Peter Wehrwein

Although the climate change, deficit reduction and tax provisions garnered most of the attention, healthcare figures prominently in the agreement between Sens. Joe Machin (D-West Virginia) and Chuck Schumer (D-New York) that was announced this afternoon.

The proposed legislation, which has been named the Inflation Reduction Act of 2022, would empower Medicare to negotiate drug prices for the first time and would cap Part D out-of-pocket costs at $2,000 per year.

Manchin and Schumer also agreed to extend to extend the expiring enhanced Affordable Care Act subsidies included in the 2021 American Rescue Plan Act for three more years 2025.

 of the bill says that prescription drug pricing reform will yield $288 billion in savings over 10 years, or almost 40% of the $739 billion in revenues the package is designed to produce.

On the spending side, the summary says that the extension of the ACA subsidies through 2025 will cost $64 billion, which is dwarfed by the $369 billion for energy security and climate change and $300 billion for deficit reduction.

Manchin’s opposition to the $1.8 billion Build Back Better bill last year effectively killed that legislation. Attention then shifted to the possibility of a “skinny” version of the legislation that would include the politically popular healthcare provisions. But the prospects of even that pared down legislation seem to dim to extinction a couple of week ago when Manchin said he wouldn’t support climate change legislation.

The narrative of much of the coverage today was that Manchin reversed course.

 headline said, “Manchin, in Reversal, Agrees to Quick Action on Climate and Tax Plan.”

“Manchin surprisingly announces spending deal with Schumer -- including health care, climate,” was the ABC News headline. And the 

 headline was “U-turn as Manchin agrees deal with Democrats on major tax and climate bill.”

Fox Newspivoted to reaction to the deal: “Lawmakers react after Manchin, Schumer agree to reconciliation deal: 'Build Back Broke'” was headline on the main story this evening.

Schumer, the Senate majority leader, now must shepherd the bill through the Senate in a legislative process called reconciliation, which requires only a majority for approval. For the bill to become law, it would also have to pass in the House, where the Democrats have only a slim, 

In a statement posted on his Senate office website, Manchin mentioned the healthcare provisions of the bill only in passing. Instead, it dwells on inflation, tax fairness and energy policies.

“The Inflation Reduction Act of 2022 invests in the technologies needed for all fuel types – from hydrogen, nuclear, renewables, fossil fuels and energy storage – to be produced and used in the cleanest way possible. It is truly all of the above, which means this bill does not arbitrarily shut off our abundant fossil fuels,” says statement from West Virginia Democrat.

This article originally appeared on Managed Healthcare Executive.

Articles

A joint statement from the two Democrats senators says prescription drug reform would save the federal government $288 billion over the next 10 years. 

Manchin, Schumer Deal Includes Medicare Drug Price Negotiation

Mark Cuban said he has come up with a way of making drugs more affordable when he launched his 

Harvard researchers lent some credence to Cuban’s claims some when they reported calculations that that Medicare program could have saved $3.6 billion in 2020 it had bought 77 generic drugs at Cuban’s prices.

The findings were reported in this week’s 

Cuban’s online pharmacy says it sets its generic drug prices based on the cost of the ingredients and manufacturing plus a 15% margin, $3 dispensing fee, and $5 shipping fee.

Hussain S. Lalani, MD, MPH, and his colleagues at the Program on Regulation, Therapeutics and Law at the Brigham and Women’s Hospital in Boston and Harvard Medical School, came up with their estimate by identifying the Cuban’s price for 109 generic drugs on Feb.8 of this year. They recorded the price for a 30-day supply and a 90-day one. Then they identified Medicare Part D spending on 89 of those drugs in 2020, excluding 20 drugs with multiple dosage forms because the Cuban prices and the Medicare information didn’t match up for those drugs.

Their estimate of the savings involved the fairly straightforward math of taking the difference in the unit price between the Cuban online pharmacy and price that Medicare paid, multiplied by the number of units dispensed. The adjusted Medicare to reflect costs as of February 8th.

Their results showed $3.6 billion in savings on 77 of the 89 drugs had they been purchased at Cuban prices in 90-day-supply amounts. That works out to a 37% savings.

The savings were less in the the 30-day-supply amounts: $1.7 billion on 42 of the 89 drugs.

The drugs that would have generated the highest savings at Cuban prices were esomeprazole (as brand-name drug sold as Nexium) $293 million; rosuvastatin (as a brand-name drug sold as Crestor), $241 million; and aripiprazole (as a brand-name drug sold as Abilify), $233 million.

Other research has also suggested Medicare overpayment. Lalani and his colleagues referenced a study that showed Medicare overspent relative to Costco member prices.

“Our findings suggest that Medicare is overpaying for many generic drugs,” they concluded. They cited a previous research that has shown that the various entities in the drug supply chain retain 64% of every dollar spent on generic drugs.

Researchers calculated that buying 77 generic drugs at prices being charged by Mark Cuban’s online pharmacy prices would have significantly lowered Medicare spending on those drugs.

Generic Prices in Mark Cuban's Service Could Have Saved Medicare $3.6 Billion

No one sure is why long Covid occurs. That absence of certainty leaves plenty of room for competing theories to sprout up.

Researchers at Harvard reported findings last week in a 

 posted on medRxiv suggessting that people with long Covid may harbor a reservoir of active SARS-CoV-2 virus, possibly in the gastrointestinal tract, long after the acute illness is over. A different group of Harvard researchers drew a causal causal line between long COVID and tiny blood clots and are testing whether blood thinners might be an effective treatment. And there is a group at the University of California, San Francisco, who linked long COVID to reactivated Epstein-Barr virus, also in a 

Researchers at Epic, the electronic health record company, have added another subplot to this complicated tale of lingering disease Using an Epic data set dubbed Cosmos that includes 142 million patients, they 

 that there is notable number of cases of “long flu” and “long viral pneumonia” when, just as with long Covid, people experience a variety of symptoms after the acute respiratory illness is over.

“This something I had never thought about as a physician,” says Jeff Trinkl, M.D., one of the Epic researchers. “I didn’t think about long-term illness —that two months later (patients) may have brain fog or maybe am having this fatigue. I never made that association.”

The Epic findings, which the company published on the Epic Research website earlier this month but have not been reported in a peer-reviewed journal, found that “long flu” and “long viral pneumonia” may be more common than long Covid.

According to Trinkl and his colleagues, 17.6% patients hospitalized for flu had new symptoms after their acute illness compared with 15.5% of those hospitalized for other viral pneumonias and 13.9% of those hospitalized for COVID-19. The symptoms included in their study included fatigue, loss of smell or taste, heart palpitations, chest pain, difficulty breathing, myalgia (muscle pain) and brain fog. The research focused on symptoms for which patients sought care starting 28 days after the acute illness was over and during the following five months (in other words, between 28 and 180 days after the acute illness was over).

Once the researchers factored in a baseline rate of symptoms (calculated by looking at the symptom complaints before the acute illness) the percentage of patients who might be classified as having long flu was smaller— 6.4% — but still larger than the 5.2% who had symptoms that might be grouped under the heading long Covid.

The Epic researchers also looked at patients seeking care for new symptoms after a bout of acute viral respiratory illness that did not result in hospitalization and, therefore, presumably had a milder acute episode. In that group, the proportion of long viral pneumonia cases was higher than the long Covid and long flu cases (11.1%, 8.7% and 5.9%, respectively).

The COVID-19 patients in the study were diagnosed between Jan. 1, 2020, and July 1, 2021. The flu and other viral pneumonia cases were diagnosed before the COVID-19 pandemic, between Jan. 1, 2018, ad and July 1, 2019.

Long Covid has put a spotlight on the after-effects of viral illness, comments Trinkl. “In 2018,” Trinkl says, “[if] you ended up having some of the symptoms that we looked at — tiredness, fatigue — and some of them are a little bit more specific, like chest pain — you may not look back and say, ‘Oh, this is tied to this viral infection I had quite a while back.’ You may not even go in for it because you would have said, ‘I’m just tired,'” says Trinkl.

“But now COVID comes,” Trinkl continues, “and there's so much discussion about some of the symptoms you can have in a long-term fashion, so I feel like the population for the COVID is more sensitized to looking for these types of symptoms.”

It is certainly possible (indeed, likely probable) that because of long Covid, and findings such as these, more people will seek care for long-term symptoms after flu and other respiratory illnesses.

Trinkl and his colleagues want their results to lead to ore more research. “It’s something that deserves to be a broader conversation, because we do see this pattern repeated across infections,” says Eric Barkley, an Epic data scientist and one of the researchers involved in this Epic research.

Epic research suggests that like COVID-19, flu and other viral pneumonias can result in long-term symptoms like fatigue and brain fog. Why that might be is open question.

More Than Long COVID, There's Flu and Pneumonia Too

After objections from patient groups and professional organizations, CVS Caremark has put Eliquis (apixaban) back on its formularies after removing the drug from its lists of covered drugs at the beginning of the year.

“This is about decisions between doctors and patients being respected,” said Beth Joyner Waldron, a patient advocate in North Carolina who has been critical of CVS Caremark. Referring to other patient groups and advocates, Waldron said, “This is testimony to the power of collective action.”

CVS Caremark issued a statement that said Eliquis was added back because it secured lower net cost for patients from negotiations with the drug manufacturer. “Anticoagulant therapies are among the nonspecialty products where we are seeing the fastest cost increases from drug manufacturers, and we will continue to push back on unwarranted price increases,” said the statement.

A company spokesman said Eliquis was being added to CVS Caremark’s Value Formulary along with Standard and Advanced Controlled formularies. The change takes effect July 1.

 reported the CVS Caremark formulary change on Wednesday.

Eliquis is in a class of drugs called direct oral anticoagulants (DOACs) that are taken by people to prevent blood clots. Other DOACs include Xarelto (rivaroxaban), Pradaxa (dabigatran), Savaysa (edoxaban), and Bevyxxa (betrixaban). For people with atrial fibrillation and other conditions that result in long-term clotting risk, the DOACs are now often prescribed instead of warfarin, the mainstay of anticoagulation for years, because the risk of bleeding is lower for patients taking DOACs rather than warfarin and patients on DOACs don’t need to be monitored as closely as patients on warfarin.

 showed that Medicare Part D spending on DOACs had increased 16-fold from 2011 to 2019, and that in 2019, Part D spending on DOACs reached $7.23 billion. Bristol-Myers Squibb reported in its 2021 annual report that Eliquis generated $10.76 billion last year, $6.45 billions of which were sales in the U.S.

Waldron, who was diagnosed with a venous thromboembolism about 20 years ago, has been taking Eliquis for eight years. She is insured by the North Carolina State Health Plan, which covers the state’s teachers and state employees. She says patient advocacy groups started to hear about Eliquis being dropped by CVS Caremark in October 2021 and that she received a letter as a member of the North Carolina State Health Plan about the formulary change in November 2021. She says she managed to stay on drug for a combination of reasons: She had a large supply on hand, she got a copay card from the manufacturer, and a decision the North Carolina State Health Plan to put the drug back on the formulary for its members.

The American College of Cardiology (ACC)and American Society of Hematology have been involved in pushing back on CVS Caremark’s formulary decision. In January 2022, the ACC posted a 

 on its website that the group, along with the American Society of Hematology, had met recently with CVS Caremark about its decision to prefer Xarelto — the article on the website uses the generic name, rivaroxaban — over DOACs on its formularies. The ACC articles says that CVS pointed to medical specialty guidelines, including atrial fibrillation guidelines issued jointly by the ACC, the American Society of Hematology and Heart Rhythm Society in 2019 as justifying the decision to drop Eliquis off of its formularies. But the ACC article says the 

 do not tier DOACs and their intent was to “encourage discussion between physicians and patients so an informed decision on the most appropriate medication can be made based on medical history and preferences.”

The ACC published a news story on Wednesday about CVS Caremark putting Eliquis back on its formularies. The article says that ACC and American Society of Hematology “engaged” with CVS Caremark about taking Eliquis off its formularies and “the potential impact on patients and practice staff.”

The ACC article says that the ACC and the American Society of Hematology told CVS Caremark that about the “real-world implications on patients and additional workloads for medical practices related to medication approvals, as well as the vital need for the selection of medications to be left to the patients and clinicians.”

Waldron said she knows of eight events in five states that are related to people losing coverage of Eliquis because of the CVS Caremark change. Waldron some of the events may be the result of gaps in anticoagulation therap, adding that it would take research to determine the link between the events to Eliquis formulary decision.

Waldron said Bristol-Myers Squibb representatives have told patient groups that CVS Caremark would be reversing its decision and putting Eliquis back on its formulary. “I am very relieved that Caremark has finally acknowledged it,” she said.

Waldron has filed a complaint that two phone calls she received earlier this year from CVS Health, the parent company of CVS Caremark, constituted a violation of the Health Insurance Portability and Accountability Act (HIPAA). According to Waldron, the calls indicated that someone at the company had inappropriately shared information from her medical records.

The American College of Cardiology and patient groups pushed the PBM to reverse its decision to take Eliquis off its formularies. CVS Caremark says it changed course after negotiating a lower net price.

CVS Caremark Reverses Eliquis Decision, Puts It Back On Its Formularies

“Paxlovid rebound is real and poorly understood,” tweeted 

, M.D., on May 11. “We need urgent study & pt counseling.”

Wachter’s tweet came as word about possible 

 rebound started to ricochet around social media and conventional media outlets. Wachter, a professor and chair of the Department of Medicine at the University of California, San Francisco, has emerged as one of the leading social media voices on the COVID-19 pandemic.

Paxlovid rebound refers to the phenomenon of symptomatic COVID-19 coming back a few days after people have finished taking the prescribed five-day course of Pfizer’s oral antiviral medication and test negative. No one is sure why it occurs.

Study results are beginning to trickle in that show that rebound is quite rare. Mayo Clinic researchers reported 

 that showed 4 of 483 (0.8%) of patients at higher risk for experiencing severe COVID-19 who were treated with Paxlovid experienced a recurrence of symptoms at a median of nine days after treatment. All four had been vaccinated. The researchers described the cases as mild and treated successfully with additional COVID-19 therapy.

FDA officials have acknowledged the problem. In an 

 posted on the FDA website in early May, John Farley, M.D., M.P.H., director of the Office of Infectious Diseases in the agency’s Center for Drug Evaluation and Research,discussed the clinical trial that supported the agency’s decision to issue an emergency use authorization (EUA) for Paxlovid. Between1% and 2% of study participants had one or more positive polymerase chain reaction (PCR) tests for the SARS-CoV-2 virus, which causes COVID-19, after testing negative or a test result showing an increase in the amount of SARS-CoV-2. Farley noted, though, the same was true for those assigned to the placebo group, so the rebound couldn’t necessarily be attributedto Paxlovid.

 that acknowledged rebound case reports. The CDC also noted that the cases of rebound illness were mild. The advisory says “possible transmission of infection during COVID-19 rebound has been described ” but also said it is unknown whether the chances of transmission during the rebound illness is the same during the initial infection.

Farley and others have noted the benefits of Paxlovid. The trial that led to the EUA showed the antiviral reduced the risk of hospitalization or death by 88% among nonhospitalized patients at high risk of developing a severe case of COVID-19. However, people enrolled in that trial were not vaccinated. The news of Paxlovid rebound has stirred up questions about whether the antiviral might have a different effect on people who have been vaccinated.

Paxlovid consists of nirmatrelvir, which acts directly on the SARS-CoV-2 virus, and ritonavir, a repurposed HIV drug that boosts the effectiveness of nirmatrelvir. As a convenient oral drug with good efficacy data behind it, the antiviral has been heralded has a key weapon in the fight against COVID-19.

One of the proposed explanations for Paxlovid rebound is that immune response to the virus is incomplete because the antiviral knocks down the viral load, so when the five days of treatment are over, the infection springs back. Paul E. Sax, M.D., clinical director of the Division of Infectious Diseases at Brigham and Women’s Hospital in Boston, has floated the idea that SARS-CoV-2 replication is drawn out in some people and that although Paxlovid reduces it, the replication ramps up again once the five-day course is over.

Paxlovid rebound has raised questions about how long people with COVID-19 who have taken the antiviral should isolate. Also unsettled is whether a second course of Paxlovid might be used to treat the rebound infection. Sax, writing in 

, said re-treatment is permitted under the EUA and is justified for high-risk patients, such as those who are severely immunocompromised. However, in the transcript posted on the FDA website, Farley said there was no evidence of benefit from longer or repeated treatment with Paxlovid. The CDC advisory also says there is no evidence of benefit from additional treatment.

Recent research has shown less than 1% of patients at high risk for experiencing severe COVID-19 who were treated with Paxlovid (nirmatrelvir and ritonavir) experienced a second bout of COVID-19.

The Paxlovid Rebound Is Rare But Real

 into the pharmacy benefits management (PBM) industry today that will require the six largest PBMs to provide information and records regarding their business practices.

The commission said that the companies it is targeted with compulsory orders under its investigative powers are CVS Caremark, Express Scripts, OptumRx, Humana, Prime Therapeutics and MedImpact Healthcare Systems.

“Although many people have never heard of pharmacy benefit managers, these powerful middlemen have enormous influence over the U.S. prescription drug system,” said FTC Chair 

, a Biden appointee, said in a prepared statement posted on the commission’s website. “This study will shine a light on these companies’ practices and their impact on pharmacies, payers, doctors, and patients.”

The FTC announcement triggered reactions from the industry and its critics.

, the president and CEO of the Pharmaceutical Care Management Association, the trade and lobbying group for the industry, issued a statement that the group was confident that any investigation will show that the “PBMs are the only member of the prescription drug supply and payment working to lower costs.”

Meanwhile, B. Douglas Hoey, the CEO of the National Community Pharmacists Association, a trade group for independent pharmacists that is critical of the industry, said in a prepared statement that PBMs have “escaped serious scrutiny for far too long but this study will bring their dirty laundry out into the open.”

The 5-0 vote for the inquiry came after the commission deadlocked on whether to investigate the industry in February. This time, Trump appointees Noah Joshua Phillips and Christine Wilson voted for going ahead with the inquiry, although they issued a 

 in which they defended their opposition in February and explained why they switched to being supportive. The current study, they wrote, was prepared with input from PBM experts at the commission and will look at the “competitive impact of PBM practices including — critically — how those practices might impact the out-of-pocket costs for consumer.”

The commission statement announcing the vote and the launching of the inquiry listed seven practices that it will “shed light on”:

Fees and clawbacks charged to unaffiliated pharmacies

Methods to steer patients towards pharmacy benefit manager-owned pharmacies

Potentially unfair audits of independent pharmacies

Complicated and opaque methods to determine pharmacy reimbursement

The prevalence of prior authorizations and other administrative restrictions

The use of specialty drug lists and surrounding specialty drug policies

The impact of rebates and fees from drug manufacturers on formulary design and the costs of prescription drugs to payers and patients

The inquiry that the commission is launching is referred to as a 6(b) inquiry in reference to the section of FTC Act that authorizes such studies. According to a 

 on the commission’s website, the 6(b) section authorizes the commission to require answers in writing to specific questions about an entity’s “organization, business, conduct, practices, management, and relation to other corporations, partnerships, and individuals.” As with a subpoena, the entity receiving the request can file a petition to limit or quash the 6 (b) order.

The commission website says the 6(b) authority “enables it to conduct wide-ranging studies that do not have a specific law enforcement purpose.” A different section of the FTC law authorizes the commission to “make public from time to time” portions of the information that it obtains, where disclosure would serve the public interest.

In her statement about the 6(b) study, FTC Commissioner Rebecca Kelly Slaughter said the information that the FTC uncovers in an 6(b) inquiry “can — and should — be presented to the public in a final report” and that a “public-facing work product” can inform policy makers and other government agencies But she also said the commission should pursue enforcement actions where it finds violations of law.

The Federal Trade Commission says its inquiry “will shed light on” clawbacks, potentially unfair audits, rebates and other business practices of the pharmacy benefits management (PBM) industry. Today’s announcement says the commission will be requiring information from the six largest PBMs.