Midweek update

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.

Tuesday Tidbits

David Ermer–AHRQ, CDC, Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, OPM, Telehealth–

The U.S. Office of Personnel Management released its first of four Benefit Administration letters for the upcoming Federal Benefits Open Season which which will run from Monday, November 9, 2020 through Monday, December 14, 2020. Here are links to the BAL, a sample email to employees and a Venn diagram displaying the interlocking aspects of the health, dental, vision, and flexible benefits programs that participate in this Open Season. The FEHBlog expects that COVID-19 public health emergency will tamp down the traditional Open Season health fairs. It will be an interesting experiment to see whether this change impacts the volume of plan changes one way or the other.

In anticipation of FDA approval of COVID-19 vaccine(s), an expert panel formed by the National Academies of Science has issued for public comment draft recommendations for staging an equitable distribution of the vaccines according to a STAT News report. A public hearing on the draft recommendations is scheduled for tomorrow. This report then goes to the Centers for Disease Control which has an Advisory Committee on Immunization Practices. The staging offered in the recommendations makes sense to the FEHBlog, e.g., first responders first etc.

The Wall Street Journal reports that Americans should add strong ventiliation to the Covid-19 prevention toolbox along with mask, social distancing, etc.

After urging steps like handwashing, masking and social distancing, researchers say proper ventilation indoors should join the list of necessary measures. Health scientists and mechanical engineers have started issuing recommendations to schools and businesses that wish to reopen for how often indoor air needs to be replaced, as well as guidelines for the fans, filters and other equipment needed to meet the goals.

There’s a recently renovated office building near the FEHBlog’s offices in downtown DC that has a big outside sign stating that its ventilation services are tops and known to be anti-COVID. The FEHBlog will retry to remember to post a picture of the sign later this week.

Becker’s Health IT discusses a Centers for Medicare and Medicaid Services proposed rule issued yesterday. “The Medicare Coverage of Innovative Technology proposed rule would speed up the FDA approval process for Medicare coverage of new medical technologies. * * * Often referred to as the “valley of death,” for innovative medical tech products, the lag time between the FDA’s approval and Medicare establishing coverage prevents seniors from accessing these new technologies during the coverage determination process.” Ouch.

Speaking of innovation, Econtalk podcast host and economist Russ Roberts speaks this week with author Matt Ridley about his fascinating book titled “How Innovation Works.” Check it out.

In other news

  • EHR Intelligence reports “Following vote in the House of Representatives to remove the bill prohibiting the use of federal funds for the adoption of a national patient identifier (NPI), the Premier Healthcare Alliance and the Patient ID Coalition call on the US Senate to also lift the ban.” Good luck.
  • FYI, here’s a link to Treasury Secretary’s Steven Mnuchin’s testimony before the COVID-19 subcommittee of the House Oversight and Reform Committee. The federal employee press does not suggest that fireworks exploded at the hearing.
  • The Department of Health and Human Services announced today that “The Federal Communications Commission (FCC), HHS, and U.S. Department of Agriculture (USDA) today announced that they have signed a Memorandum of Understanding to work together on the Rural Telehealth Initiative, a joint effort to collaborate and share information to address health disparities, resolve service provider challenges, and promote broadband services and technology to rural areas in America.” Perhaps another silver lining in the COVID-19 cloud.
  • And then another. The HHS Agency for Healthcare Research and Quality explains that

There is evidence that people who receive longer-term treatment with medications for addiction treatment (MAT) have better outcomes. But, keeping people with OUD on MAT is challenging. Now, the COVID-19 pandemic may be making retention of patients in MAT even more difficult.

Fortunately, we can report some good news that should help us fight the opioids epidemic even as we try to maintain safe distance. It appears that people with OUD will stay in treatment when given support remotely as they do in person—a major benefit that appears to be emerging during the COVID pandemic.

Monday Roundup

David Ermer–CDC, COVID-19, OPM, Rx coverage, Telehealth, U.S. Healthcare–

The Wall Street Journal provides a roundup on the status of the front runners in the race for a safe and effective COVID-19 vaccine. “Nine of these have advanced into Phase 3, which tests whether the dose that would be given to the public works safely.” The Phase 3 candidates fall into one of the following three vaccine approaches

Genetic-code vaccines deliver specific genetic instructions teaching the body’s cells to make a protein from the targeted virus, which in turn induces an immune response. One type incorporates a synthetic, engineered version of messenger RNA, or mRNA. These are molecules in the body that ferry DNA instructions for making immune-inducing proteins. Other gene-based vaccines use DNA itself.

A virus-based vaccine uses a killed or weakened form of the targeted virus to induce an immune response.

Viral vector vaccines use a modified virus different from the targeted virus to serve as a carrier of the vaccine teaching the body’s cells to make a protein from the targeted virus.

Candidates at the Phase 2 trial level are also using a protein-based approach that “incorporates a protein from the virus, or something resembling it, that will trigger an immune response.” The more, the merrier, right?

With respect to other COVID-19 ramifications:

  • Healthcare Dive discusses CDC surveys on the estimated 40% of Americans experienced a reduction in access to healthcare during the great hunkering down while Fierce Healthcare discusses how hospital systems are reacting to the drop.
  • The Healthcare Dive article also points out a “”separate CDC RANDS survey found that nearly 37% of people said their provider now offers a form of telehealth, compared to about 14% who said it was offered before the pandemic” while Health Payer Intelligence discusses what it takes to for health plans to build upon the uptick in virtual care.

In other healthcare news:

  • Fierce Healthcare reports on a new Aetna plan design for mid-sized and large employers in the Kansas City metropolitan area. “While the PPO plan will offer access to many regional providers, CVS’ HealthHubs and MinuteClinics are deeply embedded in the plan design, Aetna said.”
  • The Health Care Cost Institute released a study of its voluminous health plan claims data finding that “commercial [health plan] prices paid for the average professional service were 122% of what would have been paid under the Medicare Physician-Fee-Schedule.” The report looks at this comparison from several different angles.
  • Drug Channel analyzes GoodRx’s decision to make public stock offering. GoodRx offers prescription drug savings to consumers.

In follow up news:

  • Federal News Network reports on another National Finance Center announcement hitting the brakes on its earlier announced plan to implement the President’s August 8 executive order permitting employers to defer payroll taxes for certain employees as early as the first paycheck in September.
  • A Delaware Chancery Court judge, according to Fierce Healthcare, has decided that neither Anthem nor Cigna should receive damages as a result of the 2017 breakup of their planned merger. Hopefully that’s the end of this saga.

Weekend update

David Ermer–Congress, COVID-19, Employee Wellness Programs, U.S. Healthcare–

Photo by Dane Deaner on Unsplash

Congress remains out of town until next week following Labor Day. The Treasury Secretary Steven Mnuchin appears before the House Oversight and Reform Committee’s COVID-19 subcommittee at 1 pm on Tuesday. You can expect member questions about the Administration’s application of the President’s executive order on employment taxes to the federal workforce which take effect the same day.

Here are a few stories that recently caught the FEHBlog’s eye:

  • Mhealth Intelligence reports that “The crowded, clamorous, stuffy, sniffly waiting room has long been the scourge of healthcare, a sign of both inconvenienced patients and overworked providers. It’s here that patients are asked to announce their presence, fill out forms and check their insurance, while staff sort through the data to match them to the right provider at the right time slot. Prodded by the pandemic, health systems are now using mHealth apps, online portals and telehealth platforms to handle those administrative tasks, so that a patient arriving at the hospital or doctor’s office is seen and treated as quickly as possible.” Hopefully that’s a trend that will continue and grow as it should tamp down contagious diseases.
  • Health Payer Intelligence informs us about a UnitedHealthcare study on employee wellness programs during the COVID-19 emergency. Most notably,

More than three-quarters (77%) of survey respondents who are employed and have access to wellness programs said the initiatives have made a positive impact on their health. Nearly half (48%) said the programs motivated them to pay more attention to their health; 38% said they helped lower stress; 36% said they increased physical activity; and 33% reported improved sleep. According to the survey, wellness programs helped 17% of respondents manage a chronic condition such as diabetes, while 17% said the health initiatives helped detect a disease or medical issue.
As for job performance among those who said the wellness programs made a positive impact on their health, 54% of employees said the initiatives helped reduce stress; 51% said they improved productivity; and 31% said they took fewer sick days. Among employees without access to
wellness programs, 71% of respondents said they would be interested in such initiatives if offered.

  • The University of Alabama at Birmingham announced that “Surgical patients are more likely to experience a postoperative infection if they have low health literacy, which is a limited capacity to understand and act on health information, according to results of a new study presented at the American College of Surgeons 2020 Quality and Safety Conference VIRTUAL.” Health plans should look into filling this literacy gap.
  • The National Law Review reports that

PROGENITY, INC. (“PROGENITY”), a San Diego-based biotechnology company that provides molecular and diagnostic tests agreed to a $49 million settlement for fraudulent billing and kickback practices. The settlement resolves claims that the biotechnology company fraudulently billed federal healthcare programs for prenatal tests and provided kickbacks to physicians to persuade them to order PROGENITY tests for their patients. * * * PROGENITY has agreed to pay $16.4 million to resolve similar fraudulent billing claims related to TRICARE and the Federal Employees Health Benefits Program through a separate civil settlement.

Friday Stats and More

David Ermer–CDC, COVID-19, Electronic health records, OPM, Uncategorized–

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 34th weeks of this year (beginning May 14 and ending August 26; 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:

Note that today, the CDC revamped its COVID-19 websites. Sharp eyed readers will notice the CDC changed the scale on this hospitalization chart since last Friday. In any event, both charts continue to move in the preferred downward direction.

The CDC added a webpage on how regular folks should select, wear and clean their protective masks. It should be helpful for health plans to share this CDC webpage on their own sites.

Also, Medpage Today interviewed Dr. Anthony Fauci about the ongoing development of monoclonal antibodies to treat COVID-19.

Fauci explained how the mechanism of monoclonal antibodies “is really one of a direct antiviral.” “It’s like getting a neutralizing antibody that’s highly, highly concentrated and highly, highly specific. So, the mechanism involved is blocking of the virus from essentially entering its target cell in the body and essentially interrupting the course of infection,” he said. While Fauci noted the success of monoclonal antibodies to treat Ebola, he added that they are not practical for other viruses that only last a day or two, where the virus may already be cleared once the patient receives the treatment. “If you have a disease that’s serious enough and prolonged enough, such as what we saw with Ebola, and what we are currently seeing with COVID-19, then you have enough opportunities to get the monoclonal antibody to actually work,” he added.

The article notes that work also is underway to develop these antibodies as an HIV treatment.

Managed Healthcare Executive News reports on issues that providers are encountering with electronic prior authorization and efforts to resolve those issues. For example,

[Rose] Moore says one of the obstacles to a more streamlined approach to prior authorizations is the lack of uniformity. “There must be greater collaboration between payers and providers to set universal guidelines on requirements, starting with the high-volume, low-complexity procedure types that consume the greatest administrative cost across the healthcare continuum,” says Moore.

That should be resolvable.

Finally, Govexec.com reports that “The government will begin deferring withholding payroll taxes for federal employees [beginning September 1] to fulfill a memorandum President Trump issued earlier this month, according to a notice from one of its payroll processors.” Because the executive order cannot and does not waive these taxes permanently, this action will get Congressional attention.

Thursday Miscellany

David Ermer–COVID-19 testing, OPM, U.S. Healthcare–

The Wall Street Journal reports “The Trump administration unveiled Thursday a $750 million deal to buy 150 million rapid Covid-19 tests from Abbott Laboratories, a move that would substantially expand the nation’s capacity for rapid testing.” As noted in yesterday’s post, this $5 antigen test, which received Food and Drug Administration emergency use authorization on Wednesday, ” is roughly the size of a credit card. The test could be administered in a doctor’s or school nurse’s office and uses technology similar to home pregnancy tests. It returns results in about 15 minutes.”

While on the subject of COVID-19 testing, Fierce Healthcare informs us that

Out-of-network costs for COVID-19 testing far outpace the costs for in-network tests, according to a new report from America’s Health Insurance Plans. The results suggest that price gouging is a significant problem under the pandemic, the group argues. The AHIP analysis finds that a test for the novel coronavirus costs on average $130 for commercial insurers. However, out-of-network providers charged more than $185 for 40% of diagnostic test and 25% of antibody tests, the lobby organization found.

Shameful. Congress should step in on this one.

In encouraging developments,

Fierce Biotech lets us know that

As the world scrambles to develop diagnostics, treatments and vaccines for COVID-19, one big question looms: How will we face the next pandemic? Johnson & Johnson and the U.S. Biomedical Advanced Research and Development Authority (BARDA) are teaming up once again to answer that.

Through a joint effort dubbed Blue Knight, the duo aims to boost innovation and “amplify” scientific and technological advancements to prepare for potential health threats—starting with COVID-19. They’ve picked seven startups from J&J’s global JLABS network to participate. The startups will receive up to $500,000 in support, as well as mentorship from BARDA and J&J to help them navigate R&D challenges and regulatory pathways and get medicines and tools to patients and healthcare workers as soon as possible.

and Healthcare Dive reports that

Aetna is partnering with WellBe Senior Medical, a relative newcomer, to deliver primary care services to about 10,000 high-risk seniors in their homes, according to WellBe CEO Jeff Kang, who is also a physician. The program launched in Atlanta last month and is now available for certain seniors in the Chicagoland area. For eligible seniors, this means access to at-home care 24 hours, seven days a week, lessening the burden of getting a ride to an appointment or venturing to a medical facility amid the pandemic. Even COVID-19 testing can be done in their homes. Aetna assigns eligible high-risk patients to WellBe, which is then responsible for managing their care and receives capitated payments from Aetna. Those eligible are typically seniors in their 80s with multiple chronic conditions, including diabetes, heart failure, osteoarthritis and dementia, Kang said in an interview with Healthcare Dive.

There are plenty of elderly annuitants in the FEHBP although most of them have primary Medicare coverage.

Finally in Office of Personnel Management new:

Office of Personnel Management acting Director Michael Rigas [considerately] has issued a new memorandum to agency heads Aug. 27 informing them that [under a new regulation] employees will no longer have to pre-schedule their annual leave prior to the third pay period before the end of the year, so that the agency can then cancel and restore it. [A]ny leave that is forfeited at the end of the year due to a national emergency where the employee was deemed essential and not able to take leave would automatically be considered “scheduled in advance” and restored into a separate leave account for later employee use.

and Govexec.com updates us on the upcoming Combined Federal Campaign. This annual charity drive for federal employees runs from Sept. 21 through Jan. 15, 2021.

Midweek update

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

On the COVID-19 healthcare front –

  • The Wall Street Journal reports this evening that

The U.S. Food and Drug Administration has granted emergency-use authorization to Abbott Laboratories for a $5 rapid-response Covid-19 antigen test that is roughly the size of a credit card. The low-cost, rapid-response test could be administered in a doctor’s or school nurse’s office and uses technology similar to home pregnancy tests. It returns results in about 15 minutes. * * *Abbott’s new test, called the BinaxNOW COVID-19 Ag Card, searches for virus proteins and is intended to be used for patients within seven days of feeling coronavirus symptoms. It involves a nasal swab administered by a health-care professional such as a doctor, school nurse or pharmacist. The swab is inserted into the card-like test.

  • Beckers Hospital Review reports that to the consternation of outside experts, the Centers of Disease Control (CDC) has advised that “people without symptoms don’t always need to be tested. The original guidelines recommended testing for all close contacts of known COVID-19 patients. The updated version says known contacts “do not necessarily need a test” if they don’t have symptoms. Exceptions can be made for vulnerable individuals and if clinicians or public health officials recommend testing.”
  • MedPage Today informs us that “Patients with COVID-19 should delay getting their influenza vaccine, not because of any evidence about how the virus affects vaccination, but in order to ensure others in the healthcare setting are not exposed unnecessarily, CDC officials said on a call with clinicians on Thursday [August 20].”
  • National Committee for Quality Assurance leaders discuss in the Health Affairs blog how the NCQA’s new digital quality measures are responsive to the COVID-19 public health emergency. In the FEHBlog’s view these digital changes which tie in with electronic health record interoperability advances, e..g., HL7’s FHIR API, will lead to health care quality improvements generally.

The Abbott Labs test is an important development from the FEHBlog’s perspective.

In COVID-19 developments outside of healthcare —

  • Bloomberg Government notes, as the FEHBlog expected, that “Representatives of Rite Aid Corp, Walgreens Pharmacy, OptumRx Inc., and Express Scripts Inc., all major pharmacy and pharmaceutical benefit manager chains, said they aren’t seeing major disruptions to order times for prescriptions this year.”
  • HR Dive discusses three COVID-19 workplace trends that are likely here to stay — expanded paid leave access, increased attention to employee and customer safety, and telework as an accommodation.
  • The Society for Human Resource Management summarizes new Labor Department guidance on tracking hours worked by teleworking employees who are subject to the Fair Labor Standards Act.

In other news —

  • The FEHBlog registered this evening for the FREE Health Payment Action and Learning Network’s virtual summit scheduled for October 13. You can register here. The FEHBlog has been attending this interesting event for a few years.
  • Healio reports that according to a new CDC report on teen vaccination rates in our country, “HPV and meningococcal vaccination coverage among adolescents aged 13 to 17 years in the United States continues to improve, although geographical disparities persist, according to findings published in MMWR. Researchers found that adolescents at or above the poverty line who lived outside a metropolitan statistical area (MSA) were less likely to have received an HPV or meningococcal vaccine than adolescents living in MSA principal cities.”
  • Health Payer Intelligence reports that “To further discover trends in COVID-19 mortality and the spread of the virus, researchers are increasingly leveraging geographic and population data for new insights on how the disease operates.” Investigations of all wide spread health problems can benefit from this geographic approach because after all healthcare is local.

Tuesday Tidbits

David Ermer–AHRQ, COVID-19, Rx coverage, SCOTUS, Telehealth–

The FEHBlog noted in the latest Weekend Update that the President had allowed pharmaceutical manufacturers until August 24 to present alternative to the President’s plan to tie American drug pricing to foreign benchmarks via executive order. As of August 22, the President was waiting for such a proposal. and according to STAT News today —

The pharmaceutical industry is weighing two drug pricing policies that it could offer as a trade to President Trump, in exchange for his dropping a different proposal that drug makers detest, according to three drug industry lobbyists and a summary of the potential changes obtained by STAT.

In the meantime, the White House has not taken any action to implement this executive order.

On the COVID-19 front —

  • The Boston Globe reports that “An international meeting of Biogen leaders at a Boston hotel in February led to roughly 20,000 cases of COVID-19 in four Massachusetts counties by early May, far more than the 99 previously identified, according to three scientists involved in a new study.” Wow. That was a super spreader event for sure.
  • STAT News discusses “four scenarios on how we might develop immunity to Covid-19.” Interesting read.

Also other news from New England, Healthcare Dive informs us that

Google is investing $100 million in “Amwell, one of the biggest telehealth companies in the country, in a concurrent private placement with Amwell’s initial public offering, the two companies announced Monday. As part of the multiyear partnership, Amwell will become Google Cloud’s preferred telehealth platform and Amwell will migrate its video capabilities over to Google Cloud.”

Amwell is headquartered in Boston, Massachusetts.

Via AHRQ.gov, the FEHBlog ran across this recent study of “National Inpatient Hospital Costs: The Most Expensive Conditions by Payer, 2017.” Here are the highlights:

In 2017, aggregate hospital costs for 35.8 million hospital stays totaled $434.2 billion.

The five most expensive inpatient conditions were septicemia, osteoarthritis, liveborn (newborn) infants, acute myocardial infarction, and heart failure. The 20 most expensive conditions accounted for slightly less than half of aggregate hospital costs.

The share of aggregate inpatient hospital costs by primary expected payer was 66 percent for Medicare and Medicaid combined, 27 percent for private insurance, and 3 percent for self-pay/no charge stays.

Septicemia ranked among the three most costly conditions in the hospital for all four expected payer groups

Conditions related to pregnancy and childbirth accounted for 4 of the top 20 most expensive conditions expected to be paid by Medicaid.

Medicaid was the only expected payer for which 3 of the top 20 most expensive conditions were related to mental and substance use disorders.

Finally, yesterday, the U.S. Supreme Court allocated oral argument time in Texas v. California case (No. 19-840) which raises the constitutionality of the Affordable Care Act for the third time before the Court.

The motions of the Solicitor General for divided argument and of the U.S. House of Representatives for enlargement of time for oral argument and for divided argument are granted, and the time is allotted as follows: 30 minutes for California, et al., 10 minutes for the U.S. House of Representatives, 20 minutes for the Solicitor General, and 20 minutes for Texas, et al. The motion of Ohio and Montana for leave to participate in oral argument as amici curiae, for enlargement of time for oral argument, and for divided argument is denied.

Monday Roundup

David Ermer–Congress, COVID-19, HIPAA Privacy and Security Rules, U.S. Healthcare–

Federal News Network reports on the Postmaster General’s testimony before the House Oversight and Reform Committee today. The article explains

The Postal Service has dealt with staffing issues as a result of the coronavirus pandemic. About 40,000 postal employees have contracted COVID-19 or have shown symptoms that have required them to quarantine. Several dozen employees have died.

[Postmaster General] DeJoy said employee availability during the pandemic peaked in July, but warned that staffing has been down by about 3-4% on average. The Philadelphia and Detroit metro areas, he added, are “significantly below normal route run rates” — in some cases 20% below normal staffing rates.

The Wall Street Journal discusses new thinking on public health measures to control the infection rate without shutting down businesses. Better late than never.

The experience of the past five months suggests the need for an alternative: Rather than lockdowns, using only those measures proven to maximize lives saved while minimizing economic and social disruption. “Emphasize the reopening of the highest economic benefit, lowest risk endeavors,” said [Harvard epidemiologist] Dr. [Michael] Mina.

In other words use social distancing, good hygiene and mask wearing and avoid super spreader events.

Research by Dr. Mina and others has shown that “super-spreader” events contribute disproportionately to infections, in particular dense indoor gatherings with talking, singing and shouting, such as at weddings, sporting events, religious services, nightclubs and bars.

Dr. Mina wrote this month on the importance of is “a shift in [COVID-19 testing] strategy toward a cheap, daily, do-it-yourself test that he says can be as effective as a vaccine at interrupting coronavirus transmission — and is currently the only viable option for a quick return to an approximation of normal life [pending a vaccine]. He advocates applying the nasal or saliva sample to a paper strip that would tell you whether or not you have the COVID-19 infection. This is a step beyond this month’s saliva test advances that must be delivered to a lab. Forbes provides more background here.

Here are a couple of updates on progress being made in the COVID-19 vaccine development process from Fierce Healthcare and MedCity News.

The Department of Health and Human Services announced today that its Office for Civil Rights (“OCR”), which enforces the HIPAA Privacy and Security Rules,

issued amended guidance on how the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule permits covered health care providers (e.g., hospitals, pharmacies, laboratories) and health plans to contact their patients and beneficiaries who have recovered from COVID-19 to inform them about how they can donate their plasma containing antibodies (known as “convalescent plasma”) to help treat others with COVID-19. OCR added health plans to the June 2020 guidance that explains how HIPAA permits covered health care providers and health plans to identify and contact patients and beneficiaries who have recovered from COVID-19 for individual and population-based case management or care coordination. The guidance also emphasizes that, without individuals’ authorization, the providers and health plans cannot receive any payment from, or on behalf of, a plasma donation center in exchange for such communications with recovered individuals.

Let’s wrap up the round up with two healthcare provider survey stories —

Hospital operating margins are severely depressed, down 96% since the start of the year through July compared with the first seven months of last year, not including the financial aid from the federal government, according to the latest report from Kaufman Hall.
When factoring in federal relief funds, operating margins were down 28% for the January to July period compared with the same period last year.
However, there appear to be signs of recovery. When zeroing in on operating metrics month-over-month from June to July, operating margins did improve 24%, which the consultant group said is likely due to a backlog in patient demand.

  • A friend of the FEHBlog called to his attention this Healthcare Innovation Group report on a Physicians’ Foundation survey of physician sentiments about COVID-19.

Weekend update

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

Yesterday, the House passed H.R. 8015 by a 257-150 vote. This bill would require a roll back of certain management changes at the Postal Service and provide the Postal Services with a $25 billion grant. The New York Times reports that

Senator Mitch McConnell of Kentucky, the majority leader, said plainly on Saturday that he did not plan to bring up a stand-alone bill in the Senate when lawmakers are at a stalemate over broader coronavirus relief legislation.

“The facts show the U.S.P.S. is equipped to handle this election, and if a real need arises, Congress will meet it,” he said in a statement. “The Senate will absolutely not pass stand-alone legislation for the Postal Service while American families continue to go without more relief.”

We shall see whether this House action leads to further talks between the House leadership and the White House.

No legislative action is scheduled to occur in either House of Congress this coming week, but some committee activity is scheduled. For example, the Postmaster General, among others, will testify before the House Oversight and Reform Committee tomorrow morning at 10 a.m. ET.

Forbes reminds us that tomorrow is the deadline for the prescription drug industry to provide feedback to the White House on its most favored nation drug pricing order.

President Trump postponed moving ahead with the executive order on drug pricing until Monday, August 24th, giving time to pharmaceutical manufacturers to come up with an alternative pricing proposal. In this respect, the executive order appears to be a one-month ultimatum to establish a bargaining position. If the Trump Administration isn’t satisfied with the alternative plan, it says it would push forward with the executive order. However, as of Saturday, August 22nd, drug makers have yet to offer an alternative pricing plan, and there’s no indication that the Trump Administration will reveal precise details of the executive order, let alone implement it in the next 48 hours. If the Trump Administration were to go ahead with, say, the IPI pilot program, it would likely face strong legal challenges.

Let’s face it in order to maintain the decreasing number of COVID-19 cases pending Food and Drug Administration (“FDA”) approval of a COVID-19 vaccine, we need (1) to maintain public health protections like social distancing, mask wearing, and avoiding super spreader events, (2) to be able to practically use a reliable, inexpensive COVID-19 test like the Yale saliva test, and (3)trust in medical researchers to bring more COVID-19 treatments on line.

With regard to the third point

Covid-19 clinical trials are now under way for 10 new monoclonal antibodies, known as mAbs in industry jargon, according to the Antibody Society, a professional association of researchers.

The most advanced are already in mid- and late-stage studies in newly diagnosed as well as hospitalized patients, and in people who haven’t yet been infected. If they clear testing, the drugs might be available as soon as early in the fourth quarter, according to Geoffrey Porges, an SVB Leerink LLC analyst.

In August, late-stage studies were launched evaluating Lilly’s lead antibody in hospitalized and nonhospitalized patients, and these could be completed before the end of the year, depending on how quickly patients are enrolled.

Regeneron expects to have the first data from its study of a monoclonal antibody in hospitalized and nonhospitalized patients by the end of September. The company could seek an emergency authorization based on the data if there is a strong indication the drug is blocking the virus.

  • The Wall Street Journal also reports this evening that that FDA ultimately gave emergency use authorization to convalescent plasma therapy treatment for hospitalized patients from COVID-19. This therapy also relies on antibodies. “For Covid-19 patients and the doctors who treat them, the designation opens up the possibility for faster and easier access to a promising treatment, while studies and clinical trials continue to explore who is helped and how much.”
  • Two former FDA commissioners, Doctors Scott Gottlieb and Mark McClellan offered an opinion piece published in the Wall Street Journal. They observe that

The development of drugs to treat Covid-19 is moving at a remarkable pace. The use of steroids is a major advance that is reducing the risk of death in hospitalized patients. Novel drugs, including manufactured antibodies that mimic the body’s immune response to the virus [referring to the monoclonal antibodies], are in late-stage development and could be available by the fall. There are about 750 drugs in screening studies (Phase II) or in large, definitive clinical trials (Phase III).

The challenge is to develop evidence as quickly as possible without compromising standards. Anytime there’s an unmet medical need, the tendency is to blame the Food and Drug Administration’s regulatory process. But if we don’t know what works, and what doesn’t, we’ll waste time and money on treatments that won’t help and may harm. Even if a vaccine is discovered and approved, the pandemic won’t end unless most Americans get vaccinated, which will require confidence in the product’s safety and efficacy.

Heartily agreed.

The FEHBlog ran across this interesting Health Payer Intelligence story about how Blue Cross and Blue Shield of Kansas City has created a social needs referral network.

The social needs referral network is a collection of community-based organizations that have partnered with Blue KC and that target social determinants of health needs in the Kansas City area. When Blue KC employees and provider partners come across a patient with a social determinants of health barrier, they can refer patients to these organizations.

In the spring of 2020, Blue KC launched an electronic platform to unify organization efforts, streamline social determinants of health screening data, and help Blue KC employees and provider partners more easily identify nearby community-based organizations that can meet particular patient needs.

Creative move.