Alex Costa

Why the Hearing Aid Rule is a Big Deal

Posted In FDA

On August 16, the Food and Drug Administration (FDA) finalized rulemaking to allow hearing aids to be purchased over-the-counter (OTC), which is widely expected to increase access for millions of Americans with mild to moderate hearing loss. This rule was 5 years in the making – why now?

Background

While FDA has regulated hearing aids for decades, the agency had previously only focused on assuring safety and effectiveness of prescription hearing aids. In 2017, Congress stepped in and passed a law to require the agency to issue rules for over-the-counter devices. Lawmakers were hoping establishing a new category of hearing aids would address:

Cost: Lack of competition in the market means hearing aids can cost between $2,000 and $7,000 per pair.

Coverage: Most commercial insurance plans and Medicare don’t cover the cost of hearing aids for people with mild to moderate hearing loss because they’re not considered an essential medical device – or in other words, they’re considered “elective.”
Access: Additionally, getting hearing aids requires a prescription from an audiologist or other specialist. Buying devices in a retail setting or online would provide more options for consumers.

A Rule that Was Years in the Making

It’s taken a long time for the idea of over-the-counter hearing aid sales to go from initial concept to final rule. Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) got so fed up with the agency dragging its feet that they introduced legislation to require FDA to issue rulemaking on OTC hearing aids. Even though the bill was signed into law as part of the FDA Reauthorization Act of 2017, it still took the agency 5 years to finalize the rule. Why?

COVID. Yes, the needed change in focus of the agency to address COVID was a no-brainer, but President Trump signed the bill 2+ years before the virus struck….

Change in administration. Yes there was a change in administration but it took President Biden until July 2021 to issue an executive order directing his own agency to issue rule making.

So why the delay? It turns out that balancing stakeholder concerns was complicated. When FDA issued the proposed rule in October 2021, the agency received more than 1,000 comments from the public. Here is where the rule ended up:

Output levels: Lowers the maximum sound output to reduce the risk from over-amplification of sound
Volume control: Requires all OTC aids have a user-adjustable volume control
Label and packaging language: Simplifies phrasing so safety concerns can be easily understood

State authority: Retains authority by States to require an audiological evaluation for minors and other previously granted State exemptions applicable to non-OTC hearing aids

What’s Next?

The final rule goes into effect in 60 days, which is the date that over-the-counter hearing aids can officially be marketed. Already, Best Buy has announced that it plans to have hearing aids available in 300 of its 1,000 stores by the fall.

Even though Congressional Democrats weren’t able to get Medicare coverage for hearing aids signed into law, the rule signals real financial relief and a step toward health equity for millions. Good news for consumers makes for good politics…right ahead of the November 8^th elections.

What Happened, What You Missed: August 8-12

Posted In PUBLIC HEALTH

CDC Updates COVID-19 Guidelines

People no longer need to stay at least six feet away from other people to reduce the risk of exposure to COVID-19, according to new guidelines from the Centers for Disease Control and Prevention (CDC). The revised guidelines represent a shift away from limiting the spread of the virus through more restrictive means like social distancing and quarantines and instead focuses on reducing severe disease from COVID-19. Additional changes in the guidelines include a lifting of the requirement to quarantine if exposed to the virus and elimination of the test-to-stay recommendation for schools after a potential exposure. However, some measures in the updated guidelines remain unchanged, including a recommendation for people to wear masks indoors in counties with high levels of transmission.

FDA Issues EUA to Increase Supply of Monkeypox Vaccine

The Food and Drug Administration (FDA) issued an emergency use authorization (EUA) on Tuesday to expand the supply of the Jynneos monkeypox vaccine amid high demand. According to the EUA, the vaccine can now be administered to high-risk adults intradermally, or between the layers of the skin, as opposed to subcutaneously, or under the skin. This new strategy will allow health care providers to use an existing one-dose vial of the vaccine to administer a total of up to five separate doses, which the administration estimates will increases the number of doses available in the National Strategic Stockpile from 441,000 to over 2.2 million. However, the administration has warned that expanded access to vaccines will not be a panacea for the monkeypox outbreak, as demand for vaccines is likely to continue to exceed supply.

House Poised to Vote on Inflation Reduction Act Today

The House Rules Committees approved the Inflation Reduction Act on Wednesday, clearing the way for a floor vote on the Democrats’ long-awaited reconciliation package on Friday. The House is expected to take up the measure at 9:00 AM EDT on Friday, with three hours of debate equally divided among the leaders of the Energy and Commerce, Ways and Means, and Budget Committees. Major health care provisions of the bill would allow Medicare to negotiate with pharmaceutical manufacturers on prescription drug prices and extend enhanced Affordable Care Act (ACA) premium subsidies through 2025. .

Lawsuit Threatens ACA’s Preventative Care Coverage Requirements

The ACA’s preventive care requirements that cover everything from birth control to cancer screening could be in jeopardy thanks to a lawsuit in Texas. According to the plaintiffs in Kelley v. Becerra, the ACA’s requirements for health plans to cover preventative care like birth control and HIV medications violate the Religious Freedom Restoration Act, which states the federal government should not “substantially burden” the practice of religion without sufficient justification. Judge Reed O’Connor of the US District Court, Northern District Texas heard the case in July and is expected to make a decision within the next few weeks. Notably, O’Connor is the same judge who ruled the ACA to be unconstitutional in 2018.

ICYMI: Batman-Superfan Sen. Leahy Returns to the Hill

Sen. Patrick Leahy (D-VT) returned to the Hill last Sunday for the first time since fracturing his hip in a fall in late June. Leahy, who is recovering from two surgeries, arrived at the Capitol for the Senate’s “vote-a-rama” session on the Inflation Reduction Act in a black wheelchair featuring a Batman logo. Leahy is a longtime Batman fan as he has appeared in five Batman films and wrote a foreword to a Batman comic book in 1992. The 82-year-old senator is set to retire at the end of his term in January 2023.

What Happened, What You Missed: August 1-5

Posted In ADMINISTRATION

Administration Declares Monkeypox a Public Health Emergency

On Thursday, Health and Human Services (HHS) Secretary Xavier Becerra declared a public health emergency over the monkeypox outbreak, giving federal agencies access to emergency funding and other resources for efforts to fight the virus’ spread. Becerra is also considering a second declaration that would enable the Food and Drug Administration to issue emergency use authorizations for medical countermeasures like treatments and vaccines. So far, over 616 cases detected in the US, although that total is likely an undercount. Most cases in the US are concentrated in the gay and queer community, primarily among men who have sex with men.

Administration Releases National Research Plan on Long-COVID

The Biden administration released on Wednesday a national research plan outlining a government-wide agenda focused on improving prevention, diagnosis, treatment, and provision of services for people experiencing long-COVID. To meet the administration’s objectives, the research plan directs HHS to issue two reports within 120 days laying out an “actionable path forward” to address long-COVID and associated conditions. The administration also issued a report outlining services and supports for long-COVID patients and as well as resources for individuals confronting challenges related to mental health, substance use, and bereavement. According to a press release, the administration estimates that nearly one million Americans may be out of the workforce at any given time due to long-COVID, which equates to roughly $50 billion in lost earnings annually.

CMS Finalizes 4.3% Payment Increase for Inpatient Services in FY23

Medicare payments for hospital inpatient services will get a 4.3% boost in Fiscal Year 2023, according to a final inpatient prospective payment system (IPPS) rule released on Monday. The final rule also carries out the administration’s focus on health equity by adding health equity-focused measures to hospital reporting programs like the Hospital Inpatient Quality Reporting (IQR) Program. (https://www.russillo.com/) Among other provisions, the rule finalizes proposals to create a “birthing friendly” hospital designation, continue COVID-19 reporting requirements for hospitals, apply a budget-neutral 5% cap on any decrease to a hospital’s wage index from the prior fiscal year, and make prescription drug monitoring program queries mandatory under the Medicare Promoting Interoperability Program.

ICYMI: National Air and Space Museum to Partially Reopen in October

Since March, visitors to the Smithsonian museums in Washington, DC haven’t had the opportunity to view the Apollo 11 command module or the Spirit of St. Louis. That will change on October 14 when the National Air and Space Museum partially reopens to the public following a lengthy renovation period. In anticipation of strong interest, the museum will be requiring free timed entry passes that will be available on September 14. Come October 14, visitors to the museum will have the opportunity to see eight new exhibits, including ones on the Wright brothers and the planets of the Solar System.

Key Primary Races to Watch in August 2022 (8/2/2022)

Posted In ADMINISTRATION, CONGRESS, POLITICS

The long 2022 primary season isn’t over yet. Starting today, 15 states will hold primary elections over the next 30 days, and the results of some races will be more impactful than others. By the beginning of September, American voters are sure to have a clearer idea of the importance of political dynasties, and more importantly, how much influence former President Donald Trump wields over the GOP electorate.

Michigan Democrats: Levin v. Stevens (August 2)

Michigan lost a congressional seat in the 2020 Census. The state’s new congressional map is the product of an independent commission, and while the commission has been successful in avoiding partisan gerrymandering, it wasn’t enough to stop a race between two incumbents. Both Rep. Andy Levin (D-MI) and Rep. Haley Stevens (D-MI) could have opted to run in the new 10^th Congressional District, which leans slightly Republican and contains suburban communities northeast of Detroit. But instead, both Democratic incumbents chose to seek reelection in the 11^th Congressional District, which features a more Democratic-leaning electorate in the suburb’s northwest of Detroit. While Levin resides in the new district, Stevens’ current district includes much of the new one she’s running in.

Both Levin and Stevens first entered Congress at the start of 2019, meaning they have been incumbents for the same length of time. However, Levin has one possible advantage in the form of name recognition. His father, Sander Levin, served in the House before retiring in 2019, and his uncle, Carl Levin, served in the Senate from 1979 to 2015.

Missouri Republicans: Greitens v. Schmitt (August 2)

Eric Greitens was elected Governor of Missouri in 2016, but he resigned in 2018 following allegations of sexual misconduct and violations of campaign finance laws. Having secured Trump’s endorsement back in 2016, Greitens threw his hat in the ring as a Trump-friendly candidate in the 2022 Republican primary to replace the retiring Sen. Roy Blunt (R-MO) amid a crowded field consisting of Missouri Attorney General Eric Schmitt, Rep. Vicky Hartzler (R-MO), and Rep. Billy Long (R-MO). While Trump has yet to formally endorse a candidate in the race, he has positively commented on Greitens as recently as July 8. However, Greitens’ initial lead in the polls seems to have has fallen after allegations of domestic abuse became public and the release of a controversial ad about hunting “Republicans-in-name-only,” or RINOs.

Currently, one poll has Greitens in third place behind Schmitt and Hartzler, while another has all three candidates tied for first. As voters in Missouri head to the polls, many Republicans including members of the former president’s inner-circle are currently divided over whether to support Greitens or Schmitt. However, given Trump’s 15-point victory margin in Missouri two years ago, whichever GOP Senate candidate prevails on Tuesday is all but certain to win in November.

Arizona Republicans: Brnovich v. Masters (August 2)

Arizona State Attorney General Mark Brnovich led the polls for months as the Republican candidate in the primary race for the Senate. However, Brnovich began to lose ground after former President Trump criticized the attorney general for not supporting him during the 2020 election audit of Maricopa County. In June, Trump endorsed Blake Masters, bringing the 35-year-old venture capitalist to first place in the polls. A critic of the validity of the 2020 presidential election, Masters has been also questioning whether the results of the 2022 midterm election will be legitimate, which some Republicans worry could backfire and dissuade some GOP voters from showing up at the polls this November. Whoever secures the Republican Primary will take on freshman Sen. Mark Kelly (D-AZ) this fall in a race that the Cook Political Report currently rates as a “toss-up.” But the nomination of a hardcore Trump loyalist and election skeptic like Masters to the GOP ticket could turn off moderate and independent voters, leaving Kelly with a slight edge in November.

Wyoming: Cheney v. Hageman (August 16)

Rep. Liz Cheney (R-WY) was a rising star in the Republican Party, having been elected House GOP Conference Chair in August 2019. However, Cheney lost her leadership position in May 2021 after drawing the ire of House Republicans for her criticism of former President Donald Trump. Since then, Cheney has only doubled down on her criticism of Trump by serving as the Vice Chair of the January 6^th Committee.

Wyoming voters picked Trump over then-candidate Joe Biden in 2020 by a 40-point margin, so it’s no surprise that Cheney is trailing the Trump-endorsed attorney Harriet Hagemen by nearly 20 points in the GOP primary. Cheney’s current situation is a sharp contrast from 2020, when she won reelection with 70% of the vote. Cheney could theoretically find a narrow pathway to victory if she secures the votes of independents and Democrats over the coming days, but a landslide loss would mean the former president is still capable of commanding influence in states that strongly lean red.

The Rest of Primary Season

After August 31, only four states have primaries left: Massachusetts’ primary is scheduled for September 6, while Delaware, New Hampshire, and Rhode Island have their primary elections on September 13. Given the number of consequential primaries in August, however, voters won’t have to wait until the end of the month to get a sense of what the midterm election in November will look like – and how much of an influence the former president has on the GOP.

What Happened, What You Missed: July 25-29

Posted In CONGRESS

Schumer, Manchin Reach Deal on Sweeping Reconciliation Bill

On Wednesday, Senate Majority Leader Chuck Schumer (D-NY) and Sen. Joe Manchin (D-WV) surprised the political world by announcing they had reached a deal on a new reconciliation bill with provisions to fight climate change, reform the tax code, and extend the enhanced Affordable Care Act (ACA) premium subsidies for three years. Known as the Inflation Reduction Act, the measure would raise over $700 billion by establishing a 15% corporate minimum tax and allowing Medicare to negotiate drug prices, among other items. The bill would also invest nearly $369 billion in a host of clean energy and climate-related programs, including a new $4,000 tax credit for the purchase of used electric and hybrid vehicles.

CMS Announces Maternity Care Action Plan, Extends Postpartum Coverage

The Centers for Medicare and Medicaid Services (CMS) laid out a new Maternity Care Action Plan on Tuesday that aims to encourage health care industry stakeholders like hospitals and insurance companies to consider key commitments on improving maternal health outcomes. The action plan is a part of the Biden administration’s overall effort to improve health outcomes and reduce disparities for mothers and infants. Additionally, CMS approved the extension of 12 months of postpartum coverage under Medicaid and the Children’s Health Insurance Program (CHIP) in Connecticut, Massachusetts, and Kansas. The extension is estimated to apply to 19,000 people in each of these states, bringing the total number of people eligible for 12 months of postpartum coverage nationwide to 284,000.

W&M Advances Bill to Streamline Prior Authorization

On Wednesday, the House Ways and Means Committee voted unanimously to advance H.R. 8487, the Improving Timely Access to Care Act of 2022. This bipartisan legislation would modernize the way Medicare Advantage and health plans use prior authorization by establishing an electronic prior authorization process and creating a process for real-time decisions for services and items that are routinely approved. Backed by both payer and provider organizations, the bill is expected to be brought to consideration on the House floor this fall after lawmakers return from August recess. The Senate version of the Improving Seniors’ Timely Access to Care Act (S. 3018) has been referred to the Finance Committee, although it is unknown when the committee will take up the bill.

KFF: Vaccination Rates for Kids under 5 Remain Low

Only 7% of parents of children ages 6 months to 5 years have gotten their kids vaccinated against COVID-19, according to the latest survey data from the Kaiser Family Foundation (KFF). Unfortunately, the survey data suggests that the number of young, vaccinated children is not expected to rise significantly due to varying degrees of hesitancy among parents. About 43% of parents surveyed said they will “definitely not” get their kids vaccinated, while 27% are opting for a “wait and see” approach. The survey noted some partisan differences, as Republican-leaning parents were three times as likely as Democratic parents to say they will “definitely not” get their kids vaccinated. Additionally, the survey found that 81% of parents who have yet to get their children vaccinated are worried about the side effects or long-term effects of vaccines.

ICYMI: “The Office” Fans Can Experience Dunder Mifflin in DC

Fans of the hit mockumentary sitcom “The Office” can experience their favorite TV series in a new live exhibit that opened Thursday in downtown DC. According to the website for The Office Experience, visitors can explore 17 different areas that feature set recreations and original costumes and props from the show. The exhibit was created by the same company that put together the FRIENDS Experience in DC, which closed back in June. Fans will be able to view The Office Experience through January 16, 2023.

Insights^

Find our analysis on legislation, regulations, MedPAC meetings, and more.

Why the Hearing Aid Rule is a Big Deal

What Happened, What You Missed: August 8-12

What Happened, What You Missed: August 1-5

Key Primary Races to Watch in August 2022 (8/2/2022)

What Happened, What You Missed: July 25-29

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