People moves that caught our eye

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1 big thing: People moves that caught our eye

Health Care Policy

Prior auth has its moment (again)

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E&C telehealth payfors could have momentum

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Catch me up: Drug price warning, Chevron fallout

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1 big thing: Prior auth has its moment (again)

2. E&C telehealth payfors could have momentum

3. Catch me up: Drug price warning, Chevron fallout

TROA passes first legislative hurdle

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House panel advances Labor-HHS spending bill

Catch me up: EMTALA and Purdue Pharma rulings 

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1 big thing: TROA passes first legislative hurdle

2. House panel advances Labor-HHS spending bill

3. Catch me up: EMTALA and Purdue Pharma rulings

PhRMA kicks off IP campaign 

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CBO: Biosecure Act won't have major cost

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RSC plans for Chevron rollback

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Catch me up: Telehealth and TROA markups

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1 big thing: PhRMA kicks off IP campaign

2. CBO: Biosecure Act won't have major cost

3. RSC plans for Chevron rollback

4. Catch me up: Telehealth and TROA markups

A push to roll back drug price talks

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Scoop: Ways and Means plans TROA markup

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1 big number: Extending ACA subsidies

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What we're watching: Labor-HHS, SCOTUS cases 

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1 big thing: A push to roll back drug price talks

2. Scoop: Ways and Means plans TROA markup

3. 1 big number: Extending ACA subsidies

4. What we're watching: Labor-HHS, SCOTUS cases

The Energy and Commerce telehealth bill didn't get marked up last week (thanks to tech bill drama), but the payfors have a good chance of coming back in an end-of-year health package. 

Why it matters: The PBM and hospital outpatient department offsets are becoming more familiar to lawmakers, and they show signs of becoming go-to ways to pay for health priorities ahead of the lame duck session.

What's inside: The E&C bill extends telehealth flexibilities for two years, and pays for that through:

PBM transparency measures, as well as "delinking" in Medicare Part D, meaning paying PBMs a flat fee instead of based off the price of a drug. 

Requiring hospital outpatient departments to have unique identifier numbers to ensure they are not overcharging. 

What they're saying: "Now we're in a position where they have such strong bipartisan agreement on the need to make these reforms that they're seen as obvious and acceptable payfors for legislation," said Jen Taylor, senior director of federal relations at Families USA. "[That] is a really good sign."

Yes, but: It is still not an easy lift to get these provisions into law, given opposition from the PBM and hospital industries. 

PBMs take particular issue with the delinking provision, arguing it has not been sufficiently scrutinized and would actually cost money. 

"We do not believe the Congressional Budget Office has evaluated the policy independent of separate PBM provisions," said Greg Lopes, a spokesman for the Pharmaceutical Care Management Association. 

"We urge CBO to do a specific analysis of delinking to understand that it will not save taxpayer money," he added.

Mark Miller,  executive vice president of health care at Arnold Ventures, also said he had questions about delinking and wanted to see further analysis. "I'd like to see the score," he said. 

The bottom line: The unique identifier provision for hospitals has wide support among experts, though it faces pushback from hospitals. 

The American Hospital Association called it an "unnecessary and onerous administrative burden."

They have a good chance of coming back in an end-of-year health package.

Pharmacy benefit management (PBM)

The Energy and Commerce <a class="gtmContentClick" data-vars-link-text="telehealth bill" data-vars-click-url="https://docs.house.gov/meetings/IF/IF00/20240627/117487/BILLS-118-HR7623-C001103-Amdt-5.pdf" data-vars-content-id="0a14d214-5a18-46a4-8f53-141d409b47e1" data-vars-headline="E&amp;C telehealth payfors could have momentum" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://docs.house.gov/meetings/IF/IF00/20240627/117487/BILLS-118-HR7623-C001103-Amdt-5.pdf" target="_blank">telehealth bill</a> didn&#x27;t get marked up last week (thanks to tech bill drama), but the payfors have a good chance of coming back in an end-of-year health package. Why it matters: The PBM and hospital outpatient department offsets are becoming more familiar to lawmakers, and they show signs of becoming go-to ways to pay for health priorities ahead of the lame duck session.

The leading House bill that would freeze out select Chinese biotech companies from U.S. markets would not have a significant impact on federal spending, the CBO finds in a new analysis. 

Why it matters: The bipartisan bill has a good chance of passing at some point this year, and the lack of a significant cost removes a potential hurdle.

Driving the news: The effect on the deficit would not exceed $500,000, the CBO said. 

The measure would cut off federal funds to five Chinese biotech companies deemed national security risks for their ties to Beijing — BGI Group, MGI, Complete Genomics, WuXi AppTec, and WuXi Biologics. But CBO estimates other contract research firms companies would fill the gap  

"CBO expects that federal agencies would be able to replace any biotechnology goods or services provided by covered entities with similar substitutes provided by other companies at comparable costs," the report states. 

"Implementing the ban could change which companies receive funds from federal agencies, but would not significantly affect total spending," it says.

What's next: The legislative effort faced a setback earlier this month when it was left out of the National Defense Authorization Act. 

But it is still possible the measure will be added into the NDAA down the line. 

Rep. Brad Wenstrup, the bill's GOP sponsor, also told Axios then that he thinks there could be a standalone vote. 

The leading House bill to crack down on China biotech would not have a significant impact on federal spending, the CBO found.

China

The leading House bill that would freeze out select Chinese biotech companies from U.S. markets would not have a significant impact on federal spending, the <a class="gtmContentClick" data-vars-link-text="CBO finds" data-vars-click-url="https://www.cbo.gov/system/files/2024-06/hr8333_1.pdf" data-vars-content-id="54015536-ed28-4909-807a-321d8f2ce187" data-vars-headline="CBO: Biosecure Act won&#x27;t have major cost" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.cbo.gov/system/files/2024-06/hr8333_1.pdf" target="_blank">CBO finds</a> in a new analysis. Why it matters: The bipartisan bill has a good chance of passing at some point this year, and the lack of a significant cost removes a potential hurdle.

PhRMA today is launching a new seven-figure ad campaign defending the drug patent system as Congress ratchets up scrutiny of IP protections, the group tells Axios. 

Why it matters: The move highlights the growing threats the big industry group sees in patent reform legislation that could be part of a year-end health deal, and in the Biden administration's increased openness to consider using march-in rights to break patents unilaterally. 

PhRMA notes the digital and traditional media ads are "educational" and not specifically targeted at any particular policy proposal.

What they're saying: The effort is meant to counter "misinformation" spread by the industry's critics, Robert Zirkelbach, chief public affairs officer at PhRMA, told Axios. 

"What we're trying to do is provide better balance and education around the unique [U.S.] system and how it works," he said, adding the status quo lets companies innovate while allowing for eventual competition from cheaper generics and biosimilars. 

"More new medicines means more generic medicines ... Innovation. Competition. Lower Costs. Thanks to IP," reads one ad. 

The other side: There's bipartisan concern in Congress that drug companies are gaming the patent system simply to delay competition from cheaper alternatives. 

A bill from Sens. John Cornyn and Richard Blumenthal would save $3 billion, according to the CBO, by cracking down on some of these practices. 

An even bigger potential hammer is from the Biden administration, which last year put out a "framework" for using executive authority known as march-in rights to break patents, with the goal of lowering drug prices. 

Still, the administration hasn't exercised this power and rejected a request to do so last year for a prostate cancer drug. 

Between the lines: Asked if there are instances of drug companies gaming the system to fend off competition, Zirkelbach said: "I certainly am not able to speak to every patent practice of all of our companies, so I wouldn't dare to do that."

"But I think a lot of those claims are based on I think a misunderstanding of the way the system works," he added. 

He noted that the U.S. Patent and Trademark Office has to approve a patent, and that a company can make adjustments to make a drug easier to administer or to treat other conditions after its initial approval. 

The big picture: Protecting the IP system is another front in a multi-pronged battle the pharmaceutical industry is fighting, including pushing for reforms to PBM practices and the 340B program, as well as going to court to try stop Medicare drug price negotiations. 

First look: PhRMA's ad campaign to protect IP

Industry ads defend the drug patent system as an engine of innovation.

Big Pharma

PhRMA today is launching a new seven-figure ad campaign defending the drug patent system as Congress ratchets up scrutiny of IP protections, the group tells Axios. Why it matters: The move highlights the growing threats the big industry group sees in patent reform legislation that could be part of a year-end health deal, and in the Biden administration&#x27;s increased openness to consider using march-in rights to break patents unilaterally.

An array of conservative groups is calling on GOP leaders to roll back the drug pricing provisions of the Inflation Reduction Act and seeking to elevate the issue on the party's agenda for the next Congress. 

Why it matters: The letter to Speaker Mike Johnson and Senate GOP Leader Mitch McConnell comes two days ahead of the first presidential debate, and highlights the political stakes around Democrats' efforts to lower drug prices.

What they're saying: The groups portray the Medicare drug price negotiations as heavy handed and economically ruinous. 

"History shows that price controls never achieve their stated ends and the IRA's price controls are further evidence," the letter states. "Basic economics dictates that imposing price controls on one class of products will simply force manufacturers to stop producing or investing in those products."

The letter is signed by groups including Americans for Prosperity, Americans for Tax Reform and CPAC. 

The effort was organized by Ryan Ellis, president of the Center for a Free Economy and a lobbyist for Akin Gump, which has drug industry clients. 

The big picture: Repeal of the IRA drug pricing provisions will realistically only be on the table if Republicans sweep the House, Senate and White House in November. 

Even if that happens, congressional Republicans, while highly critical of the law, have not gone into detail about their plans for next year. 

Between the lines: Dean Clancy, senior health policy fellow at Americans for Prosperity, said there are options short of full repeal, including eliminating the 95% tax imposed on companies that refuse to participate in the Medicare negotiations. 

"I don't know what they're planning to do on this particular policy," Clancy said of congressional Republicans. "The letter that we signed was in part to try to alert them to the negative consequences that have arisen already from it, and you know, put it on their radar."

Grace-Marie Turner, president of the Galen Institute and another signer of the letter, said it is unclear if full repeal is possible. 

"Whether the whole thing could be repealed or not is a political question, not a policy question," she said. "But we certainly are going to be at the table offering as many ideas and suggestions as we can."

The other side: Democrats have made drug price negotiations a centerpiece of their campaign pitch, saying they are lowering the cost of some of the costliest drugs to Medicare and saving patients and the government money. 

The CBO has projected about $100 billion in savings over a decade.

The conservative critics argue the law will hurt innovation, and that it is not really a "negotiation" because of the hefty tax that hits companies that walk away from the table. 

The letter proposes alternative policies like passing rebates paid to PBMs on to patients. 

"Instead of hiring more bureaucrats to set up a new price control board, Congress should work to lower Medicare premiums, increase plan choices, and require insurers and pharmacy benefit managers to share discounts, rebates, and savings with patients," it states. 

Conservative groups push to roll back drug price law

Conservatives are calling on GOP leaders to roll back the drug pricing provisions of the Inflation Reduction Act next year.

Drug price increases

An array of conservative groups is calling on GOP leaders to roll back the drug pricing provisions of the Inflation Reduction Act and seeking to elevate the issue on the party&#x27;s agenda for the next Congress. Why it matters: The <a class="gtmContentClick" data-vars-link-text="letter to" data-vars-click-url="https://e217a245-0934-448f-b4ac-5bb0ce3995ec.usrfiles.com/ugd/e217a2_56ef9a2b6c5546e585f5936719453731.pdf" data-vars-content-id="8a441e8a-0932-4d4a-bd9d-76218b21ed18" data-vars-headline="Conservative groups push to roll back drug price law" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://e217a245-0934-448f-b4ac-5bb0ce3995ec.usrfiles.com/ugd/e217a2_56ef9a2b6c5546e585f5936719453731.pdf" target="_blank">letter to</a> Speaker Mike Johnson and Senate GOP Leader Mitch McConnell comes two days ahead of the first presidential debate, and highlights the political stakes around Democrats&#x27; efforts to lower drug prices.

A new CBO score is encouraging backers of a bill to overhaul drug patents who are trying to include it in a year-end health deal. 

Why it matters: The bipartisan measure from Sens. Richard Blumenthal and John Cornyn would generate about $3 billion in savings over a decade, making it a potential offset for extending telehealth flexibilities or averting Medicare physician payment cuts.

Driving the news: The new score generated about three times as much savings as in a 2022 CBO projection.

"The new score will undoubtedly add to growing bipartisan momentum on Capitol Hill to pass market-based solutions to hold brand-name drug companies accountable for gaming the patent system," said Jon Conradi, a spokesman for the Campaign for Sustainable Rx Pricing, which comprises insurers, providers and others. 

Between the lines: The Cornyn-Blumenthal bill has two main components, both aimed at preventing drug companies from gaming the patent system to fend off competition from less expensive generics. 

One piece targets "product hopping," in which a company makes small changes to the formulation of a drug in a bid to extend market exclusivity.

The other targets the use of multiple patents on the same product, referred to as "thickets," also to forestall competition. 

The pharmaceutical industry is most opposed to the product hopping section of the bill, saying it would hinder research that happens after a drug's initial approval.  

Lobbyists say it's still possible that the bill could be split up to pass only the less controversial patent thicket piece. 

Still, Megan Van Etten, a PhRMA spokesperson, said the group has concerns with the patent thicket piece, characterizing it as "Congress prohibiting innovators from enforcing lawfully granted patents."

What they're saying: "I think we will have movement, but I'm not sure of the exact timing," Blumenthal told Axios today when asked about the bill. 

The measure advanced out of the Senate Judiciary Committee last year on a bipartisan basis, along with other drug pricing patent bills, like cracking down on "pay for delay" arrangements. 

Judiciary Ranking Member Lindsey Graham at a hearing last month expressed frustration at the lack of movement on the bills so far. "We pass all these bills. We have a common view of the problem and nothing ever happens," he said. 

But a health care package in the lame duck session could finally provide an opening. 

CBO score boosts hopes for drug patent bill

A new CBO score is encouraging backers of a bill that would overhaul drug patents.

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Drug prices

A <a class="gtmContentClick" data-vars-link-text="new CBO score" data-vars-click-url="https://www.cbo.gov/system/files/2024-06/s150.pdf" data-vars-content-id="f66ad88b-66ac-47f7-8ecf-468b5f046e73" data-vars-headline="CBO score boosts hopes for drug patent bill" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.cbo.gov/system/files/2024-06/s150.pdf" target="_blank">new CBO score</a> is encouraging backers of a bill to overhaul drug patents who are trying to include it in a year-end health deal. Why it matters: The bipartisan measure from Sens. Richard Blumenthal and John Cornyn would generate about $3 billion in savings over a decade, making it a potential offset for extending telehealth flexibilities or averting Medicare physician payment cuts.

Peter Sullivan

Stories

E&C telehealth payfors could have momentum

CBO: Biosecure Act won't have major cost

First look: PhRMA's ad campaign to protect IP

Conservative groups push to roll back drug price law

CBO score boosts hopes for drug patent bill

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