FEHBlog

The FEHBlog was curious about what’s going on with the Justice Department’s lawsuit seeking judicial approval of its settlement of the CVS Health / Aetna merger. Here’s the most recent procedural order from the federal court in the District of Columbia, thanks to the government’s PACER service:

MINUTE ORDER. On the Court’s own motion, it is hereby ORDERED that the hearing scheduled for July 17, 2019, on the United States’ Motion for Entry of Final Judgment, is rescheduled to July 19, 2019, at 3:00 pm in Courtroom 18. The Court will hear oral argument from the parties and amici on that date. The United States, CVS Health Corporation, the American Medical Association, and the AIDS Healthcare Foundation will each be permitted fifteen minutes to present their respective arguments. Consumer Action and U.S. PIRG, which have filed briefs jointly and which proffered their hearing witness jointly, will collectively have ten minutes to present argument. Plaintiffs California, Florida, Hawaii, Mississippi, and Washington have filed a request to collectively address the Court for ten minutes at the hearing, and that request is hereby GRANTED. SO ORDERED. Signed by Judge Richard J. Leon on 7/8/2019.

Federal News Network reports on how the Trump Administration is using an OPM information system outage last week to support its proposal to merger OPM’s operations (other than policy) into GSA.

The incident occurred within the data center at the agency’s headquarters, an OPM spokeswoman said. The incident triggered OPM’s automated disaster recovery systems, which shut down “multiple OPM capabilities” and began the process of transferring those capabilities to a backup location, the agency said. 

“Unfortunately, some of the backup systems failed to operate as designed. There is no indication of malicious activity that led to this outage,” the OPM spokeswoman said. “The backup system just failed to respond when called into action.” 

Acting OPM Director Margaret Weichert is expected to brief senators on this incident, the agency’s broader IT challenges and the status of the OPM-GSA merger on Wednesday, a person close to the meeting told Federal News Network. 

Some sources said Weichert is using this IT problem as yet another example of the “poor” state of OPM’s systems. But sources say the administration is exaggerating both this problem and the overall state of OPM’s technology.

Fierce Healthcare reports that the Congressional Budget Office gave the green light to the Senate Health Education Labor and Pensions Committee’s bipartisan bill to lower healthcare costs (S. 1895). Next stop Senate floor.

The Washington Post released an exhaustive story tonight on sales of opioid based prescription drugs over the period 2006 through 2012 when the dispensing pendulum was reaching its peak. The data was released by the federal court hearing a massive opioid related action against prescription drug manufacturers and wholesale distributers.

In the Cleveland case, [consolidating over 2,000 individual lawsuits, U.S. District Judge Dan] Polster has been pressing the drug companies and the plaintiffs to reach a global settlement so communities can start receiving financial assistance to mitigate the damage that has been done by the opioid epidemic.

Wow.

The FEHBlog read today in the Hill that

The House [of Representatives] will vote [this] week on a full repeal of ObamaCare’s Cadillac Tax on high-cost health insurance plans, House Majority Leader Steny Hoyer (D-Md.) announced [last] Friday 

The politics: The Cadillac Tax is the rare part of ObamaCare that both parties largely agree on: They don’t like it. So the repeal vote is expected to be widely bipartisan.
The Cadillac Tax is widely supported by health economists who view it as a way to control health care costs, but it is hated by unions and employers alike, as well as many lawmakers.  Health economists are not a very strong lobbying force in Washington!

If the Democrat-controlled House passes this bill, it should be a shoo in for passage in the Senate, shouldn’t.

It’s a shame that Congress can’t seem to get its act together to repeal other self-defeating ObamaCare taxes like the health insurer fee which is scheduled to resume next year.  Better something, than nothing though.

Congress remains in session on Capitol Hill this coming week. CNBC is reporting that the Treasury Department is urging Congress to raise the national debt limit before Congress leaves town for its August recess.

One of the craziest provisions of the Affordable Care Act is its excise tax on high cost health plans a/k/a the Cadillac tax or HCPT. The Kaiser Family Foundation last week issued a report on that tax which originally was to take effect for 2018 and due to statutory delays is not set take effect for 2022. The report states

When the HCPT takes effect in 2022, an estimated 21% of employers offering health benefits will have at least one plan whose premium and account contributions would exceed the HCPT threshold (Figure 1). When potential FSA contributions are included, the percentage climbs to 31%.

The FEHBlog also took note of the following

The HCPT is a tax on employers based on the value of plans they provide in excess of designated thresholds, originally set at $10,200 for single coverage and $27,500 for family coverage. These caps grow annually with inflation. The CBO estimates that the thresholds will be $11,200 for individual coverage and $30,100 for family coverage when the law takes effect in 2022. Some employers with workers in high-risk industries or older workers face higher caps.  

The HCPT may lead employers to take advantage of the Trump Administration’s offer to send their employees into the ACA marketplace.

An Oregon newspaper, the News Guard, reports that Oregon and 29 other states reached a $10 million settlement with Premera Blue Cross over a data breach ==

From May 5, 2014-March 6, 2015, a hacker used a “spear phishing” email to gain access to the Premera network containing personal information of over 10 million consumers nationwide.

The House Energy and Commerce Health Subcommittee cleared a package of ten healthcare bills on a bipartisan basis. The package includes a no surprise medical charges bill which is similar in approach to the provision found in the bipartisan Senate bill, S. 1895. The House package is discussed in this Healthcare Leaders Media article. Many of these House bills may wind up in the S. 1895 lower healthcare costs bill winding its way through the Senate.

The Federal Times reports this afternoon that

In a 220 to 197 vote that fell primarily on party lines, the House voted to pass the fiscal year 2020 National Defense Authorization Act that includes provisions to grant federal employees 12 weeks of paid family leave and to block the breakup of the Office of Personnel Management.  The legislation now must be reconciled with the Senate version of the same bill, which does not include the family leave or OPM amendments.

The FEHBlog doubts that these non-defense items will wind up in the final bill.

The FEHBlog also doubts the numerous press reports that the President’s initiative to end prescription drug rebates in favor of lower drug prices is dead. Yes, there will be no mandate imposing this initiative on Medicare Part D and exchange plans for 2020 and it’s a good thing that the Administration listened to industry. Nevertheless, Fierce Healthcare reports that the initiative continues to percolate. It’s a long game. The Wall Street Journal adds

Even if no meaningful action passes, the political storm has the ability to hamper sales growth at drugmakers. Price increases for branded drugs lately have slowed from recent years, both in number and magnitude. Wariness of the regulatory environment has likely played a role in that shift. Don’t expect this game of regulatory Whac-A-Mole to wrap up any time soon.  

Seven years after Medicare was enacted in 1965, Congress extended Medicare coverage to Americans under age 65 with end stage renal (kidney) disease (ESRD).  If you build it they will come and now over 45 years later, dialysis center for treating ESRD are nearly as plentiful as Starbucks outlets. A 2018 Congressional Research Service report explains

Medicare spends far more on medical services for beneficiaries with ESRD than for other beneficiaries. In 2013, Medicare spent $61,996 per ESRD beneficiary, compared to $9,889 per non-ESRD beneficiary.29 Medicare per-capita spending for all beneficiaries was $10,478 in 2013, the most recent data available.

At the very end of the nearly two hour long oral argument today, Circuit Judge Jennifer Walker Elrod (a George W. Bush appointee) asked the attorney for the State of California, the lead defendant intervenor state, an intriguing question. She asked him whether the State would object to a Fifth Circuit ruling strikng down the individual mandate, which has been zeroed out, but leaving the remainder of the Affordable Care Act in force. California’s attorney replied the State would have no issue with that outcome because that is the outcome that the 2017 Congress intended when it passed the tax law zeroing out that mandate. That strikes the FEHBlog to be the likely outcome here.

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.