Catchup Sunday

Catchup Sunday

Happy Martin Luther King, Jr. Day weekend.

HHS issued several final rules on Thursday and Friday last week, none of which apply directly to the FEHBP:

  • The Centers for Medicare and Medicaid Services (CMS”) issued a final rule intended to streamline health plan prior authorization request to providers. America’s Health Insurance Plans, the health insurer trade association, was unimpressed. This rule applies to HHS’s own programs, e.g., Medicare, Medicaid, CHIP, the Qualified Health Plans in the ACA marketplace.
  • CMS also a final Calendar Year (CY) 2022 Medicare Advantage and Part D Rate Announcement, finalizing Medicare Advantage (MA) and Part D payment methodologies for CY 2022. Here’s a link to the fact sheet.
  • HHS also issued part of the final CY 2022 Notice of Benefit and Payments Parameters required by the Affordable Care Act. Katie Keith outlines the notice on the Health Affairs blog, noting

On January 14, 2021, the Centers for Medicare and Medicaid Services (CMS) released its final 2022 Notice of Benefit and Payment Parameters rule, joined in part by the Treasury Department. Historically, the “payment notice” adopts major changes for the next plan year in areas such as the exchanges and the risk adjustment program. Here, however, the final 2022 payment notice adopts only a subset of the policies considered in the proposed 2022 payment notice. This subset of policies includes the most controversial changes that had been included in the proposed rule. The final rule was accompanied by a fact sheet and a press release.

  • A friend of the FEHBlog called to his attention the fact that the Trump Administration HHS never published its proposed HIPAA privacy rule changes, announced December 10, 2020, in the Federal Register. (The HIPAA Privacy Rule does apply to the FEHBP.) What’s more the rule making cannot be found on the Federal Register’s latest public inspection list. The Biden Administration HHS will now have the opportunity to reconsider these “final actions” as well as what to do if anything with the proposed privacy rule changes.

The FEHBlog noticed that on January 7, 2021, the HHS Secretary extended the opioid crisis public health emergency another 90 days into April 2021.

Healthcare Dive informs us that

  • The Federal Trade Commission sent orders to six health insurance companies to obtain patient-level claims data for inpatient, outpatient, and physician services from 2015 to 2020, the agency said Thursday.
  • The FTC wants to figure out how hospitals’ acquisitions of physician practices has affected competition.  
  • The agency sent orders to some of the nation’s largest insurance companies, including UnitedHealthcare, Anthem, Aetna, Cigna, Florida Blue and Health Care Service Corporation.

Federal government personnel moves:

  • The Boston Globe reports that “President-elect Joe Biden on Friday nominated Eric Lander, a pioneer in the study of the human genome and the founding director of the Broad Institute of MIT and Harvard, to be his chief science adviser in a newly created Cabinet position. If confirmed by the Senate, Lander will be the first science adviser to serve in a presidential Cabinet * * *.
  • Medical Design and Resourcing reports that Food and Drug Administration (“FDA”) “veteran Dr. Janet Woodcock has been tapped as interim FDA commissioner by the Biden administration, according to published reports.” Dr. Woodcock currently serves as the FDA’s Director of the Center for Drug Evaluation and Research.
  • Bloomberg Law reports that Dr. “Francis S. Collins will stay on as NIH director under the Biden administration, making him one of the few biomedical agency directors to span three presidents.”
  • Govexec.com reports that “President-elect Joe Biden has named Jason Miller as his government management czar, tapping a former Obama administration economic adviser for the key role in setting the president’s management and federal workforce agenda. * * * Should Miller be confirmed by the Senate, he would serve under OMB Director-designate Neera Tanden if she is confirmed and replace Michael Rigas, who is serving in the OMB management role—and that of Office of Personnel Management director—in an acting capacity. The last Senate-confirmed official to hold the management position was Margaret Weichert, a Trump nominee who served concurrently as acting OPM director. Biden has yet to name a head of OPM.”
  • The Washington Post and the Partnership for Public Service offer a Biden Administration political appointee tracker.

As this is the FEHBlog, it is worth noting that Federal News Network has reported on the OPM’s Inspector General’s report on the impact of COVID-19 on the FEHBP. The OIG’s analysis was found in its September 2020 semi-annual report to Congress. Federal News Network queries “What about 2022, or future years for that matter, when FEHB enrollees flock back to their doctor’s offices again for those checkups and preventative procedures they’ve been putting off?”

Bear in mind that all health U.S. plans including FEHB plans experienced a V shaped drop in claims at the height of the great hunkering down last Spring. Many preventive tests are not required annually. The FEHBlog got his routine physical last summer by a combination of a holding a televisit with the doctor and giving blood etc. at the doctor’s office. Furthermore, prescription drug claims have held steady throughout the pandemic and flu cases remain “unusually low” during this winter. We will get through this together. When we reach the new normal, the healthcare sky will not fall in, at least in the FEHBlog’s view.

Friday Stats and More

Based on the CDC’s Cases in the U.Swebsite, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 20th through 50th weeks of this year (beginning May 14 and ending December 16; using Thursday as the first day of the week in order to facilitate this weekly update):

and here is the CDC’s latest overall weekly hospitalization rate chart for COVID-19:

The FEHBlog has noted that the new cases and deaths chart shows a flat line for new weekly deaths  because new cases greatly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2 through December 9). The FEHBlog extended this chart from April 2 to May 14 in order to display the previous high for this sad metric.

The CDC’s current Fluview report continues to state “Seasonal influenza activity in the United States remains lower than usual for this time of year.” So Americans must be doing something right.

The CDC issued a health advisory yesterday reporting

1) substantial increases in drug overdose deaths across the United States, primarily driven by rapid increases in overdose deaths involving synthetic opioids excluding methadone (hereafter referred to as synthetic opioids), likely illicitly manufactured fentanyl;
(2) a concerning acceleration of the increase in drug overdose deaths, with the largest increase recorded from March 2020 to May 2020,coinciding with the implementation of widespread mitigation measures for the COVID-19 pandemic;
(3) the changing geographic distribution of overdose deaths involving synthetic opioids, with the largest percentage increases occurring in states in the western United States;
(4) significant increases in overdose deaths involving psychostimulants with abuse potential (hereafter referred to as psychostimulants) such as methamphetamine; and

That’s the twin pandemic that the CDC feared.

The Wall Street Journal reports that

The House [of Representatives] passed a two-day spending bill Friday evening, sending it over to the Senate in a bid to prevent a partial government shutdown after midnight, as congressional leaders struggled to wrap up negotiations on a coronavirus relief package. 

In the Covid-19 talks, negotiators were still wrestling Friday to close differences on the Federal Reserve’s emergency lending powers among other final snags. Leaders have aimed to pair the passage of the Covid-19 aid bill with a broader spending bill.

The FEHBlog expected a little bit longer extension but a two day extension suggests that the compromise on the COVID-19 relief bill is near. The FEHBlog cannot believe that with the Georgia Senate primary approaching on January 5 that either party would risk a government shutdown or not COVID-19 relief. But we shall see.

In that regard, the FEHBlog read on the American Hospital Association’s daily report about this health system letter to Congress, delivered today, suggesting that there is some crazy language in that bipartisan surprise billing proposal. Again, we shall see.

HHS’s Office for Civil Rights issued “guidance on how the Health Insurance Portability and Accountability Act of 1996 (HIPAA) permits covered entities and their business associates to use health information exchanges to disclose protected health information (PHI) for the public health activities of a public health authority. The guidance provides examples relevant to the COVID-19 public health emergency on how HIPAA permits covered entities and their business associates to disclose PHI to an HIE for reporting to a PHA that is engaged in public health activities.”

Friday Stats and More

Based on the CDC’s COVID Data Trackers website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 20th through 49th weeks of this year (beginning May 14 and ending December 9; using Thursday as the first day of the week in order to facilitate this weekly update):

and here is the CDC’s latest overall weekly hospitalization rate chart for COVID-19:

It’s interesting that the weekly rate dropped two weeks in a row. Typically the chart would show a one week drop which the FEHBlog discounted.

The FEHBlog has noted that the new cases and deaths chart shows a flat line for new weekly deaths  because new cases greatly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the same period (May 14 through December 9):

The FEHBlog’s record high for weekly deaths remains 13,504 for the week ended April 22 which we now are approaching.

On the brighter side, the Wall Street Journal reports that

The U.S. Food and Drug Administration said it was finalizing the work needed to clear a Covid-19 vaccine developed byPfizer Inc. and German partner BioNTech SE, after the injection was endorsed by an expert panel.  “We could see people getting vaccinated Monday, Tuesday of next week,” Health and Human Services Secretary Alex Azar said on ABC’s “Good Morning America.”

Fierce Healthcare reports that “CVS [Health] is planning to begin administering COVID-19 vaccines in nursing homes beginning on Dec. 21, a top executive told Reuters.”

Govexec.com reports that “Civilian federal personnel are likely to begin receiving COVID-19 vaccinations as soon as Monday, officials said on Friday, though only [healthcare] employees at certain offices will receive the doses directly from their agencies.  Govexec.com offered the most details on the Defense Department’s plans which provide a helpful perspective

The Defense Department also anticipates vaccinating 44,000 employees next week, officials said on Wednesday, the vast majority of whom will be health care staff. The Pentagon plans to provide vaccines to both military and civilian staff, though it has not committed to vaccinating to its entire civil service workforce. 

“The eligibility we defined in terms of dependents, select contractors, civilian employees, and it’s going to be then how do they match up in terms of the prioritization tiers,” said Tom McCaffery, the assistant secretary of Defense for Health Affairs. 

In the initial phase, Defense will target health care workers who are closest to patients, early emergency responders and public security staff. Defense will distribute vaccines to 16 sites in that phase, 13 of which are located within the United States. McCaffery said the department recently held a “virtual tabletop exercise” to go through the first phase “in great detail to ensure seamless distribution and dissemination” of the vaccine. Defense will ultimately be responsible for vaccinating millions of individuals, including active duty personnel, civilian workers, at-risk dependents and some contractors. 

All told, Defense maintains 83 sites that have ultra-cold storage, including all 13 of those in the initial distribution.

HHS announced that the federal government

will purchase an additional 100 million doses of COVID-19 vaccine candidate, called mRNA-1273, from Moderna.

If authorized by the U.S. Food and Drug Administration for emergency use as outlined in agency guidance, doses of the vaccine will begin shipping immediately. The vaccine would be provided at no cost to Americans. Vaccine administration costs for private-sector administration partners will be covered by healthcare payers: private insurance, Medicare or Medicaid, and an HHS program to cover COVID-19 costs for the uninsured which is reimbursing the provider at Medicare rates from the provider relief fund.

Under the agreement, Moderna will leverage its U.S.-based manufacturing capacity to fill, finish and ship vials of mRNA-1273 as the bulk material is produced. The additional doses ordered today provide for continuous delivery through the end of June 2021. This strategy will help meet the anticipated demand for mRNA-1273 and safely accelerate the delivery schedule for all 200 million doses the U.S. government is purchasing.

“Securing another 100 million doses from Moderna by June 2021 further expands our supply of doses across the Operation Warp Speed portfolio of vaccines,” said HHS Secretary Alex Azar. “This new federal purchase can give Americans even greater confidence we will have enough supply to vaccinate all Americans who want it by the second quarter of 2021.”

In other news,

  • Congress approved the one week long extension of the continuing resolution funding the federal government. The new deadline is December 18 and Federal News Network reports that “Negotiators on a $1.4 trillion catchall spending bill appeared to be moving in a positive direction, said the chairman of the Senate Appropriations Committee, Sen. Richard Shelby, R-Ala.. This bill would serve as a vehicle to carry any year-end virus assistance.” Negotiations over that COVID-19 relief bill continue.
  • The HHS, the Labor Department, and the Treasury Department (a/k/a the tri-agencies) “announced a final rule that amends the [Affordable Care Act] requirements for grandfathered group health plans and grandfathered group health insurance coverage to preserve their grandfather status.”
  • The U.S. Supreme Court unanimously rejected an ERISA preemption challenge to an Arkansas state law regulating prescription benefit manager pricing of drugs. Here is Healthcare Dive’s report. This decision will raise healthcare prices in the FEHBlog’s opinion.
  • Govexec.com reports that President Trump is giving a half day off to federal employees on Christmas Eve.

The FEHBlog’s link to the HHS fact sheet on the proposed HIPAA Privacy Rule changes (posted yesterday) was inoperable until the FEHBlog fixed it tonight. Here’s a link. Have a good weekend.

Midweek update

OPM Director Nominee John Gibbs (Senate video / Federal Times)

The Senate Homeland Security and Governmental Affairs Committee held a confirmation hearing for OPM Director nominee John Gibbs this afternoon. Here’s are links to Mr. Gibbs’ testimony and a Federal News Network article on the hearing. The Committee will vote on whether to advance Mr. Gibbs’ nomination to the full Senate at a business meeting scheduled for next Wednesday October 16.

The Senate Health Education Labor and Pensions Committee heard testimony today from the NIH Director Dr. Francis Collins and the U.S. Surgeon General Vice Admiral Jerome Adams on the topic of vaccines. U.S. News and World Report highlights an important segment of Dr. Collins’s appearance before the Committee.

AstraZeneca announced on Tuesday that its late-stage [COVID-19] vaccine study was being put on hold due to a “potentially unexplained illness” in one of the participants.

“With an abundance of caution at a time like this, you put a clinical hold, you investigate carefully to see if anybody else who received that vaccine, or any other vaccines, might have had a similar finding of a spinal cord problem,” Collins said.

Those who are concerned about the safety of the approval process should be reassured by the development, Collins said. “If it turns out that that is a real consequence of this vaccine and can be shown to be cause and effect then all the doses that are currently being manufactured for that will be thrown away because we do not want to issue something that is not safe,” Collins said. He added that the U.S. is investing in six vaccine candidates “because of the expectation that they won’t all work, although it would be lovely if they did.”

AstraZeneca was one of the nine drugmakers to pledge on Tuesday to uphold standards for science and safety in their pursuit of a coronavirus vaccine.

Healthcare Finance reports on America’s Health Insurance Plan comments on how health insurers can aid the COVID-19 vaccine distribution process. For example,

Insurers can use their member data to help identify which people meet the criteria to be eligible for the vaccine, according to the best available evidence. Outreach efforts must adhere to patient privacy requirements, AHIP said.

Insurers can coordinate across partners such as public health officials for data sharing regarding their members’ vaccine status, encouraging data to be shared with state or regional databases (Immunization Information Systems).

“Health insurance providers play an important role ensuring that people receive the vaccines that are recommended for them, and have experience conducting outreach to their members to inform them of the vaccines that are recommended for them and how they can get them,” AHIP said. This may include reminders to ensure they receive multiple doses of a vaccine when needed.”

The Health Affairs Blog experts offer five recommendations on how to better integrate telehealth with primary care.

RecommendationsRepresentative Open-Text Survey Responses
Harmonize the reimbursement criteria “Some insurance companies are paying less than in-person visits for telehealth visits from Day 1. Small practices, like usual, have been left to themselves for the most part.”“Primary care is extremely challenging with the constant change in protocols, the uncertainty and enormously confusing insurance schemes.”
Create billing codes or payment models for the additional work required to offer telehealth “Insurance companies not reimbursing telephone visits at a rate that supports the level of work done on a telephone visit.”“Elderly patients have no access or are unable to access virtual – more work, have to teach them how to take BP, some hard of hearing, etc.”“I am more stressed out doing telehealth, as we spend time to fix internet, video, and voice. There are calling issues, so it’s more time consuming.”
Provide coverage for at-home monitoring devices “I need blood pressure cuffs and glucometers covered by insurance for home monitoring.” “I will do tele health… provided patients have equipment.”“Patients lack thermometers, blood pressure cuffs, and pulse oximeters.”
Incentivize the development of and access to, patient- and provider-centered telehealth technology “Telehealth information technology platform is NOT user friendly.”“Difficult to properly diagnose with telehealth. Have been using photos from patients to supplement but still not really sufficient.”“Our patients are low-income with language barriers. Requiring third party interpreter by speaker phone takes extra time and reduces quality of care.”
Review, revise, and communicate telehealth malpractice policies  “I am not going to practice telehealth; it is not reliable and may increase malpractice cases.”“I’m very concerned about being sued for managing the patients over telehealth especially since many are requesting opioids.”“Malpractice premiums are a major barrier for telehealth.”

Source: Authors’ analyses of data from surveys administered to primary care providers in New York City from April to July 2020.

CARES Act Update

The Hill reports that “[House of Representatives] Speaker Nancy Pelosi (D-Calif.) said Thursday that the House will move quickly on Friday to approve the Senate’s massive, $2 trillion coronavirus relief package [the CARES Act, H.R. 748] through the lower chamber and on to President Trump, who has vowed to sign it immediately.” NPR has provided a link to the text of the bill that the Senate passed unanimously at 11:17 pm last night.

CARES Act Update

The President and the entire Senate leadership have agreed on a third COVID-19 relief bill known as the CARES Act (H.R. 748). Senator Charles Grassley, the Senate Finance Committee Chair, has released a summary of the bill’s taxation and unemployment insurance provisions and summary of its health provisions. The key health provisions affecting federal employees benefits are the following:

Sec. 3701. Health Savings Accounts for Telehealth Services
This section would allow a high-deductible health plan (HDHP) with a health savings account (HSA) to cover telehealth services prior to a patient reaching the deductible, increasing access for patients who may have the COVID-19 virus and protecting other patients from potential exposure.

Sec. 3702. Over-the-Counter Medical Products without Prescription
This section would allow patients to use funds in HSAs and Flexible Spending Accounts for the purchase of over-the-counter medical products, including those needed in quarantine and social distancing, without a prescription from a physician.

The FEHBlog mistakenly stated on Sunday that that the House of Representatives would be back on Capitol Hill yesterday. In fact, as the Wall Street Journal explains, House members remain on recess this week. Should the Senate as anticipated pass the CARES Act today, the House leadership is expected to seek approval by a unanimous consent motion. A single member of Congress can block such a motion so a lot rides on entire House leadership support for the bill. According to the Wall Street Journal, House Speaker Nancy Pelosi wants the unanimous consent to clear the House. This motion could be brought to the House floor on tomorrow or Friday. The Journal further reports that the President is ready to sign the bill into law.

The FEHBlog has found a link to a COVID-19 statistics site, The COVID-19 Tracking Project, that displays aggregated lab results from COVID-19 testing, U.S. state by state, where available.

Weekend Update

The House and the Senate will be in session this coming week working on a third COVID-19 relief bill. The House returns from a district work week on Tuesday while the Senate cancelled its state work week which had been scheduled for this week.

On the COVID-19 front —

  • OPM posted more COVID-19 emergency related guidance for federal agencies on Friday.
  • The Wall Street Journal explains the current lockdown rules in New York, California, Illinois, and several other states. The California rule cross references to this Department of Homeland Security guidance on essential critical infrastructure workforce. While the guidance is advisory, the FEHBlog finds it significant that the list of “workers who conduct a range of operations and services that are essential to continued critical infrastructure viability” includes “Workers that manage health plans, billing, and health information, who practically work remotely” and “Workers performing cybersecurity functions at healthcare and public health facilities, who cannot practically work remotely.”
  • On Saturday, the Food and Drug Administration issued the first emergency use authorization for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test. ” “The test we’re authorizing today will be able to provide Americans with results within hours, rather than days like the existing tests, and the company plans to roll it out by March 30 [a week from today],” explained HHS Secretary Alex Azar. The COVID-19 diagnosis rate will increase more rapidly now that we continue to expand the availability of COVID-19 testing. The Vice President noted on Saturday that 195,000 Americans have been tested so far.
  • The Wall Street Journal informs us about how to avoid COVID-19 misinformation. It’s worth reading.

Weekend update

Congress is back at work on Capitol Hill this week. The FEHBlog did find an easy to read list of upcoming Congressional hearings on Congress.gov. The FEHBlog did not find any hearing relevant to the FEHBP coming up.

The FEHBlog is following news about the COVID-19 epidemic. The Wall Street Journal reports that the number of cases outside China is growing particularly in South Korea (602 cases) and Italy (155 cases). There are 34 cases in the U.S. In a Centers for Disease Control conference with the press last Friday, Dr. Nancy Messonnier explained that

We are making our case counts in two tables.  One only tracks people who were repatriated by the state department, and the second tracks all other cases picked up through U.S. public health network.  CDC will continue to update these numbers every Monday, Wednesday, and Friday.  We are keeping track of cases resulting from repatriation efforts separately because we don’t believe those numbers accurately represent the picture of what is happening in the community in the united states at this time.  As of this morning, when you break things up this way, we have 13 U.S. cases versus 21 cases among people who were repatriated [here].  The repatriated cases include 18 passengers from the “diamond princess” and three from the Wuhan [China] repatriation flights

The Wall Street Journal confirms the growing trend of large health insurers to offer their own primary care delivery services to their health plan members [previously documented by the FEHBlog].

“It’s very worrisome for hospitals,” said Chas Roades, a health-care consultant. “Suddenly, the plan you’re relying on for payment is also competing with you at the front end of the delivery system.”

Hospitals’ biggest concern may be the power that primary-care doctors have over where their patients go for care such as imaging scans and specialist procedures. Hospitals rely on doctors to direct patients to them for such services—one reason they have bought up physician practices. Insurer-owned clinics might refer patients away from certain hospital systems, cutting off important revenue. 

The FEHBlog in contrast is delighted with this trend which will hold down costs while improving health care quality. Competition itself is healthy. “’Health care has got to be more seamless and more integrated,” said Rob Falkenberg, chief executive of UnitedHealthcare’s California operation.” Agreed.

Fierce Healthcare reports that Oscar Health has creating a $3 per prescription formulary of about 100 popular prescription drugs and insulin. The formulary went into effect on January 1, 2020 for about half of Oscar’s health plan members. The other half if covered by Medicare or live in certain states like New York which have not approved the formulary. The article explains that

Oscar was able to price the drugs so low through plan design.“The price we pay to acquire the drug for our members has not changed,” [Oscar spokesperson Jackie] Kahn said. “Instead, we chose to have our members pay $3 and we are covering the rest.”