either $150.50 or $250.50, depending on a products administration setting.

While the Biden administration has yet to detail plans for a full market transition for COVID-19 vaccines and therapeutics,[10] CMSs articulation of timelines for coverage of vaccines and monoclonals provides a degree of future payment clarity for these products under Medicare.

CMSs decision to cover mAb products the same as vaccines under the Part B benefit is potentially precedent setting as future prophylactic monoclonals are licensed.[11] The agencys decision to shift coverage of mAb products for treatment to ordinary biological product coverage under Part B means that patients will begin to bear out-of-pocket costs for these products once the EUA Declaration is terminated.

CMSs continued consideration of its methods for setting vaccine administration fees and intent to extend at-home administration add-ons provides opportunities for commenters to encourage policies that promote better access to vaccines for Medicare beneficiaries.

Nija Chappel, a Summer Associate (not admitted to the practice of law) in the firms Washington, DC, office, contributed to the preparation of this Insight.

[1] CMS Proposed Rule, CY 2023 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies, 87 Fed. Reg. 45860 (July 29, 2022), available at https://www.govinfo.gov/content/pkg/FR-2022-07-29/pdf/2022-14562.pdf (hereinafter CMS CY 2023 PFS Proposed Rule).

[2] CMS Fact Sheet, Calendar Year (CY) 2023 Medicare Physician Fee Schedule Proposed Rule (July 7, 2022), available at https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2023-medicare-physician-fee-schedule-proposed-rule.

[3] CMS CY 2023 PFS Proposed Rule, supra note 1, at 46225-46226.

[4] Id. at 46218.

[5] CMS Final Rule, Medicare Program; CY 2022 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies (Nov. 19, 2021), available at https://www.federalregister.gov/documents/2021/11/19/2021-23972/medicare-program-cy-2022-payment-policies-under-the-physician-fee-schedule-and-other-changes-to-part.

[6] CMS CY 2023 PFS Proposed Rule, supra note 1, at 46219.

[7] Id. at 46222.

[8] Id.; CMS uses this example: [I]f the COVID-19 PHE ends in CY 2022, the payment amount for COVID-19 vaccine administration would change from $40 to $30 effective January 1, 2023, and would apply the proposed geographic adjustments and the proposed annual update as proposed for the other preventive vaccine administration services . . . .

[9] Inaccessibility barriers include patients having a condition due to illness or injury that limits their ability to leave home without a device or help from a caregiver, a condition that makes the patient more likely to contract COVID-19, or the patient is generally unable to leave the home and if they do, they consider it a considerable and taxing effort. CMS CY 2023 PFS Proposed Rule, supra note 1, at 46223.

[10] See Richard Hughes, As Congress, Biden administration squabble over COVID-19 funds, an ongoing pandemic response posture strains public health, HealthCareDive (July 14, 2022), available at https://www.healthcaredive.com/news/biden-administration-covid-19-funds-oped/627105/.

[11] Sara Rosenbaum, A Twenty-First Century Vaccines for Children Program, Health Affairs (July 12, 2022), available at https://www.healthaffairs.org/content/forefront/twenty-first-century-vaccines-children-program.

[View source.]

Continue reading here:

COVID-19 Vaccine and Monoclonal Coverage: A Focus of the 2023 Medicare Physician Fee Schedule Proposed Rule - JD Supra

CHEROKEE COUNTY, S.C. (WBTW) Both urban and rural counties in South Carolina top the list for the areas with the highest rate of new COVID-19 cases, according to information updated Monday by the Centers for Disease Control and Prevention.

At the top of the list is Cherokee County, with an average of 534.03 new cases, per 100,000 people, within the last week. Following is Richland County, at 525.3 per 100,000 people.

There is an extremely large divide between the areas with the highest and lowest rates, according to the data, with the top county having more than twice the rate of the region with the least.

In South Carolina, five counties are considered to have a medium spread rate, and four are in the low range, according to the most recent data from the CDC. Every county within News13s coverage area Darlington, Dillon, Florence, Horry, Marion and Marlboro is considered to have a high case rate.

Under CDC guidance, people who live in areas rated with a medium level and who are considered at-risk are urged to wear a mask. In areas with high levels,masking is recommendedfor all people regardless of vaccination status in schools and workplaces.

CDC definitionsfor the three categories are based on new case counts within the last week, new COVID-19 hospitalizations and how many hospital beds are currently occupied by those with the virus.

The top five counties with the lowest COVID-19 case rates, per 100,000 people, are:

42. Oconee 204.91

43. McCormick 179.65

44. Greenwood 117.94

45. Abbeville 171.24

46. Saluda 117.23

The top five counties with the highest COVID-19 case rates, per 100,000 people, are:

5. Lexington 480.71

4. Chester 480.36

3. Kershaw 494.36

2. Richland 525.3

Continue reading here:

What South Carolina counties have the highest COVID-19 case rates within the last week? - WSPA 7News

The study was conducted as a systematic review of published literature followed by a data synthesis6,7. For this purpose, searches were carried out for scientific publications (scientifically reviewed before publication), preprints (i.e. articles of a scientific nature that are published openly without prior review) and the gray literature (i.e. reports and documents published by organizations and authorities). The study protocol is registered in the database for structured literature syntheses and meta-analyzes PROSPERO (International prospective register of systematic reviews) no. CRD42021229514 (see Supplement S1).

The literature searches were based on the search triangle model6. Systematic searches were conducted between 22 January 2021 and 29 January 2021 of databases (PubMed, Cochrane Library, Embase, Love platform/Epistemikos), containing peer-reviewed scientific publications and systematic reviews in areas relevant to the review issue, exploratory searches were performed in preprint archives, while look-up searches were performed in the gray literature. The literature searches were reported according to the PRISMA-S protocol (see Supplement S2).

The systematic search (keywords: prediction, nowcast, forecast, simulation model, model, modeling, estimation, scenario, surveillance, Epidemiology, COVID-19, SARS-cov-2, swed*) of the collegially assessed scientific literature had the goal to identify all relevant publications (within the criteria of the study) in a transparent and reproducible manner.

The explorative searches in the preprint archives were initiated by asking a preliminary question via a tool specifically designed for searches in these archives (search.biopreprint) and then reviewing the recovered records. Thereafter, the searches were repeated iteratively until adjustments no longer led to significant changes in the set of identified preprints. A separate supplementary search was performed against the two largest preprint databases bioRxiv (which also includes preprints from medRxiv) and arXiv. Finally, a search (directed search) of the gray literature was performed. The searchalso called search for known documentswas carried out with the aim of obtaining documents from the websites of relevant Swedish and international authorities active in the area: PHAS, the National Board of Health and Welfare, the Swedish Civil Contingencies Agency and the European Center for Disease Prevention and Control (ECDC). Local and regionally produced forecast data in different healthcare regions are not included in this report. These are regarded as internal working material since they are not published and not publicly available.

scientific articles that report epidemiological results regarding actual or scenario-based predictions of morbidity, mortality, or healthcare burden caused by COVID-19 in Sweden or parts of Sweden in 2020.

reports of COVID-19 modelling published by the PHAS.

non-original analyzes (e.g. reviews, perspective articles, editorials, recommendations and guidelines).

duplicate studies.

in silico studies (pure simulations without comparison with data).

descriptive epidemiological publications (e.g. description of case incidences and geographical distributions).

models that only examine the effect of interventions (rather than predicting risk or disease burden).

articles or reports that present new mathematical models or software tools, unless an explicit central purpose of the study is to predict COVID-19 phenomena.

articles or reports from which predictions could not be extracted as a time series.

articles or reports that present predictions that are adjacent to or fall completely outside of 2020.

The systematic searches in the peer-reviewed scientific literature, the exploratory searches of preprint archives and the look-up searches in the gray literature resulted in document material being examined prior to data extraction. In this inclusion-confirming step, titles and summaries of the documents obtained were reviewed against the study criteria (inclusion/exclusion) by two independent reviewers. Documents that both reviewers considered to be included were included and those that both excluded were excluded from further analysis. In case of disagreement, the articles were downloaded in full text and a new assessment was made. If the disagreement persisted, this was resolved through discussions between the reviewers and, if necessary, with the research group. For data extraction from the final set of documents, a tool for retrieving data from each article in full text was developed. The tool included data on the authors' country of origin, study design, forecast methodology (type of model), study population, data sources, forecast period, forecast results, measures of prediction accuracy/performance (if applicable) and model documentation. One reviewer initially extracted data from each included article and then two other reviewers checked the data obtained. The data extracted from the articles were documented in a spreadsheet.

All models were assessed for systematic sources of error (bias). In articles that addressed several models, each model was assessed separately. For the assessment, a form, ROBOT (Risk of Bias Opinion Tool), was developed, based on previous guidelines for evaluations of forecast studies8,22. In summary, the following topics were examined at model level: relevance and quality of data, time frame for prediction, assumptions, and model development methods (verification and validation). The assessment of assumptions included reproduction rates, latency period, incubation period, serial interval, infectious period, population immunity, and impact of interventions during the prediction period. Model validation was classified as one out of three: retrospective/internal validation, external validation, or no validation.

The assessment of systematic sources of error was performed by two independent assessors, where another assessor assisted in case of disagreement. Each sub-aspect was given a score rating in an assessment form, ROBOT, (see Supplement S3). The partial assessments were added up to a total score for each model. To qualify for further result synthesis, a total score below a heuristically defined limit value was required (ROBOT<4). Given the impact of predictions made by PHAS these were included in the result synthesis even if they failed the ROBOT cut-off.

A secondary validation of model performance was made, where reported predictions were compared with factual outcome data. The data on the forecasting variables were retrieved from published figures using WebPlotDigitizer (v. 4.4, https://apps.automeris.io/wpd/). The models in the final set addressed the total incidence of COVID-19 cases, ICU-occupancy, and incidence of COVID-19 deaths. A simultaneous evaluation of prediction accuracy that included all models was not feasible due to differences in study populations, modeled outcome, and time period. The secondary validation was therefore broken down into subgroups based on the reported outcome variables. Data on the actual outcomes on deaths and ICU-occupancy were obtained from PHAS. Regarding the total case incidence, no source for reliable outcome data was available due to the variable testing strategy employed in Sweden during 2020. When possible, the model performance was quantified by measuring the Mean Absolute Percentage Error (MAPE) between model predictions and the outcome for the entire time period covered by each separate model. We classified the performance according to the following scheme: 0%MAPE10%excellent, 10%30%poor. Based on experiences from public health practitioners during the pandemic, as well as the fact that Sweden already before the pandemic lacked healthcare resources (for instance, at average 103 patients share 100 available hospital beds9), these limits was considered reasonable. The dates when the predictions were made (models finally calibrated) were retrieved from the articles. We acknowledge that measures have been developed that avoid some of the drawbacks of MAPE (e.g. divergence for outcomes close to zero)23, but for clarity and interpretability we opted for MAPE. To determine if difference in prediction errors had statistical significance, we employed the Diedbold-Mariano test. This test requires that the predictions are made for the exact same time period, and we therefore applied the test to the intersection of all prediction dates.

Not all predictions of the total number of cases did include entire Sweden, but all included the Stockholm region. The evaluation was therefore restricted to forecasting the pandemic development in this region (population 2.3 million). In order to be able to compare predictions of the total incidence of COVID-19 cases from PHAS, we had to adjust the predictions from PHAS, which are in terms of the number of reported cases. In the reports from PHAS (e.g. 35 in Table 1), the proportion of unconfirmed cases was estimated to be 98.7%, which made it possible to rescale the predictions of reported cases by dividing those predictions by (10.987), and thus obtaining the total number of cases.

All predictions of ICU-occupancy did not include the entire country but did include the Stockholm region. Also, this evaluation was therefore restricted to the Stockholm region. While acknowledging that assumptions regarding epidemiological homogeneity introduce uncertainty, we multiplied the predictions by the proportion of the total Swedish population that lived in the Stockholm region to allow comparisons with the entire country.

We compared predictions of the number of deaths in COVID-19 during the spring of 2020. In relation to this, we also analysed how much historical data was used to calibrate the models in relation to the length of the prediction by calculating the ratio of the number of days of data used in the calibration and the length of the prediction (in days).

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Computational models predicting the early development of the COVID-19 pandemic in Sweden: systematic review, data synthesis, and secondary validation...