3 big ways Dems’ social plan would expand health coverage

 A $1.75 trillion social and climate spending framework Democrats unveiled Thursday would reform the health-care market in several ways, expanding access and reducing costs for millions of Americans.

Chiefly, the proposal would expand subsidies available for Affordable Care Act marketplace health plans, add coverage of hearing services to Medicare and improve access to home care for seniors and disabled Americans.

Together, the measure — the result of months of negotiations between progressive and moderate Democrats — would pump about $315 billion into these initiatives, according to White House estimates.

The legislation is still in flux, and it hasn’t secured a public endorsement from some key lawmakers. The White House cut some health policies from the initial $3.5 trillion package (such as the ability to negotiate prescription drug costs and paid family and medical leave) to meet demands of centrist holdouts like Sen. Joe Manchin, D-W.Va., and Sen. Kyrsten Sinema, D-Ariz.

Here are some of the big-ticket items in Democrats’ latest framework.

Insurance subsidies

The measure would expand subsidies for health insurance in two ways, according to Cynthia Cox, director of the Affordable Care Act program at the Kaiser Family Foundation.

(The federal assistance helps reduce health insurance premiums and other costs for private marketplace plans.)

It would preserve a temporary expansion of the subsidies enacted earlier this year by the American Rescue Plan and expand access to low earners who don’t qualify for Medicaid in some states.

Together, the reforms would cost $130 billion, the White House estimates. The provisions would last through 2025. (An earlier version passed by the House would have made them permanent.)

“If it’s passed, then for the next few years almost every American citizen will have access to affordable coverage,” Cox said.

The American Rescue Plan, a pandemic relief law passed in March, made more people eligible for premium tax credits and boosted assistance for those who already qualified.

For example, prior to the pandemic law, Americans didn’t qualify for aid if their income was more than 400% of the federal poverty level (about $51,000 for a single individual or $105,000 for a family of four). New rules got rid of the upper income threshold; they also capped premiums at 8.5% of household income for a benchmark health plan.

The White House estimates extending these reforms would reduce premiums for 9 million Americans, by an average $600 a year per person, and 3 million people who’d otherwise be uninsured would gain insurance.

Additionally, in 12 states that haven’t adopted an expansion of Medicaid under the Affordable Care Act, some low earners currently don’t qualify for Medicaid or marketplace subsidies, making coverage largely unaffordable.

The Build Back Better framework would extend subsidies (premium tax credits) to those in this so-called coverage gap. About 4 million uninsured people in these states would be eligible for such assistance, the White House estimates.

″[They’d] qualify for very significant subsidies on the ACA markets that would essentially make their coverage free,” Cox said.

Home care

The legislation would invest $150 billion in home and community-based care for seniors and Americans with disabilities.

Such care is generally designed to let people stay in their home instead of move to a facility. It may include services like skilled nursing, personal care, adult daycare and home-delivered meal programs, according to the Centers for Medicare and Medicaid Services.

Medicaid is largest payer of home and community-based services in the U.S., according to Jennifer Sullivan, director of health and housing integration at the Center on Budget and Policy Priorities.

The federal funds would help strengthen the Medicaid program; ease a care backlog (the wait list is estimated to be more than 800,000 people); and improve working conditions for home-care workers, according to the White House.

“This is absolutely one of the most significant investments in home and community-based services we’ve seen in recent memory,” Sullivan said.

Currently, the system is tilted toward facilities and institutions, but the legislation would help rebalance the “strained” system, she said.

For example, the framework would offer grants to states to expand access to home and community care and give funding to states that implement an improvement program, among other things, according to a legislative outline issued Thursday by the House Rules Committee. It would also offer funding for hospice and palliative care education and training.

Medicare

Build Back Better would also expand Medicare, the public health plan for seniors, to cover hearing services.

That would add coverage for benefits like hearings aids and visits to an audiologist, according to Juliette Cubanski, deputy director of the program on Medicare policy at the Kaiser Family Foundation.

The policy would cost about $35 billion.

Prior versions of Democrats’ plan had also added dental and vision benefits, which were stripped from the most recent iteration. It also wouldn’t let the federal government negotiate prescription-drug prices for Medicare beneficiaries.

“There isn’t really much in the way of Medicare left in the bill,” Cubanski said. “What’s left standing is a hearing benefit — which is not insignificant.

“A lot of people on Medicare have trouble hearing, and hearing aids are really expensive,” she added.

Specifically, it would provide coverage of hearing aids under Medicare Part B for individuals with severe or profound hearing loss in one or both ears, once every five years, according to a legislative outline.

https://www.cnbc.com/2021/10/30/the-3-big-ways-democrats-social-plan-would-expand-health-coverage.html

Kemp, other GOP governors to sue Biden administration over vaccine mandate

 Georgia Gov. Brian Kemp (R) will file a lawsuit in federal court challenging the Biden administration's vaccine mandate for federal contractors, his office announced Friday.

Kemp and Attorney General Chris Carr (R) were joined on the complaint by leaders from Alabama, Idaho, Kansas, South Carolina, Utah, and West Virginia. It comes on the heels of a similar lawsuit filed by Florida Gov. Ron DeSantis (R) on Thursday. 

"In addition to being an unlawful and unconstitutional overreach, this vaccine mandate on federal contractors will only further divide Americans and hamstring our economy," Kemp said in a statement.

The policy is scheduled to take effect Dec. 8, and will require all federal workers and contractors to be vaccinated against COVID-19, without a testing option.

The plaintiffs are asking the court for an injunction blocking the administration and federal agencies from enforcing the mandate on any contractor based in their respective states. 

Both Kemp and Carr face reelection next year, and Kemp is likely to face a Trump-backed challenger after he ran afoul of the former president by certifying the 2020 election results.

"We will challenge this heavy-handed directive that not only serves as a clear violation of law but also places immense burden on our state," Carr said in a statement.

Shortly after Biden announced the mandate in September, Kemp said he intended to sue to stop it.

Health experts have praised mandates as an effective way to get people vaccinated, and the White House has fully leaned into them as a way to turn the tide of the pandemic, after initially steering clear of federal intervention.

On Wednesday, White House coronavirus response coordinator Jeff Zients said the purpose of the mandates isn't to punish people, and noted the deadlines for federal employees and contractors "are not cliffs."

Zients said federal employers and contractors will be expected to educate, counsel and accommodate their unvaccinated workers to persuade them to receive the shot before terminating them.

https://thehill.com/homenews/state-watch/579185-kemp-other-gop-governors-to-sue-biden-administration-over-vaccine

'Patients aren't equipped for cognitive impacts of COVID-19 — neither are their doctors'

 Forgetfulness, an inability to concentrate, a feeling that something is just “off.” COVID-19 survivors often describe an array of disquieting and disabling neurologic symptoms after their acute illness abates. The term “brain fog” was coined to encompass these neurologic complaints that patients felt were too often dismissed or ignored.

Now, new research confirms what they are telling us: 24 percent of COVID-19 survivors experience significant cognitive impairment that affects memory, executive function and processing speeds.

Of course, patients aren’t looking for affirmation. They need a solution and, until that day arrives, support. Unfortunately, we are even less prepared to meet these needs than we were their acute illness, no matter how sick they were and how stretched our health system has been.

Their recovery will require multisector collaboration between practitioners in health, education and industry. But this does not yet exist at any kind of meaningful scale.

To Long COVID, add the fact that assuming historical data on severe respiratory failure holds, 40 percent of COVID-19’s critically ill patients will be out of work one year following their illness. Not by choice, but by consequence.

It has been almost a quarter century since researchers first published data showing 75 percent of patients with acute respiratory distress syndrome (ARDS) suffered from measurable cognitive impairment one year after illness. Follow-up research has shown that psychiatric distress, financial stress, physical deconditioning and isolation are also frighteningly common. Even pre-COVID, we weren’t adequately rehabilitating and supporting the vast majority of these patients, who struggled to return to “normal” both at work and home. 

Here’s the dirty secret: If we define success by whether a severely ill patient survives to hospital discharge — as most clinical trials do — our health system is improving every year. If we define it as a full recovery — we’re failing. To fix this, the health system needs to play a far more active role in these patients’ survivorship, but its efforts will be ineffective without collaboration with private and public entities in other fields.  

Too many patients find their illness provokes a cascade of crises, like one I recently discharged from the ICU to a rehabilitation center. He hadn’t walked in months and felt unrecognizable to his former self. He had been the sole source of income for his family, and now had no idea how to cover their mortgage. He wouldn’t soon — if ever — be returning to his previous work in construction. We both understood his future was precarious.

These problems lie far beyond the scope of most of the health care workforce’s training or comfort. Multidisciplinary clinics and collaboratives dedicated to easing the challenges of critical illness and COVID-19 survivors are growing rapidly, in part due to the attention COVID-19 has brought to the challenges of survivorship. But because of funding shortages and siloed programs, the challenge of integrating non-medical needs with clinical services at scale persists.

I recently spoke with a leader in the vocational rehabilitation program at the Texas Workforce Commission, a program designed to help individuals with disabilities obtain and retain jobs. The program is just what someone with new health-related disabilities needs, and it’s located less than a mile from our hospital. But she told me that most patients only found it years after discharge from severe illness because there are no systematic efforts to connect patients from our hospital with her institution.

Reform must focus on both culture and funding. Culturally, the U.S. has long siloed its social services, both in practice and in budget, so we frequently face a “wrong pocket” problem: Investing in people via the health care system provides long-term benefits, but the health care system isn’t the financial beneficiary, so funding is difficult to obtain.

Despite burgeoning evidence that multidisciplinary programs following critical illness might reduce readmissions and improve employment prospects, these programs rely on the benevolence of institutions or research grants for their survival because remuneration does not cover expenses. 

An overhaul is long overdue, and there has never been a better time. During the Delta variant COVID-19 wave, our hospital beds filled with adults in their 40s, not vulnerable seniors. These patients aren’t being discharged to an assisted living facility and a waiting retirement account. They are returning to face rent, dependents and responsibilities.  And they will be struggling. 

Helping our critically ill COVID-19 population resume “life as they knew it” will require both a commitment from federal, state and local governments and new methods of collaboration among those working in education, industry and disability advocacy. Arguments over vaccines are far less productive than preventing illness and supporting its survivors. 

We have long understood that recovery means more than discharge. It’s time to turn that insight into action and help build the ramp to get our patients back to something they would call a normal life.

Marissa Wagner Mery, MD, MBA is a critical care physician, anesthesiologist and assistant professor at Dell Medical School at the University of Texas at Austin, and a public voices fellow with The OpEd Project. 

https://thehill.com/opinion/healthcare/579220-patients-arent-equipped-for-cognitive-impacts-of-covid-19-neither-are

Issue with lack of nuance in FDA panel kid-dose vaccine vote

 An FDA advisory panel recommended emergency use authorization (EUA) of a two-dose regimen (10 μg apiece) of Pfizer-BioNTech's COVID-19 vaccine, administered 3 weeks apart, for children ages 5-11 years.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17-0, with one abstention, that the benefits outweighed the risks of the vaccine in this population.

Several members of the committee expressed irritation at the "binary choice" of either voting "yes or no" on the recommendation, as opposed to a more nuanced recommendation. However, Peter Marks, MD, PhD, director of FDA's Center for Biologics Evaluation and Research (CBER) charged VRBPAC at the beginning of the meeting that their job was not to decide who would get the vaccine within the population, nor to discuss or consider vaccine mandates.

Michael Kurilla, MD, PhD, of the NIH National Center for Advancing Translational Sciences, was the one abstention. He pushed for more nuance in the question, namely alternate dosing for the children with prior COVID infection.

Ultimately, the committee was swayed by the idea that if they did not vote to recommend the vaccine, it would not be available to children with high-risk medical conditions or medically vulnerable children in need of protection.

"If we try to approve this for some subset of the group, that could potentially lead to a situation where this becomes a vaccine that gets used more" by those of higher socioeconomic status with access to it, Marks noted.

"I understand why the question was asked that way, but I certainly don't like it," said Michael Nelson, MD, of the University of Virginia School of Medicine in Charlottesville. He added that a model of shared clinical decision-making with "risk-informed" parents and their healthcare providers made the most sense to him.

Most members also seemed torn about such a broad authorization, particularly that states might mandate it in order for kids to go to school. Other issues at play were the fuzzy issue of vaccine-associated myocarditis risk, as well as CDC data that indicated that about 40% of children in this population had previously been infected with COVID-19.

"It's always nerve-wracking when you're asked to make a decision for millions of children based on ... [data from] a few thousand children," said Paul Offit, MD, of Children's Hospital of Philadelphia.

Ultimately, he said it came down to "do we know enough" based on the information available, and concluded that while more will be known once a larger population of children are vaccinated, there was enough data for him to vote "yes."

"When I look at this question, it's pretty clear that the benefits do outweigh the risks," said Amanda Cohn, MD, MPH, of the CDC in Atlanta. "We don't want children to be dying of COVID, and we don't want them in the ICU."

Other committee members brought up the impact school closures have had on children's learning, and the need for parents to be able to protect their children in areas where mask mandates are not enforced.

Data in FDA briefing documents was primarily from phase II/III of the phase I/II/III study C4591007, which had 3,109 participants who received vaccine and 1,528 who received placebo. It was made up of two cohorts: Cohort 1, with 1,444 in the vaccine group and 714 in the placebo group, each with at least 2 months of follow-up safety data, and cohort 2, who had a median of 2.4 weeks of follow-up data at the time of data cutoff.

The vaccine met immunobridging success criteria, FDA staff said, with increases in neutralizing antibody geometric mean titers among children ages 5-11 versus individuals ages 16-25, as well as comparable seroresponse rates among the two groups versus baseline.

A descriptive analysis found 90.7% vaccine efficacy (VE; 95% CI 67.4-98.3%), with three COVID cases in the vaccine group and 16 in placebo. None of the cases met the criteria for severe COVID. About 20% who acquired COVID-19 had comorbidities, and most infections occurred during July-August 2021.

Adverse events (AEs) were similar to other populations, with no cases of myocarditis or pericarditis, anaphylaxis, or deaths. The most common AE was fatigue (39%), followed by headache (28%) and muscle pain (12%). Most systemic AEs were mild or moderate, and resolved 1-2 days after onset, FDA staff noted.

FDA staff also conducted a series of models that measured symptomatic COVID-19 cases, hospitalizations, ICU admissions, and death compared to excess myocarditis/pericarditis cases, hospitalizations, ICU admissions, and death.

They found that the benefits were highest among kids ages 5-11 in the scenarios using the Delta-surge peak incidence, high VE, and higher COVID death rate, and lowest in scenarios with the lowest incidence.

They also pointed out that they used a "conservative assumption" for myocarditis risk, namely healthcare claims from adolescents ages 12-17, and if the risk is lower among younger children, "the benefit-risk balance would be more favorable."

VRBPAC ultimately concluded that any narrowing of these recommendations could be left up to the CDC Advisory Committee on Immunization Practices (ACIP).

Oveta Fuller, PhD, of the University of Michigan in Ann Arbor, said that a "yes" vote meant that in hindsight, the committee could look back on their decision favorably to give parents the choice to vaccinate their kids.

"We want to make the option available for what it might do to help the children as well as others in this pandemic," she said.

https://www.medpagetoday.com/infectiousdisease/covid19vaccine/95278

Tennessee Bills Would Shield Docs Who Spread COVID Misinformation

 This week, two Tennessee state representatives introduced bills that would restrict the state's physician licensing board when attempting to discipline doctors who spread inaccurate information about COVID-19 and COVID vaccines.

Katrina Green, MD, is concerned about the bills. She is an emergency physician in Nashville and Lawrenceburg, Tennessee, and also part of a group called Protect Our Care, which advocates for public health measures in the state.

"It's kind of a dangerous time to be a physician -- or really a person -- in Tennessee," Green said.

She's treated COVID patients throughout the pandemic and said it's been frustrating to combat what her patients have heard about the vaccine. She said the board should be able to curb the ability of doctors to mislead patients:

"I think it's very important that the state medical board continue to have the powers to investigate doctors and nursing board nurses who spread misinformation and lies relating to COVID and the pandemic."

"And right now we have that ability, but this bill would strip it out from us," Green continued. "How do we hold someone accountable if we don't have that ability?"

State representatives Chris Todd (R) and Debra Moody (R) introduced the bills on October 28. Rep. Todd's bill, the Tennessee COVID-19 Treatment Freedom Act, would prevent the Tennessee Board of Medical Examiners from disciplining doctors for anything "solely related to the physician's prescription, recommendation, use, or opinion relative to a treatment for COVID-19," including treatments that aren't approved by the state's health department or the FDA.

"Doctors in this state have been handed an unconstitutional ultimatum from a board that has repeatedly exceeded its legal authority," Todd told MedPage Today via email. "As representatives of the people, we must do everything in our power to rein in this abuse and restore the liberties and freedoms our physicians are guaranteed under our constitution.

"My bill not only does that, but it also guarantees the ability for doctors to practice as they are licensed and trained for treatment of COVID-19 just like any other illnesses they treat on a daily basis," he continued. "We've never seen restrictions on physicians like we have in the last 18 months."

Todd added that the bill, House Bill 9020, will be added as an amendment to another bill, House Bill 9077, which would allow employees fired for refusing a COVID-19 vaccine to receive unemployment benefits.

Rep. Moody's bill further expands on this bill, specifying the types of disciplinary actions that could be taken by the board. If passed, House Bill 9028 would prevent those actions "so long as the physician exercised independent medical judgment and believes that the medical treatment is in the best interest of the patient," and the patient consents.

These bills are likely a result of a new policy from the Tennessee Board of Medical Examiners, who discipline physicians who break professional standards, which was adopted on September 21 in an effort to rein in doctors who spread false information about the vaccine in their offices, on social media, or elsewhere.

The policy states that physicians "who generate and spread COVID-19 vaccine misinformation or disinformation are risking disciplinary action by state medical boards," including a suspended or revoked license. The policy says that doing so contradicts physicians' duty to protect patients using the latest scientific consensuses, "threatens to further erode public trust in the medical profession and puts all patients at risk."

Green said she is worried that because of a Republican super-majority in the state government, the bills will become law, along with others that aim to restrict mask and vaccine requirements, and restrict the governor's state-of-emergency powers.

"I'm very worried that they will all pass," Green said.

David Aronoff, MD, director of the Division of Infectious Diseases at Vanderbilt University Medical Center (and a MedPage Today editorial board member), said he thought the sponsors of the bill were making the case that the regulatory board shouldn't regulate practitioners' opinions.

"I think the boards aren't trying to discipline people on the basis of having opinions based on their experience and expertise," but that instead intervening when a licensed healthcare provider "is stating falsehoods or doing things that are clearly against standard of care," he said.

Green is concerned that the bills, if passed, could allow doctors more leeway to argue that false vaccine claims are "opinions." She gave the example of an Ohio doctor who claimed that the COVID vaccine would "magnetize" peoples' bodies. A law like Todd's or Moody's, Green said, "gives wiggle room to say, well, it wasn't a lie. It's just my opinion."

Aronoff said the bills, if passed, would affect only a very small portion of healthcare providers.

"The vast, vast majority of people who are caring for patients during this pandemic are really trying to do the best they possibly can to protect people's lives and take their oath as caregivers very, very seriously," he said.

But he added that the bills would set a precedent that could hinder state regulatory boards' ability to provide oversight.

"When boards of health or medical licensing boards are no longer able to enforce regulations that are intended to keep people healthy, then we risk people being less healthy," Aronoff said.

Green agreed: "We all took the Hippocratic oath to first do no harm. And when the words that come out of your mouth can directly lead to harm, I think we have an obligation to combat that. This law, if it passes, will take away our ability to do that."

Local reports have noted there have been no disciplinary actions taken yet against doctors or nurses for misinformation.

Rep. Moody, the Tennessee Board of Medical Examiners, or their legal counsel did not respond to requests for comment as of press time.

https://www.medpagetoday.com/special-reports/exclusives/95355

UnitedHealth Cries Fraud in $100M Lawsuit Against TeamHealth

 Insurance company UnitedHealth filed a lawsuit against TeamHealth, one of the country's largest emergency services staffing companies, alleging that the company's systematic upcoding has led to more than $100 million worth of overcharging.

Filing the lawsuit in Tennessee's federal district court, UnitedHealth charged that TeamHealth has "covertly and methodically engaged in a form of healthcare fraud called upcoding," wherein healthcare providers submit a claim to an insurer using a Current Procedural Terminology (CPT) code that misrepresents -- and, more importantly, overvalues -- the services provided in the emergency room (ER).

"The United Plaintiffs have reviewed tens of thousands of commercial health benefits claims submitted by TeamHealth and have determined that well over half of the claims TeamHealth submitted to United using the two highest-level CPT codes for ER visits -- roughly 60% -- should have utilized lower-level CPT codes," the complaint reads.

In one example of TeamHealth's alleged upcoding, a 23-year-old man suffering from indigestion after eating a chili dog went to a TeamHealth-staffed ER; he was sent home with the antacid Maalox. UnitedHealth says that the claim submitted to them by TeamHealth indicated that this patient received "emergency medical care of particularly high complexity under exigent circumstances," resulting in a $1,712 charge.

UnitedHealth's complaint emphasizes that the profits earned by upcoding are never seen by physicians and other healthcare professionals employed by TeamHealth.

"TeamHealth handles everything related to the coding and billing of claims from its centralized billing centers. It is TeamHealth's coders who decide which codes to utilize, applying TeamHealth's policies. It is TeamHealth that submits claims to insurance companies under the names of its affiliated or acquired medical groups," the suit states. "And it is TeamHealth -- not the medical groups or the doctors or other providers -- that keeps the profits from its fraudulent billing."

The complaint seems to be the next phase of litigation in the legal battle that the two companies have been embroiled in for the past few years. In 2019, TeamHealth filed its own complaint against UnitedHealth, accusing the insurance company and its subsidiaries of underpaying claims and working with Data iSight, a third-party administrator, to systematically reduce payment rates.

In 2020, when New-York-based emergency physician groups sued UnitedHealth for underpaying them for out-of-network services, UnitedHealth responded by saying that, "a small number of providers, and especially private equity-backed physician staffing companies like TeamHealth, are driving up the cost of care for the people and customers we serve," the insurer told media outlets.

"Some of the TeamHealth provider groups that are not part of our network today charge 700-900% of Medicare rates for the care they provide ... This sort of excessive pricing from out-of-network providers contributes to skyrocketing health care costs for everyone. TeamHealth has filed a lawsuit in an attempt to challenge our efforts to address the unreasonable and anticompetitive rates its providers charge," the statement continued.

UnitedHealth's current lawsuit against the staffing firm posits that, since its 2017 acquisition by private equity giant Blackstone, TeamHealth's coding tactics have "crossed the line from aggressive profit maximization to fraud."

In its defense, TeamHealth CEO Leif Murphy claims that UnitedHealth's lawsuit is just a way for the insurer to divert attention away from an upcoming Las Vegas court case brought by TeamHealth affiliate Fremont Emergency Medicine against UnitedHealthcare "for their gross underpayment of frontline clinicians."

"United continues to generate record profits by down coding claims and refusing to consider the expertise of frontline clinicians who make a diagnosis," Murphy told MedPage Today in an email.

"Even during a pandemic, United utilizes tactics like these to profit off the backs of emergency medicine providers who are on the front line treating patients and risking their own lives. The bottom line is the less UnitedHealth reimburses, the more profits they make," said Murphy.

Notably, UnitedHealth also had a contentious working relationship with Envision, another large staffing company backed by private equity firm KKR. After years of back and forth -- during which UnitedHealth accused Envision of having rates that were double, even triple, the median -- the insurer eventually cut the firm out of their network entirely in 2021.

https://www.medpagetoday.com/special-reports/exclusives/95349

Can we really afford to change Medicare Part D?

 One Build Back Better proposal that didn’t make it into President Biden’s reconciliation bill ‘framework’ is to allow federal government negotiation for prescription drugs in the Medicare Part D program. A framework isn’t legislation and this provision could still emerge as a compromise in the final bill.

Termed a “pay-for,” repealing the current structure of Medicare Part D price negotiation could pay for the massive expansion of other federal programs included in the Build Back Better agenda. One Congressional Budget Office (CBO) estimate for Medicare Part D government price negotiation was at least $345 billion in savings from 2023 to 2029. Another estimate showed $581 billion in federal cost savings by 2030.

Since its implementation in 2006, Medicare Part D has been a successful and popular program among seniors. According to a 2014 study, obtaining prescription drug insurance through Part D was linked to an 8 percent reduction in hospital admissions resulting in a 7 percent decrease in Medicare cost savings.

As it is currently structured prescription drug prices in Part D are negotiated between pharmaceutical manufacturers and prescription drug plans which have been successful at negotiating rebates, while giving doctors more freedom to prescribe what they believe is best for their patients.

The program’s success is largely due to a provision called the noninterference clause, which specifically bars the secretary of Health and Human Services from interfering in prescription drug pricing and leaves negotiations for such pricing to insurers and pharmacy benefit managers. Lack of government intervention in Part D drug price negotiations has allowed market forces to deliver greater competition and choice for treatments available to Medicare beneficiaries.

Medicare Part D has also provided stability in monthly premiums and many plan options to choose from. A 2020 Kaiser Family Foundation analysis showed the average Medicare beneficiary had a choice of 28 stand-alone drug plans and 24 Medicare Advantage plans available to choose from, with private sector discounts and rebates negotiated for all prescription drugs in each plan.

Repealing the Noninterference Clause would allow the secretary of the U.S. Department of Health and Human Services to negotiate the cost of prescription drugs and require a formulary that includes some drugs and excludes others. If drugs that are deemed unworthy of inclusion on the federally-negotiated formulary are no longer covered by Medicare, some people will lose access to their preferred treatments.

Advocates of government negotiation have compared this proposal to the process used by the Department of Veterans Affairs (VA) as a way to justify it. However, this comparison falls short. For one, the VA health system uses a closed set of providers, with centralized management of coverage, drug acquisition and distribution. Its prices do not include retail distribution costs that the much larger number of patients in the general population have to pay. Those costs would have to be covered somehow if Medicare Part D adopted a similar approach.

A 2013 study indicated that more than half of veterans resort to supplemental benefits outside the VA in order to obtain the medicines they need. So, although the VA system does lead to price reductions, it also narrows options. If this type of system were scaled across Medicare Part D, many more people would be in a similar situation.

Limiting seniors’ access to medicines isn’t the only concerning aspect of this proposal, there are also the long-term implications on innovation in the pharmaceutical industry to consider.

Research and development spending by the pharmaceutical industry on new drugs is influenced by three main factors: The revenue they expect to earn from a new drug, the expected cost of developing it, and policies that influence the supply and demand for drugs.

If Medicare’s Noninterference Clause is repealed a Congressional Budget Office analysis predicted expected return on investment for newly developed drugs drop by 15 to 25 percent and as a result, estimates this would lead to anywhere from eight to 15 fewer new drugs coming to market over the next 10 years. In other words, it would weaken the incentive to innovate resulting in fewer pharmaceutical innovations coming to market.

Restructuring Medicare to cut corners in order to pay for increased spending on other federal programs is irresponsible. The bigger question and one that goes beyond budgets is: Can we really afford the reduction in seniors’ access to the medicines they need and the development of fewer life-saving treatments over time? No, we really can’t.

Mia Heck is the vice president for External Affairs and Healthcare Fellow at the Joseph Rainey Center for Public Policy.

https://thehill.com/opinion/healthcare/579177-can-we-really-afford-to-change-medicare-part-d