Tuesday Tidbits

Congress

Tuesday Tidbits

David Ermer–ACA, CDC, Congress, COVID-19, Medicare, Rx coverage, Uncategorized–

At today’s House Energy and Commerce Committee hearing on the COVID-19 emergency, Dr. Fauci, according to the Wall Street Journal, remarked that “he is ‘cautiously optimistic’ that a successful vaccine could be produced around the end of 2020. ‘I believe it will be when and not if,’ he said.” Amen to that. Here’s a link to today’s Senate Health Education Labor and Pension Committee’s hearing on the same topic.

The Labor Department’s Employee Benefit Security Administration issued a wide-ranging set of frequently asked questions on the health plan related provisions of the Families First Coronavirus Response Act and the CARES Act. Check it out.

Reuters reports on a sobering CMS study of the COVID-19 emergency on Medicare beneficiaries. ““The disparities in the data reflect longstanding challenges facing minority communities and low income older adults,” said Seema Verma, administrator of the Centers for Medicare & Medicaid Services (CMS).”

MedCity News informs us that “Clinical development will soon begin for an inhaled version of a [Gilead] antiviral drug {remdesivir} used to treat Covid-19 that is currently available only to hospitalized patients in intravenous form.” That’s a pro move.

Drug Channels offers its annual study of 2019 PBM drug spending reports.

The PBMs’ data highlight key trends about drug spending:
— For 2019, CVS and Express Scripts reported overall changes in drug spending that were in the low single digits. Prime reported mid-single-digit growth in overall drug spending.
— Spending growth on traditional drugs declined by mid-single digits for the third consecutive year. This decline came from deeper commercial rebates on brand-name drugs, ongoing deflation in generic drugs, and a small increase in the generic dispensing rates.
— The results for CVS and Express Scripts were comparable. For CVS Caremark’s commercial clients, net drug prices for traditional drugs declined by -6.3%, while utilization grew by 1.5%. For Express Scripts’ commercial clients, net drug prices for traditional drugs declined by -6.4%, while utilization grew by 1.4%.

In legal news

  • It was no surprise to learn from Politico that LGBTQ advocates already have brought a lawsuit against the Department of Health and Human Services (“HHS”) “over its rollback of LGBTQ patient protections, arguing that last week’s Supreme Court decision extending workplace legal protections to gay and transgender employees invalidates the new rules.” That should be a rollover win for the plaintiffs.
  • It was a pleasant surprise to learn that the U.S. District Court for the District of Columbia today ruled in favor of an HHS rule requiring hospital to disclose real prices, e.g, negotiated prices with health plans, for their services just like retail stores. The FEHBlog expects that this rule will lead to more and better (e.g., quality based) competition among hospitals. But first the decision will need to be affirmed by the Court of Appeals.

Weekend Update

David Ermer–CDC, Congress, COVID-19, Employee Wellness Programs, OPM, SCOTUS–

Happy Fathers’ Day.

The House and Senate are holding committee hearings and floor votes this week. On Tuesday the Senate Health Education Labor and Pensions Committee will hold a hearing on applying lessons learned from the current COVID-19 emergency to prepare for the next pandemic emergency.

Speaking of the current pandemic:

  • The FEHBlog was wondering about whether there has been an uptick in COVID-19 related hospitalizations to accompany the uptick in COVID-19 cases over this month. The FEHBlog was delighted to find this handy CDC website on COVID-19 related hospitalizations which shows that new hospitalizations have continued to trend down this month.
  • On Friday, OPM released guidance on the relationship paid leave / other time off and COVID-19 work by Federal employees. According to the guidance, OPM plans to issue “regulations [that ] will deem the COVID-19 national emergency to be an exigency of the public business for the purpose of restoring forfeited annual leave. The regulations [among other things] will provide that employees who would forfeit annual leave in excess of the maximum annual leave allowable carryover because of their essential work during the national emergency will have their excess annual leave deemed to have been scheduled in advance and subject to leave restoration.”

The U.S. Supreme Court has 15 decisions left to issue before its summer break. The Court is expected to issue some of those decisions tomorrow at 10 am. The Court is continuing to hold its Thursday conferences so all of 15 of the decisions may not be ready for issuance.

Georgetown Law Professor Katie Keith provided a welcome Health Affairs blog analysis of a complicated topic — federal regulation of employee wellness programs. The key complicating factor is that there are so many different applicable federal laws in play.

Midweek update

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

On the COVID front —

  • Forbes reports on a new Centers for Disease Control analysis confirming that the disease has hit racial minority and ethnic groups, the elderly, and people with multiple chronic conditions harder than others. Also “Incidence was highest among people 80 and older (902 cases per 100,000), while it was lowest among children 9 and younger (51), but surprisingly people between the ages of 40 to 59 saw higher incidence (between 541 and 550) than people between 60 and 79 (478 and 464).”
  • The Department of Health and Human Services has posted a fact sheet on its Operation Warp Speed which “aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (collectively known as countermeasures).”
  • The FEHBlog also ran across the Food and Drug Administration’s COVID-19 resources website. Check it out.

The Senate Health Education Labor and Pensions Committee held a telehealth hearing today. Healthcare IT news reports on the hearing. “HELP Committee Chairman Sen. Lamar Alexander, R-Tenn., advocated for two particular policy changes to be made permanent: the originating site rule, allowing physicians to be reimbursed for telehealth appointments wherever a patient is located, including a patient’s home, and the expansion of Medicare- and Medicaid-reimbursable telehealth services.” Also Health Payer Intelligence identifies three telehealth challenges for payers one of which is on Sen. Alexander’s short list: “Discerning how to provide coverage for many different sites of care and for various types of telehealth technologies as well as complying with state and federal regulatory barriers can put a damper on the telehealth boom.”

Fierce Healthcare reports that two Northeastern Blue Cross licenses Highmark and HealthNow have announced a merger. “[upper New York State’s]”HealthNow will bring nearly 1 million additional members into the [central Pennsylvania based] Highmark fold and boasted $2.8 billion in revenue for 2019. It will join the fourth largest Blues organization in the country, building on Highmark’s 5.6 million members and $18 billion in operating revenue for 2019.” The affiliation agreement is subject to regulatory approval.

Weekend Update

David Ermer–Congress, SCOTUS, Telehealth, U.S. Healthcare–

Happy Flag Day.

Both Houses of Congress will be conducting committee and floor business this week. The House had added floor voting days for Thursday and Friday next week as well as all of the following week (except for next Friday which is the work holiday associated with the Fourth of July.)

The Senate Health Eduction Labor and Pensions Committee is holding a committee hearing of relevance to the FEHBP — Telehealth: Lessons from the COVID-19 Pandemic — on June 17 at 10 am.

The Supreme Court has nineteen more opinions to release before its summer break. This week the Court is releasing opinions tomorrow and Thursday, both days at 10 am ET.

Here are a couple of non-COVID-19 research items that caught the FEHBlog’s attention over the weekend:

  • Precision Vaccinations reports that “With a surprisingly simple approach in which cancer cells are first grown, ruptured and converted into nanoparticles, and then used as a vaccine, Vanderbilt University researchers say they have developed what appears to be a promising treatment for breast cancer metastasis. Metastasis is the last stage of cancer, responsible for about 90 percent of cancer-related deaths.
  • The Wall Street Journal reports that

Scientists may be just a few years away from delivering new treatments for age-related macular degeneration (AMD), the leading cause of irreversible vision loss in people more than 50 years old.

Over the past 15 years there has been only one class of successful AMD drugs, known as anti-VEGF agents, and they have worked for a minority of AMD sufferers. Now researchers are having success fighting AMD from new directions. They include an immune-system inhibitor and stem-cell therapy, which show promise for treating the dry form of AMD in its advanced stage, for which there is currently no treatment approved by the U.S. Food and Drug Administration.

“I’m cautiously optimistic that we will have markedly improved treatments for both wet and dry AMD within two to three years,” says Joshua Dunaief, professor of ophthalmology at the Scheie Eye Institute at the University of Pennsylvania.

Midweek Update

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

This morning the Senate Homeland Security and Governmental Affairs Committee favorably reported the nomination of Craig E. Leen to be Inspector General, Office of Personnel Management “en bloc by voice vote.” The Committee also favorably reported the nomination of Russel Vought to be Director, Office of Management and Budget by a 7-4 roll call vote. Next step for these nominations — the Senate floor for confirmation votes presumably later this month.

Stat News reported on another COVID-19 treatment candidate. A Boston MA company Constant Therapeutics currently manufactures an enzyme therapy that may help COVID-19 patients. The article concludes

Constant’s task ahead is the blocking and tackling of running a clinical trial, something he believes the company is well-prepared for. “I’d love to say that a year from now there’s no need for this drug because we’re all immune, but that’s not going to happen,” [Constant’s CEO] said. “I think we can provide an enormous benefit to people and to the health care system if this drug works. And my gut says that it’s going to.”

These ongoing efforts to give doctors treatments for COVID-19 is our best bet along with public health efforts to bridge the gap to an effective vaccine, in the FEHBlog’s view.

The Wall Street Journal informs us that

In the Covid-19 pandemic, people with obesity are at higher risk for severe illness and death—adding new urgency to efforts to rethink the way doctors treat what has long been a public-health problem.

Instead of focusing only on diet and exercise, medical experts say, health-care providers need to shift to a multipronged strategy that includes new prescription weight-loss medications, behavioral therapy and possibly surgery. And to ensure the best results, they argue, this new approach should be overseen by clinicians specially trained in treating obesity. * * * The fast-emerging specialty of obesity medicine aims to close the education gap.

This is encouraging news. The Journal also reports about a study authored by

Lindsey Woodworth, an assistant professor in economics at the University of South Carolina. [Her study] first showed that when a new emergency room opens, crowding at nearby facilities instantly falls an average of 10%.

She then compared mortality rates at the older emergency departments before and after the change. She found that a 10% drop in patient volume leads to a 24% reduction in mortality rates in the first 30 days and a 17% reduction over six months.

Why can’t lower cost urgent care centers have the same effect?

Monday Roundup

David Ermer–ACA, Congress, Uncategorized–

It turns out the Senate Homeland Security and Governmental Affairs Committee will be considering the President’s nomination of Craig Leen to be OPM Inspector General at its June 10 business meeting which begins at 10 am ET. The FEHBlog expect him to receive Senate confirmation later this month.

On Friday June 5 the Centers for Medicare and Medicaid Services summarized all of the COVID-19 mandates applied and flexibilities offers to non-federal governmental health plans. It’s nevertheless a useful summary for FEHB plans too.

Today the Internal Revenue Service released the PCORI fee around for plan years beginning not earlier than October 1, 2019 or later than September 30, 2020. In other words this notice applies to the current FEHB contract / plan year which aligns with the calendar year. The amount is $2.54 per belly button up nine cents from last year. The payment deadline is July 31.

Finally, Health Payer Intelligence posted a hopeful story about cooperation between the State of Washington and a community health plan in a successful effort to improve the social determinants of health data available to the plan.

Organizations may find it overwhelming to tackle every social determinant of health at once, especially when they see how expansive the social services network can be. So [Jennifer] Polello], MHPA, PCMH-CCE, director of clinical data integration and social determinants of health at Community Health Plan of Washington] recommended beginning with one social determinant of health, maybe the most prevalent.

“Create workflows and workflow aids and education around just one social issue to start the ball rolling,” she said.

Regardless of the strategy employed, building this network of community resources to address social determinants of health is important now more than ever.

Well put.

Weekend update

David Ermer–Congress, Rx coverage, SCOTUS, Telehealth–

The Senate is engaged in legislative and committee business this week. Last week the Senate passed by unanimous consent a bill (S. 279) to amend the FEHB and FEGLI Acts for the purpose of extending coverage to employees of Indian tribal grant schools. This bill would close a gap created by the Affordable Care Act which generally extended coverage under these programs to Indian tribal employees. There are 128 tribal grant schools in the U.S.

The House of Representatives is engaged in committee business this week. That body is next scheduled to hold votes over the period June 30 through July 2.

The Supreme Court continues this week to release the remaining opinions from its October 2019 term. The Hill includes an article discussing the seven opinions that are expected to be politically controversial.

In other news Fierce Healthcare reports

  • “A top Department of Health and Human Services (HHS) official acknowledged [last week] that telehealth is here to stay after an explosion of use due to COVID-19 but hedged on whether new regulatory flexibility on reimbursement is going to stick around.” The permanent flexibility depends largely on Congress and state regulators, and
  • “OptumRx researchers are highlighting three more drug products that payers should be keeping an eye on in 2020″ — Roche’s Risdiplam, NS Pharma’s Viltolarsen, and Immunomedic’s Trodelvy.

Friday Stats and More

David Ermer–Congress, COVID-19–

According to the CDC’s COVID-19 cases in the U.S. website, which the FEHBlog tracks, over the past four weeks the numbers of new cases and deaths have taken a downward path

Week ending5/155/225/296/5
New Cases297,581159,546148,210142,829
New Deaths8956816075616353

The basic infection mortality rate (as calculated by the FEHBlog) continues to drop since its peak on May 15.

The Miami Herald features a fascinating article on disease super spreaders — both people and events.

“It’s not just that superspreading events are happening with SARS-CoV-2; they appear to be driving much of the pandemic,” The University of Hong Kong epidemiologists Dillon Adam and Benjamin Cowling wrote in the New York Times.

“This fact is alarming and reassuring at the same time … because it suggests a virus swift and efficient, and so seemingly unstoppable,” and “it also suggests a way to stop SARS-CoV-2 that is both less onerous and more effective than many of the strategies that have been pursued so far.”

”Forget about maintaining … sweeping measures designed to stem the virus’s spread in all forms. Just focus on stopping the superspreading,” the epidemiologists proposed in the newspaper.

In other words, restricting large gatherings could lower transmission rates, but in the U.S., it hasn’t been that easy.

It’s probably not easy anywhere, but it needs to be done in the FEHBlog’s humble opinion.

The International Foundation of Employee Benefit Plans offers a very thoughtful article on steps that health plans should take this year and next in response to the great hunkering down. For example, health plans should

  • Communicate the safety measures that have been put in place at hospitals and clinics. The Centers for Disease Control and Prevention have issued safety guidelines, including limiting visitors and screening patients and employees for the virus.
  • Communicate the importance of seeking urgent and preventive care. “We really want to encourage people to go and seek care that is needed when it is needed,” Baker said. “If we can just share the importance of preventive care from a high-level standpoint, without getting into the employees’ personal business, that may be something really beneficial in order to help manage plan costs,” she said.
  • Tweak wellness programs. Some employees may not have been able to qualify for wellness program incentives, so employers may want to change the guidelines to allow them to qualify.
  • Steps that plans take now could flatten the cost curve for the 2020 plan year. “Just a simple communication may be beneficial as things reopen,” [Dana] Baker [from the Mayo Clinic] said.

In closing, the Wall Street Journal reports that today’s surprisingly strong May employment report “boosted hopes that the economy has moved beyond the worst fallout from the pandemic and may recover more quickly than expected.” Also the President today signed the Payroll Protection Program flexibility act into law today. Here’s a summary of the new law.

Midweek update

David Ermer–Congress, Rx coverage, Telehealth–

NBC News reports that Wednesday evening, the Senate passed by unanimous consent a House passed bill to improve the Payment Protection Program that the CARES Act created to help small businesses with liquidity issues created by the great hunkering down.

UPI provides helpful context around the new Medicare program to control Medicare beneficiary out of pocket costs for insulin.

“Among commercially insured patients, high insulin prices do not necessarily translate to high out-of-pocket costs,” study co-author Dr. Amir Meiri, a research fellow with the Harvard Medical School Department of Population Medicine and a practicing internist, told UPI.

For these patients, “insulin out-of-pocket costs are generally lower than expected and declining, except among patients in high-deductible health plans with health savings accounts, who must pay for the full cost of medications — including insulin — until they reach their deductible,” Meiri said.

The time period for the study was 2007-16. Last year, the Internal Revenue Service pursuant to an executive order issued a ruling permitting coverage of insulin before the high deductible.

A friend of the FEHBlog called to his attention this 21st century, FDA approved digital stethoscope that could revolutionize care at home. Fierce Healthcare quotes Cambia Health’s chief medical officer who notes ““Telehealth as always been a benefit,” she said. “I think physicians now know that their patients want to use telehealth.”

OPM IG Confirmation Hearing

David Ermer–Congress, OPM–

This afternoon, the Senate Homeland Security and Government Affairs Committee held a virtual confirmation hearing for the President’s nominee for OPM Inspector General, Craig E. Leen, who currently is the Director of the Labor Department’s Office of Federal Contractor Compliance Programs (“OFCCP”). The FEHBlog caught a good chunk of the hearing online. The Senators’s attention principally was on the other nominee Russell Vought who is the acting Director of the Office of Management and Budget and hopes to be made the permanent director.

Mr. Leen was in no sense ignored though. Each Senator asked him a question or two. His opening testimony is available here. Of note, Mr. Leen stated that

As Inspector General, I would focus on the following immediate priorities:
 Closing open IG recommendations and establishing a public dashboard to track my office’s progress;
 Addressing improper payments and seeking to eliminate them;
 Evaluating OPM’s guidance related to COVID-19 and learn from what went well and what could be improved;
 Increasing the amount of evaluations done by OPM Office of the Inspector General (OIG), and
 Ensuring equal employment opportunity for all protected classes, including ensuring inclusion and accommodations of individuals with disabilities (the federal government should follow the same guidance it gives federal contractors in how to ensure equal employment opportunity)

I would like to take a moment to focus on the first and last priorities. The OPM OIG has over 300 open recommendations going back many years. This is a common issue for IGs. I am concerned about what open IG recommendations does to public trust in government; a problem has been specifically identified, but not corrected. I would make closing these open recommendations a primary focus as Inspector General.

Mr. Leen mentioned during the Q&As that the OPM Inspector General historically has performed one evaluation annually. The next step will be a Committee business meeting to consider sending Mr. Leen’s nomination to the Senate floor.