New CDC Guidance

CDC

New CDC Guidance

David Ermer–CDC, COVID-19–

NPR reports that

President Trump said Friday the Centers for Disease Control and Prevention now recommends that people wear cloth or fabric face coverings, which can be made at home, when entering public spaces such as grocery stores and public transit stations. It is mainly to prevent those people who have the virus — and might not know it — from spreading the infection to others.

The guidelines do not give many details about coverings beyond: “cloth face coverings fashioned from household items or made at home from common materials at low cost can be used as an additional, voluntary public health measure.” * * * And the mask need not be professional-grade to offer some benefit. In fact, officials say it probably shouldn’t be: The CDC recommends constructing your own cloth mask.

The New York Times provides guidance on how to make your own mask. The FEHBlog can’t think of a more fun activity for the weekend.

Thursday Miscellany

David Ermer–CDC, COVID-19, HIPAA Privacy and Security Rules–

Healthcare Dive helpfully reviews the benefit improvements that large health insurers have made in response to the COVID-19 emergency.

Hospitals say that’s not enough, and are calling on the biggest payers to follow actions taken by Congress and CMS to help resolve cash flow issues, by accelerating payments or opting into releasing interim periodic payments. The American Hospital Association also is urging payers to eliminate administrative burdens such as prior authorizations.

The more things change, the more they stay the same.

Beckers Hospital Review reports that “Peak demand for hospital resources due to COVID-19 is expected by mid-April in the U.S., according to an analysis from the University of Washington’s Institute for Health Metrics and Evaluation in Seattle.” The report provides an expect peak demand date for each State in the Union and DC.

The HHS Office for Civil Rights which enforces the HIPAA Privacy and Security Rules loosened another Privacy Act provision for the duration of the COVID-19 emergency —

As a matter of enforcement discretion, effective immediately, the HHS Office for Civil Rights (OCR) will exercise its enforcement discretion and will not impose potential penalties for violations of certain provisions of the HIPAA Privacy Rule against covered health care providers or their business associates for uses and disclosures of protected health information by business associates for public health and health oversight activities during the COVID-19 nationwide public health emergency.

Although this is really inside the Beltway, the FEHBlog, as a lawyer, finds it noteworthy to relate that, according to Govexec.com, the Office of Management and Budget “is not directing agencies to extend the amount of time alloted for public feedback on regulation changes during the coronavirus outbreak, despite calls from [House Democrat] lawmakers to do so.”

Finally, the FEHBlog notes that according to the Boston Globe’s Stat News, rumblings about masking the American public continue.


In a draft document obtained by STAT, the CDC recommended that the public use homemade face coverings when in public, reserving higher-grade protective equipment like N95 masks for hospitals and health care workers, who have faced severe shortages in personal protective equipment as the coronavirus pandemic has accelerated through the United States.

Such face coverings, according to the draft guidance, would not be intended to protect the wearer, but rather prevent the wearer from unknowingly spreading the disease when in public. Individuals should wear face coverings in public settings like grocery stores, the guidance said. Children under the age of 2 and people experiencing trouble breathing would be excluded from the mask guidelines.

Weekend update

David Ermer–ACA, CDC, Congress, COVID-19–

Congress is on a State / district work period this week. The Health Affairs blog discusses the health coverage provisions in the CARES ACT. In addition to broadening coverage of COVID-19 testing [Section 3201] and any future FDA-approved vaccine [Section 3203] , the new law permits high deductible health plans with health savings account to pay for telehealth care before the deductible [Section 3701] and repeals the Affordable Care Act provision requiring a doctor’s prescription for over the counter medicines as a prerequisite to reimbursement from a health savings account or a healthcare flexible spending account [Section 3702].

The high deductible health plan telehealth provision took effect last Friday and the over the counter drug coverage change was made retroactively effective January 1, 2020.

Health Affairs blog adds that

Under [Section 3202 of] the CARES Act, all comprehensive private health insurance plans would reimburse a test provider based on the rate negotiated between the plan and the provider (i.e., the in-network rate) that was put in place prior to this emergency. If there is no negotiated rate between the plan and provider (i.e., the provider is out-of-network), the plan would fully reimburse the provider based on the provider’s own “cash price” (or a lower price if the plan can negotiate one). This “cash price” must be publicly available (listed on a public website) while there is a declared public health emergency. Providers that fail to make their price public could face a civil monetary penalty of up to $300/day. This provision essentially allows out-of-network labs to set their own price and expect full reimbursement from the plan, potentially leading to dramatic price increases for testing.

Fierce Healthcare reports that that healthcare actuarial consulting firm TowersWillisWatson has released a projection of healthcare spending associated with the COVID-19 emergency.

On the low end of the spectrum, should the outbreak infect just 10% of the population and prove to have low morbidity, costs will increase by under 1%. However, if the virus infected 50% of the population with high morbidity, costs could increase by 6.8%, the study found. The scenario with the highest cost increases is if the virus 30% of people with high morbidity—a combination that could lead to 7.2% in cost increases, Willis Towers Watson found.

A major federal agency and two other health plan accrediting bodies have centralized their COVID-19 emergency guidance:

Apple in partnership with the Centers for Disease Control has posted a COVID-19 screening tool for consumers.

Friday Stats and More

David Ermer–CDC, Congress, COVID-19, HIPAA Privacy and Security Rules–

Here are the week by week COVID-19 case statistics for this month from the Centers for Disease Control:

3-6-203-13-203-20-203-27-20
Travel36138290712
Person to Person181293101326
Cause under invest.1101362984283,318
Total Cases164162910,44285,356
Total Deaths1501246
Deaths over cases1.44%1.46%

Quite a spike. In the FEHBlog’s view, it will be interesting to see whether there is any leveling off in the case count increase.

The CDC’s latest Fluline reports “that [according to CDC estimates] so far this season there have been at least 39 million flu illnesses, 400,000 hospitalizations and 24,000 deaths from flu.” That represents a deaths over cases percentage of .06%.

With regard to COVID related guidance from that is relevant to FEHBP carriers and others

  • The Department of Health and Human Services Office for Human Rights has gathered together all of its COVID-19 emergency guidance on the HIPAA Privacy and Security Rules in one website.
  • The Department of Labor and the IRS have issued additional guidance on the Families First Coronavirus Response Act’s paid sick leave mandate and expanded FMLA leave.
  • The National Committee for Quality Assurance has assembled its COVID-19 emergency guidance here.

As previously mentioned the Office of Personnel Management has taken the same consolidated approach with its online COVID-19 emergency guidance which generally is directed at federal agencies.

Monday Musings

David Ermer–CDC, COVID-19–

The FEHBlog was pleased to learn about the President’s initiatives to expand COVID-19 testing discussed in last Friday’s post. The President explained that Google would offer a website that allows concerned persons to find out if they need to be COVID-19 tested and if so arrange for a drive thru appointed. The Wall Street Journal reports that Google/ Alphabet ‘s Verily Health subsidiary launched a pilot platform in northern California. The pilot platform was “overwhelmed” by requests. Here’s a Verily Health link to more information on the platform. It’s good to see that Verily already is engaged in a trial and error pilot process and hopefully the platform will be ready for prime time soon because testing for disease also is important.

Speaking of diseases, here are some highlights from the Centers for Disease Control’s latest Fluline report:

  • Laboratory confirmed influenza associated hospitalization rates for the overall U.S. population remain moderate compared to recent seasons, but rates for children 0-4 years and adults 18-49 years are now the highest CDC has on record for these age groups, surpassing rates reported during the 2009 H1N1 pandemic. Hospitalization rates for school-aged children (5-17 years) are higher than any recent regular season but remain lower than rates experienced by this age group during the pandemic.
  • Pneumonia and influenza mortality has been low, but 144 influenza-associated deaths in children have been reported so far this season. This number is higher for the same time period than in every season since reporting began in 2004-05, except for the 2009 pandemic.
  • CDC estimates that so far this season there have been at least 36 million flu illnesses, 370,000 hospitalizations and 22,000 deaths from flu.

The Health Affairs blog discusses one of the FEHBlog’s favorite topics — opportunities for providers, payers and governments in the U.S. to expand telehealth use in response to the COVID-19 emergency. FEHBP plans generally offer telehealth benefits and there’s no time like the present to promote them.

TGIF

David Ermer–AHRQ, CDC, COVID-19–

The President declared COVID-19 to be a national emergency this afternoon. The Wall Street Journal reports that the President announced that efforts are well underway to greatly expand COVID-19 testing, including drive thru testing. Furthermore,

A new, high-speed coronavirus test was earlier granted emergency clearance by the Food and Drug Administration. Developed by Roche Holding AG, the test is designed to run on the company’s automated machines, which are already installed in more than 100 laboratories across the U.S. It will be available immediately.

The FEHBlog understand that these high speed tests can turn around results in 24 hours, rather than a few days.

The FEHBlog compared the Centers for Disease Control’s COVID-19 U.S. case statistics from last Friday compared to today.

CDC COVID-19 stats
6-Mar13-Mar
Travel-related36138
Person-to-person spread18129
Under Investigation1101362
Total cases1641629

That’s quite a jump. CMS and Healthcare Dive also have offered their perspectives on the import of the emergency declaration.

In other news

  • Healthcare Dive reports on a Rand study on the value of out of network cost controls.
  • On this last day of AHRQ’s Patient Safety Week, the agency called public attention to its “Guide to Patient and Family Engagement in Hospital Quality and Safety.” The FEHBlog thinks its important for health plans to help families to support their hospitalized family members.

This Guide reminded me of a related human nature anecdote that I heard on the Econtalk blog which I can share

Russ Roberts: I was talking to this nurse about the challenges of doing a good job because it can be a very boring job, and then all of a sudden it’s unbelievably intense. And at one point he said to me–and at this point, my brother and sister, our mom had all been in the room for hours over a course of three or four days.

He said, he conceded, that–he said, ‘It really helps to have family here with the patient.’

And I thought he was going to say, you know, ‘Because it helps them sustain their morale.’

He said, ‘I think it makes us do a better job.’

And I thought, of course, of Adam Smith’s impartial spectator. It’s like we’re the actual spectator, watching him, and he said–this was a great thing–he said, ‘It shouldn’t be that way.’ And he’s right, of course. It should be that you’re equally motivated whether no one’s watching. But as human beings we sometimes fall short. He said, ‘It shouldn’t be that way, but sometimes it is.’

Russ Roberts is a University of Chicago trained economist who has written on Adam Smith.

Monday Musings

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

The U.S. Office of Personnel Management issued additional COVID-19 guidance and FAQs on Saturday March 7. The Federal News Network summarizes OPM’s issuances here.

Here are the Centers for Diseases Control’s March 9 COVID-19 statistics for the U.S.

  • Travel-related 72
  • Person-to-person spread 29
  • Under Investigation 322
  • Total cases 423

The CDC has issued guidance for people at risk of contracting serious illness from COVID-19. According to the CDC,

Early information out of China, where COVID-19 first started, shows that some people are at higher risk of getting very sick from this illness. This includes:

  • Older adults
  • People who have serious chronic medical conditions like:
  • Heart disease
  • Diabetes
  • Lung disease

Becker’s Hospital News reports on a study recently published in the Journal of American Medical Association. The study which was conducted in Singapore finds that from a contagion standpoint the COVID-19 virus does not linger in the air but it does contaminate surfaces.

As predicted, the Trump Administration released its final electronic health record interoperability and data blocking rules today. The objective of the rules is to give patients better access to their health records. The rules take effect as early as January 1, 2021. The implementation of the interoperability rule is staged over time.

Here are links to the government fact sheets on the final interoperability rule and the final data blocking rule. WEDI, which an information technology advisor to the HHS Secretary, prepared a helpful comparison of the proposed and final data blocking rules.

Healthcare Dive reports on industry reaction to the final rules. Healthcare Dive explains

The CMS rule requires Medicaid, the Children’s Health Insurance Program, Medicare Advantage plans and Affordable Care Act exchange plans to provide their collective 125 million patients with free electronic access to their personal health data, including medical claims and encounter information including cost, by 2021.

MA plans, state Medicare and CHIP programs, CHIP managed care entities, Medicaid managed care plans and qualified health plans in the federal exchanges now have to “implement, test, and monitor” a Health Level Seven FHIR-compliant API, which the government has selected as the new national standard.

Those plans also have to make their provider directories available to current and potential enrollees through the API technology, too (excepting the federal exchanges, which already do so), by 2021, with the hope insurers will carry over those practices to private plans as well.

Finally it’s worth noting that HHS’s Agency for Healthcare Quality and Research has deemed this to be Patient Safety Awareness Week.

TGIF

David Ermer–CDC, COVID-19, Rx coverage–

OPM now has a prominent page on its website that gathers together the agency’s COVID 19 guidance. Just in time for a group of Democrat Senators to criticize that guidance as Govexec reports. In salient point the Senators state that

OPM work with health insurance providers to ensure that federal employees can affordably access the preventive care and treatment they may need as a result of COVID 19.

Here are today’s COVID 19 statistics for our country from the Centers for Disease Control

Travel-related36
Person-to-person spread18
Under Investigation110
Total cases164

Here’s a link to the CDC’s latest statistics for another coronavirus, the flu.

  • Pneumonia and influenza mortality has been low [this flu season], but 136 influenza-associated deaths in children have been reported so far this season. This number is higher for the same time period than in every season since reporting began in 2004-05, except for the 2009 pandemic.
  • CDC estimates that so far this season there have been at least 34 million flu illnesses, 350,000 hospitalizations and 20,000 deaths from flu.

Modern Healthcare discusses an interesting Humana social determinants of health program in the Medicare Advantage program. The program kicked off this month with Oschner Health in New Orleans. The FEHB Act and the Internal Revenue Code don’t allow FEHBP plans to copy this program but they can take steps to emulate it, in the FEHBlog’s view.

The Boston Globe’s StatNews provides an interesting overview of the state of the biosimilar drug market in our country. Biosimilars are the specialty drug equivalent of generic drugs. Congress opened the door to biosimilar development in the Affordable Care Act. Biosimilars are poised to create a substantial amount of drug cost savings over the next five years according to the article.

Tuesday Tidbits

David Ermer–ACA, CDC, HIPAA Privacy and Security Rules–

Fierce Healthcare reports on how health insurers are communicating with their members and the public about COVID-19. This is a good idea.

The U.S. Preventive Services Task Force has decided to expand its Hepatitis C screening B level recommendation to all asymptomatic people aged 18 to 79. “This recommendation incorporates new evidence and replaces the 2013 USPSTF recommendation, which recommended screening for HCV infection in persons at high risk for infection and 1-time screening in adults born between 1945 and 1965.” The Task Force took this action because among other factors “Since 2013, the prevalence of HCV infection has increased in younger persons aged 20 to 39 years.” “The USPSTF concluded that broadening the age for HCV screening beyond its previous recommendation will identify infected patients at earlier stages of disease who could greatly benefit from effective treatment before developing complications.” The ACA requires health plans to cover the expansion of this service with no patient cost-sharing when provided in-network beginning January 1, 2022. It occurs to the FEHBlog that there may be practical difficulties distinguishing claims from the original and expanded group members.

Forbes reports that Anthem, a Blue Cross licensee, has closed on its acquisition of behavioral health services provider Beacon Health Options.

Beacon manages mental health, substance abuse and other behavioral health services for more than 36 million people across the U.S. Anthem, which owns Blue Cross and Blue Shield plans in 14 states, didn’t disclose a price it is paying Bain Capital Private Equity and Diamond Castle Holdings for Beacon Health, which is privately held. 

The AP informs us that “The Justice Department said Monday [March 2] that pharmaceutical company Sandoz Inc. will pay a $195 million penalty to resolve criminal charges of conspiring to fix prices and rig bids to stifle competition for generic drugs.” “The price-fixing affected more than $500 million in Sandoz’s generic drug sales, the Justice Department said. It involved drugs used to treat a range of chronic problems and pain conditions including arthritis, hypertension, seizures, various skin conditions and blood clots, according to officials.”

The Department of Health and Human Services announced that its Office for Civl Rights has reached a HIPAA Security Rule settlement with an Ogden Utah medical practice.

“All health care providers, large and small, need to take their HIPAA obligations seriously,” said OCR Director Roger Severino. “The failure to implement basic HIPAA requirements, such as an accurate and thorough risk analysis and risk management plan, continues to be an unacceptable and disturbing trend within the health care industry.” 

Monday Musings

David Ermer–CDC, Congress, SCOTUS, Uncategorized–

The FEHBlog got to work this morning around 8:30 am. Before he knew it, it was past 9:30 am, the time at which the Supreme Court releases online its orders from the latest conference of the Justices. He clicked on the Adobe Acrobat PDF link to the Court’s order list — no go. Bad PDF. He tried different browsers — same result. Twitter ho and there it was “blue State victory” the Supreme Court had agreed to review the Texas v. U.S. case holding the ACA’s individual mandate unconstitutional. The political comment did not make sense to the FEHBlog because only four Justices need to approve a petition for certiorari / review and there are four Democrat appointees on the Court. However, you need five Justices for a final victory. In any event by then the FEHBlog was able to open the Court’s order list and he found the following on page 3:

CERTIORARI GRANTED

19-840 CALIFORNIA, ET AL. V. TEXAS, ET AL.

19-1019 TEXAS, ET AL. V. CALIFORNIA, ET AL.
The motion of 33 State Hospital Associations for leave to file a brief as amici curiae in No. 19-840 is granted. The petitions for writs of certiorari are granted. The cases are consolidated, and a total of one hour is allotted for oral argument.

Case No. 19-1019??!! The FEHBlog was aware of the unmentioned Case No. 19-841 which is the House of Representative’s cert. petition. But what is Case No. 19-1019? It turns out that on Valentine’s Day the red states had filed a cross motion for review / cert with the Supreme Court. So it appears that both sides won at the first stage of the Supreme Court proceedings.

The Supreme Court will hear oral argument in the cases early in its next Term which begins on the first Monday in October 2020. There is no way the Court will decide the case before the Presidential election day on November 3. Hopefully, to avoid a political kerfuffle at the oral argument, the Court will schedule the argument for later in November.

Meanwhile the federal district court for the Northern District of Texas will hold off reconsidering the unconstitutional individual mandate’s proper degree of severance from the remainder of the massive law. The Fifth Circuit in its December order vacated the lower court’s initial decision that the remainder of the law was inseparable and therefore equally unconstitutional. The FEHBlog’s guess is that the Supreme Court took the case in order to short circuit that remand. But time will tell.

In another surprise, the FEHBlog learned along with the healthcare world today that President Trump will speak on the issue of electronic health record interoperability at the next Monday’s opening day of the monstrous HIMSS conference in Orlando, Florida. Health IT News reports that while former Presidents Clinton and Bush 43 have spoken at this conference, President Trump’s appearance will be the first by a sitting President.

Trump’s speech will touch on various aspects of interoperability, innovation and digital health. If past HIMSS conferences are any indication, his appearance may also be timed with the long-awaited final rules on information blocking and patient access from the Office of the National Coordinator for Health IT.

Another probable topic of discussion will be an update on the Trump Administration’s ongoing response to the COVID-19 coronavirus outbreak.

Again time will tell.

Medicare provides coverage for Americans under age 65 with end stage renal / kidney disease for Americans. However,

Medicare is the secondary payer to group health plans (GHPs) [including FEHB plan] for individuals entitled to Medicare based on ESRD for a coordination period of 30 months regardless of the number of employees and whether the coverage is based on current employment status.  Medicare is secondary to GHP coverage provided through the Consolidated Omnibus Budget Reconciliation Act (COBRA), or a retirement plan.

Given the FEHBP’s role in the early stages of this serious disease, the FEHBlog wanted to point out this Centers for Disease Control page on understanding chronic kidney disease. End stage renal disease is a later stage of chronic kidney disease. The CDC explains that

The two main causes of CKD are diabetes and high blood pressure. About 1 in 3 adults with diabetes and 1 in 5 adults with high blood pressure have CKD.

People may not feel sick or notice any symptoms until CKD is advanced. The only way people find out if they have CKD is through simple blood and urine tests. The blood test checks for creatinine (a waste product) in the blood to see how well the kidneys work. The urine test checks for protein in the urine (an early sign of kidney damage).

Here’s another reason why annual physical exams are important.