Weekend Update

Uncategorized

Weekend Update

David Ermer–CDC, Congress, COVID-19, Uncategorized–
Photo by Clarisse Meyer on Unsplash

Congress continues it floor and committee work this coming week. Committees are in engaged in organizational meetings on both sides of Congress. Senate Committees principally will be engaged in holding hearings on Presidential cabinet nomination.

The House Oversight and Reform Committee, whose jurisdiction includes the FEHBP, holds its organizational meeting tomorrow at 2 pm. The Chair will continue to be Rep. Carolyn Maloney (D NY) and the Ranking Member will be Rep. James Comer (R KY). The party ratio will be 25 Democrats and 20 Republicans.

Meanwhile, Bloomberg reports that

Joe Biden’s presidency began at a choreographed sprint, with a series of executive actions to erase Donald Trump’s legacy and reset the nation’s course. But as his first full week in office came to a close, the new president was discovering the limits of his power.

His administration’s efforts to bolster vaccine production ran into the same hurdles that plagued the Trump administration — bottlenecks both at factories and in clinics — and Biden’s advisers had to clean up after the president said any American would be able to get inoculated by the spring. * * *

[FEHBlog note — Per the CDC’s Vaccinations site, on average 1.3 million doses of COVID-19 vaccine were administered on Friday and Saturday.]

He’s meanwhile encountering familiar roadblocks in Congress, where just four of his cabinet nominees have been confirmed 12 days into his presidency, and he’s found no traction among congressional Republicans for another big stimulus bill. * * *

Ten GOP senators wrote to Biden on Sunday with an alternative proposal for a slimmed-down stimulus bill. The White House says it will review the offer. A smaller plan that passed with bipartisan support would leave Democrats free to pursue more contentious elements using a partisan budget tool.

The Wall Street Journal adds

The offer is the first Republicans have forwarded since Mr. Biden proposed the $1.9 trillion plan, which Republicans have said is too costly and includes unneeded initiatives, and tests whether the Biden administration and Democrats in Congress will seek compromise or try to pass the relief package themselves. Democratic leaders have said they plan to begin a legislative process that would bypass the need for Republican support this week, with the first step coming as soon as Monday.

FEHBlog Public Service Announcement: The Centers for Disease Control on Saturday implemented one of the President’s executive orders by requiring

the wearing of masks by all travelers into, within, or out of the United States, e.g., on airplanes, ships, ferries, trains, subways, buses, taxis, and ride-shares. The mask requirement also applies to travelers in U.S. transportation hubs such as airports and seaports; train, bus, and subway stations; and any other areas that provide transportation.  Transportation operators must require all persons onboard to wear masks when boarding, disembarking, and for the duration of travel. Operators of transportation hubs must require all persons to wear a mask when entering or on the premises of a transportation hub.

This order will be effective on February 2, 2021. For more information on the Order or to view frequently asked questions, visit: https://www.cdc.gov/quarantine/masks/mask-travel-guidance.html

Friday Stats and More

David Ermer–Uncategorized–

Based on the Centers for Disease Control’s COVID Data Tracker website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 14th week of 2020 through 4th weeks of this year (beginning April 2, 2020, and ending January 27,2021; 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 noticed 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 2020 through January 27, 2021):

Finally here is a COVID-19 vaccinations chart for the past six weeks which also uses Thursday as the first day of the week:

Nearly 1.7 million doses of the COVID-19 vaccine were administered yesterday.

STAT News reports that ” The [Johnson & Johnson single dose COVID-19] vaccine reduced severe disease alone by 85%, and prevented Covid-related hospitalization or death, Johnson & Johnson said. “In a pandemic, if you can, with a single-dose vaccine, very quickly eliminate the severe consequences of death, hospitalization, and severe disease, that’s what’s important for society,” Paul Stoffels, the company’s chief scientific officer, told STAT. * * * Johnson & Johnson expects to file with the FDA for an emergency use authorization in early February, and, assuming the vaccine is authorized, will have some product ready to ship immediately after getting a go-ahead.” That’s great news.

The Paper Gown explains how to help people overcome vaccination fears.

The CDC’s FluView reports that “Seasonal influenza activity in the United States remains lower than usual for this time of year.“

The CDC today called attention to its Antibiotic Resistance Investment Map.

The Health Affairs Blog offers information on “suicide risk and protective factors, highlights current suicide prevention strategies, and notes policy opportunities for improving multisectoral prevention efforts. “

On the regulatory freeze front,

In accordance with the memorandum of January 20, 2021, from the Assistant to President Biden and Chief of Staff, entitled “Regulatory Freeze Pending Review,” and given the pendency of litigation, Pharmaceutical Care Management Association v. U.S. Department of Health and Human Services, et al., Civil Action No. 21-95 (JDB) (D.D.C.), challenging the final rule, HHS has released an action that temporarily delays for 60 days from the date of the memorandum the effective date of the final rule titled “Fraud and Abuse: Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees,” published in the November 30, 2020, Federal Register. The effective date is delayed until March 22, 2021.

The anti-rebate rule would only affect federal government health plans, e.g., Medicare Part D, which are subject to the Federal Health Programs anti-kick back act. The FEHBlog is thankful that Congress exempted the FEHBP from this law when it was expanded beyond Medicare in 1996. The anti-rebate rule should be withdrawn.

Catchup Sunday

David Ermer–ACA, CDC, Congress, Federal employment benefits, OPM, U.S. Healthcare–

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.

Thursday Miscellany

David Ermer–Uncategorized–
Photo by Juliane Liebermann on Unsplash

The National Law Review shares its notes on the third and final day of this week’s virtual JPMorgan healthcare conference. Here’s an interesting tidbit

TalkSpace, a pure-play virtual behavioral health platform that is subscription based and offers text-based asynchronous (i.e., not “live”) therapy, has shown immense growth during 2020 and has demonstrated that increased access and lower costs for behavioral health services can drive better outcomes. You may have seen the company’s advertising recently that features Olympic swimmer Michael Phelps or actress Demi Lovato. The company connects directly with consumers and through health plans and employee benefit plans to over 46,000 members. It has a network of over 2,650 providers and has 39 million commercial covered lives. Perhaps the most critical aspect of its offering is the ease of use. Connecting with a therapist or psychiatrist can take days, weeks or months to set up in a traditional in-person setting.

With TalkSpace, members are typically matched through an algorithm with, and then connected to, a provider on the same day, dramatically reducing the time between the decision to seek care and the provision of actual care. The patient can change therapists as needed within the platform or consult with a psychiatrist, and patient progress is measured through machine learning/artificial intelligence with feedback to the therapists. Therapists also are mentored during the onboarding process and then as they work for TalkSpace. Therapists agree to respond to patients’ texts within a specified time period and post their working and non-working hours. TalkSpace is growing nationally and works with both employers directly, with consumers/patients directly and with insurers. Public reports estimate TalkSpace’s estimated 2021 net revenue at $125 million, up approximately 69% from 2020 estimated net revenue.

STAT News adds another twist —

Buoyed by the pandemic, 2020 was undoubtedly the year that telehealth turned the corner to mainstream. But for savvy investors, the big question isn’t what’s hot now — it’s what’s the future holds. 

“If it’s straight telehealth, we’re not interested,” Lynne Chou O’Keefe, founder and managing partner of Define Ventures, said on a panel Wednesday on digital health business opportunities at the all-virtual Consumer Electronics Show. “To me, telehealth is a pipe… It’s about the use case and what are we trying to solve.” 

She pointed to her firm’s investment in MedArrive as an example of a company with a telehealth component that’s got the right idea. MedArrive, which launched out of stealth mode this fall, plans to send paramedics and EMTs to deliver home-based care under the supervision of remote physicians who are “piped” in. 

“I think we believe in hybrid models.  You know, there are going to be areas where virtual and virtual only will be enough. And I think there are others where we’re going to have a mixed model — to the home as an example.”

The federal government’s Pandemic Response Accountability Committee (“PRAC”) has issued a “report examines COVID-19 testing efforts for six federal health care programs [including the FEHBP] during the first seven months following the declaration of a public health emergency in the United States.” The FEHBP section runs from pages 24 to 28 of the report.

The Centers for Disease Control issued a report yesterday titled “COVID-19 Trends Among Persons Aged 0–24 Years — United States, March 1–December 12, 2020.” Bloomberg sums up the CDC report as follows:

The return to in-person classes in nearly two-thirds of the U.S. hasn’t led to a rash of community outbreaks, federal scientists said in a study of 2.87 million cases among those under age 24.

Disease rates in counties where in-person learning is available for school-aged children and adolescents is similar to areas where classes are entirely online, according to a report by the U.S. Centers for Disease Control and Prevention. It concludes [K-12] schools should be the last to close, and the first to re-open.

Meanwhile, young adults ages 18 to 24, who led the country in infections during the summer and fall, may have contributed more to community transmission, the agency said in its Morbidity and Mortality Weekly Report.

Also the Department of Health and Human Services announced today that “it will publish Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder*, to expand access to medication-assisted treatment (MAT) by exempting physicians from certain certification requirements needed to prescribe buprenorphine for opioid use disorder (OUD) treatment.” The HHS news release explains

More than 83,000 drug overdose deaths occurred in the United States in the 12 months ending in June 2020, the highest number of overdose deaths ever recorded in a 12-month period, and an increase of over 21% compared to the previous year, according to recent provisional data from the Centers for Disease Control and Prevention (CDC).

The increase in overdose deaths highlights the need for treatment services to be more accessible for people most at risk of overdose and today’s action will expand access to and availability of treatment for opioid use disorder.

“The medical evidence is clear: access to medication-assisted treatment, including buprenorphine that can be prescribed in office-based settings, is the gold standard for treating individuals suffering from opioid use disorder,” said Adm. Brett P. Giroir, MD, assistant secretary for health. “Removing some of the certification requirements for an  X-waiver for physicians is a step toward providing more people struggling with this chronic disease access to medication assisted treatment.”

Without MAT, the chances of relapse for a person who suffers from OUD are significant; studies have shown that outcomes for people with OUD are much better with MAT.

Weekend Update

David Ermer–COVID-19, COVID-19 vaccine, Uncategorized–
Photo by JOSHUA COLEMAN on Unsplash

On January 7, 2021, the Secretary of Health and Human Services extended the COVID-19 public health emergency for another 90 days from January 21 until April 21, 2020. The COVID-19 testing mandate and emergency use authorizations used for the vaccines hinge on the existence of the public health emergency.

Speaking of which NPR reports that people in the U.S. are beginning to receive the booster doses of the COVID-19 vaccines.

Many health care workers and others at high risk who had the Pfizer shots in mid December lined up for their “booster” shot this week, due to be given 21 days after the initial dose. * * * So far, there don’t appear to be widespread problems with people missing their second dose, but experts say it’s still early and the feasibility of a two-shot mass vaccine effort will be tested in the coming weeks, especially as those who received the Moderna vaccine await their follow up shot, which comes 28 days after the first.

A opinion piece in Bloomberg further advises

Take a look at the pipelines of Moderna and BioNTech. They include drug trials for treating cancers of the breast, prostate, skin, pancreas, brain, lung and other tissues, as well as vaccines against everything from influenza to Zika and rabies. The prospects appear good.

Progress, admittedly, has been slow. Part of the explanation [BioNTech founders Drs.] Sahin and Tureci give is that investors in this sector must put up oodles of capital and then wait for more than a decade, first for the trials, then for regulatory approvals. In the past, too few were in the mood.

Covid-19, fingers crossed, may turbo-charge all these processes. The pandemic has led to a grand debut of mRNA vaccines and their definitive proof of concept. Already, there are murmurs about a Nobel Prize for Kariko. Henceforth, mRNA will have no problems getting money, attention or enthusiasm — from investors, regulators and policymakers.

That doesn’t mean the last stretch will be easy. But in this dark hour, it’s permissible to bask in the light that’s dawning

Monday Roundup

David Ermer–COVID-19, COVID-19 vaccine, OPM, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

Govexec.com provides an update on COVID-19 vaccine administration by federal agencies to their employees. A friend of the FEHBlog asked him today whether he knew how long it took for a COVID-19 to provide protection following the injection. Good question. The New York Times reported last week that “The protective effects of vaccines are known to take at least a couple of weeks to kick in.” To wit,

Data from Pfizer’s clinical trials suggests the vaccine might start safeguarding its recipients from disease around one or two weeks after the first injection. A second jab of mRNA, delivered three weeks after the first, helps immune cells commit the virus’s most prominent features to memory, clinching the protective process.

Biopharma Dive reports that “AbbVie raised the list prices of many of its drugs on Jan. 1, while Biogen hiked the price tag of its old multiple sclerosis treatment Tysabri, part of broad, sector-wide increases typically taken at the start of a new year. The hikes could feature in calls for drug pricing legislation as a new Congress and new administration begin work.” Timing is everything.

Here a few loose ends that have been tied up.

  • According to Healthcare Dive, “Haven, the high-profile, secretive venture to lower healthcare costs backed by Amazon, J.P. Morgan and Berkshire Hathaway, is suspending operations in February after three years, the company announced Monday. Haven caused waves when launched in 2018, with a lineup of notable hires from within the healthcare industry. However, the nonprofit, independent company is now closing with little concrete to show, hinting at the difficulty of reforming the complex insurance system and curbing rising costs in the deeply entrenched healthcare industry. Haven said in a statement on its website that Amazon, J.P. Morgan and Berkshire Hathaway would use the information it gained moving forward and continue working to create programs addressing the health needs of their combined 1.2 million employees. Shares of major U.S. insurers got a bump in Monday trading following the news, with UnitedHealthcare and Humana each climbing more than 2% since noon.”
  • According to Fierce Healthcare, “New York Life completed its acquisition of Cigna’s group life, accident and disability insurance businesses in a deal valued at $6.3 billion.” Cigna like CVS Health / Aetna has decided to focus its attention on healthcare.
  • Congress.gov reported today that the Senate has returned to the President his nomination of Craig Leen to be OPM Inspector General because the Senate failed to act on the nomination during the 116th Congress. The President may renew the nomination for the 117th Congress.

Thinking about the OPM Inspector General caused the FEHBlog to check to see whether the latest OPM Inspector General semi-annual report to Congress (period ended September 30, 2020) is online and by golly it has been posted right here. The lead article in the report discusses the impact of the COVID-19 public health emergency on the FEHBP. The management response to the Inspector General’s report is available here.

Weekend Update

David Ermer–Uncategorized–

The 117th U.S. Congress convened today, and Rep. Nancy Pelosi (D Calif.) was re-elected Speaker of the House. The Wall Street Journal reports that “Democrats expect to have 222 seats to Republicans’ 211.” Party leadership in the Senate hinges on the two special elections that will be held in Georgia on January 5.

The federal mandate for health plans to cover the Moderna COVID-19 vaccine begins today. According to the CDC as of yesterday at 9 am ET, 13,071,925 doses of the Pfizer-BioNTech and Moderna vaccines have been distributed across the U.S. and 4,225,756 initial doses of those vaccines have been administered.

Turning back to the Affordable Care Act amendments included in Division BB of the Consolidated Appropriations Act, 2021, that require health plan attention in order to implement then for 2022:

  • Section 107 requires health plan identification cards to include the following information:

‘‘(1) Any deductible applicable to such plan or coverage.

‘‘(2) Any out-of-pocket maximum limitation applicable to such plan or coverage.

‘‘(3) A telephone number and Internet website address through which such individual may seek consumer assistance information, such as information related to hospitals and urgent care facilities that have in effect a contractual relationship with such plan or coverage for furnishing items and services under such plan or coverage’’.

  • Section 116 creates new requirements on health plan network provider directories and holds health plans and providers liable to consumers/ patients liable for errors in those directories, although the provider may shift certain aspects of that liability to the health plan in the network contract.

There is one requirement in the new law (relating to mental heath parity) that takes effect on February 9, 2021. The section requires specific comparative analyses to demonstrate health plan compliance with the most complicated provision of the federal mental health parity law, non-quantitative treatment limitations, e.g, medical necessity, pre-authorization. Here is a link to the most recent federal government FAQs on NQTLs.

Section 203 of Division B states

In the case of a group health plan or a health insurance issuer offering group or individual health insurance coverage that provides both medical and surgical benefits and mental health or substance use disorder benefits and that imposes nonquantitative treatment limitations (referred to in this section as ‘NQTLs’) on mental health or substance use disorder benefits, such plan or issuer shall perform and document comparative analyses of the design and application of NQTLs and, beginning 45 days after the date of enactment of the Consolidated Appropriations Act, 2021, make available * * * the Secretary of Health and Human Services [FEHBlog note edited for the FEHBP], upon request, the comparative analyses and the following information:

‘‘(i) The specific plan or coverage terms or other relevant terms regarding the NQTLs and a description of all mental health or substance use disorder and medical or surgical benefits to which each such term applies in each respective benefits classification.

‘‘(ii) The factors used to determine that the NQTLs will apply to mental health or substance use disorder benefits and medical or surgical benefits.

‘‘(iii) The evidentiary standards used for the factors identified in clause (ii), when applicable, provided that every factor shall be defined, and any other source or evidence relied upon to design and apply the NQTLs to mental health or substance use disorder benefits and medical or surgical benefits.

‘‘(iv) The comparative analyses demonstrating that the processes, strategies, evidentiary standards, and other factors used to apply the NQTLs to mental health or substance use disorder benefits, as written and in operation, are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards, and other factors used to apply the NQTLs to medical or surgical benefits in the benefits classification.

‘‘(v) The specific findings and conclusions reached by the group health plan or health insurance issuer with respect to the health insurance coverage, including any results of the analyses described in this subparagraph that indicate that the plan or coverage is or is not in compliance with this section.

The law permits that Secretary of HHS to use the comparative analyses for investigative purposes when a mental health parity compliance complaint has been made against the health plan.

Monday Roundup

David Ermer–ACA, Congress, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

Today, the House of Representatives voted 322-87 to override the President’s veto of the Fiscal Year 2021 National Defense Authorization Act. Govexec notes that “The NDAA contains several provisions for federal employees, such as making technical corrections to the paid parental leave policy from last year’s bill and waiving the normal annual cap for unused leave from year to year.” The Senate is expected to complete the veto action in a vote tomorrow. This would be the first time that Congress has overridden one of President Trump’s vetoes.

The House of Representatives also voted in favor of a “clean bill” to amend the latest COVID-19 relief law (H.R. 133) by increasing the direct stipend from $600 to $2000 per person. That bill now goes to the Senate.

The FEHBlog noted earlier this month that the American Hospital Association had asked Congress not to disrupt payer / provider network contracting in the COVID-19 relief bill. Of course, the surprise billing restrictions may encourage in-network providers to make the jump to out-of-network status particularly if the surprise billing arbitration decisions favor the providers. Time will tell on that one, but the following ACA amendment in H.R. 133 reminded the FEHBlog of the AHA’s warning.

Division BB, SEC. 108. IMPLEMENTING PROTECTIONS AGAINST PROVIDER DISCRIMINATION.

Not later than January 1, 2022, the Secretary of Health and Human Services, the Secretary of Labor, and the Secretary of the Treasury shall issue a proposed rule implementing the protections of section 2706(a) of the Public Health Service Act (42 U.S.C. 300gg-5(a)). The Secretaries shall accept and consider public comments on any proposed rule issued pursuant to this subsection for a period of 60 days after the date of such issuance. Not later than 6 months after the date of the conclusion of the comment period, the Secretaries shall issue a final rule implementing the protections of section 2706(a) of the Public Health Service Act

Congress has set the fuse on another one of the Affordable Care Act’s time bombs directed at provider networks. Section 2706(a) reads as follows:

A group health plan and a health insurance issuer offering group or individual health insurance coverage shall not discriminate with respect to participation under the plan or coverage against any health care provider who is acting within the scope of that provider’s license or certification under applicable State law. This section shall not require that a group health plan or health insurance issuer contract with any health care provider willing to abide by the terms and conditions for participation established by the plan or issuer. Nothing in this section shall be construed as preventing a group health plan, a health insurance issuer, or the Secretary from establishing varying reimbursement rates based on quality or performance measures.

The Obama Administration on April 29, 2013, issued the following ACA FAQ on this law:

Q2:  Will the Departments be issuing regulations addressing PHS Act section 2706(a) prior to its effective date?

No.  The statutory language of PHS Act section 2706(a) is self-implementing and the Departments do not expect to issue regulations in the near future.  PHS Act section 2706(a) is applicable to non-grandfathered group health plans and health insurance issuers offering group or individual health insurance coverage for plan years (in the individual market, policy years) beginning on or after January 1, 2014. 

Until any further guidance is issued, group health plans and health insurance issuers offering group or individual coverage are expected to implement the requirements of PHS Act section 2706(a) using a good faith, reasonable interpretation of the law.  For this purpose, to the extent an item or service is a covered benefit under the plan or coverage, and consistent with reasonable medical management techniques specified under the plan with respect to the frequency, method, treatment or setting for an item or service, a plan or issuer shall not discriminate based on a provider’s license or certification, to the extent the provider is acting within the scope of the provider’s license or certification under applicable state law.  This provision does not require plans or issuers to accept all types of providers into a network.  This provision also does not govern provider reimbursement rates, which may be subject to quality, performance, or market standards and considerations.

The Departments will work together with employers, plans, issuers, states, providers, and other stakeholders to help them come into compliance with the provider nondiscrimination provision and will work with families and individuals to help them understand the law and benefit from it as intended. 

The FEHBlog recalls that ancillary providers such as chiropractors were particularly exercised by, and insurers were relieved by, the Administration’s statement that “This provision does not govern provider reimbursement rates, which may be subject to quality, performance, or market standards and considerations.” While the statute does not expressly mention consideration of “market standards and considerations,” such a fine point has not stopped federal agencies from elaborating on statutory standards in the past. The FEHBlog expects that this mandated rule making will be a tug of war over statutory interpretation that will wind up in the courts If the providers win this tug of war and the surprise billing arbitrations, then healthcare spending will resume its upward curve.

And there’s more to follow tomorrow. If you want to find the text of H.R. 133 visit this Congress.gov website and download the PDF of the enrolled bill. The ACA amendments may be found in Division BB. You can search for Division BB using the Adobe Acrobat find tool.

Weekend update

David Ermer–Congress, COVID-19, COVID-19 vaccine, HIPAA Privacy and Security Rules, U.S. Healthcare, Uncategorized–
green pine trees during snow season
Snow trees on trail by Ian Schneider on Unsplash.com

The Wall Street Journal reports that

Lawmakers raced to put finishing touches on a roughly $900 billion coronavirus aid package, pushing up against a midnight deadline to complete the agreement and pass it through Congress. 

With a disagreement on the Federal Reserve’s emergency lending powers settled earlier in the weekend, negotiators on Sunday were finalizing details for the rest of the bill. Senate Majority Leader Mitch McConnell (R., Ky.) said Sunday afternoon that negotiators were hours away from completing the deal. * * *

The emerging agreement is expected to provide $300 a week in enhanced federal unemployment benefits, a $600 direct check to many Americans, as well as aid for schools, vaccine distribution and small businesses. Final votes in the House and Senate could occur as early as Sunday.

Lawmakers raced to put finishing touches on a roughly $900 billion coronavirus aid package, pushing up against a midnight deadline to complete the agreement and pass it through Congress. 

With a disagreement on the Federal Reserve’s emergency lending powers settled earlier in the weekend, negotiators on Sunday were finalizing details for the rest of the bill. Senate Majority Leader Mitch McConnell (R., Ky.) said Sunday afternoon that negotiators were hours away from completing the deal. * * *

The emerging agreement is expected to provide $300 a week in enhanced federal unemployment benefits, a $600 direct check to many Americans, as well as aid for schools, vaccine distribution and small businesses. Final votes in the House and Senate could occur as early as Sunday.

The House is expected to vote on a 24-hour extension of government funding Sunday evening, setting up votes on the relief agreement and broader spending bill for Monday. The aid package is tied to a roughly $1.4 trillion annual spending package and Congress has passed a series of temporary spending bills in recent days to keep the government funded while it finished the negotiations.

Significantly, Politico reports that “Congress is set to include a long-elusive ban on “surprise” medical bills as part of a major spending deal lawmakers were working to finalize Sunday evening.”

(P.S. Govexec.com confirms that Congress passed a one day extension of the continuing resolution Sunday night.)

On the COVID-19 front —

The Centers for Disease Control now has a COVID-19 vaccines website which indicates that as of 1 pm today 2,838,225 doses of vaccine have been distributed and 556,208 doses have been administered in the first week.

In accordance with CDC Advisory Committee on Immunization Practices recommendations, the current phase 1A of distribution is directed at healthcare personal and nursing home residents, The Wall Street Journal reports that ACIP today approved phases 1B and 1C as follows:

The next group would include people ages 75 and older, whose hospitalization and death rates are the highest of all age groups. It would also include teachers, factory workers, police and firefighters, grocery store workers and others who are considered essential to the functioning of the economy and at high risk of exposure to Covid-19.

Another group would follow them, comprised of people between the ages of 65 and 74, anyone age 16 or over with a medical condition that puts them at high risk of complications from Covid-19, and other essential workers. They include people who work in transportation and logistics, food service, water and wastewater, and energy sectors.

The ACIP vote was 13-1. State governors are the ultimate decision makers in their states but the FEHBlog understands the governors generally defer to ACIP. As the FEHBlog has noted the vaccines are being directly distributed to federal agencies too.

On the COVID-19 treatment front, the Wall Street Journal reports that

Doctors are treating a new flood of critically ill coronavirus patients with treatments from before the pandemic, to keep more patients alive and send them home sooner.

Last spring, with less known about the disease, doctors often pre-emptively put patients on ventilators or gave powerful sedatives largely abandoned in recent years. The aim was to save the seriously ill and protect hospital staff from Covid-19.

Now hospital treatment for the most critically looks more like it did before the pandemic. Doctors hold off longer before placing patients on ventilators. Patients get less powerful sedatives, with doctors checking more frequently to see if they can halt the drugs entirely and dialing back how much air ventilators push into patients’ lungs with each breath.

“Let us go back to basics,” said Dr. Eduardo Oliveira, executive medical director for critical-care services for AdventHealth Central Florida, which recommends its doctors stick with pre-pandemic guidelines for ventilator use. “The less you deviate from it, the better.”

Advances also include new drugs, most notably steroids, for severely ill patients.

In other healthcare news, Health Payer Intelligence informs us that

Payers may consider promoting ambulatory surgery centers as the ideal site of care for joint replacement surgeries, UnitedHealth Group’s recent research findings suggested.

“Findings from new UnitedHealth Group research underscore the importance of optimizing sites of care to improve patient safety and reduce costs,” the report summarized.

The study analyzed data 2018 and 2019 procedures conducted at Optum’s ambulatory surgery centers. The researchers used low- and medium-severity surgeries to from the baseline and gauge shifts in costs and savings. They used the Ambulatory Surgery Centers Quality Collaboration’s recommended outcome measures to assess quality of care.

On the SolarWinds backdoor hack front, check out this ArsTechnica article:

Of the 18,000 organizations that downloaded a backdoored version of software from SolarWinds, the tiniest of slivers—possibly as small as 0.2 percent—received a follow-on hack that used the backdoor to install a second-stage payload. The largest populations receiving stage two were, in order, tech companies, government agencies, and think tanks/NGOs. The vast majority—80 percent—of these 40 chosen ones were located in the US.

These figures were provided in an update from Microsoft President Brad Smith. Smith also shared some insightful and sobering commentary on the significance of this almost unprecedented attack. His numbers are incomplete, since Microsoft sees only what its Windows Defender app detects. Still, Microsoft sees a lot, so any difference with actual numbers is likely a rounding error.

The FEHBlog had been wondering why not all of the victims of the backdoor hack were breached. It was a conscious decision by the hackers.

Friday Stats and More

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

Based on the CDC’s Cases in the U.S. website, 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.”