What a glorious summer evening. The FEHBlog is watching the Major League Baseball All Star Game on mute while listening to the 1:45 hr long recording of this afternoon’s oral argument of the ACA constitutionality case before a Fifth Circuit Panel.  Here’s a link to Fierce Healthcare’s report on the argument.

Today, the Department of Health and Human Services began to implement the provision of the President’s June 24 executive order requiring the creation of a health care quality roadmap.  Here’s a link to HHS’s announcement if its new Quality Summit which will craft the roadmap and a link to more background on the Quality Summit. Presumably at some point this HHS work will be extended to the FEHBP’s quality program.

Healthcare Dive reports that the federal district court for the District of Columbia ruled yesterday that the Food and Drug Administration lacks the regulatory authority to require that prescription drug television advertisements display pricing.

HHS spokeswoman Caitlin Oakley said Trump and HHS Secretary Alex Azar remain committed to improving drug price transparency.

“Although we are not surprised by the objections to transparency from certain special interests, putting drug prices in ads is a useful way to put patients in control and lower costs, and as seen from the President’s executive order, we are working on many different avenues for delivering transparency,” she wrote in an emailed statement.

Congress is back at work on Capitol Hill this week and will remain there for two more weeks until the August recess. The Wall Street Journal reports that Congress faces funding deadlines as the end of the government fiscal year, September 30, creeps closer. Also the federal government is approaching the debt limit.

The Senate Health Education Labor and Pensions Committee leadership will keep on pressing the full Senate leadership to bring forward its wide ranging bill to control healthcare costs, S. 1895. America’s Health Insurance Plans has made available a helpful summary of the bill as it stands following HELP Committee approval on June 26.  Further additional and edits are expected before the bill is considered by the Senate.

Also this month, as Govexec.com reminds us, the Postal Service is expected to provide Congress with its ten year business plan. A satisfactory business plan will cause Congress to return to work on a postal reform law. Based on the FEHBlog’s review of the article, the FEHBlog doubts that Congress will be satisfied with the business plan under development.

The Wall Street Journal is reporting that

President Trump said Friday he was preparing an executive order that would lower drug prices so that the federal government would pay no more than the costs paid by other countries. He said the action would focus on a “favored-nations clause,” which is generally a contract under which a seller gives buyers the same best terms it offers to others.

Bad idea.  Focus on the patent law problems instead. What’s next? Will a public option be included in the President’s healthcare plan which he plans to announce this Summer.

The Journal also reports that

The U.S. Food and Drug Administration approved a record 43 new drugs last year through fast-track programs that skip or shorten major steps other drugs must pass, or 73% of total new drugs. That compares with 10 expedited drugs, or 38% of the total, approved 10 years ago. The proportion of new drugs receiving expedited approvals has been at least 60% for each of the past five years. It was below 60% in the previous five. 

The article assesses whether the additional speed to market outweighs the skipped research steps. It’s evidently a mixed bag.

Here are a few items called to the FEHBlog’s attention by his friends and relatives:

• A detailed Kaiser Family Foundation report on the case challenging the constitutionality of the Affordable Care Act that the U.S. Court of Appeals for the Fifth Circuit will hear next Tuesday. 

Happy Fourth of July eve.

Today initially was the due date for briefing on the justiciability issue in the Texas v. United States case in which the constitutionality of the Affordable Care Act is being challenged.  In contrast to State courts, which hold general jurisdiction, federal courts are courts of limited jurisdiction and cases submitted to federal courts must meet certain justiciability requirements. The U.S. Court of Appeals for the Fifth Circuit, which is hearing the case, asked for these supplemental briefs principally because the U.S., which was initially the defendant in the case, is now supporting the plaintiff States.  The Court extended the supplemental brief submission deadline to July 5 at the request of the plaintiff States. The plaintiff states had requested a 20 day extension which would have moved the July oral argument date into August. So the case will be argued on Tuesday afternoon In New Orleans.

Healthcare Dive reports on how the various approaches that insurers are taking to coverage of Zolgensma the new genetic therapy drug that is priced at $2.125 million per course of treatment.

So far, 11 of 30 major insurers tracked by Bernstein, an investment firm, have published policies for Zolgensma, with all opting to cover the gene therapy. But some, like Anthem and several Blue Cross Blue Shield affiliates, include limits on maximum age at treatment and whether patients must be symptomatic to receive the drug.

The Centers for Medicare and Medicaid Services has extended Medicare coverage to ambulatory blood pressure monitoring in certain circumstance.  Health Data Management explains that

ABPM, a non-invasive diagnostic test that uses a device to track blood pressure over 24-hour cycles, was only previously covered under specific conditions for those patients with suspected white coat hypertension—having higher blood pressure in a doctor’s office than out-of-office BP.

Now, CMS has also extended its policy to beneficiaries with suspected masked hypertension—the opposite of white coat hypertension, which occurs when blood pressure measurements in a doctor’s office are lower than measurements taken outside of the clinical environment.

“ABPM devices provide a larger number of readings than (office blood pressure monitoring) and a profile of blood pressure in the patient’s usual environment,” states the agency’s decision memo, which notes that CMS received a request from stakeholders to reconsider its national coverage determination. “ABPM is intended to allow identification of white coat and masked hypertension, uncover nocturnal hypertension, and assess blood pressure variability over a 24-hour period as well as the 24-hour efficacy of antihypertensive medication.”

Health Payer Intelligence informs us that

UnitedHealthcare (UHC) is launching a hearing healthcare program to combat hearing loss and improve access to quality, affordable hearing aids. The program, titled UnitedHealthcare Hearing, is available to all consumers, including members enrolled in individual, employer-sponsored, and Medicare Advantage plans, the payer stated in a recent announcement. Eligible members will have access to customized hearing aids at up to 80 percent less than the traditional price.

Stat discusses the status of a 21st Century Cures Act initiative to study the extent to which, if at all, real-world evidence can be used to replicate the results of a specific randomized, controlled clinical trial. A Food and Drug Administration “spokeswoman said  [based on the  results of a recent FDA funded analysis] there is a ‘stronger scientific justification’ for randomized controlled trials, but that ‘recent efforts to use rigorous design and statistical methods’ might lead to a greater chance of obtaining valid results with real-world evidence.

The Texas v. United States case concerning the constitutionality of the Affordable Care Act will be held a week from tomorrow before a three judge panel of the U.S. Court of Appeals for the Fifth Circuit in New Orleans beginning ar 1 pm CT. The panel includes Judeeeges Carolyn D. King (Carter appointee), Jennifer W. Elrod (G.W. Bush appointee) and Kurt D. Engelhardt (Trump appointee). The Court makes recordings of their oral arguments available to public at this site.

The Burlington (NC) Times Journal reports on the avalanche of lawsuits against two major medical providers LabCorp and Quest Labs which used American Medical Collection Agency to collect its patient invoices. AMCA is now in bankruptcy court following the disclosure of a massive patient data breach. It will be interesting how the courts rule in these cases (assuming they are settled first). In any event businesses will need to engage in greater due diligence over their vendors that hold and/or process their confidential consumer information.

Currently telehealth services generally are provided in real time. Mhealth Intelligence reports on the development of alternative asynchronous or store and forward telehealth services.

Video-based telehealth programs require that both patient and provider be online and in front of a video screen at the same time, he said, while store-and-forward platforms aren’t that rigid, allowing patient and provider to access the platform when and where they want. 

According to the article, the development of alternate telehealth approaches has been slowed by state law limits and reimbursement approaches. Carrier should give alternate telehealth approaches a look.

The FEHBlog’s alma mater is the University of Connecticut. The FEHBlog read in UConn Today that

Using blood pressure self-monitoring is an effective way to empower patients with hypertension to stick with an exercise program, according to a first-of-its-kind study conducted by a multidisciplinary team of UConn researchers in collaboration with Hartford Hospital.

The findings, recently published in the Journal of Hypertension, confirm a long-held but previously untested theory by the study’s principal investigator, Linda Pescatello, a distinguished professor in UConn’s Department of Kinesiology, and Dr. Paul Thompson, chief of cardiology at Hartford Hospital, that blood pressure self-monitoring can and should be used as a behavioral strategy to help keep patients with hypertension engaged in an aerobic exercise training program, a proven means of addressing the chronic condition known to be a leading risk factor for cardiovascular disease.

Interesting.

Finally when you have a free hour, listen to today’s Econtalk episode in which physician and author Adam Cifu of the University of Chicago talks about being a medical conservative with EconTalk host Russ Roberts. Fascinating.

Congress is out of town this week for the Independence Day holiday. The FEHBlog is surprised that the Senate did not consider Dale Cabaniss’s nomination to become OPM Director last month. Congress returns to Capitol Hill next week for the remainder of July. A Congressional recess will occur in August because this is not  Congressional election year.

The Wall Street Journal reports that

Doctors are taking a second look at the procedure known as shock therapy, saying the long-stigmatized treatment is safer than before and can be remarkably effective in patients with severe symptoms. 

Electroconvulsive therapy, its official name, is a brief electrical stimulation of the brain that causes about a minute-long seizure, helping to realign disrupted circuits. Although the treatment’s most serious potential side effect—memory loss—remains a meaningful risk, advances in technology and technique have reduced the severity. Experts say ECT is among the most effective treatments for serious depression when medications and talk therapy don’t work.

Given the fact that the FEHBP’s enrollment is 50% annuitants, it’s worth calling attention to this Fierce Healthcare story on a recent UnitedHealth survey finding that

Nearly 70% of Americans ages 62 and older named physical health their top concern * * * In fact, 86% of the demographic are worried about falling ill or becoming hospitalized in the near future. 

Other concerns for this demographic that made the UnitedHealthcare survey included cognitive health (16%), social health (13%), and financial health (6%). Collectively, health was of greater concern than financial stability, with 63% of respondents saying maintaining physical ability to live in retirement was more of a concern than maintaining financial stability (37%).

FEHB plans typically offer healthcare coaching programs. Perhaps coaching program attention should be directed at annuitants (if not already.)

Govexec.com reports on an OPM employee town hall held yesterday. The FEHBlog admires the job that Acting OPM Director Margaret Weichert does at OPM. It’s certainly not easy particularly considering she also holds a larger job at OMB and she knows how to maintain her cool.

Minneapolis Business Journals reports that UnitedHealth Group has named an Optum executive Dirk McMahon to replace Steve Nelson who is retiring after 15 successful years as CEO.

The Wall Street Journal reports that two large non-profit midwest hospital systems, Sanford Health and Unity Point, intend to merge their operations.

Sanford and UnityPoint have more than $11 billion in combined operating revenue from health-care and health-insurance operations and hospitals across Iowa, Illinois, Minnesota, North Dakota, South Dakota and Wisconsin. Sanford also operates long-term-care services in two dozen states after its January merger with the Evangelical Lutheran Good Samaritan Society, a Sioux Falls-based nonprofit.

StatNews offers an interesting report on flu vaccine effectiveness rates. Many vaccines have effective rates of at least 90%. The flu vaccine, whose composition changes annually, is considered successful if it has a 40% effectiveness rate. Last years vaccine had a 29% effectiveness rate. Nevertheless,

Flu shots are recommended for virtually all Americans age 6 months or older. Officials say the vaccine is still worthwhile since it works against some strains, and it likely prevented 40,000 to 90,000 hospitalizations over the winter flu season.

Becker’s Hospital Review informs us that “Access to a patient portal through the EHR can help improve patients’ self management of healthcare services, resulting in increased outpatient appointments and reduced emergency room visits and hospitalizations, according to a recent study published in PLOS One.” Bravo.

The FEHBlog was stunned to read in Health Payer Intelligence that “PwC’s Health Research Institute (HRI) predicted a six percent increase in medical cost trend in 2020, with a five percent net growth rate after adjusting for increased employee cost sharing or altering of benefits.” Wow.

The FEHBlog was prompted by a pop up notice on his computer to look into a new arrangement between Amazon and Rite Aid drug stores. The FEHBlog thought that the deal concerned PillPack. However, it turns out according to TechCrunch, that Rite-Aid agreed to allow Amazon to place its new Amazon package pickup service called Counter in one 100 of their stores, at least to start.

The FEHBlog ran across a press release confirming that UnitedHealth’s Optum unit has closed on the acquisition of DaVita’s Medical Group with the exception of Davita’s Las Vega’s doctors who wound up with Intermountain Healthcare at the direction of the Federal Trade Commission. It’s an interesting trend that large insurers are rapidly expanding into providing healthcare. Whether intended or not, such a move is necessarily a hedge against a Medicare for All bill passing in the next decade that would kill the U.S. private health insurance market.

Federal News Network reports that the House Oversight and Reform Committee beat OPM like a drum again today over the President’s reorganization plan. One of the Committee’s takeaways is that

Stephen Billy, OPM Deputy Chief of Staff, testified that his agency could not provide a legal analysis of the Administration’s plan to abolish an agency that provides health care and benefits to more than 8 million people because it does not exist. This makes it clear that the Administration has no idea whether its actions related to eliminating OPM are legal, and proves that the Administration’s plan is reckless and ill-conceived.

The Administration never intended to abolish FEGLI, FEHBP, FEDVIP, etc. and the reorganization would not kill those programs. The Administration intends to transfer these functions to GSA and send the policy work to OMB.  Similarly, and for many years, federal government procurement policy is set in OMB and the contracts are created and administered in the agencies principally GSA. No doubt this particular OPM-GSA transfer requires Congressional action. But it’s not reckless or ill-conceived. Acting Director Weichert sought bipartisan legislation to iron out the fine points.

Today, according to the Wall Street Journal, the House relented from its position and passed a Senate bill on emergency appropriations for the Mexican border. Does the FEHBlog think this means that eventually the House will accede to a Senate appropriations bill that adopts the Administration’s reorganization plan for OPM. No way. The FEHBlog does not think that anyone in Congress wants to expend political capital on this issue. (as opposed to making political hay on it which is happening now) He does think that this development means that it’s more likely that the bipartisan Senate bill to lower healthcare costs (S. 1895) will become law this year (see PwC report above).  

At today’s Senate Health, Education, Labor, and Pensions Committee meeting, the Committee approved by a 20-3 vote a further revised version of S. 1895, a bill to lower healthcare costs, for full Senate consideration.  The Chairman Sen. Lamar Alexander ( TN) expects additional bipartisan bills from the Senate Finance Committee and other committees to be included in the bill before a Senate vote is held before the August recess.  The FEHBlog  listened to the hearing and hoo boy there was an entertaining combination of bipartisanship and hyperbole. The FEHBlog is looking forward to finding and reviewing a current version of the bill, which as they say on the Hill has legs.

Also today, the House of Representatives approved HR 3351, the Fiscal Year 2020 Financial Services and General Government appropriations by a 224-196 vote. As discussed in this Federal News Network article, the bill, which now goes to the Senate, includes a 3.1% 2020 pay raise for federal employees and clamps down on Trump Administration efforts to dismantle OPM.

Tomorrow, the U.S. Supreme Court will hold its last decision day for the October 2019 term. Today the Supreme Court issued its decision in Kisor v. Wilkie, an Administrative Procedure Act case that the FEHBlog had been following. The decision is too complicated for full FEHBlog treatment. Suffice it to say that the Supreme Court did not reach the outcome that the FEHBlog hoped to read. But it’s not the end of the legal world either.

In other judicial news, a three judge panel of the U.S. Court of Appeals for the 5th Circuit, which on July 9 will hear the Texas v. United States case concerning the ACA’s constitutionality, asked the parties for supplemental briefing on the following topics:

(1) Whether or not the state intervenors and the U.S. House of Representatives have standing to intervene in this appeal, see, e.g., Va. House of Delegates v. Bethune-Hill, No. 18-281 (U.S. June 17, 2019), and whether the interventions were timely as to all issues, including whether the U.S. House of Representatives’ intervention was timely as to both orders of the district court;
(2) Whether or not, if none of the intervenors have standing, there is a live case or controversy between the plaintiffs and the federal defendants given their positions on appeal, see United States v. Windsor, 570 U.S. 744 (2013); and
(3) What the appropriate conclusion is if the federal defendants’ change in position has mooted the controversy and no other defendant has standing to appeal. See, e.g. U.S. Bancorp Mort. Co. v. Bonner Mall P’ship, 513 U.S. 18 (1994); United States v. Munsingwear, Inc., 340 U.S. 36 (1950).

As you can see from item 1, the panel’s action was triggered by a very recent U.S. Supreme Court decision. The FEHBlog’s sense is that if the Court finds that the intervening defendants lack standing, then the whole case, including the district court decision, would collapse like a house of cards. But we shall see. The FEHBlog firmly expects the Fifth Circuit or the Supreme Court to reverse the district court decision holding the ACA constitutional if the courts get to the merits.

Also today, the HHS Office for Civil Rights, which enforces the HIPAA Privacy and Security Rules, issued frequently asked questions on permissible uses and disclosures of protected health information for coordination / continuity of care purposes. Check the out.

The House of Representatives began debate this afternoon of the Fiscal Year 2020 Financial Services and General Government Appropriations bill (HR 3351) which funds OPM, its Inspector General and the FEHBP, among other line items.  Federal New Network reports on Democrat and federal employee union efforts to block the Administration’s efforts to transfer certain OPM functions, including FEHBP administration to the General Services Administration. HR 3351 would block funding for this initiative.

The Senate Health Education Labor and Pensions Committee will consider the bipartisan leadership bill to lower healthcare costs (S 1895) tomorrow morning. The FEHBlog skimmed through this lengthy bill yesterday. It substance a wide variety of hot button issues, like price and quality transparency and data exchange, surprise billing, and drug pricing. Needless to say while bipartisan, it remains controversial so tomorrow’s meeting will be interesting.

The Wall Street Journal reported this morning on a noticeable surge in hospital lawsuits against patients for collection of unpaid bills

The Affordable Care Act, the signature achievement of former President Barack Obama, set new requirements for nonprofit hospitals that were largely expected to curb aggressive collection efforts. These hospitals must post and provide information on their financial-assistance policies and send notices that they are planning to sue. They also must limit the amount charged to the uninsured and wait four months before using stepped-up collection efforts such as filing a lawsuit. And yet, concerns persist.

Affordable Care Act indeed!

On the prescription drug front —

• The Wall Street Journal reports that “AbbVie Inc. agreed to buy Allergan AGN 25.36% PLC for about $63 billion in a bet by the two drugmakers that a combination will deliver new sources of growth that they have struggled to find on their own.” The article adds that “Buying Dublin-based Allergan would deliver a dominant position in the $8 billion-plus market for Botox and other beauty drugs, as well as a number of popular eye treatments, as AbbVie braces for the end of patent protection for the world’s top-selling drug, Humira.”

• Drug Channels explains how a CVS Health lawsuit recently revealed three aspects of Amazon’s PillPack strategy. 

Finally, Health Data Management discusses the efforts of cooperative Blockchain Health Utility Network to identify and implement blockchain technology in the healthcare sector. “Blockchain offers the potential to find easier solutions in healthcare for problems that stem from lack of standards or doubts about how to facilitate the secure exchange of healthcare information, said Dan Sanders, director of technology and innovation for Anthem.”