David Ermer, Author at Ermer and Suter PLLC

Weekend update

David Ermer–Congress, COVID-19 vaccine, SCOTUS–July 5, 2020July 5, 2020

The House of Representatives is engaged in Committee work this week. The Senate is on a State work period for the next two weeks. Meanwhile, according to Fierce Healthcare,

a collection of unions, business groups and policy institutes wrote to congressional leaders Wednesday asking for a provision on surprise medical bills to be included in the next coronavirus stimulus package. “We urge you to end surprise medical billing for all patients through the implementation of fair, market-based payments for out-of-network charges,” the letter said. The American Benefits Council, the AFL-CIO, the Business Group on Health and the American Health Policy Institute were among the groups that signed on to the letter.

That resolution is also the FEHBlog’s preference while provider groups often call for arbitration of some sort.

The U.S. Supreme Court has eight more cases to decide before its summer break. All of these cases were argued virtually in May 2020, and include one PPACA case involving the scope of the contraception mandate. Tomorrow is another decision day. This will be the first time in 24 years that the Supreme Court has released decisions in July. The most famous Supreme Court decision issued in July in the FEHBlog’s memory was the U.S. v. Nixon case decided July 24, 1974, which lead to the President’s resignation early the following month.

The Wall Street Journal brings us up to date on the state of COVID-19 vaccine development. Several candidates are headed into large scale final/phase 3 testing this month.

The U.S. federal government is planning to fund three 30,000-person trials starting this summer: Moderna Inc.’s vaccine starting this month, followed in August by a vaccine co-developed by University of Oxford and AstraZeneca PLC, and in September, a vaccine developed by Johnson & Johnson. Oxford’s vaccine recently began late-stage testing outside the U.S.
The scale is so large it means trials are effectively competing with each other for recruits. “One volunteer cannot be in two different studies. It’s a zero-sum game in that regard,” said Dr. Joseph Kim, chief executive of Inovio Pharmaceuticals Inc., which last week announced positive results in a small study and is preparing for a larger study. PRA Health Sciences Inc., which helps recruit trial patients, is mining busy Covid-19 testing locations, including public-health departments, testing labs and pharmacies, to find healthy volunteers, said Kent Thoelke, PRA’s chief scientific officer.

Fingers remain crossed.

On Friday, the FEHBlog suggested that readers check out last Monday’s Econtalk interview about healthcare reform. The discussion of Iora Health. Iora Health is a multi-state group practice which holds a Medicare Advantage plan contract and is looking to expand to employer groups. Their model is centered on the use of health coaches.

A Suggestion

David Ermer–U.S. Healthcare–July 3, 2020July 3, 2020

While enjoying the Fourth of July weekend with perhaps a favorite beverage, listen to or read the transcript of the Econtalk podcast in which the host Russ Roberts interviews Vivian Lee, MD, about her book on healthcare reform called The Long Fix. Ms. Lee was CEO of the University of Utah health system and she currently is an executive with Alphabet’s Verily Life Sciences. Very informative. Happy Fourth of July to all.

Thursday Stats and More

David Ermer–Congress, COVID-19, Federal employment benefits, Rx coverage–July 2, 2020July 2, 2020

As tomorrow is the federal holiday celebrating the Fourth of July, the FEHBlog will report COVID-19 stats today. It’s not pretty. The stats are based on the CDC’s COVID-19 Cases in the U.S. website.

Week ending	Total Cases	Total Deaths
May 21	297,581	8,956
June 4	148,210	7,561
June 18	161,289	4,865
June 25	199,252	5,270
July 2	304,496	6,215

The first row was the high point in new cases and new deaths over the past six weeks. The new cases are back at the mid-May level but deaths are still below mid-May (but above mid-June). The FEHBlog firmly believes that this new surge in cases will be more manageable than the first surge because doctors know how to manage the disease and treatments are available.

Senator Chuck Grassley (R Iowa), who is Chairman of the Senate Finance Committee, has introduced his Updated Prescription Drug Pricing Reduction Act of 2020. It’s worth noting that the Senator’s Committee approved the 2019 version of this bill last summer by a 19-9 vote. Sen. Grassley then worked with Sen. Ron Wyden (D. Ore.) to make the bill more bipartisan in nature. However, the bill has no Democrat Senator co-sponsors because after all this is an election year. There may wind being action on this bill in the lame duck session following the November election.

The Society for Human Resource Management offers three checklists to help employers avoid LGBTQ discrimination in their benefit programs following the recent Supreme Court decision including sexual orientation and gender identity within the scope of prohibited sex discrimination. Check it out.

The Department of Health and Human Services has posted its current list of sub regulatory guidance. The website explains that

On October 9, 2019, the President issued Executive Order (EO) 13891 entitled Promoting the Rule of Law through Improved Agency Guidance Documents (84 FR 552350). The EO requires HHS to establish a single, searchable, indexed database that contains links to all of HHS’s guidance documents currently in effect. Guidance documents come in a variety of formats, including interpretive memoranda, policy statements, manuals, bulletins, advisories, and more. Please note, the contents of this database do not have the force and effect of law and are not meant to bind the public in any way. These documents are intended only to provide clarity to the public regarding existing requirements under the law or HHS policies.

The FEHBlog looks forward to reviewing OPM’s companion site.

Speaking of OPM, Federal News Radio reports

Existing health and retirement benefits are a significant incentive for employees to take or keep a job in the federal government, according to the latest survey results from the Office of Personnel Management.
About 70% of those who took OPM’s 2019 benefits survey said the ability to receive insurance through the Federal Employee Health Benefits Program influenced their decision to a “great or moderate” extent to take a job in government, while 80% said the program influenced their decision to keep their jobs.

Hey what’s not to like? Great benefits and if you have FEHBP coverage for the five years preceding your civil service retirement you carry FEHBP coverage into retirement with the full government contribution. Well deserved benefits.

Midweek update

David Ermer–Congress, COVID-19 vaccine, OPM–July 1, 2020July 1, 2020

On the bright side, OPM has taken advantage of a recent IRS ruling. In Benefit Administration Letter 20-803

This BAL is issued pursuant to Internal Revenue Service (IRS) Notice 2020-29. As the Plan Administrator of FedFlex, OPM is permitting FSAFEDS Program participants to make certain mid-year changes for a limited period. OPM is not authorizing a new opportunity to enroll or make changes in enrollments under the Federal Employees Health Benefits (FEHB) Program or Federal Employees Dental and Vision Insurance Program (FEDVIP).
Under this BAL, participants who made an election to a DCFSA in the plan year ending December 31, 2019, can now use any 2019 funds remaining in their DCFSA account until December 31, 2020. The extended claim period is automatic for qualified participants.
Pursuant to BAL IRS Notice 2020-33, BAL 20-803 also allows an increase in the carryover amounts for HCFSA and LEX HCFSA from $500 to $550, beginning with funds remaining at the end of 2020 and carried over into 2021.Finally, OPM is extending the operational flexibilities discussed in BAL 20-201 past June 30, 2020, as necessary, depending on an agency’s operating status.

The FEHBlog heartily agrees with OPM’s decision not to create a special Open Season for FEHBP or FEDVIP because federal employees whose eligible family members have lost their employer sponsored coverage due to the COVID-19 emergency have the right under OPM’s regulations to switch their existing coverage to self plus one or self and family as necessary when a family member loses their employer sponsored coverage.

On the not so bright side, the Office of Federal Contractor Compliance Programs issued a final rule today that would subject FEHB network health care providers to federal contractor affirmative action requirements. It’s worth noting that these providers generally are subject to federal and state non-discrimination laws. The OFFCP affirmative action provisions call for time and employee consuming projects. Since the inception of the FEHB Acquisition Regulation in 1986, healthcare providers have been exempt from these requirements. Now OFFCP has overridden OPM’s approach which has allow FEHB networks to blossom. So much for deregulation. Hopefully OFCCP eventually will come to it senses as suggested on page 25 of the final rule.

On the COVID-19 vaccine front, Fierce Pharma reports

With the eyes of the world turned on the global COVID-19 vaccine race, Pfizer and its partner BioNTech posted early positive data from one of their four candidates. With this first win—and other data yet to come—the partners are prepping for a late-stage test that could begin as early as this month.
In a phase 1/2 trial, all participants who received 10 micrograms (mcg) or 30 mcg of the mRNA vaccine candidate generated antibodies that were 1.8 times and 2.8 times higher, respectively, than the average of a group of patients who had confirmed prior infections.
Importantly, this was a small, early-stage test with just 45 participants, and the vaccine has not yet proven it can prevent COVID-19. To win a full regulatory approval, the partners will have to run a large efficacy study in thousands of participants to demonstrate whether the vaccine prevents disease.

Hope springs eternal.

Healthcare IT News reports that “CMS [had create[d a] new Office of Burden Reduction and Health Informatics In addition to reducing the hours and costs clinicians and providers incur for CMS-mandated compliance, the office will also focus on how health data can be harnessed for more efficient healthcare and improved patient experience.” Bravo.

On the COVID-19 emergency relief front, according to the Wall Street Journal the House today joined the Senate in passing by unanimous consent legislation (S. 4116) extending the Paycheck Protection Program loan application period through Aug. 8. The PPP loan deadline expired last Tuesday. The President is expect to sign the bill into law.

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.

Weekend Update

David Ermer–Congress, COVID-19, Rx coverage, SCOTUS, U.S. Healthcare–June 28, 2020June 28, 2020

The House and Senate will be conducting legislative and committee business this week preceding the Fourth of July holiday. Of note, on Tuesday at 10 am the Senate Health Education Labor and Pensions Committee will hold a hearing on ways to return to work and school safely following the great hunkering down.

The Supreme Court has thirteen more opinions to release before its summer break. The Court is expected to release opinions on Monday, Tuesday, and Wednesday this week, all at 10 am.

On the COVID-19 front —

Fierce Healthcare discusses how the Walgreen’s Pharmacy chain has leveraged its partnership with Microsoft and other technology companies to better respond to the COVID-19 emergency.
A few weeks ago, the Journal podcast offered a fascinating show on the Hertz bankruptcy. It’s worth a 17 minute long listen. The story highlights how a strong balance sheet helps companies weather storms like the COVID-19 emergency. Becker’s Hospital Review identifies 14 well known health systems in this favorable situation, including Kaiser Permanente. It’s not an exclusive list.
Healthcare Dive reports on the significant adverse financial impact that the COVID-19 emergency has had on primary care practices in the U.S. Surprisingly that article does not note that these practices have been eligible for Payroll Protection loans and federal grants. The government deserves credit for trying to soften the blow to this critical sector of our health care system. Tuesday June 30 is the deadline for applying for a PPP loan.

On the human nature front, the Wall Street Journal reports that COVID-19 first responders have been relaxing by playing a boardgame called Pandemic.

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.

Midweek update

David Ermer–COVID-19, Rx coverage, U.S. Healthcare–June 24, 2020June 24, 2020

Fierce Healthcare reports on PriceWaterhouseCooper’s three tier approach to estimating 2021 health care costs. Of course, the variable is impact of the COVID-19 emergency. The Goldilocks increase is estimated at 6%.

Fierce Pharma informs us that Gilead’s as yet unpriced remdesivir treatment for severe COVID-19 has gained stiff competition for a “low-cost [drug called] dexamethasone.”

According to results just published on preprint site medRxiv, dexamethasone treatment led to a 35% reduction in death rate among patients on invasive mechanical ventilation and 20% for those receiving oxygen without invasive ventilation.
Because of that showing, clinical experts told ICER that dexamethasone could soon become the new standard of care throughout the U.S., “and that the relative benefits of remdesivir will now be judged to be most pertinent as an adjunct to dexamethasone treatment,” the organization noted in its new analysis. In the ACTT-1 trial, the death rate for remdesivir among severe patients were reduced to 7.7% from 13% for placebo, a difference that was not statistically significant.

Both drugs remain under study.

Smartbrief offers four innovative approaches for payers in the post hunkering down world. The FEHBlog’s favorites approach is as follows:

Humana Vice President Caraline Coats defined whole person care through the lens her company’s Bold Goal initiative uses: Primary care, social determinants of health, pharmacy, home health and behavioral health. Their work strives to help members in targeted communities enjoy more Healthy Days per month – when they feel physically and mentally well. A lot of their progress comes down to taking the time to ask members the right questions, and then having the ability to act on what is learned.
In an industry built around episodic care, “whole-person care is really different,” Coats said, and it is still being defined. So, her team’s work looks a lot like vetting of clinical interventions: rigorous testing, followed by publication of results so others may learn, too. Among their recent promising experiments is a partnership with Mom’s Meals to meet the needs of certain members with diabetes and a program with Papa (which provides companionship and help with everyday tasks) that measurably brought down loneliness scores among participants.

Meanwhile Blue Cross and Blue Shield of North Carolina is offering monetary support to primary care practices in that State. That’s quite a helping hand. Bravo.

On the technology front —

Anthem, the large Blue Cross licensee, is now an Alexa skill. Currently

Using the Anthem Skill, you can:

Order your digital member ID card.
Access your health savings account (HSA) or health reimbursement account (HRA) balance.
Check your progress toward meeting your medical plan’s deductible and out-of-pocket maximum.
Schedule a call with someone from our Member Services team.
Refill, renew and check the order status of any home delivery prescription medicines.
Find out how close you are to reaching your dental plan’s deductible and annual maximum.
Use the glossary to learn what a health care term means.

STAT News has an interesting article about about how North Dakota is testing a contacts app with COVID-19 patients. The app was developed by a Microsoft engineer for use with North Dakota football games. Unfortunately, however, according to the article:

While apps can’t replace health care workers, they may be used to bolster their efforts — so long as enough people use them. So far, though, that hasn’t gone as planned: Early excitement over cutting-edge technology has given way to a largely lackluster role for contact tracing apps. Many states have opted against adopting the tools as part of their arsenal. And the handful of states that are launching such apps — including North Dakota — haven’t seen them gain much traction.