Monday Roundup

Congress

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.

Tuesday Tidbits

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

The Senate Health Education Labor and Pensions Committee held a hearing this morning on progress made in reopening schools and businesses from the great hunkering down. Fierce Healthcare reports on the hearing here.

The Department of Health and Human Services announced today the extension of “its partnership with national pharmacy and grocery retail chains CVS, Rite-Aid, Walgreens, Quest (through services at Walmart) and eTrueNorth (through services at Kroger, Health Mart, and Walmart) so they may continue to seamlessly provide Americans convenient access to COVID-19 testing. The partnership, which is part of the Community-Based Testing Program, has scaled up to more than 600 COVID-19 testing sites in 48 states and the District of Columbia. Approximately 70% of these testing sites are located in communities with moderate-to-high social vulnerability, as evidenced by their racial, and ethnic composition, and their housing, economic, language barrier, and similar considerations.” “The [partnership] contract utilizes a federal bundled payment program paid directly to retailers that receive a flat fee for each test administered, with participating retailers responsible for coordinating the full end-to-end testing.” So far the collaborative program has tested 750,000 Americans. That makes sense.

The Office of Management and Budget’s Office of Information and Regulatory Affairs issued its anxiously awaited Spring 2020 regulatory agenda. The regulatory agenda tells you what’s baking in each agency’s regulatory oven but you can rely on the oven timers’ shown in the reports. Here’s a link to OPM’s “rule list.” Nothing earth shaking to report.

The FEHBlog’s favorite healthcare quality consulting firm, Discern Health, notes the release of the National Health Quality Roadmap by the Department of Health and Human Services. “The National Health Quality Roadmap highlights not only many of the challenges that have been faced by health care stakeholders across the quality environment, but also a plan for addressing them,” Discern Health Vice President Donna Dugan said. “It will be important for stakeholders across the continuum to participate where possible in order to facilitate this transformation and aid in the realization of quality goals.”

Becker’s Hospital Review reports on a class action settlement of a phishing attack related lawsuit against UnityPoint Health which is based in Iowa. ‘The class action lawsuit alleges the health system didn’t notify [over 16,000] patients of the breach in a timely manner and told patients Social Security numbers weren’t compromised, but they were.’ The settlement is valued at $2.8 million.

For what it’s worth, Forbes reports an IRS announcement that that “the 2019 tax filing deadline remains July 15, 2020.” Forbes considers and the FEHBlog agrees that this will be the IRS’s final work on the topic. Also the Labor Department yesterday added q&a 93 to its list of frequently asked questions on the Families First Coronavirus Response Act’s paid leave program

Weekend Update

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

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

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

On the COVID-19 front —

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

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

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.