CDC Archives - Ermer and Suter PLLC

Midweek Update

David Ermer–CDC, COVID-19 testing, COVID-19 vaccine, Medicare, Rx coverage–August 12, 2020August 12, 2020

It’s another rainy night in Bethesda.

Fierce Pharma reports that “the U.S. has ordered 800 million doses [of various COVID-19 vaccines currently in phase 3 testing] for a country with a population of about 330 million, likely under the assumption that some vaccines won’t make it through clinical testing. The government is “assembling a broad portfolio of vaccines to increase the odds that we will have at least one safe, effective vaccine as soon as the end of this year,” HHS secretary Alex Azar said in a statement.”

The Wall Street Journal informs us that

Doctors, nursing homes and federal officials are scrambling to get rapid-response Covid-19 antigen testing supplies from the two companies that secured emergency approval to produce them, as cases continue to rise in the U.S.
Rapid-response antigen tests make up a small but growing area of Covid-19 testing in the U.S. and are seen as helpful in tamping down outbreaks because they offer faster results than many molecular tests that must be sent to labs for processing. The tests search for virus proteins while other tests look for the virus’s genetic material.
Quidel Corp. QDEL 4.36% and Becton Dickinson & Co., the only companies that so far have federal emergency authorization to supply such diagnostic tests, also make machines that process them. The boxlike test-analyzers, which before the pandemic processed tests for ailments such as the flu, are found in doctors’ offices and nursing homes, allowing facilities to avoid shipping samples to commercial labs for processing. They can deliver results in about 15 minutes and process dozens of samples an hour.
Quidel is struggling to produce enough analyzers to meet demand, while Becton Dickinson’s challenge is making enough tests, the companies say. * * *
Public health officials have raised some concerns that rapid antigen tests deliver false-negative results at a higher rate than other tests. But federal officials have said that, as these tests become more widespread, they appear equal in sensitivity to the more broadly used polymerase chain reaction diagnostic tests.

Perhaps Kodak can help (FEHBlog humor).

Fierce Healthcare lets us know that “According to the J.D. Power 2020 U.S. Pharmacy study, the expansion of pharmacy companies into the primary care realm has driven ‘significant increases in both satisfaction and consumer spending.'” On a related note, Forbes reports that “CVS Health is back on track with the rollout its new health hub concept to 1,500 stores across the U.S. within the next two years despite the continuing spread of the coronavirus strain Covid-19. CVS Health currently has 205 HealthHubs opened in 22 states. “CVS HealthHubs dedicate more than 20% of the store to health services that include new durable medical equipment, supplies and various new product and service combinations. CVS is adding thousands of new personal care items as well as additional services at its MinuteClinics in the HealthHub stores.”

The Centers for Medicare and Medicaid Services announced today its proposed national coverage decision that would allow local Medicare administrative contractors to make the initial decision on whether to cover an artificial heart or a ventricular assist device for Medicare beneficiaries with end stage heart disease. Currently the devices are treated as experimental treatments that CMS can cover on an exception basis. The CMS announcement explains that 6.5 million Americans “are living with heart failure.” A CMS decision whether or not to finalize the proposal will be made within 60 days following the end of the 30 day public comment period which began today.

Earlier this week the Centers for Disease Control announced their “Hear Her” campaign to reduce maternal mortality.

Over 700 women die each year in this country from problems related to pregnancy or delivery complications. Every death is a tragedy, especially when we know that two thirds of pregnancy-related deaths could be prevented. As many as 50,000 women experience severe, unexpected health problems related to pregnancy that may have long-term health consequences.
CDC’s Division of Reproductive Health is committed to healthy pregnancies and deliveries for every woman. The Hear Her campaign supports CDC’s efforts to prevent pregnancy-related deaths by sharing potentially life-saving messages about urgent warning signs.
Women know their own bodies better than anyone and can often tell when something does not feel right. The campaign seeks to encourage partners, friends, family, coworkers, and providers—anyone who supports pregnant and postpartum women—to really listen when she tells you something doesn’t feel right. Acting quickly could help save her life.

How true. This campaign deserves support from health plans as well as healthcare providers.

Thursday Miscellany

David Ermer–CDC, COVID-19, COVID-19 testing, COVID-19 vaccine–July 30, 2020July 30, 2020

Fierce Biotech reports on other successful double blind studies of COVID-19 vaccines on non-human primates / monkeys. It’s interesting and encouraging that the manufacturers are taking varied approaches to COVID-19 vaccine development. Thanks monkeys.

The Department of Health and Human Services has launched a public service advertising campaign asking COVID-19 survivors to donate plasma for the convalescent plasma treatment nearing FDA emergency authorization. That may be a good initiative for health plans and providers to promote as well.

Bear in mind this Wall Street Journal article reminding COVID-19 survivors that the length of time that the body’s antibodies protects survivors from COVID-19 reinfection is as yet unknown.

USA Today offers a hopeful article about the ongoing development of rapid, inexpensive at-home COVID-19 testing. What’s more, “The XPRIZE, a nonprofit that designs and hosts public competitions, announced Tuesday that it would split a $5 million prize among five winners who can produce a test that delivers results in as little as 15 minutes and costs less than $15.”

HR Dive discusses the impact of recent CDC changes its COVID-19 self quarantine guidelines for non-hospitalized COVID-19 patients on employer return to work policies. As with most COVID-19 personnel issues, it’s complicated.

Thursday Miscellany

David Ermer–CDC, COVID-19 testing, COVID-19 vaccine–July 16, 2020July 16, 2020

On the COVID-19 front —

The Wall Street Journal reports that in the course of reporting its second quarter 2020 financial results, Johnson & Johnson (“J&J”) announced that “it plans to begin the first human studies of its experimental coronavirus vaccine next week, as it races to make the shot available starting early next year. * * * J&J could get an answer about whether the vaccine safely prevents Covid-19 by the end of the year, Dr. Stoffels said. If successful, the company expects the shot to become available in early 2021, and J&J plans to manufacture up to one billion doses by the end of next year.
Fierce Healthcare provides an update on the state of COVID-19 testing in our country. “Admiral Brett Giroir, M.D., Assistant Secretary for Health at the U.S. Department of Health and Human Services (HHS) said 45 million COVID-19 tests had been performed in the U.S. so far, or about 700,000 a day. “We see early indicators that in the hot areas, the red zones, we’re seeing the positivity rate start to go down or plateau. That’s an early sign that we’re getting control of this outbreak,” he said. “This is no victory lap, but it does show that our efforts are starting to make an impact,” he said. “In Arizona, the positivity rate has dropped dramatically.” Giroir said basic, simple measures will help to curb the pandemic, namely, closing bars and indoor dining at restaurants and individuals adhering to guidance to wear masks in public, practice social distancing and avoid large groups.” Good message.

Regrettably, the Wall Street Journal also reports that

U.S. fatal drug overdoses rose last year, new federal data show, reversing a one-year-decline and indicating that another public-health crisis was worsening as the coronavirus pandemic was poised to begin.
Provisional data from the Centers for Disease Control and Prevention include 70,980 fatal overdoses in 2019 with about 1,000 more deaths likely to be added, marking a 4.8% increase from the year before. The data indicate the U.S. last year likely eclipsed the prior record high of 70,237 overdose deaths set in 2017, said Robert Anderson, chief of the mortality-statistics branch at the CDC’s National Center for Health Statistics.

[P]roblems with synthetic drugs like methamphetamines and bootleg versions of the opioid fentanyl have challenged the nation’s ability to build on improvements. Overdose deaths in drug categories including meth and fentanyl continued to rise last year, the CDC data show, while deaths from cocaine, another stimulant, also rose.
Jim Hall, an epidemiologist in Florida who has studied the drug crisis, said the rising availability of the overdose-reversal drug naloxone helped tamp down the number of fatal overdoses in 2018. But the toxicity of fentanyl and the mixture among many users of both fentanyl and stimulants remain potentially deadly problems, he added.

For more details here’s a link to the CDC report.

The CDC also released a public health report today about the use of prescription opioids by pregnant women.

Among respondents reporting opioid use during pregnancy, most indicated receiving prescription opioids from a health care provider and using for pain reasons; however, answers from one in five women indicated misuse. Improved screening for opioid misuse and treatment of opioid use disorder in pregnant patients might prevent adverse outcomes. Implementation of public health strategies (e.g., improving state prescription drug monitoring program use and enhancing provider training) can support delivery of evidence-based care for pregnant women.

Supplement to Friday Stats

David Ermer–CDC, COVID-19–July 12, 2020July 12, 2020

In the last Friday’s COVID-19 stats, the FEHBlog pointed out that while cases have been rising rapidly, deaths fortunately have not over weeks 20 through 27 of 2020 (counting from Friday through Thursday). The FEHBlog decided to go back an take a look at the preceding six weeks which started at the beginning of April and ended in mid-May. The great hunkering down began in mid-March.

Week	14	15	16	17	18	19
New Cases	180,867	177,930	166,382	180,917	162,154	144.995
New Deaths	8,241	9,886	13,504	11,126	10,745	8.949

As you can see from the supplemental stats, the weekly deaths in the U.S. peaked in mid-April and have been falling since then notwithstanding the increasing number of cases which spiked in mid-May and again in July.

The CDC last week posted a helpful discussion of similarities and differences between COVID-19 and the flu. The CDC notes

[While the flu and COVID-19 generally spread in similar ways,] COVID-19 is more contagious among certain populations and age groups than flu. Also, COVID-19 has been observed to have more superspreading events than flu. This means the virus that causes COVID-19 can quickly and easily spread to a lot of people and result in continuous spreading among people as time progresses.

Thursday Miscellany

David Ermer–ACA, CDC, COVID-19 vaccine, Federal employment benefits, OPM, SCOTUS–July 9, 2020July 9, 2020

The Supreme Court wrapped up its October 2019 term today. Because it relates to the Affordable Care Act, the FEHBlog calls attention to the ever reliable and prodigious Katie Keith’s Health Affair’s blog post about yesterday’s Little Sisters of the Poor v. Pennsylvania decision. As Ms. Keith explains, this decision “was the third time in six years that the Supreme Court has ruled on the scope of the contraceptive mandate. This post recounts the history of the litigation, summarizes the decision, and discusses the impact of the ruling.” This decision has no impact on the FEHBP coverage of contraceptives. Enjoy your time off, Justices.

Also on the ACA front, Fierce Healthcare reports that

The Affordable Care Act’s insurance exchanges could add more than 1 million new members because of the COVID-19 pandemic.
The analysis released Thursday by Avalere attributes the spike to special enrollment due to massive job losses caused by COVID-19. The boost in customers could cause more insurers to return to a market they have left after financial losses over the past few years.
“With unemployment rates at or near 10% in almost all states, many consumers have been separated from their previous employer-sponsored plans,” the analysis said. “The economics of Medicaid eligibility in many states and the recent boost to unemployment assistance indicate that many are turning to the exchanges for coverage.”

On the COVID-19 vaccine development front,

Fortune reports that

At Fortune Brainstorm Health this week, there was lots of talk about the 200-plus efforts to find a COVID vaccine, and the extraordinary collaboration among companies and governments to get vaccines tested, manufactured and distributed—far faster than ever before. “We are taking what normally takes five to seven years, and doing it in five to seven months,” said Johnson & Johnson CEO Alex Gorsky. But Gorsky—whose company is one of the leaders in the vaccine race—also issued a strong warning to the group not to think of a vaccine as a silver bullet.

However, an effective vaccine certainly would be better than a poke in the eye with a sharp stick. Must everyone feel the need to dampen expectations?

In the same vein, Fierce Pharma discusses an internal CDC debate over what would be an effective COVID-19 vaccine.

One of public health’s greatest accomplishments was eradicating smallpox back in 1979. To eradicate SARS-CoV-2, the virus that causes COVID-19 illness, we’ll need a vaccine that’s 70% effective—and 70% of the population will need to receive it, an FDA vaccine official said Wednesday.
That’s a higher bar than the FDA set last week. To pass muster at the agency, a COVID-19 vaccine will need to be at least 50% more effective than placebo, according to new FDA guidelines.

It’s worth noting that the smallpox eradication effort began in the 1790s and that pharma is on course for more than one vaccine concoction for COVID-19 which should lead to broader efficacy, right?

On the OPM front,

Federal News Network informs us OPM will be proposing to anoint greater Des Moine, IA as the latest metropolitan area in which federal employees will receive locality pay. Congrats Hawkeyes. “OPM will also propose an expansion of the existing Los Angeles/Long Beach, California, locality pay area to include Imperial County, California.” The changes if (when?) finalized would be effective January 1, 2021, and
Fedweek reports on a recent OPM Inspector General report on OPM’s federal employee retirement services. The Inspector General compliments OPM for its process improvements.

Monday Roundup

David Ermer–CDC, Congress, COVID-19, Medicare, OPM–July 6, 2020July 6, 2020

The FEHBlog has explained that OPM scores FEHB plans principally on certain HEDIS and CAHPS scores measured against where other health plans (generally not just FEHB plans) score. NCQA which manages HEDIS and CAHPS for health plan scoring purposes, released last Wednesday two years of specifications for HEDIS measures (the 2020 and 2021 measurement year “specs.”).

The happy result of this NCQA action is that beginning next year FEHB and other health plans subject to HEDIS will know the rules of the road five months before the measurement year begins rather than six months into the measurement year which has the the case right through this 2020 measurement year. Bravo NCQA.

Meanwhile Health Payer Intelligence reports on an America’s Health Insurance Plans commissioned study finding that “Nearly three-quarters of NCQA HEDIS quality measures will experience a negative impact from the coronavirus pandemic.” Marvelous. The article also suggests some ways that health plans can boost their HEDIS scores in these hard times.

Speaking of these hard times, three major healthcare provider associations (the American Hospital Association, the American Medical Associations, and the American Nurses Association) issued a letter today encouraging the public “to take the simple steps we know will help stop the spread of the virus: wearing a face mask, maintaining physical distancing, and washing hands.” That’s good advice for health plans to spread around too.

RevCycle Intelligence informs that the American Hospital Association and its fellow hospital groups are urging the Department of Health and Human Services to delay the January 1, 2021, effective date for the Administration’s hospital pricing transparency rule at least until the case challenging the rule works it way through the court system. At this point a federal district court has upheld the rule and the American Hospital Association has appealed that decision to the U.S. Court of Appeals for the D.C. Circuit. The article adds that

No response from CMS was available as of July 2. However, lawmakers are looking to make the price transparency rule law. Introduced by Senator Chuck Grassley (R-IA) on June 30th, the PRICE Transparency Act seeks to codify the hospital price transparency rule and a similar rule requiring payers to publicly share cost-sharing and in- and out-of-network provider rates.

In other 2021 news, the Centers for Medicare and Medicaid Services issued a proposed rule for pricing Medicare end stage renal disease coverage next year. “CMS is proposing that certain new and innovative equipment and supplies used for dialysis treatment of patients with ESRD in the home would qualify for an additional Medicare payment. These proposed changes would encourage the development of certain new and innovative home dialysis machines that would give beneficiaries more dialysis treatment options in the home that can improve their quality of life.”

Tuesday Tidbits

David Ermer–CDC, Congress, COVID-19 testing, HIPAA Privacy and Security Rules, OPM–June 30, 2020June 30, 2020

The Senate Health Education Labor and Pensions Committee held a hearing this morning on progress made in reopening schools and businesses from the great hunkering down. Fierce Healthcare reports on the hearing here.

The Department of Health and Human Services announced today the extension of “its partnership with national pharmacy and grocery retail chains CVS, Rite-Aid, Walgreens, Quest (through services at Walmart) and eTrueNorth (through services at Kroger, Health Mart, and Walmart) so they may continue to seamlessly provide Americans convenient access to COVID-19 testing. The partnership, which is part of the Community-Based Testing Program, has scaled up to more than 600 COVID-19 testing sites in 48 states and the District of Columbia. Approximately 70% of these testing sites are located in communities with moderate-to-high social vulnerability, as evidenced by their racial, and ethnic composition, and their housing, economic, language barrier, and similar considerations.” “The [partnership] contract utilizes a federal bundled payment program paid directly to retailers that receive a flat fee for each test administered, with participating retailers responsible for coordinating the full end-to-end testing.” So far the collaborative program has tested 750,000 Americans. That makes sense.

The Office of Management and Budget’s Office of Information and Regulatory Affairs issued its anxiously awaited Spring 2020 regulatory agenda. The regulatory agenda tells you what’s baking in each agency’s regulatory oven but you can rely on the oven timers’ shown in the reports. Here’s a link to OPM’s “rule list.” Nothing earth shaking to report.

The FEHBlog’s favorite healthcare quality consulting firm, Discern Health, notes the release of the National Health Quality Roadmap by the Department of Health and Human Services. “The National Health Quality Roadmap highlights not only many of the challenges that have been faced by health care stakeholders across the quality environment, but also a plan for addressing them,” Discern Health Vice President Donna Dugan said. “It will be important for stakeholders across the continuum to participate where possible in order to facilitate this transformation and aid in the realization of quality goals.”

Becker’s Hospital Review reports on a class action settlement of a phishing attack related lawsuit against UnityPoint Health which is based in Iowa. ‘The class action lawsuit alleges the health system didn’t notify [over 16,000] patients of the breach in a timely manner and told patients Social Security numbers weren’t compromised, but they were.’ The settlement is valued at $2.8 million.

For what it’s worth, Forbes reports an IRS announcement that that “the 2019 tax filing deadline remains July 15, 2020.” Forbes considers and the FEHBlog agrees that this will be the IRS’s final work on the topic. Also the Labor Department yesterday added q&a 93 to its list of frequently asked questions on the Families First Coronavirus Response Act’s paid leave program

Monday Roundup

David Ermer–CDC, COVID-19, Rx coverage, U.S. Healthcare–June 29, 2020June 29, 2020

Modern Healthcare reports tonight that

HHS spokesperson Michael Caputo on Monday tweeted that HHS intends to extend the COVID-19 public health emergency that is set to expire on July 25. The extension would prolong the emergency designation by 90 days. Several payment policies and regulatory adjustments are attached to the public health emergency, so the extension is welcome news for healthcare providers.

The Centers for Disease Control released updated guidance on the use of cloth face coverings during the COVID-19 emergency.

Cloth face coverings are recommended as a simple barrier to help prevent respiratory droplets from traveling into the air and onto other people when the person wearing the cloth face covering coughs, sneezes, talks, or raises their voice. This is called source control. This recommendation is based on what we know about the role respiratory droplets play in the spread of the virus that causes COVID-19, paired with emerging evidence from clinical and laboratory studies that shows cloth face coverings reduce the spray of droplets when worn over the nose and mouth. COVID-19 spreads mainly among people who are in close contact with one another (within about 6 feet), so the use of cloth face coverings is particularly important in settings where people are close to each other or where social distancing is difficult to maintain.

Healthcare Dive alerts us that

Gilead will charge between $2,340 and $3,120 for a typical course of treatment with its COVID-19 drug remdesivir, which has been shown to speed the recovery of patients hospitalized with the infectious disease.
The drug’s price will depend on whether patients are covered by government insurance or commercial health plans. Gilead will offer remdesivir to governments in developed countries at a price of $390 per vial. In the U.S., private insurers will pay $520 per vial.
Most patients will be treated for five days, using six vials, Gilead said in announcing its much anticipated pricing decision Monday. If treatment stretches to 10 days — initially the standard treatment course — remdesivir’s cost would rise to $5,720 for patients who are commercially insured.

The announced prices are in line with expert predictions.

MedCity News discusses Walmart’s new health clinics.

The company rolled out two Walmart Health clinics this month, in Loganville, Georgia and Springdale, Arkansas.
These aren’t your usual walk-in clinics that might serve as a quick place to get vaccinated or get a cold checked out. Rather, they’re more like a one-stop shop for healthcare, with primary care, urgent care, diagnostics, x-rays, behavioral health and dental care.
Walmart Health’s other big differentiator: A primary care appointment costs just $40. For children? $20.

Friday Stats and More

David Ermer–CDC, COVID-19, OPM, U.S. Healthcare–June 26, 2020June 26, 2020

According to the CDC’s COVID-19 cases in the U.S. website, which the FEHBlog tracks, over the past seven weeks the numbers of new COVID-19 cases had taken a downward path for the first four weeks and then has turned up for the past three weeks. New deaths saw steady weekly reductions over the same time span until this week when there was a slight upturn. The COVID-19 hospitalization rates continue to trend down.

Week ending	New Cases	New Deaths
May 15	297,581	8,856
May 22	159,496	8,160
May 29	142,210	7,561
June 5	142,289	6,353
June 12	153,371	5,850
June 19	161,289	4,865
June 26	199,252	5,270

In other healthcare news —

Health Payer Intelligence reports that the CDC “estimates that 90 percent of national healthcare spending goes toward chronic disease management and mental healthcare, which means that strong mental health and chronic disease prevention strategies can help reduce payer spending. The CDC has named the eight most expensive chronic diseases in the US. The good news for payers is that most of these can be prevented to some degree. By being aware of preventive care strategies for these eight chronic conditions, payers can actively reduce their healthcare spending and support positive patient outcomes.”
The Commonwealth Fund and the Healthcare Transformation Task Force have created a Maternal Health Hub.

In federal agency news

Govexec.com informs us about the President’s executive order, issued today, requiring federal “agencies to increase the use of skill assessments and interviews with subject matter experts to determine an applicant’s qualifications, rather than simply looking at educational achievements. Degree requirements will not go away entirely, and certain positions—such as those in medical, legal and certain technical fields—will still require advanced degrees. The goal of the order, Trump administration officials said on Friday, is to create a broader pool of potential federal employees and a more equitable hiring process.”
Federal News Network reports that “The Postal Service expects to withstand the financial impact of the coronavirus impact better than it anticipated a few months ago, but warns that it could still run out of cash before the end of 2021 without long-term reform from Congress.”

Thursday Miscellany

David Ermer–CDC, COVID-19, U.S. Healthcare–June 25, 2020June 25, 2020

Robert Redfield, MD, the Director of the Centers for Disease Control gave a press conference on the COVID-19 emergency today as discussed in this STAT News article.

“I’m asking people to recognize that we’re in a different situation today than we were in March, in April, where the virus was being disproportionately recognized in older individuals with significant comorbidities and was causing significant hospitalizations and deaths,” he said.
“Today we’re seeing more virus. It’s in younger individuals. Fewer of those individuals are requiring the hospitalizations and having a fatal outcome. But that is not to minimize it.”
But Redfield went on to note that descriptions of the state of the pandemic in the country can be misleading, with maps that show where transmission is high suggesting much of the nation is experiencing high levels of spread. In reality, he said, about 110 or 120 counties in the country currently have significant transmission. There are more than 3,100 counties in the United States.

The CDC also released updated guidance identifying categories of people who are most at risk for severe illness by contracting COVID-19.

The Washington Post reports that drug manufacturers are increasing production of the flu vaccine for the next flu season. “Getting a flu shot does not protect against the coronavirus, but disease experts said reducing episodes of flu could prove pivotal in freeing up space in hospitals and medical offices to deal with covid-19, the disease caused by the coronavirus.”

Healthcare Dive informs us that pediatric visits are lagging in the recent doctors office visit rebound following the great hunkering down. “[O]ver the past week, visits to some specialists have returned to normal, including dermatology and rheumatology. However, pediatric practices are among the hardest hit and have seen the greatest decline in visits when comparing specialties . . .”

Health Payer Intelligence discusses CVS Health’s new service called “Return Ready.” It’s “a COVID-19 testing strategy for employers whose workforces are returning to the workplace and academic populations returning to campus.” Timely. Here’s a link to current Equal Employment Opportunity Commission guidance on employer compliance with the Americans with Disabilities Act and the Rehabilitation Act in COVID-19 related matters. .

The Society for Human Resource Management provides observations about how the the Supreme Court’s recent ruling holding that Title VII’s sex discrimination protections extend to sexual orientation and gender identity situations affects employer sponsored health coverage.