According to the Wall Street Journal and Bloomberg, legislative negotiations continue over the latest COVID-19 relief bill. This bill will be added to the omnibus spending bill for the federal government’s current fiscal year. That bill is ready to go. In order to allow time for the relief bill negotiations to conclude successfully, it’s likely that tomorrow Congress will extend the current continuing resolution into next week.

On the COVID-19 front —

• The Food and Drug Administration yesterday “issued a new Emergency Use Authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test for at-home use with a prescription. The BinaxNOW COVID-19 Ag Card Home Test is an antigen test that detects fragments of proteins from SARS-CoV-2, the virus that causes COVID-19, from a nasal swab sample. It is authorized for use at home with self-collected samples in individuals age 15 years or older who are suspected of having COVID-19 by a health care provider within the first seven days of symptom onset. The test is also for use with individuals aged four years or older who are suspected of having COVID-19 by a health care provider within the first seven days of symptom onset, when an adult collects the sample.The BinaxNOW COVID-19 Ag Card Home Test is being offered in partnership with eMed Labs, LLC., a telehealth service that will take users step-by-step through the sample collection process, explain how to perform the test, and provide assistance in reading and understanding the results.”
• Today the Centers for Disease Control (“CDC”) released a report concluding that the COVID-19 virus can be transmitted person to person on a commercial airline. The report was based on an analysis of a commercial airline trip that occurred in Australia last March before people began to take protective measure seriously. The CDC’s point though is well taken. Be careful.

In other Health and Human Services Department news —

• Today HHS released “the first-ever national plan to address the public health crisis caused by alarming increases in rates of sexually transmitted infections (STIs) in the United States over the past six years. The STI National Strategic Plan 2021-2025 (STI Plan) sets national goals, objectives, and strategies to respond to the STI epidemic. The plan will serve as a roadmap to help federal and non-federal stakeholders at all levels and in all sectors reverse the sharp upward trends in STI rates.”
• Also today, “the Office for Civil Rights (OCR) at HHS released its 2016-2017 HIPAA Audits Industry Report that reviewed selected health care entities and business associates for compliance with certain provisions of the HIPAA Privacy, Security, and Breach Notification Rules.” Although the report is somewhat dated, the summary of findings likely are still relevant, in the FEHBlog’s view:

• Most covered entities met the timeliness requirements for providing breach notification to individuals;
• Most covered entities that maintained a website about their customer services or benefits satisfied the requirement to prominently post their Notice of Privacy Practices on their website;
• Most covered entities failed to provide all of the required content for a Notice of Privacy Practices;
• Most covered entities failed to provide all of the required content for breach notification to individuals;
• Most covered entities failed to properly implement the individual right of access requirements such as timely action within 30 days and charging a reasonable cost-based fee;
• Most covered entities and business associates failed to implement the HIPAA Security Rule requirements for risk analysis and risk management. 

The announcement concludes — “The audit results confirm the wisdom of OCR’s increased enforcement focus on hacking and OCR’s Right of Access initiative,” said OCR Director Roger Severino. “We will continue our HIPAA enforcement initiatives until health care entities get serious about identifying security risks to health information in their custody and fulfilling their duty to provide patients with timely and reasonable, cost-based access to their medical records.”

ArsTechnica offers a comprehensive update on the SolarWinds hack.

The supply chain attack used to breach federal agencies and at least one private company poses a “grave risk” to the United States, in part because the attackers likely used means other than just the SolarWinds backdoor to penetrate networks of interest, federal officials said on Thursday. One of those networks belongs to the National Nuclear Security Administration, which is responsible for the Los Alamos and Sandia labs, according to a report from Politico.

“This adversary has demonstrated an ability to exploit software supply chains and shown significant knowledge of Windows networks,” officials with the Cybersecurity Infrastructure and Security Agency wrote in an alert. “It is likely that the adversary has additional initial access vectors and tactics, techniques, and procedures (TTPs) that have not yet been discovered.” CISA, as the agency is abbreviated, is an arm of the Department of Homeland Security.

Elsewhere, officials wrote: “CISA has determined that this threat poses a grave risk to the Federal Government and state, local, tribal, and territorial governments as well as critical infrastructure entities and other private sector organizations.”

So the hacking effort may expand beyond the identified Solarwinds “backdoor.” Wow.

Both Houses of Congress are on break this week for the Thanksgiving holiday.

We will be half way through the current Federal Benefits Open Season in the middle of this coming week. Open Season ends on December 14.

Believe or not, there was one more HHS final rule issued last Friday on top of three others discussed in Friday Stats and More. The Centers for Medicare and Medicaid Services “finalized a rule that is designed to increase the supply of lifesaving organs available for transplant in the United States by requiring that the organizations responsible for organ procurement be transparent in their performance, highlighting the best and worst performers, and requiring them to compete on their ability to successfully facilitate transplants.”

Healthcare Dive reports that even though COVID-19 hospitalizations have been surging in the our country at least the large hospital chains are weathering this COVID-19 storm better than the earlier surges this year.

Top executives from hospital chains Tenet and UHS said that’s because there aren’t as many unknowns as in the previous coronavirus surge earlier this year, speaking this week at Wolfe Research’s virtual healthcare conference.

“Yes, we are seeing increases across the country. Clearly that is what you read, but it’s not anywhere near where we’re not able to handle it,” Tenet CEO Ron Rittenmeyer said Wednesday.

Tenet has more facilities in Texas than any other state, and reports on the ground there paint a far more harrowing picture, though. Hospitals across the country say they are overrun, and some have had to halt or pare back on elective procedures to ensure they have enough staff and equipment to care for COVID-19 patients.

​For UHS’ acute care hospitals, the second wave around the July timeframe was much worse than what they’re experiencing today, CFO Steve Filton said Thursday — though UHS does have two hospitals, both in Texas, with record levels of COVID-19 patients.

The Wall Street Journal reports that

The billionaire Walton family that controls Walmart Inc. is among a group of investors backing a startup aiming to design at-home Covid-19 tests to sell for as little as $10 at the retail giant’s stores and elsewhere.

NowDiagnostics Inc., based 20 miles south of Walmart’s corporate headquarters, has filed requests for emergency authorization from the U.S. Food and Drug Administration for a Covid-19 antibody blood test, according to the Springdale, Ark., company.

It is also developing two at-home Covid-19 tests that would use a patient’s saliva and deliver results in minutes, said Chief Executive Kevin Clark. One of those would be an antigen test that looks for virus proteins to diagnose an active infection and the other an antibody test, which looks for an immune response that can signal a previous infection. None of the tests have been authorized by the FDA for use.

The Boston Globe offers this attention-grabbing quote (and more)

“The [COVID-19] virus is not likely to go away, maybe ever, but certainly not for a long time,” said Dr. Ashish Jha, dean of the Brown University School of Public Health. “But that said, we’re not going to be living like this forever, and in fact, I expect by springtime that things will start really getting much, much better [due to the Pfizer / BioNTech and Moderna vaccines]. And then it’ll continue to get better. And at some point, we will no longer feel like we’re living in the middle of a pandemic.”

Though experts varied on how quickly these things might happen, with some saying it could be summer before a shift toward normalcy begins, all agreed on the rough outline: As vaccination increases, major outbreaks will decrease in size and frequency and restrictions will gradually lift.

Our new normal will not be without its reminders of the pandemic, experts said. A high level of public health surveillance will be crucial to monitoring and preventing outbreaks. Taking a rapid test before eating out or starting work could well be part of our new normal. And because COVID-19 could recede at different times in different countries based on vaccine availability, travel screening and some level of international border restrictions could remain in place for years to come.

In this regard, the Wall Street Journal opines that “Even after a Covid-19 vaccine, changes to how we shop, dine, work out and entertain ourselves are likely to endure.”

As marketers of new technologies can tell you, the hardest part is getting people to adopt new ways of doing things. But this tendency also means that new innovations can be sticky: Once a habit is established, it’s not easily broken.

During the pandemic, 10 years of consumer adoption of e-commerce was compressed into three months, according to a recent survey by McKinsey. Adoption has varied by age, since younger people were already more likely to shop—and do everything else—online. A survey just out from digital consultancy Mobiquity found a 47% increase in the number of baby boomers reporting they had ordered delivery from a restaurant through a website or app; a 193% increase in the number ordering groceries through a website or app; and a 469% increase in the number who had used telemedicine. Nearly 9 in 10 boomer respondents said they’ll continue to use such technologies even after the pandemic ends.

Count this boomer in.

Because OPM’s press release links to 2020 premiums, here are OPM’s charts for

• 2021 Non Postal Nationwide / Fee for Service Premiums
• 2021 Non Postal HMO Premiums
• 2021 Postal Nationwide / Fee for Service Plan Premiums
• 2021 Postal HMO Premiums

OPM also distributed this interesting chart comparing nationwide fee for service plan and local HMO plan premium increases for 2021.

FEHB plans post benefit change information on their respective websites before OPM does next month. Blue Cross FEP and Kaiser, among others already have done so.

On the pharmacy / PBM front —

• Fierce Healthcare reports on Cigna CEO David Cordani’s talk at the HLTH Conference yesterday and Drug Channels discusses the improving relationship between Prime Therapeutics and Cigna’s PBM Express Scripts.
• Fierce Healthcare also reports on the HLTH Conference talk by Jim Peters, Rite Aid’s chief operating officer, speaking at the HTLH 2020 virtual conference. It appears that Rite Aid is looking to pull the Health Hub page out of CVS Health’s playbook.

Today, the American Hospital Association’s lawyers argued before a three judge panel that the U.S. Court of Appeals for the D.C. Circuit should reverse the District Court’s decision upholding an HHS rule requiring to post payer-negotiated rates for popular hospital services. The AHA’s lawyer wants to place this burden on the health plans. A friend of the FEHBlog told him that the oral argument was “wild.” Unfortunately, the FEHBlog’s MacBook Air could only get through five minutes of the online argument. In any event Fierce Healthcare reports that the oral argument did not go well for the AHA’s lawyers. “The judges, all of which were appointed by Democratic presidents, were skeptical of the AHA’s argument that HHS doesn’t have the authority to implement the rule.” The appellate court will release a decision in three months or so.

Federal News Network reports that OPM is creating a new federal pay locality for Des Moines Iowa and expanding the Los Angeles pay locality to include Long Beach California. The change affects 3,800 Iowa employees and 1860 California employees. However, “Trump’s federal pay plans for 2021 may also complicate matters. The president proposed a 1% across-the-board pay raise for federal employees next year. To date, he hasn’t proposed any locality pay adjustments, and Congress hasn’t suggested it will step in and pass its own raise for federal workers, meaning employees in Iowa and California may not see a change in 2021.”

The FEHBlog was wondering today whether any progress has been made in the COVID-19 relief bill negotiations. CNET has the answer. Not much. But you never know in an election year.

Finally Forbes reports

According to the results of the Envoy Return to Work Survey that was released today, 73% of Americans are afraid of putting their personal health and safety at risk by returning to the workplace, with 75% saying they would consider quitting their jobs if the Covid-19 prevention measures by employers were inadequate or inappropriate. Workers in the business or tech services are more likely to consider leaving their job than those in the construction, manufacturing, retail or service industries. * * *

Their concerns notwithstanding, 90 percent of workers miss their workplace. Most miss their friends and teammates (47%), perks such as lunch and snacks (36%), and small talk at the coffee machine or water cooler (31%). Slightly more workers — 94% of those polled — said they want to spend at least one day a week in the office.

The survey indicates that some employers need to do a better job ensuring that the workplace is safe to come back. Of those who returned to their place of employment, 42% said they experienced preventive measures that were either ineffective or not enforced, including six-foot distancing measures (25%), mask requirements (21%), and hand washing requirements (18%).

What a crazy year.

The Hill reports that

House Democrats reached a deal with Republicans on legislation to avert a government shutdown after rekindling talks over disputed farm assistance, with a vote planned as soon as Tuesday night [/ tonight]. Speaker Nancy Pelosi (D-Calif.) said in a statement that Democrats had reached an agreement to add nearly $8 billion in nutrition assistance for low-income children and families in exchange for “accountability” in assistance for farmers sought by the Trump administration.

Yippee. Duly predicted by the FEHBlog.

The Wall Street Journal reports‘ that

U.S. health regulators have drafted guidelines that would require a Covid-19 vaccine to meet rigorous standards to gain clearance for use, according to people familiar with the matter. Among the proposed requirements is that a coronavirus shot reduce the rate of infections by 50% compared with placebo, which the regulators have already required for a regular approval of any Covid-19 vaccines. The Food and Drug Administration (FDA) submitted the draft plan for review last week to Secretary of Health and Human Services Alex Azar, according to the people. The White House Office of Management and Budget is also reviewing the plan, the people said.

Rigorous. Good. People are more likely to trust vaccines that have been subjected to rigorous standards. A

Speaking of the FDA, that agency today “announced it is launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). The launch of the Digital Health Center of Excellence is an important step in furthering the agency’s overarching dedication to the advancement of digital health technology, including mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and technologies used to study medical products.” Good move.

The Centers for Medicare and Medicaid Services announced today “that it will expand the Medicare Prior Authorization Model for Repetitive, Scheduled Non-Emergent Ambulance Transport (RSNAT) nationwide. The model has saved Medicare about $650 million over four years while preserving quality of care and access to essential services. * * * [Today’s] Second Interim Evaluation Report * * * found that the model reduced RSNAT service use by 63% and RSNAT expenditures by 72% among beneficiaries with end stage renal disease and/or severe pressure ulcers during the first four years of the model. This decrease in RSNAT service expenditures, in turn, caused a total decrease of Medicare fee-for-service (FFS) expenditures of 2% (about $650 million over four years). The report did not find evidence that the model adversely affected quality of care.” It’s good news that CMS has found a way to reduce the cost of this service which is important to Medicare beneficiaries,