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Cybersecurity for revenue cycle should be a KPI
The revenue cycle is an important target for cybercriminals because of the information that flows through it.
Intermountain Healthcare’s chief information security officer Karl West kicked off the HIMSS19 Revenue Cycle Solutions Summit with a strong message for his captive audience. If you’re a revenue cycle leader, you need to understand a fundamental reality: There’s a whole host of data available for hackers in your rev cycle. Not only is there payment information, there is also member information and all of your PHI. All of those are sources of cyber risk.
For example, patient portal credentials are highly valuable for hackers at around $1,500 or more according to one study, West said.
As such, there needs to be a strong partnership between your cyber organization/operation and your revenue cycle. You also need to understand what are the threats and sources of loss. First, there’s phishing. It’s common and proven to be effective. At Intermountain, they phish their employees four times a year to test their proclivity to fall victim. Even though some find the measure frustrating, it’s essential to flushing out vulnerability.
Malware is also a significant security threat. To thwart such threats, it’s important to keep your systems patched. In your system, you need to have someone watching for vulnerability and patching.
“That’s the basic blocking and tackling,” West said.
Another source of loss is the misconfiguration of public-facing systems, which occurs when at build time, the proper protections are not built in.
And then there are nation-state actors, which are harder to protect against because smaller organizations do not have the resources to spend a lot on cybersecurity. Intermountain has a 24/7 security station/operation with eyes on such threats.
Finally, there are theft or loss/inadvertent accidents that involve employee error or bad action.
“If you aren’t, those are things you should be considering,” West said.
As consumerism continues to drive healthcare, the revenue cycle must move with that trend, and in a consumer-driven revenue cycle organization, fraud, breach, patient card information, PHI, personally identifiable information and the cloud are both assets and areas of risk.
As such, vulnerability management in the revenue cycle should be a big part of your operation and claims processing.
“When a caregiver gives care, they must be current on flu shots and vaccines,” West said. “It’s not an option. It’s a condition of employment. It means that the caregiver is protected to the best ability that we can. In the cyber world, it’s the same. Your networks, laptops and servers, how are you protecting them?”
While updates are annoying, vulnerabilities do need to be patched. Most healthcare organizations patch on an annual basis. At Intermountain, however, it is on a weekly or monthly basis. It’s a different mindset, West said. That is because not only did healthcare cyber attacks increase 320 percent between 2015 and 2016, but the attacks are also growing in sophistication. They don’t just slow systems down – they can cripple them for days, weeks or even months.
So, it is important to know that your patches are in place and your action plans are in place, he said. Have arrangements with vendors and partners. And for the many who have migrated to the cloud to streamline and cut costs, develop a strategy that isn’t just focused on one cloud but the whole cloud and know the controls required to protect you. West asked, does your cloud partner have a vulnerability and what are their safety practices?
“Have an inventory of your partnerships and manage them. Establish governance. As the primary organization, you are the one accountable to your patients,” he said.
Have an inventory of your data – where it is stored, where will it move to, and how it will move safely and securely. This should be a key performance indicator (KPI). Classify your data as public, restricted, private, classified or confidential, such that it is properly protected, and have data loss protection tools.
“When you wonder how did one system get taken down and not another, it’s your patching and practices,” West said.
Spending money on the social determinants is an investment
Value-based care demands the switch to wellcare to raise outcomes and decrease costs, Claire Pomeroy says.
Claire Pomeroy, CEO and president of the Albert and Mary Lasker Foundation, an expert in infectious diseases and a long-time advocate for patients, drove home the point of the importance of the social determinants of health by relating a story of a young woman who needed asthma medication but was unable to afford it.
She got a prescription for an inhaler she couldn’t afford, Pomeroy told a full room at HIMSS19. She knew the story because she was that woman. She needed a ride, food and money for a few days and had no way to get any of that, let alone buy a drug she couldn’t afford.
The clinicians followed all of the right clinical protocols for her condition. But, she said, “They didn’t have the information they truly needed to make me better.”
What was needed was for her clinicians to pay attention to the social determinants of health, an issue that providers are increasingly realizing need to be addressed if their population of patients is to remain healthy.
Without this attention being paid to housing, food, transportation and other socio-economic needs, costs will never be brought inline, as hospitals see patients returning to be admitted or get care through the emergency room.
“Our cost and our outcomes demand change,” Pomeroy said.
The statistics show the need. Black mothers die at truly unacceptable rates in this country, she said and all blacks in the United States have a life expectancy that is on average, 10 years less than whites.
All people in the United States who have a college degree live longer than those with a high school diploma. Stress on the job plays a part. And the opioid crisis has led to overdose deaths surpassing the odds of dying than from a car accident.
“We must redesign the U.S. healthcare system from one of sick care to wellcare,” Pomeroy said.
Healthcare makes up only 10 percent of what goes into the social determinants of health. The biggest percentage goes to behavioral patterns, genetic predisposition and social circumstances.
“We work all day and are only impacting 10-15 percent of the social determinants of health,” Pomeroy said. “Spending on social determinants make sense. We need to move beyond pilot programs and start scaling some of these things.”
Hospitals that spend money on housing to take care of their homeless population see a a 93 percent reduction in costs. For every $25 increase in delivered meals for older adults, there’s a 1 percent decline in nursing home admissions.
“Addressing the social determinants is an investment,” she said.
The biggest challenge is lack of funds for hospitals struggling to stay in the black, lack of data and siloed proprietary care information.
Information connectivity allowed one health system to learn that 31 percent of the Medicaid moms in its area were not enrolled in WIC, and therefore not getting access to food and supplies for their babies.
Technology is needed, as are more health policies for reimbursement that address risk adjustment. State innovation models help, as does the Centers for Medicare and Medicaid Services accountable health communities model, a five-year pilot looking at the connection between social assistance, health and costs.
EHRs should include information on housing, food, transportation and other needs. Systems must transform their thinking, create a new strategy, empower multidisciplinary teams, educate health professionals, invest in research and “raise our voices to drive change,” Pomeroy said.
14 hospitals with strong finances
Here are 14 hospitals and health systems with strong operational metrics and solid financial positions, according to recent reports from Moody’s Investors Service, Fitch Ratings and S&P Global Ratings.
Note: This is not an exhaustive list. Hospital and health system names were compiled from recent credit rating reports and are listed in alphabetical order.
1. Dallas-based Baylor Scott & White Health has an “Aa3” rating and stable outlook with Moody’s. The health system has strong cash flow margins, and its favorable demographics will contribute to volume and revenue growth, according to Moody’s.
2. Los Angeles-based Cedars-Sinai Medical Center has an “Aa3” rating and stable outlook with Moody’s. The hospital has strong margins, excellent balance sheet metrics and a strong reputation locally and nationally for patient care and research, according to Moody’s.
3. Orange, Calif.-based Children’s Hospital of Orange County has an “AA-” rating and stable outlook with Fitch. The hospital has a strong financial profile, and Fitch expects its capital-related ratios to improve.
4. Newark, Del.-based Christiana Care has an “Aa2” rating and stable outlook with Moody’s. The health system has solid margins and a robust balance sheet, according to Moody’s.
5. Fort Worth, Texas-based Cook Children’s Medical Center has an “Aa2” rating and stable outlook with Moody’s. The hospital has a strong market position and solid operating performance, according to Moody’s.
6. Durham, N.C.-based Duke University Health System has an “Aa2” rating and stable outlook with Moody’s. The health system is a leading provider of tertiary and quaternary services and has solid margins and cash levels, according to Moody’s.
7. Midland County (Texas) Hospital District has an “Aa3” rating and stable outlook with Moody’s. The district, which was created to operate a hospital in the county, has a manageable debt load, a modest pension liability and the ability to produce strong operating margins, according to Moody’s.
8. Chicago-based Northwestern Memorial HealthCare has an “Aa2” rating and stable outlook with Moody’s. Moody’s expects that the health system’s operating model and comprehensive IT systems will enable it to execute growth strategies while maintaining strong margins.
9. Winston-Salem, N.C.-based Novant Health has an “Aa3” rating and stable outlook with Moody’s. The credit rating agency expects Novant to continue generating strong cash flow margins in favorable markets.
10. Boston-based Partners HealthCare has an “Aa3” rating and stable outlook with Moody’s and an “AA-” rating and stable outlook with S&P. The health system has an excellent reputation in the clinical and research spaces, a long track record of fundraising, and adequate balance sheet measures, according to Moody’s.
11. St. Louis-based SSM Health Care has an “AA-” rating and stable outlook with Fitch. SSM has a strong financial profile, and Fitch expects the system to continue growing unrestricted liquidity and to maintain improved operational performance.
12. Appleton, Wis.-based ThedaCare has an “AA-” rating and stable outlook with Fitch. The health system has a leading market share in a stable service area and strong operating performance, according to Fitch.
13. Cincinnati-based TriHealth has an “AA-” rating and stable outlook with Fitch. Fitch expects the health system to maintain good operating ratios, leading to liquidity growth.
14. Yale New Haven (Conn.) Health has an “Aa3” rating and stable outlook with Moody’s. The health system has a leading market position in Connecticut, with a broad reach for tertiary and quaternary patients from throughout the state, and strong brand recognition, according to Moody’s.
Here’s How Microsoft Plans To Modernize Healthcare
http://fortune.com/2019/02/07/microsoft-healthcare-artificial-intelligence/
Microsoft announced its new service to help healthcare companies store patient data in the cloud and a Healthcare Bot service that will be integrated with Electronic Health Records.
The tool will be based on Microsoft’s Azure cloud platform, which it describes as a secure end-to-end platform that organizations can use to store and analyze sensitive data.
“Healthcare leaders are thinking about how they bring their data into the cloud while increasing opportunities to use and learn from that data,” Microsoft wrote in a blog.
With its new healthcare push, Microsoft aims to create a system that makes health records more easily accessible and sharable between clinicians, researchers, and patients, Bloomberg reports.The corporation also sees its integrated healthcare storage as a way to attract companies to Microsoft, over its competitor Amazon Web Services.
Why The Next Evolution Of Global Health Care Will Be Blockchain-Based
This distributed ledger technology can improve security, efficiency, and the coordination of health care systems as an answer to aging legacy infrastructures.
Health care systems are cornerstones of all modern societies since they provide vital services. As they grow, however, many become less efficient and secure, which can make health care services more expensive and less accessible to the general public. Beyond being the buzzword of 2017, blockchain opens the door to solutions in an increasing global healthcare expenditure that is expected to increase to USD $10.059 trillion by 2022.
Healthcare Today
While the digitization of healthcare has paved the way for modern infrastructure, current privacy laws, software, and databases have slowly taken the power from the patient. Our existing software faces a few key problems that have both short-term and long-term implications—affecting both healthcare providers and their patients. Inefficiency, disjunction between databases, the disempowerment of patients, high expenses, and security concerns are just some of the many problems the healthcare industry faces.
With a move towards ease of access to data and decentralization in a world where security continues to pose a serious risk, blockchain is becoming the answer to many industry-wide obstacles. Here is how blockchain is applied to many of industry’s burgeoning issues:
Security
Healthcare systems are being targeted by cyber attacks because their legacy infrastructures make data vulnerable. In 2017, the ransomware “WannaCry” crippled the National Health Service (NHS) in the United Kingdom and affected over 150 countries. In 2018 and 2019 respectively, hackers broke into Singapore’s government health database and most recently the HIV status of over 14,000 people leaked online, Singapore authorities say.
Given that blockchain is a distributed ledger technology and does not require third-party interventions, it allows institutions to decentralize their databases. Hence, by using blockchain, health care systems can significantly reduce their risk of being subject to cyber threats. It would take too much time and energy for hackers to access all of the nodes within the network and to infect the system.
It is highly important to create an environment where clinicians, administrators, and patients (also known as consumers of healthcare) know that their privacy and data are protected. Such an ecosystem can be enabled by blockchain, either by allowing users to own their information by joining the chain or by helping hospitals to secure their servers and distribute the data on a network.
Efficiency & Coordination
Health care systems are remarkably inefficient. Since they operate with many independent databases, especially in large centralized systems, there is a lack of cohesive communication between these distinct silos. By creating a unified ecosystem of data, distributed ledger software encourages cooperation between networks, improving payment processing, patient tracking, and enterprise workflow.
Sectors like the food industry are already seeing wins with blockchain that healthcare can emulate in regards to supply chain management. Companies like Walmart implemented IBM’s blockchain for food traceability, impacting pharmaceutical stakeholders to participate in the non-profit Center For Supply Chain Studies DSCSA and Blockchain Phase 2 Study. The FDA who is behind this initiative, as declared by current FDA Commissioner Gottleib requires all entities governed under FDA “full implementation of the Drug Supply Chain Security Act, [and] to make sure that every link in the U.S. Drug Supply must be secure.”
Other emerging use cases such as clinical trials involve the management of numerous locations, sources, and stakeholders, along with supervision of substantial amounts of sensitive data. Since blockchain may facilitate data storage, the technology can fuel innovation, as researchers will have greater access to medical record information.
The Future of Healthcare
Blockchain technology is expected to transform the way key players in health care systems interact with each other. Nonetheless, this technological revolution can only succeed with consortium thinking, which implies collaboration between all stakeholders in the sector. In the United States, Synaptic Health Alliance, a diverse consortium of healthcare organizations and other emerging startup consortia are working to identify and monetize shared opportunities in the blockchain space.
Blockchain is not without its problems.
Right now the initial costs can be high, and the integrations need to happen. Currently, most blockchain networks are designed so transactions are publicly accessible. While blockchain systems can be made private and permissible, making it so only certain parties can access boils down to aligned incentives. But it’s clear that the technology is there and can change healthcare for good.
Medicare for All Emerges as Early Policy Test for 2020 Democrats
Senator Elizabeth Warren spoke at length this week about her vision for improving the American health care system, like strengthening the Affordable Care Act and making prescription drugs more affordable. Twice, though, she ignored a question posed to her: Would she support eliminating private health insurance in favor of a single-payer system?
“Affordable health care for every American” is her goal, Ms. Warren said on Bloomberg Television, and there are “different ways we can get there.”
To put it another way: I am not walking into that political trap.
Ms. Warren of Massachusetts and three other liberal presidential candidates support a Medicare for All bill, which would create a single-payer health plan run by the government and increase federal spending by at least $2.5 trillion a year, according to several estimates. But Ms. Warren’s determination to sidestep an essential but deeply controversial issue at the heart of the single-payer model — would people lose the choices offered by private insurance? — illustrated one of the thorniest dilemmas for several Democrats as the 2020 primary gets underway.
Their activist base, inspired by Senator Bernie Sanders of Vermont, believes that the party should unabashedly pursue universal health care, ending private insurance entirely. But polls indicate that the broader electorate, particularly the moderate- and high-income voters who propelled the party’s sweeping suburban gains in the midterms, is uneasy about this “Medicare for all” approach in which many would lose their current insurance options and pay higher taxes.
Senator Kamala Harris of California drew immediate attacks from Republicans this week by taking on the issue that Ms. Warren dodged. Ms. Harris breezily acknowledged in a CNN town hall forum that she would “eliminate all of that,” referring to ending private insurance in a country where almost 60 percent of the population receives coverage through an employer.
Her remark triggered an intraparty debate about an issue that until now had been largely theoretical: A decade after Democrats pushed through the most significant expansion of health care since the Great Society, should they build incrementally on the Affordable Care Act or scrap the insurance sector entirely and create a European-style public program?
Four Democratic presidential candidates — Ms. Harris, Ms. Warren, Senator Kirsten Gillibrand of New York and Senator Cory Booker of New Jersey — are among the co-sponsors of Mr. Sanders’s Medicare for All bill, which would replace the Affordable Care Act with a single government health plan for all Americans. Medicare is the federal program providing health coverage to people 65 and older.
The concept of Medicare for all has become popular with Democrats: 81 percent support it, according to a recent Kaiser poll. Yet voter opposition to surrendering the insurance they are used to led to a backlash over President Barack Obama’s repeated promise that “if you like your plan, you can keep your plan” after it proved false for several million people under his health law. Many Democrats are keenly aware of that backlash, and the 2020 presidential race will be the first where many of the party’s leading candidates will have to explain and defend the meaning of Medicare for all.
For now, as Ms. Warren demonstrated, many candidates do not want to wrestle publicly with the details. After Ms. Harris’s comment, her aides hastened to add that she would also support less sweeping changes to health care; like most other candidates, Ms. Harris declined an interview request. And by Friday, Mr. Booker, hours after announcing his presidential bid, sought to curtail the matter by offering a brisk “no” when asked if he supported eliminating private coverage.
Yet there is one likely 2020 contender who is thrilled to discuss Medicare for all.
Mr. Sanders, in an interview, did not mince words: The only role for private insurance in the system he envisioned would be “cosmetic surgery, you want to get your nose fixed.”
“Every candidate will make his or her own decisions,” Mr. Sanders said, but “if I look at polling and 70 percent of the people support Medicare for All, if a very significant percentage of people think the rich, the very rich, should start paying their fair share of taxes, I think I’d be pretty dumb not to develop policies that capture what the American people want.”
But Michael R. Bloomberg, the former New York City mayor who is considering a 2020 bid on a centrist Democratic platform, said it would be folly to even consider a single-payer system. “To replace the entire private system where companies provide health care for their employees would bankrupt us for a very long time,” Mr. Bloomberg told reporters in New Hampshire on Tuesday.
The Congressional Budget Office has not scored Mr. Sanders’s Medicare for All bill, but a study last year by the Mercatus Center of George Mason University predicted it would increase federal spending by at least $32.6 trillion over the first decade. The cost could be even greater, the study says, if the bill overestimated the projected savings on administrative and drug costs, as well as payments to health care providers.
The divide between Mr. Sanders, a democratic socialist, and Mr. Bloomberg, a Republican-turned-independent-turned-Democrat, reflects the large chasm in a party that has been reshaped by President Trump.
The president’s hard-line nationalism has simultaneously nudged Democrats to the left, emboldening them to pursue unambiguously liberal policies, and drawn independents and moderate Republicans to the party because they cannot abide his incendiary conduct and demagogy on race. These dueling forces have created a growing but ungainly coalition that shares contempt for Mr. Trump but is less unified on policy matters like health care.
And these divisions extend to what is wisest politically.
Liberals argue that the only way to drive up turnout among unlikely voters or win back some of the voters uneasy with Hillary Clinton’s ties to corporate interests is to pursue a bold agenda and elevate issues like Medicare for all.
“Those who run on incremental changes are not the ones who are going to get people excited and get people to turn out,” said Representative Pramila Jayapal of Washington, the co-chair of the Congressional Progressive Caucus.
And by preserving their options, Democrats risk alienating liberal primary voters, some of whom consider support for Medicare for all a litmus test.
“The center is not a good place to be on these policies anymore,” said Mary O’Connor, 61, a substitute teacher and horse farmer in Middleburg, Va., who wants a single-payer system. “I’ll be watching extremely closely, and I will most likely jump on board and volunteer for whoever it is that’s going to be the most forceful for this.”
But moderates believe that most Democratic primary voters are more fixated on defeating Mr. Trump than applying litmus tests — and that terminating employer-sponsored insurance would only frighten the sort of general election voters who are eager to cast out Mr. Trump but do not want to wholly remake the country’s health care system.
“Most of the freshmen who helped take back the House got elected on: ‘We’re going to protect your health insurance even if you have a pre-existing condition,’ not ‘We’re going to take this whole system and throw it out the window,’” said Kenneth Baer, a Democratic strategist.
While polling does show that Medicare for all — a buzz phrase that has lately been applied to everything from single-payer health care to programs that would allow some or all Americans to buy into Medicare or Medicaid — has broad public support, attitudes swing significantly depending on not just the details, but respondents’ age and income.
On the House side, a bill similar in scope to Mr. Sanders’s is under revision and will soon be reintroduced with Ms. Jayapal as the main sponsor. Other Democrats have introduced less expansive “Medicare buy-in” bills, which would preserve the current system but would give certain Americans under 65 the option of paying for Medicare or a new “public option” plan. Another bill would give every state the option of letting residents buy into Medicaid, the government health program for poor Americans.
The buy-in programs would generally cover between 60 and 80 percent of people’s medical costs and would require much less federal spending because enrollees would still pay premiums and not everyone would be eligible. Some proponents, like Senator Jeff Merkley, Democrat of Oregon, have described them as a steppingstone on the way to a full single-payer system; some of the Democrats running for president are co-sponsoring these “Medicare for more” bills as well as Mr. Sanders’s.
Mr. Sanders has suggested options to raise the money needed for his plan, such as a new 7.5 percent payroll tax and a wealth tax on the top 0.1 percent of earners. He has also predicted several trillion dollars in savings over 10 years from eliminating the tax exclusion that employers get on what they pay toward their workers’ insurance premiums, and other tax breaks.
But Robert Blendon, a health policy professor at Harvard who studies public opinion, said it would be wise not to delve into financing details for now.
“The reason it failed in Vermont and Colorado was taxes,” Professor Blendon said, referring to recent efforts to move to a near-universal health care system in those states, which flopped resoundingly because they would have required major tax increases. “But Democratic primary voters will not go deep into asking how these plans will work. What they will say is, ‘Show me you have a principle that health care is a human right.’”
The general election will be a different story, Professor Blendon added. If Ms. Harris were to become the Democratic nominee and keep embracing the idea of ending private coverage, he argued, “she’s going to have terrible problems.”
The difficulty for Democrats, added Ezekiel Emanuel, a former Obama health care adviser, is that many voters look at the health care system the same way they view politics. “They say Congress is terrible but I like my congressman,” as Mr. Emanuel put it.
According to the Gallup poll, 70 percent of Americans with private insurance rate their coverage as “excellent” or “good;” 85 percent say the same about the medical care they receive. The Kaiser poll found that the percentage of Americans who support a national health plan drops by 19 percentage points when people hear that it would eliminate insurance companies or that it would require Americans to pay more in taxes.
Among those who make over $90,000 a year — the sort of voters in the House districts that several Democrats captured in the midterms — those surveyed in the Kaiser poll were particularly wary of an all-government system: 64 percent in this income group said they would oppose a Medicare for all plan that terminated private insurance.
“My constituents are tired of bumper sticker debates about complex issues,” said Representative Lizzie Pannill Fletcher of Texas, a freshman from an affluent Houston district. “We don’t want ideologues in charge.”
In Vermont, where former Gov. Peter Shumlin shelved his ambitious plan for a single-payer system in 2014 after conceding it would require “enormous” new taxes, advocates for universal health care are now resigned to a more incremental approach.
Dr. Deb Richter, a primary care doctor who helped lead the state’s single-payer movement, said that while the Democratic field is “going to have to face the T word,” being upfront about the required tax increases, she now thinks phasing in a government-run system is a better approach.
“There’s ways of doing this that don’t have to happen all at once,” she said, pointing to a push in Vermont to start with universal government coverage for primary care only. “But you need to talk about the end goal: We are aiming for Medicare for all, and this is a way of getting it done.”
Reference Pricing in Germany: Implications for U.S. Pharmaceutical Purchasing
ABSTRACT
- Issue: The German health care system resembles that of the United States in important ways — it is financed by multiple private payers and relies principally on negotiation rather than regulation to establish prices. New drugs that offer minimal benefits compared with existing alternatives within a therapeutic class are subject to reference pricing; those with incremental benefits are subject to price negotiations. Together, the reference and negotiated pricing systems have held German prices substantially below U.S. equivalents.
- Goal: To describe the German reference-pricing system and compare it to tiered formularies and consumer cost-sharing in the United States.
- Methods: Document review and interviews with leaders in payer, policy, and pharmaceutical industry organizations in Germany.
- Key Findings and Conclusions: The German pharmaceutical pricing system uses modest levels of consumer cost-sharing to influence consumers’ choices for drugs with therapeutically equivalent alternatives. Manufacturers are free to set the prices of their products, but insurers will not pay more for a new drug than for its comparators unless it offers an additional clinical benefit. For drugs covered by reference pricing, the insurers’ payment maximum is set at a level that ensures sufficient choices of low-priced options. These models offer an alternative to the U.S. system of tiered formularies.
Introduction
In reference pricing — a component of health insurance design — a health care purchaser establishes a maximum payment it will contribute toward covering the price of a drug. It is used when there is a wide variation in the prices for therapeutically similar products. The payment limit is set at the minimum, median, or other point along the range of drug prices within a therapeutic class. If a patient’s physician prescribes a drug with a price at or below the reference limit, the patient pays only a modest copayment. If a more expensive option is selected, he or she pays the copayment plus the full difference between the reference limit and the price of the chosen product.
Reference pricing offers several advantages over the most commonly used insurance designs in the United States, such as annual deductibles and coinsurance, which expose consumers to financial obligations without providing an affordable option or guidance on how to select products offering the best value. To date, however, reference pricing has been applied only by a limited number of purchasers and only to drug classes that feature multiple generic or therapeutically equivalent alternatives. For these therapeutic classes, it can reasonably be assumed that all products work similarly. Purchasers can limit their payments to the level charged for the cheaper products in each class and patients desiring a higher-priced option reasonably can be required to pay the difference themselves. Patients with physician-identified clinical needs for higher-priced options can be granted an exception.
In its efforts to improve the effectiveness and efficiency of pharmaceutical purchasing, the U.S. can learn from Germany, which manages traditional drugs using reference pricing and novel drugs using comparative-effectiveness pricing. Germany has developed evidence-based methods to assess the clinical benefit of new products, establish reference-based payments for drugs that do not offer incremental benefits over existing products, and negotiate new prices for drugs that do offer incremental benefits.1 This approach enjoys considerable social legitimacy as a mechanism for ensuring patient access while moderating payer expenditures.
The health care system in Germany resembles that of the U.S. in several important respects yet differs in others. (See box.) Both feature multiple nongovernmental insurers rather than a single governmental payer, favor negotiation over regulation for determining prices, enjoy declining expenditures for many traditional, nonspecialty drugs but face rising expenditures for novel specialty products, and are embedded in a culture that values patient access to even the most expensive treatments. However, in Germany, the clinical assessment of each new drug is centralized and the negotiation of drug prices is done collectively by the umbrella organization of health insurers, rather than by each insurer individually. This issue brief describes the structure of drug assessment and pricing in Germany and its potential applicability to the U.S. market.2
THE INSTITUTIONAL FRAMEWORK OF PHARMACEUTICAL PRICING IN GERMANY
In Germany, reference pricing falls within an institutional system that features publicly regulated and accountable associations of insurers, physicians, and other stakeholders. Statutory and case law establish the rules governing interactions among these entities, and the Ministry of Health continuously monitors and supports their processes. But the government does not directly assess the comparative clinical benefit of new drugs or negotiate their prices. In this regard, it resembles the U.S. framework more than other European systems where the heavy lifting in pharmaceutical cost control is done directly by governmental payers.
The German institutional framework does differ from its U.S. counterpart in important respects. The organization that assesses the comparative clinical performance of new drugs, the Federal Joint Committee (GBA), consists of representatives of the national insurance, physician, and hospital organizations. Patient advocacy organizations have nonvoting seats on the board. The GBA, in turn, delegates the clinical evaluation of new drugs to a privately governed but publically accountable entity, the Institute for Quality and Efficiency in Health Care (IQWiG). IQWiG bases its evaluations on: dossiers submitted by manufacturers, which include a systematic review of the incremental benefit of the drug; the clinical trials for initial market authorization by the European Medicines Agency, as well as other clinical trials; reports by technology assessment agencies in other nations; and other available evidence. GBA then makes its official assessment of each drug’s contribution based on the IQWiG study, further input from the manufacturers, and follow-on testimony at public meetings.
The GBA assessments are used by the umbrella organization of Sickness Funds, the GKV-SV. The GKV-SV works within a statutory and regulatory framework that assigns it special rights and responsibilities, and interprets its role as negotiating the best prices from the point of view of the health system, and not merely that of its constituent insurers.
Assessment of Comparative Effectiveness
In the German pharmaceutical system, new drugs are assessed and priced relative to existing treatments for the same conditions. Drugs that offer additional clinical benefits are paid higher prices; reference pricing is applied to new drugs with clinical performance similar to products already on the market. Comparative-effectiveness pricing applies to new products that perform better than their comparators.
All drugs authorized for market access by the European Medicines Agency (EMA) are immediately available after launch for physicians to prescribe and patients to use. The manufacturer unilaterally sets the new drug’s price at time of launch and is reimbursed in full at that price for the drug’s first year. During this first year, an assessment is conducted of the drug’s comparative clinical safety and efficacy by the Federal Joint Committee (GBA), a self-governing but publicly accountable entity representing associations of nongovernmental insurers (also known as “Sickness Funds”), physicians, and hospitals.
The GBA makes several important decisions regarding the assessment of each drug’s incremental benefit, with input from the Institute for Quality and Efficiency in Healthcare (IQWiG), the pharmaceutical manufacturer, relevant medical associations, patient advocacy organizations, and other interested entities. First and often most importantly, GBA decides which drug will be used as the comparator against which the new product is to be assessed; a drug treating multiple indications may have multiple comparators. If the new drug is found to offer incremental benefits, its price will be negotiated upwards from the comparator’s price, and so the manufacturer has an interest in having the GBA select a high-priced comparator. However, if GBA picks as the comparator a drug with high price but also high efficacy, the new drug faces a more difficult challenge in demonstrating incremental benefit. A finding of no incremental benefit leads to the drug being assigned to a therapeutic class subject to reference pricing. All products are reimbursed at a level based on the lowest prices charged within the class, if it falls within a therapeutic class for which reference prices have been established. If the new drug is found not to offer an incremental benefit but also does not fall into a reference-priced therapeutic class, its price is subject to negotiation with the proviso that the negotiated price not exceed that of its comparator drug.
Second, the GBA chooses the metrics that will assess the new drug’s benefit. These metrics may differ from those used by the EMA, the European equivalent of the U.S. Food and Drug Administration (FDA), in its review of the drug for initial market authorization and for which the manufacturer has conducted clinical trials. In some cases, GBA has rejected metrics acceptable to EMA, such as “progression free survival” for cancer drugs, as it deems them not relevant to the patient’s quality of life. Progression free survival indicates how many months the patient survives posttreatment without an increase in the size of his or her tumors. This metric is correlated with the more important overall survival metric, which indicates the number of months the patient remains alive posttreatment, but is often not correlated with patient quality of life. In other cases, GBA has required that pharmaceutical firms provide metrics that EMA does not require, principally quality-of-life indicators such as change in pain and nausea.
The GBA delegates the clinical evaluation of the new drug to IQWiG,3 which considers the portfolio of evidence used for market authorization by EMA plus other studies conducted by the manufacturer. The final assessment of the drug’s benefit then is decided by the GBA. Drugs can be judged by the GBA to offer a major, substantial, minor, positive but nonquantifiable, or no incremental benefit, relative to the comparator treatment. The nonquantifiable benefit is used when the drug is considered likely to offer incremental benefit but lacks sufficient evidence for a confident judgment of the scale. Orphan drugs, which often have no direct comparator and for which the clinical evidence may be based on very small patient samples, usually are awarded a nonquantifiable benefit. The GBA also evaluates the strength of the available evidence (weak, moderate, or strong). The clinical benefit of a drug can be reassessed by GBA in response to changes in the available evidence, sometimes triggering a renegotiation of the price.
REFERENCE PRICING FOR PRODUCTS THAT DO NOT OFFER INCREMENTAL BENEFITS
If the GBA considers a drug not to offer an incremental benefit over existing treatments, it usually assigns it to one of the therapeutic classes covered by reference pricing. Manufacturers are permitted to set whichever price they feel is appropriate for drugs falling into these classes, but the umbrella organization of health insurers (GKV–SV) establishes a limit to what individual insurers will contribute toward payment. The GKV–SV sets its payment limit near the 30th percentile in the distribution of prices within each therapeutic class, high enough to ensure that patients have more than one choice but low enough to ensure that the payer is not responsible for paying the highest prices within the class. Most generic drugs fall into the reference pricing system. Approximately 34 percent of drugs, 80 percent of prescriptions, and 33 percent of drug spending in Germany is for drugs subject to reference pricing.4
Patients must pay out of pocket the difference between the price set by the manufacturer and the reference-based reimbursement limit set by the purchaser organization. Many patients are unwilling to contribute out of pocket and prefer drugs priced below the reference limit and their physicians will prescribe drugs at or below the limit. Of products subject to reference pricing, approximately 84 percent are priced by their manufacturers at or below the reference price limit and therefore not subject to additional cost-sharing.5 These products make up 92 percent of all prescriptions made for reference-priced drugs. Manufacturers can submit new prices up to twice a month for drugs in the reference pricing system. The umbrella organization of insurance firms is required to update the therapeutic classes every quarter and the payment limits at least annually. Manufacturers are permitted to lower their prices to the reference limit to avoid the otherwise inevitable reduction in sales volume; many do.
For drugs included in the reference pricing system, patients may be required to pay additional copayments, depending on which drug they select in consultation with their physicians. Patients selecting a drug priced above the reference maximum for their class contribute a copayment plus the difference between their drug’s price and the reference maximum. These extra copayments do not count toward the patients’ annual out-of-pocket cost-sharing maximum. However, the extra copayments are modest, since most of the drugs included in the reference pricing system are older, generic medications with typically low prices. For drugs not included in the reference pricing system, German health insurers require patients to pay the cost-sharing amount only.
Aside from the requirement that patients pay the difference between the reference limit and the full price of a product, which applies only in contexts where the patient can choose a low-priced option, Germany places tight limits on patients’ out-of-pocket financial responsibilities. The statutory copayment ranges from a minimum of EUR 5 to a maximum of EUR 10 per prescription, up to an annual out-of-pocket maximum (for all health care services) of 1 percent of gross income for people with chronic diseases and 2 percent for others. Approximately one-quarter of enrollees also have complementary private insurance, which covers these cost-sharing requirements.6
NEGOTIATED PRICING FOR PRODUCTS THAT OFFER INCREMENTAL BENEFITS
If a new drug is judged by the GBA to offer an incremental benefit over existing treatments, it is referred to the GKV–SV for price negotiations with the manufacturer. The insurer umbrella association uses the GBA’s assessment of clinical benefit, as well as the prices of the comparator drug, therapeutically similar medications, and prices charged in other European nations to negotiate a discount off the new drug’s launch price.
Some drugs are judged by the GBA not to offer an incremental benefit yet do not fall into an existing reference-priced therapeutic class, as there must be at least three therapeutically equivalent drugs to constitute a class for reference pricing. These drugs also have their prices negotiated between the manufacturer and the insurer association, but with the proviso that the price of the new drug cannot exceed that of the comparator product chosen by the GBA.
If negotiations between the insurer umbrella association and the drug manufacturer do not conclude with a price agreeable to both sides, the drug is referred to arbitration. In this process, a three-person panel selected by the manufacturer, the insurance organization, and the GBA assesses the evidence and renders a decision. Through the end of 2017 one of five (35 of 186) new drugs assessed by the GBA received a final price through arbitration rather than negotiation; for another 24, the negotiating parties reached an agreement after an arbitration process had been initiated.7
If a manufacturer cannot obtain an acceptable price either through negotiation or arbitration, it can withdraw its product from the market. Between 2011 and 2017, 148 drugs were subjected to comparative-effectiveness assessment and had their prices negotiated by the insurers and manufacturers. Of these, 29 were removed by the manufacturer from the German market by 2018.8 For 12 of these, the manufacturer chose to withdraw the product immediately following the results of the GBA evaluation — this is known as “opting out” of the pricing process. In 16 cases, drugs were withdrawn in reaction to the determined price, mainly through arbitration, and one was withdrawn because its manufacturer went bankrupt.9
Lessons for the United States
The German system uses modest levels of cost-sharing as an instrument to influence consumer choices for drugs with therapeutically equivalent alternatives. However, it does not apply cost-sharing to new drugs that lack alternatives. Comparative-effectiveness pricing is used for new specialty medications that offer clinical benefits over existing treatments. Manufacturers are free to set the prices of their products, but insurers will not pay more for a new drug than for its comparators unless it offers an additional clinical benefit. For drugs covered by reference pricing, the insurers’ payment maximum is set at a level that ensures sufficient choices of low-priced options. These models offer an alternative to the U.S. system of tiered formularies.
In the United States, the level of cost-sharing and the resulting financial burden on patients is high, especially for patients with complex medical conditions. U.S. payers often impose modest copayments on low-cost drugs with many direct substitutes but onerous coinsurance on high-cost drugs with few substitutes. Coinsurance does not point the patient toward the most cost-effective drug choices. In contrast, insurance designs built on reference pricing identify drugs that are priced below the insurer’s payment maximum and require only minimal cost-sharing.
HENRY KOTULA 