Joseph Burns

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It’s difficult to imagine how the nation’s two political parties could be further apart on health care. With voters going to the polls early in record numbers and Election Day next week looming large in the country’s collective consciousness, it seems there is little, if any, agreement between the Democrats and Republicans on healthcare issues. The division has been widened by the COVID-19 pandemic, with President Trump saying the country is “rounding the corner” with respect to the pandemic and Democratic candidate, Joe Biden, calling for national mask mandate.

Republicans v. Democrats on the ACA, health insurance

The Democrats who have a list of what they see as the solutions to the healthcare problems that many Americans face as the cost of care rises and the economy wobbles because of the pandemic. Increasing unemployment has meant more Americans (perhaps as many as 12 million according to some estimates) have lost their employer-sponsored health insurance and the Democrats want to provide them with coverage. The Democrats would prefer to provide coverage under the ACA, which was signed into law in 2010 with the major provisions going into effect in 2014. They could do so through Medicaid — at least in the 38 states (and Washington, D.C.) that chosen to expand the state-and-federal health care program under the ACA. In addition, some progressive Democrats favor a sweeping Medicare-for-all, single-payer system. The centrists in the party, including presidential candidate Joe Biden, favor modifying the ACA. Biden has proposing increasing subsidies for people buying coverage on the ACA exchanges and allowing people to enroll in Medicare starting at age 60.

President Donald Trump and Republicans want to repeal the ACA. The administration supports the 20 states that filed a lawsuit arguing that the ACA is unconstitutional because the individual mandate provision was eliminated. The U.S. Supreme Court is scheduled to hear oral arguments in that case, Texas v. California, on Nov. 10.

In place of the ACA, which sets requirements on what health plans must cover, the Trump administration and the Republicans have promoted short-term, limited-duration (STLD) health plans and association health plans. The premiums for these plans are lower than plans that comply with the ACA, but they are limited in the services that they cover.

On its website, the campaign to re-elect President Donald J. Trump touts such accomplishments as expanding access to Association Health Plans (AHPs) to allow small business to pool risk across states and for allowing STLD plans to be extended for as long as 364 days for consumers seeking lower premiums and less robust coverage.

Under the Tax Cuts and Jobs Act of 2019, the Trump administration repealed the individual mandate that had been part of the ACA. On its website, the Trump campaign says the mandate forced consumers to buy expensive insurance. The website also mentions that the president signed a six-year extension of the Children’s Health Insurance Program to pay for health insurance for 9 million children.

Controlling drug prices top issue for Republicans

Controlling drug prices is a top health care priority of the Trump administration, says James C.

 Capretta, a resident fellow and the Milton Friedman Chair at the right-leaning think tank, the American Enterprise Institute. “In the healthcare sphere, drug pricing would be number one,” he said. “Then other issues, such as price transparency and health reimbursement accounts, would follow behind that.

If Trump wins re-election and the Republicans control at least the U.S. Senate, then it’s safe to say that past will be prologue for 2021 if not longer, Capretta observes.

“The agenda for Republicans is almost certainly going to remain as it has been since 2017,” he notes. “By that I mean there will be a focus on administrative action related to loosening regulations.”

If there is a second Trump administration, executive orders and administrative changes are likely to be the main tools of its healthcare policies because Democrats are expected to retain control of the U.S. House of Representatives regardless of how the presidential vote turns out — and whether the Republicans keep their current 53-47 hold on the Senate.

“It’s possible that there could be some legislation in a second Trump term around drug pricing, but it’s more likely that the president and his team would push something around an international drug-price index,” Capretta says. During the second half of this year, Trump has signed a flurry of executive orders that would, among several things, tie prices that CMS pays for certain Medicare Part B and D drug to the lowest price paid by a comparable country. Trump has also signed executive orders that would facilitate the importation of drugs by individuals.

“The idea of any kind of Trump legislative initiatives making it through the Congress seems quite remote,” Capretta continues. “Moreover, I don't think they have a legislative health agenda that they would be ready and wanting to push as a priority.”

Among the administrative and regulatory changes they are likely to pursue is price transparency initiatives that HHS proposed in 2018 for hospitals and health insurers. “This is a huge priority for the administration,” he said. That means the Republicans will press for even more disclosures on price and ways to make price transparency useful for consumers.

In addition, the administration is likely to push for wider use of health reimbursement arrangements (HRAs) by promoting them hat as an option for consumers buying health insurance in the individual market and encourage that employers promote HRAs to their workers as a way to cut health care costs, Capretta suggested.

Expanding healthcare insurance coverage top issue for Democrats

While Trump and the Republicans will focus on drug prices and cost control, the Democrats will call for more health insurance coverage for those who are uninsured, including those who have lost their employer-sponsored insurance, says Daniel Mendelson, the founder of the health care consulting firm Avalere Health.

Healthcare is almost always a top priority for Democrats, and healthcare and COVID-19 are together because virtually all Democrats want to get the pandemic under control, Mendelson said.

When the pandemic took off this spring, most of infections and serious cases and deaths were in blue states, including Washington State, which is where the first outbreak occurred, California and New York where the most deaths occurred. But the pandemic started to affect red states this summer and fall. This week, the CDC is reporting that North and South Dakota, Montana, Arkansas and Tennessee are experiencing the highest rate of deaths per 100,000 population.

"As a result, it has changed from being a blue-state issue to being one that all of us share collectively,’ says Mendelson.

What that means, in Mendelson’s opinion, is that the government’s role in healthcare is likely to increase.

Layoffs and the loss of employer-sponsored health insurance will create an urgency for a public option, Mediare for all, or both, says Mendelson.

“Even before the recession, Medicare and Medicaid and then after the recession started, even more people became eligible for Medicaid,” he reported.

“Interestingly, the states are expanding Medicaid through ballot initiatives, and some of those initiatives have succeeded because voters in those states are concerned about the issues around uninsurance and the high cost of health care,” he noted.

Mendelson also noted that more seniors choosing to sign up for Medicare Advantage plans rather than traditional Medicare because they want more control over their health care expenses.

“Those two trends mean that the government role in health care is growing and health plans are very attentive to these trends,” Mendelson explained. “That’s one of the reasons they are focused on having great relationships with the state governments and with the federal government.”

For all these reasons, Democrats are likely to work to expand health insurance for more Americans, he predicted.

“If Biden wins, Democrats will want to expand coverage options through the channels that are in place now, such as Medicare, Medicaid, and the health insurance exchanges,” he said. “They are not likely to try to create massive new government programs or to put everybody into Medicare.”

Articles

Here's what healthcare executives can expect depending who  wins next week's election.

Trump and the Republicans vs. Biden and the Democrats on Healthcare

About a month before COVID-19 began sweeping across the country, the results of an important study of a program — designed to address the needs of patients who are high utilizers of the healthcare system — were published in the 

. Sometimes called frequent fliers, these high utilizers tend to have multiple chronic conditions, make frequent visits to the emergency department and get admitted to the hospital often. They constitute about 5% of patients but account for about 50% of total costs, according to the federal Agency for Healthcare Research and Quality. “Hot spotting” programs, which would find ways to intervene before the high utilizers’ healthcare problems became so regular, serious and expensive, hold a lot of appeal and make common sense.

 study was supported by the Abdul Latif Jameel Poverty Action Lab (J-PAL), a research organization at the Massachusetts Institute of Technology whose founders shared the Nobel Memorial Prize in Economic Sciences in 2019. J-Pal has pioneered the use of randomized controlled trials (RCTs) to test the effectiveness of health, economic and social programs; its findings have upended prevailing beliefs more than once. The results from this particular study showed that a hot spotting program in Camden, New Jersey, that had been praised by Atul Gawande, M.D., among others, did not reduce hospital readmissions. Although hospital readmissions were 40% lower among the patients in the program, the decline was nearly the same among patients in the control group.

When the results were published in the Jan. 9, 2020, issue of the prestigious medical journal, Kathleen Noonan, CEO of the Camden Coalition of Healthcare Providers, the group running the program, told 

, “We’re disappointed by the results.” Noonan added that treating such patients with effectivity “is very, very hard work.”

Now, more than a half a year later, Camden Coalition officials say they have made adjustments to their program as a result of the RCT. “The Camden Coalition adapted its care intervention throughout the RCT and continues to do so based on what we learned since then,” Noonan says. “We found early on that we need to focus on cultivating deeper partnerships with social service organizations and launching programs that look beyond healthcare to get at the root causes of poor health outcomes.”

Since 2003, when Jeffrey Brenner, M.D., founded the coalition, the staff has recognized that these patients need primary care, social services, housing, food and, in some cases, a lawyer. “During the course of the RCT, we started programs in response to the overwhelming need we saw on the ground for things like housing and legal support,” says Noonan, pointing to the 7-Day Pledge, a citywide program that aims to get patients a primary care appointment within seven days after they have been discharged.

Noonan summarized what coalition leaders and staff have learned about patients with high utilization patterns:


Extreme hospital and emergency room utilization is driven by the complexity of the healthcare system and the inability of most care systems to manage this complexity.

Patients who need complex care are outliers in the health system,
“so we need to build new care models capable of providing integrated care.”

Care models need to be tailored to deliver trauma-informed and evidence-based services. Care models must address the social determinants of health such as housing, which is a critical component of the coalition’s work.



Implementing these solutions is difficult in a healthcare system built to provide episodic care in which emergency rooms or urgent care centers may do little more than “treat and street.” Instead, almost all these patients need seamlessly integrated care in which anyone with high needs can get treatment tailored to his or her specific health and social-service needs. Getting funding for this care is a barrier to developing systems for these patients because it costs more than usual care.

Other challenges loom, ones that are beyond the easy reach of the healthcare system, Noonan says. “We must acknowledge how the issues of racism, poverty and the disinvestment in many urban areas underlie our patients’ challenges,” she says. “Without major financial and political investments in addressing those issues, any intervention will have limited impact.”

Despite these hurdles, Noonan says the coalition will continue to apply lessons learned from the RCT.

“Our next steps are to continue to adapt and test programs that aim to reduce utilization of the health system (and) also to achieve our broader goals concerning quality of life for these patients, self-advocacy and other patient-identified goals.

“It’s clear that there is still so much to learn,” she notes. “We will, as we did all along, look to the data for additional insights and listen to our community and front-line staff in order to evolve our programs.”

Joseph Burns is an independent journalist in Massachusetts who writes about healthcare.

Results of an RCT of the coalition’s ‘hot spotting’ approach resulted in some reevaluation.

Camden Coalition Finds New Ways to Care for High Utilizers 

Jeffrey Brenner, M.D., who has pioneered programs for vulnerable populations and high utilizers of health care, has left his position at UnitedHealth Group to open up a primary care clinic in southern New Jersey.

“I'm going to do a primary care startup,” he said during a telephone interview today with Managed Healthcare Executive.® “I'm a family doc, and my true love has always been primary care.”

Brenner, 51, said he has been looking for office space the past few days. UnitedHealth Group has announced his departure internally, but there has been no external announcement.

Brenner was hired by UnitedHealth in February 2017 after he founded the 

 in 2003. Brenner and the coalition took the then-novel approach of identifying people who went to  emergency departments often and were high — and expensive — utilizers of heath care. The group offered preventive services, including some outside of the normal boundaries healthcare, to address their illnesses and reduce their use of healthcare services and the associated expenditure. 

Brenner and the coalition’s efforts are partly responsible for the current focus on addressing the 

. Atul Gawande, M.D., wrote a profile of Brenner and the coalition for 

." In 2013, Brenner was awarded a MacArthur “Genius” Grant.

At UnitedHealth, Brenner led the creation of programs in over a dozen cities that provide housing and other non-medical services to vulnerable populations covered by the country’s largest insurer.

Brenner said he is planning to return to his roots as a family physician beginning sometime this fall. He said he will be working with 

, MBA, who worked with him in Camden and at UnitedHealth Group, where she was president and chief operating officer for clinical redesign.

Brenner and Stillo ran a “pandemic hotel” in Secaucus, New Jersey, for COVID-19 patients earlier this year. The site was set up to temporarily separate patients from their families in an effort to stop the spread of the deadly virus. “In that setting, it was really nice to be back close to frontline care again,” Brenner said. 

Founder of the Camden Coalition and a SDOH pioneer is looking to establish a primary care clinic in southern New Jersey.

Jeffrey Brenner Is Leaving UnitedHealth To Return To Primary Care Roots

Pharmacy benefit managers (PBMs) argue that they play a vital role in the labyrinth of U.S. healthcare as pharmaceutical company intermediaries, serving purchasers (such as employers) and payers (such as Medicare and commercial health insurers). Critics, however, contend that PBMs serve the needs of pharmaceutical companies at the expense of purchasers, payers and, ultimately, patients. 

Over the past two-plus years, PBMs have begun pushing back against this criticism, in part, by expanding their efforts and going beyond managing
	pharmaceutical costs - de-emphasizing rebates and streamlining formularies - to accepting more responsibility for managing the total cost of health- care for their insurer and employer clients. The larger PBMs have also strengthened their market positions through mergers and acquisitions. PBMs have also improved their data analytics.

Here are four ways that the PBM industry is changing:

Supporting physicians and providers at the point 

One of the most pressing problems PBMs face today is how to help physicians and other prescribers while face-to-face visits with patients are limited during the COVID-19 pandemic. Even though in-person visits are limited, doctors and other providers still need to prescribe, monitor  and/or change medications, says David Calabrese, RPh, M.H.P., senior vice president and chief pharmacy officer at OptumRx and a member of the 

editorial advisory board.  To address this challenge, OptumRx is supporting telemedicine visits between physicians and patients by having pharmacists participate in some visits. Calabrese says the company is also making digital engagement tools available to physicians and other providers. “We have tools to deliver information about patient adherence to improve cost efficiency and drive quality at the point of care,” he says. “In our specialty pharmacies, for example, we use a video chat-type format to engage patients, educate them and empower them to take a more active role in their care.”

Prime Therapeutics, a PBM in the suburban Twin Cities serving 23 Blue Cross Blue Shield Plans, also recognizes the increased need for virtual care and, additionally, has put more emphasis on infectious disease prevention for every patient, says Kelly McGrail-Pokuta, Prime’s vice president of pharmacy trade relations. “The COVID-19 pandemic has certainly altered every part of the healthcare system in the past couple months,” she comments. “No one knows exactly what the future will hold, but PBMs are working with all parts of the supply chain and with payers and providers to make the changes needed quickly and thoughtfully. All parties are aligned in helping to drive the best care in a consumer-focused manner at the most affordable price.” 

Historically, the function of PBMs has been to manage the cost of prescription medications. Now, however, PBMs are “going beyond the pill” and assuming a larger role in managing the total cost of care.  Last year Express Scripts signed a contract with eight of the 16 member-employers of the National Drug Purchasing Coalition to, among other things, hire care managers to improve medication adherence. 

OptumRx aims to lower the total cost of care by working closely with patients who have chronic and costly conditions, such as diabetes. “Not only do we use pharmacists, but we also use certified diabetes educators, nurses and nutritionists across our Optum Enterprise to better care for patients with diabetes. Monitoring adherence is one of the main arrows in the PBM quiver. “We do that as one of the many components of our solution suite to manage the total cost of care. That’s where we’re focusing our efforts.”

Prime Therapeutics is doing similar work under value-based care contracts in which payers and employers pay more for medications when pharmaceutical companies can show that their drugs are working as intended and helping to drive down the total cost of care, McGrail-Pokuta says. On the flip side, payers and employers pay less for medications that do not work
	as intended.  

“Pharma is becoming more comfortable with value-based care agreements, which means they’re collaborating with PBMs on how quality outcomes are defined for certain medications,” McGrail-
	Pokuta notes. “Those agreements will continue to grow in number because validating drug performance using real-world evidence is a priority for most pharma companies and because payers want to ensure the treatments that they pay for actually work.” 

In addition, Prime Therapeutics is going outside the traditional PBM lane of managing the drug benefit only by taking on the medical benefit. “For some categories, such as specialty drugs, managing across benefits provides a more holistic view of total plan spending,” she says. “We also offer reinsurance for some specialty drugs and apply predictive analytics to control spending for high-cost utilizers.”

To the criticism that PBMs are greedy middlemen, McGrail-Pokuta offers this counterview: “Prime and other PBMs serve as a counterbalance against rising drug prices and are a part of the system that help control overall healthcare costs,” she says. “Without them, drug prices would go unchecked.”

Utilization review, prior authorization, formulary tiers - familiar tools in the managed care toolkit. Today, PBMs are supplementing these tools with copay accumulators, point-of-service rebates and formularies that exclude high-cost or low-value medications. “These approaches can increase market share in preferred products and help save the member and payer on drug costs,” McGrail-Pokuta explains. Prime Therapeutics also uses assessments from the Institute for Clinical and Economic Review (ICER), an independent drug pricing and value organization in Boston. “ICER’s analyses help to shape our outcomes-based contracts and coverage determinations,” she notes.

In an effort to eliminate wasteful, low-value medications, OptumRx announced a new formulary this year.

“We’ve heard clearly from the client community that they want more aggressiveness in formulary design to eliminate waste in formularies and improve affordability,” Calabrese explains. “Our Premium Value Formulary is designed to address those concerns” and eliminate access to products that don’t deliver value. The new formulary excludes select high-cost, brand-name medications that have high rebates from pharmaceutical companies and instead includes lower-cost, generic alternatives Calabrese says that OptumRx’s new formulary is designed to address those concerns and “eliminate access to products that don’t deliver value.” 

The new formulary excludes high-cost brand-name medications that have high rebates from pharmaceutical companies and instead includes lower-cost generic alternatives that offer the same clinical outcomes. Some of the brand-name drugs excluded from OptumRx’s new Premium Value formulary because far less-expensive generic alternatives are available include Vyvanse (lisdexamfetamine), Clindagel (clindamycin gel) and Edarbi (azilsartan medoxomil). Calabrese says the new formulary allows OptumRx to move away from the traditional rebate model. “Instead,” he says, “we will contract with clients in a more performance-driven model where we are paid based on our ability to manage the cost and quality of pharmacy care.” 

Responding to criticism about PBM contracting strategies

Like other PBMs, OptumRx and Prime Therapeutics have modified their business strategies in response to demands from payers and purchasers, particularly following criticism of PBM practices last year from Congress and some state legislatures. 

OptumRx, for example, has sought to transform its operations. “We’ve moved away from a traditional business-focused type of model into what we like to refer to as more of a pharmacy-care services model,” Calabrese notes. “We do that by focusing on making medications more affordable for payers, purchasers and patients. In specialty drug management, in particular, we’re moving away from just managing the cost of drugs to managing the total cost of care.” 

Prime Therapeutics also is going beyond the financial management of medications, says McGrail-Pokuta. “PBMs, including Prime, provide an important service in evaluating the clinical appropriateness of therapies to ensure members are receiving the appropriate drug in the right clinical setting,” she explains, noting that Prime and other PBMs have a hand in managing many aspects of prescribing, medication use and adherence. “

Rebates from drug companies are controversial because they may lead to formularies with low-value, high-cost medications.

“Prime’s model is to pass all rebate dollars back to our client health plans so they can use those savings to help keep healthcare costs affordable for their members,” McGrail-Pokuta says. “Then they can use those funds to lower premiums (or) copays or to offer point-of-sale rebates.” 

Pharmacy benefit managers are taking steps to be more responsible for the total cost of care and to become more transparent, while adding technology tools to support patients, payers and physicians in a post-COVID-19 world.

Joseph Burns

Articles

Trump and the Republicans vs. Biden and the Democrats on Healthcare

Camden Coalition Finds New Ways to Care for High Utilizers

Jeffrey Brenner Is Leaving UnitedHealth To Return To Primary Care Roots

4 Ways PBMs are Changing