Tuesday Tidbits

COVID-19

Tuesday Tidbits

David Ermer–ACA, COVID-19 vaccine, SCOTUS–

Good news! STAT News reports that “Moderna’s Covid-19 vaccine led patients to produce antibodies that can neutralize the novel coronavirus that causes the disease, though it caused minor side effects in many patients, according to the first published data from an early-stage trial of the experimental shot.” The FEHBlog will take it. What’s more, “The [Moderna] data roughly mirror the results from a similar vaccine being produced by Pfizer and BioNTech, which were released July 1.” Fingers remain crossed.

Healthcare Dive informs us about a FairHealth analysis which concludes that 

The median charge for hospitalized COVID-19 patients aged 23-30 was about $35,000, while those aged 51-60 had median charges of about $46,000.
The most common other illness found in those patients is chronic kidney disease or kidney failure. Nationally, those patients accounted for 13% of all hospitalized COVID-19 patients during the study period from January to May. The second most common comorbidity in all but one region is Type 2 diabetes, according to the study that looked at private healthcare claims. The exception, the South, had hypertension in that rank.
The report also found the most common venue for an initial COVID-19 diagnosis nationally was a traditional doctor's office. About 33% of COVID-19 patients sought help from an office, while 23% went to an inpatient facility, such as an emergency room. In the Northeast, about 7% of COVID-19 diagnoses in that region came via telehealth appointments, versus 6.2% from ER visits.

The Health Affairs Blog provides details on how the COVID-19 virus impacts people differently when viewed from a racial or ethnic perspective. These disparities deserve the attention of the healthcare industry.

We used data from the Medical Expenditure Panel Survey to explore potential explanations for racial-ethnic disparities in coronavirus disease 2019 (COVID-19) hospitalizations and mortality. Black adults in every age group were more likely than whites to have health risks associated with severe COVID-19 illness. However, whites were older on average than blacks. Thus, when all factors were considered, whites tended to be at higher overall risk compared to blacks, with Asians and Hispanics having much lower overall levels of risk compared to either whites or blacks. We explored additional explanations for COVID-19 disparities, namely differences in job characteristics and how they interact with household composition. Blacks at high risk of severe illness were 1.6 times as likely as whites to live in households containing health-sector workers. Among Hispanic adults at high risk of severe illness, 64.5 percent lived in households with at least one worker who was unable to work at home, versus 56.5 percent among blacks and only 46.6 percent among whites.

FYI, HealthIT.gov reports that at the request of Congress the federal government “is investigating strategies to improve patient identity and matching. Stakeholder input and insight into existing challenges and promising innovations in patient identity and matching will inform [Office of the National Coordinator of Health Information’s] ONC’s report to Congress on technical and operational methods that improve patient identity and matching. We invite all stakeholders to submit comments to identity.onc@hhs.gov by September 18, 2020.”

Supreme Court journalist Amy Howe reports that the U.S. Supreme Court has announced its oral argument calendar for October 2020. The calendar does not include the ACA constitutionality case, Texas v. California. The FEHBlog is willing to bet the ranch that the Supreme Court will uphold the ACA’s constitutionality (although it may remove the individual mandate from the statute which is what Congress intended when it zeroed out the individual mandate penalty).

In other litigation news, the FEHBlog discovered today that on August 3, 2020, at 2 pm, the U.S. District Court for the District of Columbia will hear oral argument on the Whitman-Walker Clinic’s motion to preliminarily enjoin enforcement of the recent HHS revised ACA Section 1557 rule. Section 1557 is the ACA’s individual non-discrimination provision. The FEHBlog is keeping an eye on this case.

Regrettably , Federal News Network reports that OPM has decided not to award any Presidential Rank award this year due to the disruptions created by the COVID0-19 emergency. The FEHBlog was honored ten years ago to participate in judging these awards. The FEHBlog was and remains very impressed by the work of the federal employees wh0 are nominated for these awards. Hopefully the awards which also were suspended for 2013 will return next year.

Monday roundup

David Ermer–Congress, COVID-19, HIPAA Privacy and Security Rules, OPM, Rx coverage–

The Wall Street Journal seeks to answer a question that the FEHBlog has been pondering — “Scientists Hoped Summer Temperatures Would Tamp Down Covid-19 Cases. What Happened?” “There are three likely reasons, public-health and infectious-disease experts said. They have to do with the current [relatively low] levels of immunity in the population, how the virus is transmitted [by respiratory droplets] and how people behave [/fail to follow public health guidance].” Oh well.

The Hill reports that “The two main health insurance lobbying groups, America’s Health Insurance Plans (AHIP) and the Blue Cross Blue Shield Association, wrote a letter to congressional leaders on Friday making a [wide] range of requests for the next coronavirus response package, expected later this month.” Check it out.

HHS’s Substance Abuse and Mental Health Services Administration today finalized a revised 42 CFR Part 2 rule intended to better facilitate coordination of patient care. Part 2, which dates back to 1975, applies to substance use disorder patient records held by certain federally assisted health care providers. Here is a link to the FAQs on the final rule. The next time that SAMHSA revises this rule it will do so to align the rule with the generally applicable HIPAA Privacy Rule in accordance with the CARES Act. The statutory deadline for this action is March 27, 2021.

Fedsmith offers an article discussing whether federal annuitants with FEHB coverage also should elect to purchase Medicare Part prescription drug coverage. Here is OPM’s guidance:

Part D: There is a monthly premium for Part D coverage. Most Federal employees do not need to enroll in the Medicare drug program, since all Federal Employees Health Benefits Program plans will have prescription drug benefits that are at least equal to the standard Medicare prescription drug coverage. Still, you may want to be aware of the benefits Medicare is offering, so you can help others make informed decisions. If you have limited savings and a low income, you may be eligible for Medicare’s Low-Income Benefits. For people with limited income and resources, extra help in paying for a Medicare prescription drug plan is available. Information regarding this program is available through the Social Security Administration (SSA). For more information about this extra help, visit SSA online at www.ssa.gov, or call them at 1-800-772-1213 (TTY 1-800-325-0778).

Supplement to Friday Stats

David Ermer–CDC, COVID-19–

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

Week141516171819
New Cases    180,867 177,930166,382180,917162,154144.995
New Deaths8,2419,88613,50411,12610,7458.949

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

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

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

Friday Stats and More

David Ermer–ACA, COVID-19, COVID-19 vaccine, Rx coverage–

This week’s chart of new COVID-19 cases (and deaths) is startling. Week 27 ended on July 9.

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What strikes the FEHBlog is that the number of COVID-19 related deaths has remained stable over this time period. If the number of new cases is a leading indicator of deaths, then the number of deaths should have steadily increased following week 20. That hasn’t happened. Why you ask? In the FEHBlog’s opinion, the at risk folks have been taking effective protective measures, and the doctors have learned better approaches to treating the disease.

On the COVID-19 vaccine front —

  • Medcity News reports that Moderna is making progress with its vaccine studies. If the studies prove successful, “The company said that it is on track to provide about 500 million and potentially up to 1 billion doses of the vaccine annually starting next year.”
  • Fierce Pharma reports that “In separate interviews this week, Pfizer CEO Albert Bourla and BioNTech CEO Ugur Sahin said their mRNA vaccine candidate could be ready to submit to regulators in the fall or winter, respectively, pending success in a massive pivotal study yet to kick off.”

Fingers crossed.

Pharma Catalyst informs us that “more than 20 leading biopharmaceutical companies are launching the AMR Action Fund, a ground-breaking partnership to invest nearly $1 billion to ensure a robust and diverse pipeline of new medicines to treat drug-resistant infections.” That’s important too.

The Affordable Care Act created “grandfathered plan” status for electing employer sponsored plans. Grandfather status exempts the plan from many of the ACA mandates. The Obama Administration used its regulatory authority to minimize the availability of this exemption. The Kaiser Family Foundation reported last year that 13% of employees were covered under a grandfathered plan. Most of the grandfathering occurs in the midwest. That’s more than the FEHBlog expected to find. In any event, today the Trump Administration’s ACA regulators issued a proposed rule to create two new flexibilities that would help employers preserve grandfather plan status. Here’s a link to the FAQ on the proposed rule.

Thursday Miscellany

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

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

Also on the ACA front, Fierce Healthcare reports that

The Affordable Care Act’s insurance exchanges could add more than 1 million new members because of the COVID-19 pandemic.

The analysis released Thursday by Avalere attributes the spike to special enrollment due to massive job losses caused by COVID-19. The boost in customers could cause more insurers to return to a market they have left after financial losses over the past few years.

“With unemployment rates at or near 10% in almost all states, many consumers have been separated from their previous employer-sponsored plans,” the analysis said. “The economics of Medicaid eligibility in many states and the recent boost to unemployment assistance indicate that many are turning to the exchanges for coverage.”

On the COVID-19 vaccine development front,

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

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

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

One of public health’s greatest accomplishments was eradicating smallpox back in 1979. To eradicate SARS-CoV-2, the virus that causes COVID-19 illness, we’ll need a vaccine that’s 70% effective—and 70% of the population will need to receive it, an FDA vaccine official said Wednesday.

That’s a higher bar than the FDA set last week. To pass muster at the agency, a COVID-19 vaccine will need to be at least 50% more effective than placebo, according to new FDA guidelines.

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

On the OPM front,

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

Midweek Update

David Ermer–Congress, COVID-19, Federal employment benefits, Medicare, OPM, Rx coverage, U.S. Healthcare–

A House of Representatives appropriations subcommittee approved by voice vote today the bill funding financial services and general government for the 2021 fiscal year. That bill encompasses OPM and the FEHBP. Yesterday’s FEHBlog post discussed the relevant substance of the bill considered today. The bill now moves onto full appropriations committee consideration.

Fierce Healthcare reports that “Healthcare leaders and health IT groups are calling on Congress to repeal a section of the law that prevents the U.S. Department of Health and Human Services (HHS) from working with the private sector to develop a nationwide patient identification strategy.” The advocates are pointing to the COVID-19 emergency as another reason for taking this sensible action. ” Amid the COVID-19 pandemic, contact tracing efforts are hampered without accurate demographic information that correctly identifies the right patient.”

Also, on the COVID-19 front, the National Institutes of Health (“NIH”) announced today that “The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, has established a new clinical trials network that aims to enroll thousands of volunteers in large-scale clinical trials testing a variety of investigational vaccines and monoclonal antibodies intended to protect people from COVID-19.”

The Wall Street Journal reports that

Drugmaker Emergent Biosolutions Inc. plans to work with Mount Sinai Health System in New York City to test whether a drug derived from the blood plasma of recovered Covid-19 patients can prevent infections in doctors, nurses and military forces. The proposed study, which the partners announced Wednesday, would add to efforts evaluating the coronavirus-fighting potential of experimental drugs made from plasma donated by recovered patients. If the drug proves to work safely, it could help protect health-care workers and other people working in essential jobs who are at high risk of infection until a vaccine is ready and perhaps even after.

On the general U.S. healthcare front Healthcare Dive reports that

Walgreens on Wednesday announced plans to open up to 700 primary care clinics across the country over the next five years in partnership with medical services provider VillageMD, and “hundreds more” after that. As part of the agreement, Walgreens will invest $1 billion in equity and convertible debt in Chicago-based VillageMD over the next three years, including a $250 million equity investment Wednesday. VillageMD will use 80% of the funds to pay for opening the clinics, called Village Medical at Walgreens, and integrate digitally with Walgreens.

and that

Walmart will now sell health insurance policies directly to its customers, a spokesperson told Healthcare Dive, confirming speculation sparked by job postings from the retailer for Medicare sales managers and insurance agents, first reported by the Arkansas Democrat Gazette. Analysts with SVB Leerlink said the move underscores the attractiveness of this market and the likelihood of increased competition over time, while Walmart’s reach across U.S. consumers — including seniors — has the potential to drive up volume for Medicare plans.

What’s more, Health Payer Intelligence discusses why some health plans seek out seriously ill members to wit “By developing a greater understanding of seriously ill populations, payers and policymakers can more accurately target their population health management strategies.”

And a Forbes columnist criticizes government telehealth parity mandates. The column provides an interesting perspective on the telehealth craze. As the FEHBlog’s late grandmother frequently advised “moderation in all things.”

Last but not least, FedWeek explores the OPM Federal Employees Benefits Survey to understand why some federal employees don’t enroll in our beloved FEHBP.

the survey found that of those not enrolled [roughly 19% of the surveyed population], 90 percent are obtaining health care through some other program, most commonly through a spouse’s employment and most commonly through the military TRICARE program. “Less than one percent of respondents said that they are not enrolled in FEHB and do not have health insurance because they do not think there is a need,” OPM said.

Monday Roundup

David Ermer–CDC, Congress, COVID-19, Medicare, OPM–

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

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

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

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

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

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

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

Weekend update

David Ermer–Congress, COVID-19 vaccine, SCOTUS–

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.

Thursday Stats and More

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

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 endingTotal CasesTotal Deaths

May 21
297,581
8,956
June 4148,2107,561
June 18161,2894,865
June 25199,2525,270
July 2304,4966,215

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–

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 allowed 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.