Insights^

The first presidential debate for the 2024 electionis upon us, with President Biden and former President Trump set to take the stage in Atlanta on June 27. As the candidates and the country prepare, we at Chamber Hill Strategies are also watching for the release of two proposed Medicare rules, a possible Ways and Means markup, and more. So, let’s get into it, welcome to the Week Ahead!

The Administration

Summers in Washington bring blazing heat and crowds of tourists. Summer is also when we start seeingthe arrival of more Medicare payment proposed rules. So as the temperature climbs,we are hearing these 2 rules could be released as early as June 28:

• Proposed CY 2025 Physician Fee Schedule Rule: The PFS is how the Centers for Medicare and Medicaid Services (CMS) pays for physician services, incidental services, non-clinical laboratory diagnostic tests, and radiology services.
• Proposed CY 2025 Outpatient Prospective Payment System. The OPPS is how CMS generally pays for hospital outpatient department services.

We are eagerly anticipating the rules governing the Home Health Prospective Payment System and the End-Stage Renal Disease Prospective Payment System, but those are still under review at the Office of Management and Budget.

These proposed rules are vitally important to health care providers and the Medicare beneficiaries they serve. They also provide an opportunity for the Administration to advance health care priorities with a Republican-controlled House and a Senate that lacks a filibuster-proof majority for Democrats. For example, we could see the Administration try to advance payment policies in the PFS that require inclusion of data on social determinants of health. We might also see the Administration include provisions in the OPPS rule designed to encourage hospitals to adopt stronger cybersecurity protections. We will be watching closely for the release of these rules and diving into the details as soon as they come out.

The Senate

The Senate is out of session until after the 4^th of July Holiday. We will provide updates when they return the week of July 8.

The House

Ways and Means Looks at Innovative Products

Rumor is that that the House Ways and Means Committee could meet this week to mark up legislation that would extend Medicare coverage for new and innovative technologies and products.  While the markup has yet to be noticed, the Committee’s interest in advancing coverage for newly developed treatments and devices is not a secret in health policy circles. One possible candidate for consideration is H.R. 1691, the Ensuring Patients Access to Critical Breakthrough Products Act, which was introduced last year by Ways and Means member Rep. Brad Wenstrup (R-OH) and fellow committee members, Reps. Suzan DelBene (D-WA), Blake Moore (R-UT), and Rep. Terrie Sewell (D-AL); the bill would extend temporary Medicare coverage to devices approved under the Food and Drug Administration’s Breakthrough Devices Program.  Also, rumored for possible consideration is H.R.5389, National Coverage Determination Transparency Act, which counts committee member Rep. Mike Kelly (R-KY) among its lead cosponsors. The legislation which was introduced by Energy and Commerce Health Subcommittee Chair Rep. Brett Guthrie (R-KY) was approved by the Energy and Commerce Committee in December.

These bills both become prime contenders for a House vote during a possible “health care week” in July.

Other Health Care Hearings on the Radar

• June 26: House Ways and Means Health Subcommittee hearing on Value-Based Care
• June 26: House Veterans Affairs’ Oversight Subcommittee hearing on the VA’s Healthcare Network
• June 27: House Education and the Workforce Health, Employment, Labor, and Pensions Subcommittee hearing on the Employee Benefits Security Administration
• June 27: House Appropriations Labor, Health and Human Services, Education Subcommittee Markup

There You Have It

Did you know that the first televised debate about a presidential election featured two women? That’s right,in 1956, former First Lady Eleanor Roosevelt, acting as a surrogate for Democratic candidate Adlai Stevenson, debated Sen. Margret Chase Smith, acting as a surrogate for Republican President Dwight Eisenhower. Do you know any other fun facts about presidential debate history? If so, let us know! Make it a great week!

After two tumultuous weeks dominated by historic trials, reactions to an Israeli hostage recuse mission, and a visit to Capitol Hill by former President Trump, this week looks to be a lot quieter. But looks can be deceiving, and things are always going on behind the scenes in this town if you know where to look. So, let’s get to it. Welcome to the Week Ahead!

The Administration

OMB on the Clock to Review DEA Rule on Prescribing Controlled Substances Via Telehealth

The Office of Management and Budget (OMB) has received a proposed rule from the Drug Enforcement Agency (DEA) that would allow individuals to be prescribed certain controlled substances from a practitioner utilizing telehealth even if they had not had an in-person evaluation from the practitioner. The proposed rule would only apply to non-narcotic schedule III-V controlled medications when certain circumstances are met.

The DEA currently has temporary telehealth flexibilities in place through the end of the year. If the agency does not finalize its proposed rule before then, patient advocates argue that those who have been utilizing the flexibilities will face barriers to prescriptions for conditions such as ADHD.

The Senate

Senate Finance Chair Readies Rural Maternal Health Bill

Senate Finance Committee Chair Ron Wyden (D-OR) announced on June 14 that he will be holding a press call on June 17 to preview legislation he plans to introduce to address concerns about the availability of maternal health services in rural areas. The press call is scheduled for 2 PM EST.

Both rural and maternal health care are areas with huge potential for bipartisanship. But the devil is in the details…

While the House is Away the Senate will Play…Detective

What do you do if you’re in the Senate, but the House is out of session? Of course, you can vote on nominations. But It’s a lot more fun to hold investigations on hot button issues that are sure to make headlines. We are tracking a couple of such investigations in 2 committees this week.

• Senate Health, Education, Labor, and Pensions (HELP) Committee
  • o   Chair Bernie Sanders (I-VT)was ready to hold a vote to subpoena Novo Nordisk’s President of North American Operations to testify about the company’s pricing of Ozempic and Wegovy in the United States.
  • However, Chair Sanders dropped his threat after the company’s global CEO Lars Fruergaard Jørgensen said he will testify at a hearing scheduled for September, according to Inside Health Policy.
  • This sets the stage for a potentially dramatic hearing 2 months before the 2024 elections.
  • But Novo Nordisk is not out of the woods yet, because the HELP Committee is still scheduled to vote to authorize an investigation into the company at a hearing scheduled for June 18.
• Senate Homeland Security and Governmental Affairs Committee (HSGAC)
  • HSGAC is scheduled to hold a hearing on the origins of the COVID-19.
  • We’ve seen a lot of action on this issue in the House Oversight Committee, with Republicans and Democrats often disagreeing about what the focus of those efforts should be (even issuing conflicting reports).
  • But this is the Senate.  And the Senate is controlled by Democrats. Will we see bipartisan agreement about needed actions to understand the origins of COVID-19, unlike the partisan outcomes of the House hearings?

The House

The Ways to End a Month and What it Means

The House is in recess, so we are looking ahead to when they return. As we wait, we are tracking rumors that the Ways and Means Committee may be planning a markup related to innovation and medical coverage issues.

So What?

After July ends, we go to August recess and the unofficial final push to the November elections. As that date gets closer, many members of Congress will start having more things to do outside of Washington (and we are not talking about field hearings). These rumored hearings might be some of the last ones we see from the committee until after the elections or even until after the end of the year.

There You Have It

One of the reasons this week is so quiet is because Wednesday, June 19 is Juneteenth, the federal holiday that marks the date when the news of emancipation reached slaves in Texas in 1865. As we take time to celebrate this important date, we look back on progress so far and recognize the work that still needs to be done to form a more perfect union with liberty and justice for all.  Make it a great week!

Not two weeks have passed since the historic felony conviction of former President Trump, and now we could be heading towards another historic felony conviction, this time for Hunter Biden, the son of the current president. If these last few weeks have shown us anything, they show us that history stops for no one. So, let’s get to it. Welcome to the Week Ahead!

The Administration

JUUL Catches a Break from FDA

The Food and Drug Administration (FDA) statswork.com) ” href=”https://nam10.safelinks.protection.outlook.com/?url=https%3A%2F%2Fpolicycrush.us4.list-manage.com%2Ftrack%2Fclick%3Fu%3D376b597042727023b90a0d75c%26id%3D3092f83419%26e%3D765e242272&data=05%7C02%7Ctashi%40chamberhill.com%7Cba03d0c431624a3a346a08dc89575ef8%7C88aa046a655e4b09a66d2b5a1e19609a%7C0%7C0%7C638536255571213166%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=7JYtVGlbFjTM17Yx6T%2B0kTSOQV2SiPKFQOAoqjXJvmM%3D&reserved=0″ target=”_blank” rel=”noopener noreferrer” data-auth=”Verified” data-linkindex=”0″>announced the agency is rescinding its marketing denial orders (MDOs) against JUUL Labs, Inc. tobacco products, including e-cigarettes on June 6. These MDOs, issued on June 23, 2022, called for JUUL tobacco products to be removed from the market. Weeks later, FDA issued an administrative stay on the MDOs on July 5, 2022, because “certain scientific issues warranted additional review.” In its June 6 update, FDA cited this review and recent court decisions as the basis for the recession. The agency was clear in its announcement that the decision is not an authorization or denial of JUUL’s marketing applications and that the applications are once again under review.

JUUL wasted no time in celebrating the announcement and noted that JUUL products would be on the market during the review process.

Now What? 

• Health advocacy groups, such as the American Lung Association and the Campaign for Tobacco-Free Kids, expressed disappointment regarding the decision.  What next steps will they take to pressure the FDA to pull JUUL products from the market?
• What will congressional opponents of e-cigarettes do in response to this decision?  Appropriations season is underway, and opponents could use funding legislation to direct or block agency action.

Save the Date: June 20 is when the Supreme Court is scheduled to hear a request from the FDA to overrule a previous court ruling that found FDA had to consider applications for e-cigarettes one at a time, and could not just reject all of them, according to Inside Health Policy.

The Senate

Stillbirth Prevention Act up for UC?

We are hearing that the Senate could move by unanimous consent to pass H.R.4581, Maternal and Child Health Stillbirth Prevention Act of 2024. This bill would allow Maternal and Child Health Services Block Grant funds to be used for stillbirth research and prevention activities. Since this bill has already passed the House, the bill would go to the President’s desk if passed.

But this bill isn’t out of the woods yet. The UC process is dicey because a single senator can stop the process at any point. Senators have been known to block bills even if they agree with the underlying premise but have another issue (i.e. procedural concerns, concerns about related bills not getting a vote).

Health Care Hearings in the Senate

• June 12: Senate Finance Committee hearing on youth residential treatment facilities
• June 12: Senate Judiciary Committee hearing on youth vaping

The House

E&C Mark-Up Watch

What we are hearing: The House Energy and Commerce is expected to put out a notice of a mark-up on June 12 of several health care bills. These bills could be on a range of different topics, but we expect them to be non-controversial.

Just because these bills are non-controversial does not mean they are insignificant. Even bills that may not produce rage-inducing headlines can still involve significant appropriations in public health programs and major changes to the health care system. Plus, those non-controversial bills have the best shot of becoming law. Speaking of which…

Health Care Week? 

Just when we thought bipartisanship was dead, rumors of a bipartisan “health care week in the House” keep hopes alive. This rumored health care week would most likely occur in the second week of July and would be marked by votes on health care legislation. What bills would be included? Although we don’t know for sure, we bet that any bills coming out of that expected E&C markup would be prime contenders.

Now that we’ve talked about what might happen, here’s a look at the health care hearings in the House this week:

• The show-stopper will be CMMI Director Liz Fowler on the hot seat at the June 13 House Energy and Commerce Health Subcommittee hearing on the CMS Innovation Center.  Director Fowler, a Hill alum, will try to defend the results-to-date of the evergreen funding the learning lab received from the ACA.
• June 13: House VA Committee hearing on spinal cord injuries and disorders in the veteran community
• June 13: House Budget Committee hearing on Medicare and Social Security

There You Have It

Flag Day is June 14! Check out these interesting facts about Flag Day. Let us know if you know any other fun facts about the Stars and Stripes. Make it a great week!