Monday Roundup

ACA

Monday Roundup

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

Good news on the COVID-19 front —

Bloomberg’s headline story this evening is that

More Americans have received at least one dose of a Covid-19 vaccine than have tested positive for the virus, an early but hopeful milestone in the race to end the pandemic.

As of Monday afternoon, 26.5 million Americans had received one or both doses of the current vaccines, according to data gathered by the Bloomberg Vaccine Tracker. Since the first U.S. patient tested positive outside of Seattle a year ago, 26.2 million people in the country have tested positive for the disease, and 441,000 have died, according to data from Johns Hopkins University.

The U.S. has been administering shots at a faster daily rate than any country in the world, giving about 1.35 million doses a day, according to data gathered by Bloomberg. While the rollout stumbled in its early days, in the six weeks since the first shots went into arms almost 7.8% of Americans have gotten one or more doses, and 1.8% are fully vaccinated.

“It’s worth noting that today, for the first time, the data said that more people were vaccinated than were reported as newly diagnosed cases,” said Paula Cannon, a professor of microbiology at the University of Southern California’s Keck School of Medicine. “That’s worth celebrating. I’m all for that win.

A New York Times columnist earlier today explained

Right now, public discussion of the vaccines is full of warnings about their limitations: They’re not 100 percent effective. Even vaccinated people may be able to spread the virus. And people shouldn’t change their behavior once they get their shots.

These warnings have a basis in truth, just as it’s true that masks are imperfect. But the sum total of the warnings is misleading, as I heard from multiple doctors and epidemiologists last week.

“It’s driving me a little bit crazy,” Dr. Ashish Jha, dean of the Brown School of Public Health, told me.

“We’re underselling the vaccine,” Dr. Aaron Richterman, an infectious-disease specialist at the University of Pennsylvania, said.

“It’s going to save your life — that’s where the emphasis has to be right now,” Dr. Peter Hotez of the Baylor College of Medicine said.

The Moderna and Pfizer vaccines are “essentially 100 percent effective against serious disease,” Dr. Paul Offit, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said. “It’s ridiculously encouraging.”

Let’s go.

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

The Biden administration said it has reached a $230 million deal with Australian diagnostics company Ellume USA LLC to produce at-home, over-the-counter Covid-19 tests. 

The Food and Drug Administration previously authorized the test. So far, the FDA has cleared three Covid-19 tests that can be processed entirely at home, but Ellume’s is the only one that doesn’t require a prescription. None are widely available at this point. 

The company is expected to produce 19 million tests a month by the end of the year, Andy Slavitt, senior adviser to the White House Covid-19 response team, said Monday. Based on the agreement, 8.5 million tests will be guaranteed to the U.S. government. 

Smart move.

In other news —

  • Roll Call brings us up to date on the COVID-19 relief bill developments on Capitol Hill.
  • Katie Keith helpfully updates us on Affordable Care Act litigation in the Health Affairs blog.
  • Dispatch Health and Humana announced ” an [interesting] agreement to provide Humana members with access to an advanced level of care in the home – to help enhance patients’ experience and health outcomes. These services will be available in Denver, Colo., and Tacoma, Wash., with expansion to additional markets in Texas, Arizona and Nevada planned for later this year. The agreement will provide members living with multiple chronic conditions – such as cellulitis, kidney and urinary tract infections, chronic obstructive pulmonary disease, heart failure and many others – an opportunity to be treated safely at home and thereby avoid hospital visits. Last November, the U.S. Centers for Medicare & Medicaid Services announced a waiver program to allow qualified health care providers to offer acute, hospital-level care in the home. The Dispatch-Humana agreement is believed to be the country’s first program to provide hospital-level care involving a national payer.

In pharmacy C-suite news —

  • Healthcare Dive reports that “Karen Lynch has officially stepped into the CEO role at CVS Health [on February 1, 2021]. Lynch previously served as president of the Aetna business, and was a key figure in directing CVS Health’s COVID-19 response.”
  • AP reported last week that “Walgreens has tapped Starbucks executive Roz Brewer as its new CEO, which will make her the only Black woman leading a Fortune 500 company. Starbucks announced Tuesday January 26 that Brewer was departing after a little more than three years as its chief operating officer. Walgreens later confirmed that Brewer will take over as its CEO on March 15.

Good luck.

Thursday Miscellany

David Ermer–ACA, CDC, COVID-19, COVID-19 vaccine, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

As the FEHBlog mentioned on Sunday, today was healthcare day at the White House. Here are links to the President’s executive order intended to strengthen Medicaid and the Affordable Care Act and the related fact sheet. Health Payer Intelligence explains that

In response to the executive order, the Department of Health and Human Services (HHS) will open a special enrollment period on the federal health insurance marketplace platform. The special enrollment period will last from February 15, 2021 through May 15, 2021.

This move will give the uninsured or underinsured individuals more time to enroll on the Affordable Care Act marketplace. Not only will it open up the federally-facilitated marketplace, but this executive order will also allow state-based marketplaces on the federal platform to have a special enrollment period.

“The President will also direct federal agencies to reconsider rules and other policies that limit Americans’ access to health care, and consider actions that will protect and strengthen that access,” said the fact sheet.

The Wall Street Journal adds “Mr. Biden’s sweeping call to review decisions that could limit access to health care marks the start of a tougher battle that is likely to spur political conflict between his administration and Republicans.”

The FEHBlog did watch the Washington Post’s online Prognosis 2021 today. Dr. Vivek Murthy, the President’s nominee for Surgeon General, commented that the President’s goal of 100,000,000 doses of COVID-19 vaccine in his first 100 days in office / April 30, 2021 is a floor not a ceiling. The ultimate goal of achieving herd immunity “goes beyond” April 30. On January 26 and 27, over 2.65 million doses were administered according to the CDC. Progress is being made.

Prognosis 2021 also featured BCBSA CEO Kim Keck, who discussed the Affordable Care Act. She accurately quipped that the Affordable Care Act should be known as the Access to Care Act as we are still waiting for a law that would reduce healthcare costs.

Prognosis 2021 also included an interview with U.S. Senator and Doctor Bill Cassidy (R La.). He touted the recently enacted No Surprises Act intended to protect patients against out of network surprise billing in emergency care, air ambulance and ancillary care at in-network hospital situations. While this law will be a heavy lift to implement, the FEHBlog does expect it to be effective. Video highlights of Prognosis 2021 are available here.

Speaking of healthcare costs Healthcare Dive reports that “U.S. hospitals lost more than $20 billion from suspending elective surgeries over three months at the beginning of the COVID-19 pandemic’s onset in this country, according to an article published recently in the Annals of Surgery.” Holy smoke.

Patient safety advocate the Leapfrog Group announced

“Recognizing Excellence in Diagnosis, a new national initiative to publicly report and recognize hospitals for preventing patient harm due to diagnostic errors. Developed in collaboration with The Society to Improve Diagnosis in Medicine (SIDM) and key experts, the project is funded with a two-year grant of $1.2 million by the Gordon and Betty Moore Foundation. * * *

Joining Leapfrog in leading this effort is SIDM, a nationally recognized organization focused on catalyzing efforts to improve diagnostic quality and safety, as well as convener of the Coalition to Improve Diagnosis, of which Leapfrog is a member. SIDM will develop resources to guide health systems and clinicians on improving diagnostic safety. * * *

Recognizing Excellence in Diagnosis will be conducted over two years. As a first step, the initiative will convene an advisory group of Leapfrog and SIDM representatives, patient and payor stakeholders, and experts in diagnosis and performance analysis. With guidance from the advisory group, the project will identify best practices in diagnosis and put together a roadmap for hospitals and health systems to achieve excellence. SIDM will facilitate the development of training and educational materials to support hospitals and health systems in their adoption of the best practices. In year two, Leapfrog will pilot test a national survey, similar to the annual Leapfrog Hospital Survey, to collect data from up to 100 hospitals and health systems on their adoption of identified best practices. A national report will be issued on the current status of diagnostic safety, best practices for achieving excellence, and strategies for payors and patients to incentivize improvement.

Good luck with this initiative.

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.

Midweek Update

David Ermer–ACA, HIPAA Privacy and Security Rules, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

On Monday of this week, the FEHBlog carefully was reading through Division BB of the Consolidated Appropriations Act 2021, Pub. L. No.  116-260, and he discovered to his great surprise that the new law adds a new subsection 8902(p) to the FEHB Act. Division BB, Section 102(d)(1) found at page 1616 of the enrolled bill version of H.R. 133.

The FEHBlog was surprised because Division BB like virtually every federal healthcare mandate for the past 25 to 30 years has taken the shortcut of reaching all health plans and providers by amending the Public Health Service Act (“PHSA”), ERISA, and the Internal Revenue. However, in two laws passed in 2020, the CARES Act and Division BB, Congress expressly has amended the FEHB Act too.

This new FEHBA Section 8902(p) applies the No Surprises Act and a patient rights provision (Public Health Service Act (“PHSA”) Section 2799A-1,-2, -7)) contractually to FEHB plan carriers and statutorily to the health care providers who serve FEHB plan members. This means that several of the Division BB provisions about which the FEHBlog has expressed concern, e.g. the continuity of care provision (PHSA Section 2799A-3) and the provider directory provision (PHSA Section 2799A-5) do not apply to FEHB plans. You may recall that the FEHBlog expressed concern about the continuity of care provision because the FEHBP has offered transitional care to it members for over 20 years. Why upset the apple cart?

In any event, the No Surprises law will be a real bear to implement and administer. What’s more, Becker’s Hospital News reports that “The arbitration system implemented by New Jersey in 2018 to resolve surprise billing disputes between insurers and out-of-network providers is advantageous to hospitals and other providers, according to a study published Jan. 5 in Health Affairs.”

1. The authors found that providers won 59 percent of arbitration decisions, and health plans won in 41 percent of decisions in the study period.

2. The average arbitration awards were considerably higher than typical in-network payment amounts. The average award was $7,222. This payment award is nine times higher than the median in-network price for the rendered service.

The FEHBlog was intrigued to read this morning about Optum’s acquisition of one of the largest healthcare clearinghouses in the country, Change Healthcare. Assuming timely shareholder and regulatory approvals, the deal is expected to close in the second half of this year. Interestingly, “Neil de Crescenzo, President and CEO of Change Healthcare * * * will serve as OptumInsight’s chief executive officer, leading the combined organization.”

Becker’s Hospital Review lists fourteen health systems with strong balance sheets. Becker’s cautions that “This is not an exhaustive list. Hospital and health system names were compiled from credit rating reports and are listed in alphabetical order.” Nevertheless it’s worth a gander.

The Department of Health and Human Services announced today the launch of

the HPV VAX NOW campaign with the long-term goal of increasing human papillomavirus (HPV) vaccination rates among young adults ages 18–26. The campaign will specifically target young adults and healthcare providers in Mississippi, South Carolina, and Texas — states with some of the lowest HPV vaccination rates in the country.

Currently, fewer than half of young adults in the United States have received one or more doses of the HPV vaccine, and only 22% have completed the vaccine series. According to the Centers for Disease Control and Prevention (CDC), HPV causes nearly 36,000 cases of cancer in men and women each year in the U.S.  

HPV VAX NOW aligns with the OASH immunization “Catch-up to Get Ahead” campaign as part of HHS’ efforts to improve vaccination uptake in the United States. “With the increased awareness of vaccination opportunities that HHS has prioritized during the COVID pandemic, now is an important time for young adults to complete their HPV vaccine series.” said Dorothy Fink, M.D., Deputy Assistant Secretary for Women’s Health.

The HPV VAX NOW campaign is launching during Cervical Cancer Awareness Month, bringing attention to one of the six cancers and pre-cancerous cervical lesions that the HPV vaccine prevents.

The federal government’s Cybersecurity and Infrastructure Security Agency released a joint statement yesterday from the FBI, CISA, the Office of the National Intelligence Director and the National Security Agency about the status of their work on investigating and remediating the SolarWinds backdoor hack. The statement explains each agency’s role in this work.

Tuesday Tidbits

David Ermer–ACA, COVID-19, COVID-19 vaccine, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

STAT News reports that “Nancy Messonnier, a top federal health official involved in the distribution of Covid-19 vaccines, predicted on Tuesday [in an interview with STAT] that delays in the administration of the shots would improve soon.” (On the bright side, the CDC has begun to update its COVID-19 vaccinations site daily. Around 275,000 initial doses were administered yesterday.) Furthermore

During the discussion Tuesday, Messonnier said she hoped the supply of vaccine would expand greatly in the spring, a time when the shots could be made more widely available to the general public, not just people with certain jobs or health conditions. But making the vaccine is only one step: successfully inoculating the vast majority of the population will require major efforts to educate the public, to build out accessible sites where people can easily get vaccinated, and to ensure individual people show up when it’s their turn to get the shot.

Health Payer Intelligence updates on how three large payers “extended temporary COVID-19 benefits in 2021.” Technically the COVID-19 public health emergency period expires on January 21, 2021, but unquestionably the federal government will extend that period for another 90 days before then.

Under the Affordable Care Act, effective January 1, U.S. Preventive Services Task Force A and B recommendations made two years earlier become eligible for health plan in-network coverage with no member cost-sharing. If you pick out from the USPSTF list those recommendations that received an A or B grade in 2019, you will find ten recommendations that are eligible for “no additional cost” coverage in 2021. Fierce Healthcare provides insights into how health plan members can take advantage of one of those 2019 recommendations -“The USPSTF recommends that clinicians offer preexposure prophylaxis (PrEP) with effective antiretroviral therapy to persons who are at high risk of HIV acquisition.”

On the OPM front, Federal News Network lets us know that

Federal employees who forfeited vacation time in excess of the usual annual leave carryover limit at the end of 2020 may be able to get some of those days back for use later this year, thanks to a policy in the new annual defense authorization law. The Office of Personnel Management on Tuesday issued detailed guidance covering the new annual leave policy and instructed agencies to implement it.

On the mergers and acquisitions front —

  • Fierce Healthcare reports that “Harvard Pilgrim Health Care and Tufts Health Plan officially combined Jan. 1. The deal, announced in August 2019, comes about a decade after the organizations attempted to merge in 2011. * * * The combined Massachusetts organization will serve 2.4 million members. Both the Tufts and Harvard Pilgrim brands will be in the market for a period of time, the organizations said.”
  • Healthcare Dive reports that health insurer “Centene has entered into a definitive agreement to acquire Phoenix, Arizona-based Magellan Health for $2.2 billion, or $95 per share, the payer said Monday. Magellan will operate independently under the Centene umbrella. Executives said the combination will result in one of the nation’s largest behavioral health platforms as the two will provide behavioral services to about 41 million members in the U.S. The deal also boosts Centene’s already established footprint in government sponsored health plans with the addition of 5.5 million lives and another 2.2 million to add to its pharmacy benefit management platform.

Midweek update

David Ermer–ACA, Congress, HIPAA Privacy and Security Rules, U.S. Healthcare–
Photo by Manasvita S on Unsplash

Per the Office of Personnel Management, “The effective date of the Open Season change is the first day of the first full pay period in January. For annuitants this date will always be January 1.” It turns out that Sunday January 3, 2021, is the first day of the first full pay period in January 2021. How convenient.

The Consolidated Appropriations Act, 2021, does include the three standard FEHBP appropriations provisions — a prohibition on applying full Cost Accounting Standards coverage to FEHB contracts (Sec. 611), an abortion coverage restriction (Secs. 613, 614), and a limited contraceptive coverage mandate (Sec. 726) which the Affordable Care Act has overridden. What’s more this new law extends the option of FEHBP and FEGLI coverage to 120 tribal grant schools thereby filling a coverage gap erroneously created by the Affordable Care Act. This option is exercised by the tribal employers who must make the minimum federal civil servant government contribution toward the benefit coverage.

For the past 20 years or so, the FEHBP has offered plan members transitional care protection pursuant to President Clinton’s Bill of Consumer Rights which states in pertinent part as follows:

Consumers who are undergoing a course of treatment for a chronic or disabling condition (or who are in the second or third trimester of a pregnancy) at the time they involuntarily change health plans or at a time when a provider is terminated by a plan for other than cause should be able to continue seeing their current specialty providers for up to 90 days (or through completion of postpartum care) to allow for transition of care.

FEHB plan carriers intending to terminate a network provider for cause generally could comply with this requirement by giving affected members 90 days advance notice of the change.

It turns out that Section 113 Division BB of the Consolidated Appropriations Act, 2021, includes an Affordable Care Act amendment ensuring continuity of care. The requirements of this new law bear similarities to the FEHBP’s transitional care protections. However, as always, the devil is in the details. For example, the new law’s transitional care provisions apply to any provider contract termination, including passive non-renewals, whether triggered by the provider or the payer, with the limited exception of payer termination for fraud or failure to meet applicable quality standards. FEHB plans and OPM have a year to sort out the details before the new requirements take effect on January 1, 2022.

In other news —

The Senate moved forward today on overriding President’s veto of the FY 2021 National Defense Authorization Act but not on the $2000 COVID-19 relief direct stipend per the Wall Street Journal:

Moving through the procedural steps for overriding Mr. Trump’s veto of the National Defense Authorization Act could take up much of the Senate’s time before Sunday. Sen. Bernie Sanders (I., Vt.), in a push for a stand-alone vote on increasing the size of the direct checks, has stopped Mr. McConnell from fast-tracking votes on the NDAA override. As a result, the final vote on the NDAA may not take place until Saturday due to a series of procedural steps.

The Senate took one of those steps late Wednesday, voting 80-12 to move forward with the bill, in another show of broad, bipartisan support for the legislation Mr. Trump vetoed.

Bleeping Computer updated us on how the federal government is addressing the SolarWinds backdoor hack.

The Cybersecurity and Infrastructure Security Agency (CISA) has ordered all US federal agencies to update the SolarWinds Orion platform to the latest version by the end of business hours on December 31, 2020. CISA’s Supplemental Guidance to Emergency Directive 21-01 demands this from all agencies using Orion versions unaffected in the SolarWinds supply chain attack.

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.

Monday Roundup

David Ermer–ACA, Congress, HIPAA Privacy and Security Rules, Rx coverage–
Photo by Sven Read on Unsplash

Tonight the House is voting on the Consolidated Appropriations Act, 2021(Amendment to H.R. 133), which includes the Fiscal Year 2021 omnibus spending bill, COVID-19 relief measures, and a whole lot more. After the House votes, the Senate will vote and send the Congressionally approved bill along to the President for his expected signature.

Late this afternoon, the FEHBlog found, thanks to the Hill, a complete version of the bill which included 400 pages of complicated amendments to the Affordable Care Act (Division BB). However, when the FEHBlog tried to find that version on the House Rules Committee website tonight in connection with this post, he couldn’t. There’s no sense delving into those healthcare provisions until a law is passed. In the words of John Godfrey Saxe (according to WikiQuotes), “Laws, like sausages, cease to inspire respect in proportion as we know how they are made.”

(P.S. This morning Bloomberg reports that Congress passed H.R. 133 by wide margins. Congress wisely also passed a seven day extension of the current continuing resolution funding the federal government because as Bloomberg reports)

Before the president can sign the full package, it must be enrolled on parchment paper, physically delivered to the White House and reviewed by administration lawyers — a process complicated by the pandemic and coming Christmas holiday.)

Moving on, under current law, a prescription drug manufacturer cannot sell a prescription drug at a price below the best price paid by Medicaid. Only Medicare Part D is excepted from that rule. Today, the Centers for Medicare and Medicare Services (“CMS”) finalized a rule that creates a second exception for value based pricing arrangement. CMS explains:

Under current regulations, prescription drug manufacturers face challenges accounting for VBP arrangements in their Medicaid best price reporting to CMS. This has the unintended consequence of hindering providers, insurers and prescription drug manufacturers in their efforts to develop innovative payment models for new drug therapies and other innovative treatments. Current regulations also discourage payers and manufacturers from designing new payment arrangements based on the value their product may provide.

With the new flexibilities under this final rule, manufacturers will be more willing to negotiate with payers, including Medicaid, with drug pricing being driven by the value of their drug to the individual patient. This is significant, especially in the era of new genetic-based treatments which may initially be expensive, yet in the long run offer significant value to the patient and payer. Payers will be able to negotiate prices with manufacturers for these genetic-based treatments based upon outcomes and evidence-based measures such as reduced hospitalizations, lab visits, and physician office visits, ensuring that if such measures fail to support the value of a drug, the payer is not held accountable for the full price. 

Today’s final rule codifies a broad definition of VBP, which can better align pricing and payment to observed or expected evidence and/or outcomes-based measures in a targeted population. The final rule also allows manufacturers to report multiple best prices instead of a single best price when offering their VBP arrangements to all states. By making these changes, effective in January 2022, CMS hopes to encourage VBP arrangements and negotiations to help make new, innovative therapies more available to all patients. As a result, it is estimated that these new VBP approaches could save up to $228 million in Federal and state dollars through the year 2025.  

Bravo. This action will support FEHB plan efforts to control drug costs.

On the Solarwinds backdoor hack front, Federal News Network discusses its impact on federal government cybersecurity efforts.

Monday Roundup

David Ermer–CDC, COVID-19, COVID-19 vaccine, Wellness–
Photo by Sven Read on Unsplash

The FEHBlog should rename Monday’s column COVID-19 Vaccine Good News because for the fourth Monday in a row that news leads the FEHBlog.

Healthcare Dive reports that “Moderna on Monday released new study results showing the [messenger RNA based] coronavirus vaccine it developed with U.S. government scientists to be 94.1% effective at preventing COVID-19 in a large clinical trial, data the company will use to request emergency approval” from the Food and Drug Administration.

According to Moderna’s announcement

[P]rimary analysis was based on 196 cases [of COVID-19 within the test group of 30,000 individuals, half of whom received the vaccine and the other half of whom received a placebo]. 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the mRNA-1273 [vaccine] group, resulting in a point estimate of vaccine efficacy of 94.1%. A secondary endpoint analyzed severe cases of COVID-19 and included 30 severe cases (as defined in the study protocol) in this analysis. All 30 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. There was one COVID-19-related death in the study to date, which occurred in the placebo group.

Efficacy was consistent across age, race and ethnicity, and gender demographics. The 196 COVID-19 cases included 33 older adults (ages 65+) and 42 participants identifying as being from diverse communities (including 29 Hispanic or LatinX, 6 Black or African Americans, 4 Asian Americans and 3 multiracial participants).

The safety profile of the Phase 3 study of mRNA-1273 was previously described on November 16. A continuous review of safety data is ongoing and no new serious safety concerns have been identified by the Company. Based on prior analysis, the most common solicited adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site. Solicited adverse reactions increased in frequency and severity in the mRNA-1273 group after the second dose.

Healthcare Dive adds that

Moderna said it will submit on Monday [today] an application for emergency use authorization in the U.S. and for conditional marketing approval in Europe. The FDA will convene a panel of independent advisers to publicly review Moderna’s application, likely on Dec. 17. * * *

An authorization for either vaccine [Pfizer – BioNTech or Moderna] would kick off a mass immunization campaign in the U.S. But supplies of each shot will be extremely limited for months. Moderna expects to have just 20 million doses available in the U.S. this year, and between 500 million to 1 billion in 2021. [Two doses protect one person. The Wall Street Journal notes that Pfizer and BioNTech said they would deliver about 25 million doses by year’s end, potentially enough for about 12.5 million people in the U.S.]

A Centers for Disease Control and Prevention advisory committee will meet on Tuesday to vote on how vaccine doses will allocated. Healthcare workers on the front lines of the pandemic will likely be vaccinated first.

The Wall Street Journal expands on this last point:

Expected to be first in line: health workers treating coronavirus patients and in something of a surprise, nursing-home residents.

The Advisory Committee on Immunization Practices, the outside medical experts advising the U.S. Centers for Disease Control and Prevention, will vote on who should get the first doses, after discussing plans for distributing the shots and monitoring for potential side effects.

In other news

  • The FEHBlog overlooked the CDC’s Antibiotic Awareness Week which was held from November 18 – 24. Better late than never right. This is an important public health cause and the link provides useful resources.
  • The FEHBlog noticed a Health Payer Intelligence article about a health plan that “has reduced out-of-pocket healthcare spending by collectively giving members millions of dollars in rewards through their My Health Pays program.” The FEHBlog did a little investigative work and he discovered that the health plan in question participates in the ACA marketplace. It is crazy that individual health plans have no limits on wellness reward uses while group health plans generally must limit their wellness rewards to reimbursing medical services and supplies or Medicare premiums. Congress should level the playing field.

Weekend Update

David Ermer–ACA, Congress, COVID-19–

Congress returns to committee work and floor action this coming week for an expected two more weeks of the its lame duck session.

Top House and Senate appropriators on Tuesday [November 24] clinched a deal on a bipartisan set of funding levels, paving the way for a $1.4 trillion spending package to avert a government shutdown next month. The agreement on the funding allocations, confirmed by a House Democratic aide, establishes overall totals for 12 appropriations measures that will be rolled into one massive omnibus bill that would boost federal budgets for the rest of the fiscal year. Negotiators plan to keep the numbers — known as 302(b)s — under wraps until a bipartisan, bicameral omnibus is finalized, the aide said.

This means that Congress remains on track to pass an FY 2021 omnibus spending bill before the current continuing resolution funding the federal government expires on December 12.

Negotiations on another Covid-19 relief bill are at an impasse. Some measures may get attached to a spending package that must pass by Dec. 11 to avert a government shutdown. Another weekly boost to unemployment benefits would most likely be part of the mix, according to unemployment and policy experts.  The subsidy would probably fall between $250 and $600 a week and be retroactive to early September, they said.

  • The Wall Street Journal reports that “President Trump’s decision to defer payroll taxes until the end of the year is leaving challenges for lawmakers to manage after he leaves office in January, and they haven’t figured out what—if anything—to do. * * * [P]ayroll processor Paychex Inc. said take-up has been very low. The one big exception—which could create pressure for Congress to act—is the federal workforce, including many members of the military. Mr. Trump required executive-branch employees to participate. Lawmakers, particularly those from the Washington [D.C.] area, support legislation to let employees decide whether their taxes can be deferred. As the weeks tick by toward the year’s end, that becomes less feasible.

Late Wednesday, the Department of Health and Human Services released the proposed ACA Notice of Benefit and Payment Parameters for 2022. Of note, to community rated FEHB plan carriers HHS proposes to make the following changes to the medical loss ratio (“MLR”) calculation:

We propose to amend the MLR regulation to establish the definition of prescription drug rebates and other price concessions that issuers must deduct from incurred claims for medical loss ratio (MLR) reporting and rebate calculation purposes beginning with the 2022 MLR reporting year (MLR reports filed in 2023). We additionally propose to explicitly allow issuers the option to prepay a portion or all of the estimated MLR rebate for a given MLR reporting year in advance of the deadlines set forth in §§ 158.240(e) and 158.241(a)(2) and the filing of the MLR Annual Reporting Form. We also propose to establish a safe harbor allowing such issuers, under certain conditions, to defer the payment of any remaining rebates owed after prepayment until the following MLR reporting year beginning with the 2020 MLR reporting year (MLR reports filed in 2021). In addition, we propose to allow issuers to provide MLR rebates in the form of a premium credit prior to the date that the rules currently provide and beginning with the 2020 MLR reporting year (MLR reports filed in 2021). Lastly, we propose to clarify MLR reporting and rebate requirements for issuers that choose to offer temporary premium credits during a public health emergency declared by the Secretary of HHSfor future benefit years, beginning with the 2021 MLR reporting year (MLR reports filed in 2022). 

Of note to all FEHB plan carriers, HHS proposes to make the following changes to the out of pocket (“OOP”) cost sharing ceilings for in-network care:

The proposed 2022 maximum annual limitation on cost sharing is $9,100 for self-only coverage and $18,200 for other than self-only coverage. This represents an approximately 6.4 percent increase above the 2021 parameters of $8,550 for self-only coverage and $17,100 for other than self-only coverage. Similar to the proposal for the premium adjustment percentage index, for the 2023 benefit year and beyond, we propose to release the maximum annual limitation on cost sharing in guidance by January of the year preceding the applicable benefit year. 

For more details on the Notice check out Katie Keith’s columns on the Health Affairs Blog.

The Biden Administration’s HHS will finalize the Notice next year. HHS has a good deal of statutory discretion over the MLR calculation but very little discretion over (“OOP”) cost sharing ceiling calculations in the FEHBlog’s opinion.

The FEHBlog has learned that a two step process exists for approval a COVID-19 vaccine for individual and group health plan coverage.

  • First, as discussed in the FEHBlog, the FDA must give emergency use authorization to the vaccine. The relevant FDA advisory committee is meeting December 10 to consider the Pfizer – BioNTech vaccine. The Committee’s recommendation goes to the FDA Commissioner for final approval.
  • Once FDA approval has been given, the CDC’s relevant advisory committee the Advisory Committee on Immunization Practices (ACIP) must add its approval.
  • Fifteen days after ACIP approval is given, individual and group health plans, including FEHB plans will become obligated to cover the administration of the approved vaccine in and out of network without member cost sharing. That effective date will be in late December at the earliest. 
  • An emergency use authorization can only trigger plan health plan coverage of a vaccine during a related public health emergency. The current COVID-19 public health emergency period expires on January 20, 2021, unless as expected HHS extends that period for another 90 days before then,