On The Hill

Senate GOP Poised to Unveil Next Relief Package Monday

Senate Majority Leader Mitch McConnell (R-KY) is working to find agreement amongst his caucus and the administration over the contents of the next coronavirus relief package, ‘CARES 2.0.’

At a press conference Thursday (Jul. 23), McConnell indicated the package will focus on children, health care, and jobs, and will likely include: a fund to reopen schools with upwards of $100 billion; a second round of direct payments and reformed Paycheck Protection Program; a reformed unemployment insurance program; Sen. Mitt Romney’s (R-UT) TRUST Act; additional resources for hospitals and health care workers; a provision to prevent Medicare Part B premium increases; and liability protection for businesses, schools, and workers.

Democrats have criticized Republicans for delaying additional coronavirus aid even as protections from the CARES Act are set to expire.

“This weekend, millions of Americans will lose their Unemployment Insurance, will be at risk of being evicted from their homes, and could be laid off by state and local government, and there is only one reason: Republicans have been dithering for months while America’s crisis deepens,” House Speaker Nancy Pelosi (D-CA) and Senate Minority Leader Chuck Schumer (D-NY) said in a joint statement Friday (Jul. 24).

The GOP package will be a starting point for negotiations with Democrats.

 

President Trump Signs EOs on Drug Pricing

President Trump signed four executive orders intended to lower drug prices Friday afternoon (Jul. 24).

Most-Favored Nation: The much anticipated, so-called most-favored nation rule will tie Medicare Part B drug costs to prices in economically-comparable countries through the International Pricing Index (IPI). This executive order will go into effect August 24; however, the president is meeting with pharmaceutical executives on Tuesday (Jul. 28) and has agreed to drop the order if pharmaceutical companies can come up with a better plan.

The text of this executive order has yet to be released.

Executive Order on Access to Affordable Life-saving Medications: The second executive order will allow federal community health centers to pass on discounts they receive on insulin and injectable epinephrine through the 340B program directly to patients.

To view the executive order, click here.

Executive Order on Increasing Drug Importation to Lower Prices for American Patients: Another order will launch drug importation programs. One of the programs will allow the importation of low-cost drugs from Canada, with the exception of biosimilars, intravenous drugs, and controlled substances. Insulin imports from Canada will be permitted. Additionally, the executive order will grant HHS Secretary Alex Azar to authorize personal importation of drug products, not limited to specific countries or drug products.

To view the executive order, click here.

Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen: The final executive order will ensure discounts negotiated by manufacturers and pharmacy benefit managers (PBMs) and health plan sponsors are passed onto the patients at the pharmacy counter.

To view the executive order, click here.

Lawmakers have had mixed reactions, along party lines, to the executive orders.

“I applaud President Trump for fighting to lower drug prices, and I believe the one-month delay on international pricing is an opportunity for the President to work with medical innovators to lower drug prices without harming innovation.” House Ways and Means Ranking Member Kevin Brady (R-TX) said in a statement on the executive orders.

“In support of our shared goal of making drugs affordable, House Republicans are championing H.R. 19, a bill comprised of bipartisan solutions to lower the costs of medicines for workers and seniors while accelerating new life-saving cures. We believe this is a better approach to achieve the President’s goal than importing foreign price controls that slow down the development of new medical cures,” Brady continued.

Senate Finance Ranking Member Wyden (D-OR) criticized the president’s move, calling it “snake oil for Trump to sell on the campaign trail.”

“Americans need lower drug prices now, not some day in the future that may never come. The president has had over a year to bring Congress together on a bipartisan plan to lower drug prices, but he has chosen to take the easy route of empty rhetoric instead,” Wyden said in a statement.

“If he were serious about lowering drug prices for Americans in need, he would be pushing Republicans to take on Big Pharma as Congress considers additional pandemic relief legislation,” Wyden continued.

The executive orders will launch regulatory action and will require extensive rulemaking before they are enforceable. However, it is anticipated the process will move quickly as the orders have long been in the works.

 

HHS Extends Deadline for Provider Relief

On Friday (Jul. 24), HHS extended the deadline for eligible Medicaid, dental, and CHIP providers to apply for the $15 billion of the Provider Relief Fund. The deadline to apply has been extended to August 3. HHS will be holding a webcast July 27, at 3 PM ET to explain the application process.

For additional information, click here.

 

Dem Finance Leader Wyden, Ways and Means GOP Release Separate Telehealth Expansion Proposals

On Monday (Jul. 20), Senate Finance Ranking Member Ron Wyden (D-OR) proposed legislation to vastly expand telehealth services. Wyden’s proposal would make permanent the telehealth changes Congress and the administration have made to expand service options during the pandemic, including: making mental health and evaluation and management services (E/M) available through Medicare, removing geographic restrictions, expanding originating sites, and permitting telehealth access at home.

“Out of necessity during this pandemic, doctors, patients and public health officials have come to recognize that telehealth works,” Wyden said.

“Telehealth allows seniors, especially those with multiple chronic conditions, to stay on top of their medical care without taking unnecessary risks or the inconvenience of leaving home. The COVID-19 pandemic has been a trial by fire, but the experience to date has made clear that the health care system is ready for broader access to telehealth on a permanent basis. I’m also proud to say that my bill makes mental health care via telehealth a right for all seniors in Medicare, which is more necessary than ever at a time of increased isolation and anxiety such as this,” he continued.

To view Wyden’s proposed legislative text, click here.

Following the release of Wyden’s proposal, House Ways and Means Health Subcommittee Ranking Member Devin Nunes (R-CA) and full committee Republicans released a discussion draft outlining their plan for telehealth Wednesday (Jul. 22).

“Given the success of increased access to telehealth for Americans during the pandemic, Congress should prioritize making increased access to telehealth a permanent function of our nation’s healthcare system,” Nunes said in a press release.^[1] 

The draft purposes making permanent six key telehealth changes made by CMS in the wake of the coronavirus pandemic, including: making telehealth accessible from home; lifting restrictions on Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs); allowing certain clinical practitioners (i.e. physical and occupational therapists, and speech pathologists) to provide telehealth services; permitting audio-only telehealth services where there is an existing physician-patient relationship; allowing HSA-eligible plans to cover telehealth prior to meeting the deductible; and allowing dialysis authorization through telehealth.

Additionally, the draft includes several provisions to protect telehealth ‘program integrity’ through audits, oversight, and education.

“As we continue to fight the novel coronavirus, Republicans are working to make health care more convenient and accessible for all Americans,” House Ways and Means Ranking Member Kevin Brady (R-TX) said. “I want to thank all of our Members for their work on this agenda – we will continue to engage with patients, stakeholders, and policy makers as we move these bold ideas forward.”

To view a summary of the discussion draft, click here.

To view the full discussion draft, click here.

 

Preparing for the Next Pandemic Act

This week, Senate Health, Education, Labor, and Pensions Committee Chairman Lamar Alexander (R-TN) unveiled the “Preparing for the Next Pandemic Act.” The legislation includes provisions to incentivize domestic pharmaceutical manufacturing and improve state and federal stockpiles and was developed through stakeholder input in response to Alexander’s June 9th white paper.

The act will provide $5 billion over ten years to maintain onshore manufacturing of tests, treatments, and vaccines. Another $10 billion over ten years would be distributed to states so they can create and maintain individual stockpiles with federal support. The legislation would also modify Strategic National Stockpile (SNS) management by allowing the federal government to work with companies to maintain supplies and manufacturing capacity.

“Let’s not succumb to the familiar dangerous habit of ‘Panic. Neglect. Panic.’ Congress can take these three steps to keep vaccine manufacturing on shore and stockpiles supplied, now, while the pandemic has our attention, while we have our eye on the ball.” Alexander said of the legislation.^[2] 

To view the legislative text, click here.

To view Alexander’s floor speech on the Preparing for the Next Pandemic Act, click here.

 

FDA Opioid Label Change

On Thursday (Jul. 23), the FDA announced it will now require opioid drugs to include naloxone information on the label in an attempt to curb spikes in opioid-related deaths. The agency is also urging providers to discuss the availability of naloxone when prescribing these medications.^[3] 

 

References

^[1]U.S. House Committee on Ways and Means, (Press Release) 23 Jul. 2020. https://link.edgepilot.com/s/24da0524/N2-9dLW56EGHWAuO4mYdNQ?u=https://gop-waysandmeans.house.gov/ways-and-means-republicans-unveil-new-vision-for-the-future-of-telehealth/

^2] U.S. Senate Committee on Health, Education, Labor and Pensions, “Senate Health Chairman Alexander Introduces Bill to Prepare for the Next Pandemic,” (Press Release) 20 Jul. 2020. https://link.edgepilot.com/s/2e56864e/RBa63dlYlkWW9Wytwe7Mbw?u=https://www.help.senate.gov/chair/newsroom/press/senate-health-chairman-alexander-introduces-bill-to-prepare-for-the-next-pandemic

^[3] Brennan, Zachary “FDA requires labeling change for opioids,” Politico Pro, 23 Jul 2020. https://link.edgepilot.com/s/a9a71c47/A4rBYlnE30O0JVRWiems9A?u=https://subscriber.politicopro.com/article/2020/07/fda-requires-labeling-change-for-opioids-3982772