Weekend update

Medicare

Weekend update

David Ermer–Congress, COVID-19, Federal employment benefits, Medicare, U.S. Healthcare–
Thanks to ACK15 for sharing their work on Unsplash.

Congress does not plan to hold votes this week. The Senate Judiciary Committee begins Judge Amy Coney Barrett’s Supreme Court nomination confirmation hearing tomorrow.

Fox Business brings us up to date on the COVID-19 relief bill negotiations, and Federal News Network outlines new federal employment bills to watch.

This week the HLTH conference will virtually occur. Healthcare Dive describes five conference highlights.

On the afternoon of Tuesday October 13, the HCP-LAN will hold its virtual summit meeting. The FEHBlog has enjoyed these summits and, in contrast to HLTH, there’s no charge to attend. “The 2020 LAN Virtual Summit will center around how value-based payment models and the larger health care system have adapted to become more responsive and resilient in the wake of the public health emergency.”

On Thursday October 15, the Medicare Open Season begins. This is time when Medicare beneficiaries can enroll in or switch Medicare Advantage and Part D plans. The Open Season end on December 7.

Hopefully this week also will spotlight OPM’s 2020 Open Season announcement.

In recent news —

  • Health Payer Intelligence discusses a PriceWaterhouseCoopers report on strategies that health plans are implementing to control prescription benefit costs.
  • The Wall Street Journal considers “Lessons for the Next Pandemic—Act Very, Very Quickly / Scientists and public-health leaders are working on new ways to find infections before they spread; smarter lung scans and screening blood samples.” It’s never too early to start evaluating and planning.
  • The Federal Times reports on the virtual ceremony held to honor the federal employees who received the 2020 SAMMIE awards. SAMMIE is short for Samuel J. Heyman Service to America Medals. Congratulations SAMMIE winners.
  • NPR reports that

When developing a vaccine, scientists have a few strategies to try. They can take a piece or component of the bacteria and use that to trigger an immune response in a person. They can kill the pathogen and use its corpse as the vaccine. Or they can take a live pathogen and weaken it in the lab.

The latter are called “live, attenuated vaccines,” and over the past century, scientists have noticed something peculiar about these vaccines: They seem to offer some protection, not just from the targeted disease, but also against many different diseases, including respiratory infections.

COVID-19, of course, is a respiratory infection.

The nasal flu vaccine, in contrast to the injection, is a “live, attenuate vaccine.” However, it is only available to certain age groups. The Centers For Disease Control explains “The nasal spray flu vaccine is approved for use in healthy non-pregnant individuals, 2 years through 49 years old. People with certain medical conditions should not receive the nasal spray flu vaccine.” Of course, this is a conversation to hold with your doctor if you are eligible for the nasal flu vaccine.

Midweek Update

David Ermer–Congress, COVID-19, HIPAA Privacy and Security Rules, Medicare, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

Late this afternoon, the Senate approved the compromise FY 2021 continuing resolution (H.R. 8337) by a vote of 84-10. The President is expect to sign the bill into law tonight. The bill provides continued funding for the federal government through December 11. Congress will hold a lame duck session following the national election on November 3 to consider next steps on FY 2021 appropriations.

This bill includes two provisions relevant to the FEHBP:

  • Section 2401 caps any increase to the Medicare Part B premium at 25% of what it otherwise would be for 2021. Presumably this cap only applies to the basic Part B premium and not to the increased premiums paid by high earners. In any event it should help encourage annuitants to join or stay enrolled in Part B. CMS should be announcing Medicare Part B and other traditional Medicare cost sharing amounts later in October.
  • Section 138 allows OPM, “which is still grappling with its own funding shortfall after the governmentwide security clearance business transferred to the Defense Department last year, to tap into the trust funds it oversees to keep its own operations going.” How would this impact the FEHBP? Section 8909 of the FEHB Act imposes a 4% surcharge on net to carrier premiums. 75% of that surcharge is deposited in a contingency reserve for the carrier which acts like a premium stabilization fund. The remaining 25% of that surcharge is available to cover OPM costs of FEHB administration to the extent appropriated by Congress. Congress typically appropriates only 1/4 of the administration fund to OPM and the balance per Section 8909 is deposited into the FEHB plan contingency reserves based on enrollment. It appears to the FEHBlog that this new law has given OPM the authority to tap into that surplus that otherwise would have been available to the FEHBP carriers. This is not the only such trust fund available to OPM.

The Wall Street Journal and the Hill report that the House Speaker Nancy Pelosi and the Secretary of the Treasury Steven Mnuchin will continue to discuss a compromise fourth COVID-19 relief bill tomorrow. The two leaders met today for 90 minutes and they hope for more progress tomorrow.

On the COVID-19 front —

  • The U.S. National Science Foundation discusses how it has been funding small businesses in the fight to control COVID-19. “Startups nationwide responded with creativity and a diversity of experiences to create innovative technology solutions in the COVID-19 crisis,” said Andrea Belz, director for the Division of Industrial Innovation and Partnerships. “NSF-funded solutions have the potential to make a significant impact in the fight against COVID and future pandemic threats.” That’s encouraging.
  • Forbes reports on a deal between startup tech company doc.ai and major health and Blue Cross licensee Anthem. “One of the products that Anthem is offering its members through doc.ai is called Passport, which helps employees safely return to in-person work during the Covid-19 pandemic. An employer decides on the parameters and each morning the employee answers a self-assessment that determines whether or not the app generates a unique barcode to enter the office building. But the key here is that the protected health information is never sent to the employer—it stays on the employee’s phone—and all the employer sees is whether the QR code was issued. De Brouwer likens it to “soft contact tracing,” where privacy comes first. The data is never uploaded to a server, but stays on the mobile device.” Also encouraging
  • In not so encouraging but understandable news, MedPage Today reports that “Overall frequency of alcohol consumption among adults ages 30-80 increased 14% versus 2019, with increases of 17% for women, reported Michael Pollard, PhD, of RAND Corporation in Santa Monica, California, which administers the survey, and colleagues. * * * ‘Health systems may need to educate consumers through print or online media about increased alcohol use during the pandemic and identify factors associated with susceptibility and resilience to the impacts of COVID-19,’ Pollard and co-authors wrote.”

On the healthcare fraud front, the HHS Inspector General announced today

The Department of Health and Human Services (“HHS”) Office of Inspector General, along with our state and federal law enforcement partners, participated in a health care fraud takedown in September 2020. More than 345 defendants in 51 judicial districts were charged with participating in health care fraud schemes involving more than $6 billion in alleged losses to federal health care programs. Since 2016, HHS-OIG has seen a significant increase in “telefraud”: scams that leverage aggressive marketing and so-called telehealth services. The conspirators include telemedicine company executives, medical practitioners, marketers, and business owners who scammed hundreds of thousands of unsuspecting patients in their homes.

Wow.

In miscellaneous news —

  • HHS created a Hospital Price Transparency website today three months before the final rule takes effect on January 1, 2021.
  • HHS also announced today “five cooperative agreements to health information exchange organizations (HIEs) to help support state and local public health agencies in their efforts to respond to public health emergencies, including disasters and pandemics such as COVID-19.” These HIEs provide a vital framework for sharing health information.
  • “The U.S. Cybersecurity and Infrastructure Security Agency (CISA) and the Multi-State Information Sharing & Analysis Center (MS-ISAC) have released a joint Ransomware Guide that details practices that organizations should continuously engage in to help manage the risk posed by ransomware and other cyber threats. The in-depth guide provides actionable best practices for ransomware prevention as well as a ransomware response checklist that can serve as a ransomware-specific addendum to organization cyber incident response plans.” Check it out.
  • Health Payer Intelligence helpfully reports on a surprise billing study published in the American Journal of Managed Care which finds that

More than 10% of health plan spending is attributable to ancillary and emergency services that commonly surprise-bill. Reducing payment for these services by 15% would reduce premiums by 1.6% ($67 per member per year), and reducing average payment to 150% of traditional Medicare rates—the high end of payments to other specialists—would reduce premiums by 5.1% ($212 per member per year). These savings would reduce aggregate premiums for the nation’s commercially insured population by approximately $12 billion and $38 billion, respectively.

The study is based on claims data from major health insurers housed in the Healthcare Cost Institute.

Thursday Miscellany

David Ermer–Congress, Medicare, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

The Wall Street Journal reports today that the Blue Cross Blue Shield Association (BCBSA) has reached with class plaintiffs’ counsel a tentative settlement agreement in a employer and individual consumer class action alleging anti-trust law violations among Blue Cross licensees that was filed in 2012. The settlement which includes $2.7 billion in payments and BCBSA operational changes intended to increase competition among Blue Cross licensees. The agreement is pending approval by the Blue Cross licensees and an Alabama federal court judge.

BCBSA also is facing a similar class action brought by a class of healthcare providers. The Journal report indicates that this case is headed to litigation. If you can’t access the Journal article due to its paywall (which is worth the investment in the FEHBlog’s humble opinion), Becker’s Hospital Review summarizes the settlement here.

Somewhat ironically, according to this Health Payer Intelligence report, the House of Representatives earlier this week passed a bill to repeal a law passed in 1945 that exempts health insurers from certain federal anti-competitive regulations.

The President issued an executive order today discussing his healthcare strategy and warning Congress that Health and Human Services will act to end healthcare surprise billing if Congress fails to pass its own surprise billing law by the end of the year. HHS issued a press release about the following agency actions taken today to implement the President’s strategy:

  • Issued a final rule from the Food and Drug Administration to open the first-ever pathway for states to use to safely import prescription drugs to lower patients drug costs.
  • Solicited private-sector proposals, as called for in the President’s July executive order, on allowing Americans to get lower-cost FDA-approved drugs and insulins from American pharmacies via importation and reimportation.
  • Released the 2021 Medicare Advantage and Medicare Part D Premium landscape, showing that average 2021 premiums for Medicare Advantage plans are expected to decline 34.2 percent from 2017 while plan choice, benefits, and enrollment continue to increase, and that Part D premiums will be down 12 percent from 2017, with over 1,600 drug plans offering insulin at no more than $35 per month.
  • Issued a notice of proposed rulemaking from the Health Resources and Services Administration to pass on steep discounts at community health centers on insulin and epinephrine to Americans who are uninsured or have high cost-sharing, including the nearly 3 million health center patients with diabetes.

The Society for Human Resource Management compares the Presidential candidate’s health plan coverage proposals here.

Last month the FEHBlog noted that GoodRx, the prescription drug discounter, was planning an initial public offering. Fierce Healthcare reports that

GoodRx raised $1.1 billion in its initial public offering after pricing its deal well above its expected price range. The GoodRx IPO began trading Wednesday at $46 per share, 39% above its $33 per share offering price. GoodRx stock rose above $49 per share in early afternoon action, Investors.com reported. That boosted the consumer healthcare technology firm’s market cap to about $12.7 billion.

Whoa Nelly.

Weekend update

David Ermer–Congress, COVID-19, Federal employment benefits, Medicare, OPM–
Photo by Dane Deaner on Unsplash

Greetings from North Beach, NJ. The FEHBlog will be writing from outside the Beltway for the coming week.

Both Houses of Congress are is session for committee and legislative business this coming week. The House Rules Committee will consider the FY 2021 continuing resolution tomorrow.

The FEHBlog noticed that last week the President nominated OPM’s Acting / Deputy Director Michael Rigas to fill permanently fill his other and more important acting position, Deputy Director for Management at the Office of Management and Budget. It’s too bad that Mr. Rigas was not nominated for OPM Director back in 2017. He certainly has impressed people in the Trump Administration.

The Federal News Network reports that

“Due to the ongoing management challenges that the COVID-19 pandemic presents for our workforce, the Government Managers Coalition believes the federal government would benefit from the establishment of a [permanent] emergency leave transfer program (ELTP) both as a management tool and as a means by which to support our workforce,” the organizations said in a recent letter to Michael Rigas, acting director of the Office of Personnel Management. “An ELTP would be a novel solution, especially for employees with caregiving responsibilities affected by school and daycare closures.” Under an emergency leave transfer program, federal employees can donate unused annual leave to their colleagues who are adversely impacted by a major disaster. Employees who are impacted by a national emergency can apply in writing to become recipients of the donated leave.

This is a good idea for other large and even mid-sized employers.

In other news

  • The Wall Street Journal reports that

When enough people become immune such that the whole community is protected, it’s called herd immunity. Herd immunity can sometimes occur naturally from survivors of the disease within a population, but often not without many deaths. Covid-19 has so far killed close to 200,000 people in the U.S. Epidemiologists believe only a small percentage of the nation has been infected and developed some level of immunity. The introduction of a vaccine can be the quickest, safest way of creating herd immunity, since people can develop immunity without getting the disease.

According to the Great Influenza, the world’s population eventually achieved herd immunity from the 1918 influenza, by a mild first wave of the virus and millions upon millions of deaths from the second wave. Of course, there was no vaccine for the great influenza one hundred years ago.

  • Healthcare Dive informs us that “One year after the first Walmart Health location opened in Dallas, Georgia, the retail giant is moving forward with nationwide expansion of its health superstores.” The FEHBlog is intrigued by Walmart’s healthcare actions.
  • Last week, the Centers for Medicare and Medicaid Services announced that “it has finalized the End-Stage Renal Disease (ESRD) Treatment Choices (ETC) Model (fact sheet), to improve or maintain the quality of care and reduce Medicare expenditures for patients with chronic kidney disease. The ETC Model delivers on President Trump’s Advancing Kidney Health Executive Order and encourages an increased use of home dialysis and kidney transplants to help improve the quality of life of Medicare beneficiaries with ESRD. The ETC Model will impact approximately 30 percent of kidney care providers and will be implemented on January 1, 2021 at an estimated savings of $23 million over five and a half years.”

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

Healthcare Dive informs us about the American Hospital Association’s reaction to yesterday’s final FY 2020 inpatient prospective payment system rule.

The American Hospital Association quickly criticized the price transparency element of the final rule Wednesday night.

“By continuing to focus on negotiated rates rather than expanding access to a patient’s out-of-pocket costs, the Administration fails to meet the goal it set for itself — assisting consumers in becoming more prudent purchasers of health care,” the group said in a statement. “We once again urge the agency to focus on what is really important to patients — ready access to their out-of-pocket costs.”

Evidently, the hospitals seek to dump the entire transparency burden on the health plans. The FEHBlog thinks that consumers would better informed by requiring hospitals and all providers to publicly announce the health plan network(s) in which they participate, an analog to the summary of benefits and coverage that health plans must distribute to members.

Speaking of comparison tools, the Centers for Medicare and Medicaid Services today launched

Care Compare, a streamlined redesign of eight existing CMS healthcare compare tools available on Medicare.gov. Care Compare provides a single user-friendly interface that patients and caregivers can use to make informed decisions about healthcare based on cost, quality of care, volume of services, and other data. With just one click, patients can find information that is easy to understand about doctors, hospitals, nursing homes, and other health care services instead of searching through multiple tools.

CMS notes that “Although the tool was created for people with Medicare in mind, many of the measures shown here apply to people who may not have Medicare. Information on this site isn’t an endorsement or advertisement for any provider type.”

Speaking of FY 2020, the Hill reports

Treasury Secretary Steven Mnuchin and Speaker Nancy Pelosi (D-Calif.) have informally agreed to pursue a clean, short-term stopgap measure to avert a government shutdown at the end of the month, sources in both parties confirmed Thursday. That means the continuing resolution (CR) needed to keep the government open past Sept. 30 would be free of controversial policy riders that have bogged down previous funding bills, significantly lowering the odds of a shutdown leading up to the crucial Nov. 3 elections.

That my friends is good news for the country.

In other news —

  • The Wall Street Journal brings us up to date on the cost, accuracy, and turnaround times for popular (?) COVID-19 testing methods.
  • The Department of Human Services released an action plan for improving rural healthcare in the United States.
  • Beckers Hospital Review reports that Walmart will be bringing Oak Health primary care centers into their super centers located in Arlington, Benbrook and Carrollton, Texas, later this year.
  • HR Dive discusses recent back to school guidance from the Labor Department regard the federal relief acts COVID-19 paid leave program. It’s complicated just like COVID-19.

Midweek update

David Ermer–ACA, COVID-19, Medicare, Rx coverage, U.S. Healthcare–

Section 1557 is the individual non-discrimination provision of the Affordable Care Act. In June 2020, the Department of Health and Human Services issued a final rule making numerous changes to the Obama Administration’s rule. Both rule makings sparked lawsuits challenging their legality.

Last time around, the lead case, Franciscan Alliance v. HHS, was filed in the Northern District of Texas. That case is still pending on appeal before the U.S. Court of Appeals for the Fifth Circuit.

This time around, the lead case, Whitman-Walker Clinic v. HHS, was filed in Washington, D.C. Roughly one month following oral argument in the case, U.S. District Judge James Boasberg this afternoon denied the plaintiffs’ motion for a preliminary injunction against enforcement of HHS’s revised Section 1557 rule with two exceptions:

  • The Court preliminarily enjoined the revised rule’s repeal of the sex discrimination definition found in the replaced Obama Administration rule. That definition afforded express protection to transgendered people.
  • The Court also preliminarily enjoined the revised rule’s religious organization exception to the law’s sex discrimination restrictions.

Here is a link to the lengthy yet illuminating opinion and the implementing order. The decision called to the FEHBlog’s attention another interesting civil rights provision of the ACA — Section 1554. This provision places limits on the HHS Secretary’s broad reaching regulatory powers under the ACA.

Judge Boasberg’s decision expands on the Brooklyn federal court decision issued August 17, 2020, that stayed enforcement of the sex discrimination definition repeal. While the federal government has not appealed the Brooklyn decision, the plaintiffs in the FEHBlog’s opinion are likely to appeal the denial of their preliminary injunction motion in the Whitman-Walker Clinic case. And so it goes.

The Centers for Medicare and Medicaid today released its final Medicare Part A inpatient prospective payment system rule for the government fiscal year beginning October 1, 2020.

The increase in operating payment rates for general acute care hospitals paid under the IPPS that successfully participate in the Hospital Inpatient Quality Reporting (IQR) Program and are meaningful electronic health record (EHR) users is approximately 2.9 percent. This reflects the projected hospital market basket update of 2.4 percent and a 0.0 percentage point productivity adjustment. This also reflects a +0.5 percentage point adjustment required by legislation.

Hospitals may be subject to other payment adjustments under the IPPS, including:

— Penalties for excess readmissions, which reflect an adjustment to a hospital’s performance relative to other hospitals with a similar proportion of patients who are dually eligible for Medicare and full-benefit Medicaid
— Penalty (1 percent) for worst-performing quartile under the Hospital-Acquired Condition Reduction Program
— Upward and downward adjustments under the Hospital Value-Based Purchasing Program

Medicare is one complicated program. Medicare is relevant to the FEHBP because the program impact the prices that FEHB plans pay for patient care and there is a large cadre of annuitant enrollees with Medicare Part A coverage.

In other healthcare related news —

  • Reuters reports that “President Donald Trump said on Tuesday he planned to meet with pharmaceutical companies this week regarding his so-called most- favored-nation executive order aimed at lowering drug prices paid by the U.S. federal government.”
  • STAT News reports that

A new analysis of several studies in which [inexpensive] steroid drugs were used to treat severely ill Covid-19 patients found the drugs significantly helped reduce patient deaths, bolstering earlier, preliminary evidence for the benefit of these medications. In multiple studies involving a total of 1,700 patients, a number of corticosteroids—anti-inflammatory drugs that can damp the effects of an overactive immune system—helped reduce deaths from Covid-19 by about a third, compared with patients who didn’t receive steroids, according to the analysis published Wednesday in the Journal of the American Medical Association.

  • HHS’s Office for Civil Rights, which enforces the HIPAA Privacy and Security Rules, has created a consolidate website regarding HIPAA and Health Apps. The site includes links to generally helpful technical information on cloud computing and HIPAA and HIPAA and health IT. Check it out.

Midweek Update

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

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.

Tuesday Tidbits

David Ermer–Federal employment benefits, Medicare, Rx coverage, Telehealth–

The U.S. Office of Personnel Management today announced the companies that were awarded FEDVIP contracts for a seven year term beginning January 1, 2021. OPM added two new dental carriers — UnitedHealthCare (nationwide) and HealthPartners (regional) for a total of twelve dental carriers. OPM added one new vision carrier — MetLife (all vision plans are nationwide) — for a total of five vision carriers beginning next year.

The Centers for Medicare and Medicaid Services announced an initiative to “transform rural health.” Healthcare Dive explains

CMS’s new payment model for rural hospitals and accountable care organizations that will use upfront and capitated payments. Participating facilities will be able to waive cost-sharing for Medicare Part B services, provide transportation for beneficiaries and expand telehealth services, among other flexibilities.

The Community Health Access and Rural Transformation model has two tracks, one of which is focused on ACOs. In the other track, $75 million will be provided to lead organizations in 15 rural communities, which will be announced early next year with a planned start of the model next summer.

The lead organizations, which can be state Medicaid agencies, local health departments or academic medical centers, among others, will receive $2 million after being accepted and another $3 million in upfront funding as the model progresses.

Fierce Healthcare discusses Teladoc’s acquisition of Livongo which was announced Wednesday August 5. “The combination of two of the largest publicly-traded virtual care companies announced Wednesday will create a health technology giant just as the demand for virtual care soars.” However,

Both companies’ stock dropped Wednesday after news of the deal broke. Teladoc’s stock was down 15% and Livongo’s stock also fell by 14%. As of Thursday, both companies’ stock was still trading lower.

Analysts say the total deal price of $158.99 per share represents a 10% premium over Livongo stock’s record closing price of $144.53 as of Aug. 5, leading to the market pushback on the high valuation.

The Drug Channels blog offers its useful annual update “on pricing at five of the largest pharmaceutical manufacturers—Eli Lilly, Janssen, Merck, Novartis, and Sanofi.” Drug Channels finds that

Average discounts from [prescription drug manufacturer] list prices have been deepening.Merck’s average discount rate went from -41% in 2016 to -44% in 2019, while Lilly’s rate went from -50% to -57%. We estimate that in 2019, the total value of gross-to-net reductions for brand-name drugs was $175 billion. That figure has doubled over the past six years.

In other encouraging news, STAT News tells us about an experimental drug to treat coronaviruses like COVID-19.

A research team at the University of California, San Francisco, has synthesized a molecule that they say is among the most potent anti-coronavirus compounds tested in a lab to date. Called nanobodies because they are about a quarter of the size of antibodies found in people and most other animals, these molecules can nestle into the nooks and crannies of proteins to block viruses from attaching to and infecting cells.
The lab-made one created by the UCSF team is so stable it can be converted into a dry powder and aerosolized, meaning it would be much easier to administer than Covid-19 treatments being developed using human monoclonal antibodies. While the work is still very preliminary, the goal is to deliver the synthetic nanobody via simple inhaled sprays to the nose or lungs, allowing it to potentially be self-administered and used prophylactically against Covid-19 — if it’s shown safe and effective in both animal tests and clinical trials.

Let’s go. This my friends is the difference between 1918 and 2020. We must have faith in medical research.

Finally the FEHBlog’s favorite podcast EconTalk provided a timely insight into Shakespeare’s Romeo and Juliet in this week’s episode. Journalist and author Ben Cohen talked about his book, The Hot Hand, with EconTalk host Russ Roberts. The Hot Hand concerns streaks. and Shakespeare wrote three of his most popular plays, including Romeo and Juliet, from 1605-1606 when London was suffering from the plague. What’s more,

The reason why Romeo doesn’t know that Juliet has taken this potion and that she is simply sleeping and not actually dead is because this whole harebrained scheme had not been explained to him because he never gets the [explantory] letter [that a messenger was tasked to bring him].

So, if you think about it, it’s really a bonkers plot line. The flyer says, ‘I will–Juliet, take this sleeping potion, it will knock you out. Your family will think you’re dead. When they think you’re dead, Romeo is going to come back and he’s going to sweep you away and take you and live happily ever after.’

Now, this is the stuff that like you wouldn’t even see on a reality show or some terrible soap opera now. And yet, it’s our most famous love story.

And so, why does it fall apart? She takes the sleeping potion, right? She gets knocked out. Her family thinks she’s dead. Romeo comes back and sees her in the open crypt. All of the crazy stuff [Romeo and then Juliet committing suicide] actually turns out–where the whole scheme falls apart–is simply on getting a letter to Romeo. And it falls apart because the plague is sweeping through and the messenger gets stuck in quarantine.

So, all of this is the plague.

Now that’s a 1605 twist that rings true nearly 400 years later.

Monday Roundup

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

The Wall Street Journal reports tonight that the Democratic House leadership and the White House are cautiously optimistic about achieving a compromise COVID-19 relief bill this week. The negotiations continue tomorrow.

The FEHBlog listened to the oral argument this afternoon over the Whitman-Walker Clinic’s motion for a preliminary injunction to stay the upcoming effective date of the newly revised HHS rule implementing the ACA’s individual non-discrimination clause, Section 1557. The Court focused the parties’ attention on the Constitutionally required standing of the Clinic and its co-plaintiffs to bring the case and the justiciability of the issue. The Court allowed the government defendants to submit a brief responding to the new case law support that the plaintiffs raised at the oral argument. That brief is due on August 10 a week before the rule takes effect on August 18. Associational standing is a complicated issue.

The President today signed a wide ranging executive order on improving rural health and telehealth access. Speaking of executive orders, Health Payer Intelligence reports that America’s Health Insurance Plan’s recently criticized the President’s recent executive order against pharmacy rebating practices because “Nothing in the proposed rule would require Big Pharma to lower their prices,” the payer organization stated, referring to the rebate rule. “Instead, it undermines competitive negotiations – a misguided approach that makes the problem of out-of-control drug prices worse.” That is indeed the rub.

On the COVID-19 front,

  • Fierce Biotech reports that “Eli Lilly has started a phase 3 trial to evaluate whether its antibody LY-CoV555 stops the residents of nursing homes from developing COVID-19. Lilly has created customized mobile research units to run the clinical trial at nursing homes as the long-term care facilities lack experience running studies.”
  • The FEHBlog’s dogs requested that after all of his compliments to the monkey community last week he should point out that a German study has found that specially trained dogs may be able smell the COVID-19 virus in saliva or other human bodily discharges.

In other healthcare news —

  • Healthcare Finance reports that the second House appropriations minibus appropriations bill passed last Friday includes a provision that would permit the government to fund work on the develop and promulgation of the HIPAA patient identifier rule.
  • Forbes reports that

Health insurer Humana said [last Wednesday July 29] it is investing $100 million in the in-home primary care company, Heal, to bring in-person physician “house calls and one-touch medicine” to seniors in its Medicare Advantage plans. Heal is a fast-growing startup company that offers primary care house calls on-demand and has delivered more than 200,000 home visits in the company’s first five years in eight U.S. markets. Heal’s services also include telemedicine, telepsychology and related digital monitoring services, which Humana says will be key for its elderly health plan subscribers.

  • Health Payer Intelligence informs us today that in reaction to CMS’s decision to open Medicare Advantage to Medicare beneficiaries under age 65 suffering from end stage renal (kidney) disease “Humana will be partnering with a chronic kidney disease management and awareness organization to provide home healthcare and care coordination to Medicare Advantage members. * * * The payer is partnering with REACH Kidney Care, a nonprofit affiliate of Dialysis Clinic, Inc., in order to provide better kidney care services in Alabama, North Carolina, South Carolina, and Tennessee.”