Tagged: AHRQ T32 Research Fellow
Prescription drug spend in the U.S. is the highest in the world. Americans pay up to three times the amount per capita of other countries. This is problematic for our growing aging population since their income becomes limited. While Medicare covers prescription drug costs, there are policy gaps that make it unaffordable. One major barrier to price controls is part D of title XVIII of the Social Security Act, in which explicitly prohibits the federal government “from negotiating directly with pharmaceutical companies to lower drug prices”. President Donald Trump proposed several policies to reduce the cost burden of prescription drugs on consumers through free-market competition approach, focusing mainly on cost transparency and promoting use of biosimilar or generic drugs. The policies are praised as a “small step in the right direction”. Yet, many Americans are dissatisfied since the proposals do not include direct Medicare negotiations with drug manufacturers. Pharmaceuticals argue that price controls would strain their investments in research and development (R&D) of new drugs. After taking a closer look, that is not fully the case. Greater price control measures can be taken, but there must be political will to support it. For now, the President’s policies are a small victory for seniors across America.
Medicare Coverage Today
Prescription drugs are covered under Medicare Part A, B, and C plans, but to a limited capacity. Part A is hospital insurance, part B is traditional medical insurance, and part C (Medicare Advantage) is like a health maintenance organization (HMO) or preferred provider organization (PPO) plan type. Only drugs administered within these respective settings are covered. Because of these limitations, the Medicare Modernization Act of 2003 was enacted, creating Medicare part D drug benefit.
Part D is an “optional” supplemental insurance that can be purchased with any of the other Medicare plans. It, however, is severely flawed. First, Congress did not commit any financing for part D, leaving costs falling on the recipient. Second, and most notoriously, is the “donut hole” coverage gap between initial enrollment and a “catastrophic coverage threshold”. The entry-point coverage limit is currently $3,750. Once this amount is reached, the patient is then responsible for fully paying for their medication until the maximum amount of the out-of-pocket (OOP) costs have been paid, or the annual time period lapsed. The OOP threshold now is $5,100, unaffordable for many seniors that suffer multiple chronic conditions.
Additionally, the plan disincentivizes patients from purchasing brand name drugs by increasing patient coinsurance payments. Provisions of the Affordable Care Act attempted to close this gap by 2020 by limiting patient payments to 25% of the gap. Under the Trump Administration, the Bipartisan Budget Act of 2018 advanced that date to 2019. Another caveat to Part D is that it is not really “optional”. If an individual fails to sign up once qualified and decides to enroll later, they will pay penalty fees for as long as they are on part D, with the exception of a few circumstances, such as having drug coverage from an employer.
The President’s Policies
To mitigate the Medicare drug coverage issues, the Trump Administration released his “blueprint” rules and policies, supplemental to the Bipartisan Budget Act. Provisions that went into effect include:
- “Step therapy” rule within the Medicare Advantage plans- clinicians are to prescribe cheaper drugs and monitor patient progress closely. If the drug is found to be ineffective, then a clinician can prescribe the next expensive drug. Clinicians in the Advantage plan get commission for the drugs they provide. The rationale is to curb physicians from “gaming” for greater profits. This rule is now in effect.
- Taking harder action, the President recently signed legislation to ban “gag clauses” that prevented pharmacists from disclosing the best drug prices with customers. This is helpful for those who may be in the coverage gap of part D and would have to pay full price of the drug.
Other policies proposed and will likely be revisited for the upcoming session include:
- Limiting doctor’s offices to charge consumer price index (CPI) of drugs administered in their office.
- Shifting drugs from part B to D to promote greater market competition among drug makers to lower prices.
- Allowing drug rebates to go to the consumer rather than the healthcare provider or health plan.
- Promoting the use of biosimilars and generic biotechnology drugs.
- Closing loopholes, such as the 180-day exclusivity that allow brand-name drug companies to “game” Food and Drug Administration (FDA) rules in ways that hinder generic competition.
- Requiring drug manufacturers to disclose list prices in their advertisements.
These policies are a great step towards drug price controls. Yet, many argue that true price controls could only be achieved by allowing Medicare to directly negotiate drug prices. Perhaps that may be the case, as demonstrated by many other rich democracies. Pharmaceuticals, however, dispute this on the grounds that it would limit R&D investments.
In a recent study, Yu et al. evaluated the “top 15 drug companies in 2015” and found that the inflated prices are not justified by the R&D costs. Securities and Exchange Commission (SEC) laws and regulations require all public holding companies to publically disclose their financial statements. Knowing this, I reviewed the 2017 financial report of the largest pharmaceutical company in the world, Pfizer. Their R&D costs were $7.7 billion and accounted for 14.7% of their reported revenue of $52.5 billion. After discounting other expenses, their net income was $21.4 billion, allowing them to maintain 40.6% in profits. These figures are not uncommon. According to the International Trade Association, 15-20% of gross revenues is how much U.S. pharmaceutical companies spend on average on R&D (with the exception of the few that price gouged). In other countries, the R&D investments are much less, but drug costs are also lower.
Given these figures, it is of no surprise that advocates for better price controls are not convinced that R&Ds should be the main reason to maintain the inflated drug costs. Cost-effectiveness analysis (CEAs) may help determine the value of the drug, however it would likely, by default, favor biosimilars and generic drugs. In that case, the promotion of these drugs employed by the Federal government serve as a cost-effectiveness measure to some extent. For drugs that treat severe progressive conditions, such as Alzheimer’s disease or multiple sclerosis, it may be difficult to ascertain a value on new treatments since outcomes are unique to a patient’s condition. Moreover, measures involved in formal CEAs are derived from nationally administered quality/disability-adjusted life-year (Q/D-ALY) surveys of healthy people, thus not capturing the value of the treatment for those who are ill.
The President’s policies may not be perfect, but it is an experiment worth trying. Prior policies that attempted to “assist” our elderly population have failed, leaving those with chronic conditions and limited incomes forgoing treatment due to the high cost. For advocates of government price-fixing, it is important to keep in mind how much will prices be limited to, and it would likely require government to subsidize a portion of R&Ds. It is difficult to imagine that government would be willing to make such an investment if they are barely subsidizing part D costs.
Sarah Zahakos, MPH is working toward a PhD in Health Law, Policy & Management at the Boston University School of Public Health.
AHRQ T32 Research Fellow
Training in Health Services Research for Vulnerable Populations
Grant # 2T32HS022242
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Healthcare is on the frontlines of legislative debates— the U.S. has the most expensive care and reports the poorest outcomes of all rich democracies (RDs). Several states have proposed legislation to innovate healthcare access and to safeguard against the destruction of the ACA. One “old idea” that recently gained momentum is single-payer, and for New York (NY), it may become a reality, with its fate resting with the new legislature. To date, only one state has briefly “experimented” with single-payer – Vermont, and it failed due to gross underestimation of its costs. In NY, a landmark study that evaluates the viability of NY’s single-payer bill, known as the New York Health Act (NYHA), conducted by RAND, detailed benefits and setbacks of the proposed legislation, and public reaction was mixed. Despite the not so encouraging findings, lessons can still be learned from this report.
Single-payer, coined as “Medicare for all”, is a health insurance system in which a single public agency organizes healthcare financing, ideally covering all types of essential healthcare services. Delivery of care itself, however, would remain largely private in a single-payer system.
Proposals for single-payer in the U.S. are not new. The earliest version came in 1943 by Senators Robert Wagner (D-New York), James Murray (D-Montana), and Representative John Dingell, Sr. (D-Michigan), known as the Wagner-Murray-Dingell Bill (and subsequently endorsed by President Truman in 1945). The post-World War II bill proposed funding health care through payroll and income taxes. The bill became entangled with the Cold War , was vilified as “socialized medicine” by its opponents, and was discarded. The idea was revived in the 1950s, when it was nearly impossible for an aging population to get private health insurance. The elderly advocated for subsidized coverage since they are no longer able to afford their care, and hospitals advocated for it to ensure that the healthcare services they provide were paid for. The result: Medicare was enacted in 1965— the first form of single-payer insurance in the U.S.
Single-payer is gaining popularity once again. According to a Reuters poll, 70% of Americans support some form of single-payer coverage. Why? First, with the implementation of the ACA, there was a national momentum for states to expand their healthcare coverage. The health exchange created by the ACA made coverage accessible for many middle-income families and individuals. On the Medicaid side, progressive states elected to expand their eligibility coverage for individuals earning up to 138% of the federal poverty level in exchange for a 50% match in federal subsidies, a benefit many states enjoy. The most appealing provision of all is the mandated coverage of pre-existing conditions. With the all Republican take-over of the federal government in 2016, many Americans worried about what would happen to their coverage. Over the next two years, the ACA underwent congressional budget cuts, but despite efforts by Congress and President Trump, the ACA has grown in popularity with the general public.
In NY, the concept of single-payer was first introduced in 1992 by Assembly member Richard Gottfried (NY-D). The goal of NYHA is to provide universal insurance coverage with no cost-sharing for New Yorkers, regardless of legal status, and would cover almost all comprehensive services. Bill proponents expect increased access to care and reduced costs by removing high administrative overhead costs and reducing unjustifiably high prescription drug costs. Much like the Wagner-Murray-Dingell Bill, NYHA would be funded through payroll and income taxes. Since 2015, the NYHA has passed the Assembly floor four times. Although 31 state senators co-signed the bill, it has been stopped in the Senate by just one vote. This may now change with the Democrats taking back the Senate majority, although the cost may be a deterrent.
Despite the national and legislative enthusiasm, New Yorkers have been skeptical of single-payer reform. According to a 2018 Mercury Public Affairs poll, only 33% support the bill. Over 60%, however, said they would support increased subsidies to assist low and middle-income families. Why the opposition? The number one reason of 66% polled: taxes would pose a high burden.
The RAND study assessed “near-term” and “long-term” impacts of the bill. Overall, it found that single-payer would be viable, but with big caveats. The system would expand health care access, all while generating an estimated $15 billion in net savings (3.1%) on healthcare costs by 2031. Still, near-term are where the problems lie. From the political side, this would require the federal government to issue a waiver to redirect all federal and state funds to NYHA. Just weeks prior to this report, the Centers for Medicare & Medicaid Services called California’s similar proposal “unworkable” and indicated similar waivers would not be approved. On the fiscal side, health care reform comes with a steep price: $139 billion in additional state tax revenue would be needed by 2022, that is 156% more than what is currently being collected. This amount would be amassed through payroll and income tax that would supplant the employer contribution and premiums and out-of-pocket costs. RAND applied a generic tax schedule based on three income brackets. For low-income families, they would be taxed 6.1% of their payroll income and 6.2% for non-payroll income by 2022. For middle-income families, the rates would range from 12.2% to 12.4%, and for high-income, their tax rate would increase up to 18.3% - nearly three times of what they are paying now. Moreover, Medicaid and Essential Plan (i.e. the NY Health Exchange) enrollees would pay more to get healthcare coverage. Assembly member Gottfried praised the study and suggested that they can adjust taxes accordingly so that high income families would pay more in taxes in order to help low and middle-income families afford their care. These tax hikes would exceed the combined costs of what New Yorkers are currently paying in taxes and healthcare benefits—explaining the bill’s unpopularity. Using the RAND report as a guide, it is likely that the state legislature will explore mechanisms to help finance their proposal in the upcoming session.
While single-payer hasn’t had much luck in the U.S., universal care payment methods, including single-payer, have been successful in other RDs. Regardless of each RD’s financing method, there is one consistent feature of success: national political will to implement it. Imagine if the politics of the cold war did not interfere with establishing a national health insurance plan? Would it have been possible to implement a streamlined and efficient plan? If our culture would have capitalized on the Medicare momentum, would we accept a collective sense of community regarding our healthcare? Vermont tried to implement single-payer with little success due to gross budget underestimations and faint national support. The RAND report sheds light on the cost of single-payer and suggests that there needs to be federal political will to support it. Let these findings and other evidence guide lawmakers as the search for a modest solution continues. Perhaps Wagner’s vision may still be a solution.
Sarah Zahakos is working toward a PhD in Health Law, Policy & Management at the Boston University School of Public Health.
AHRQ T32 Research FellowTraining in Health Services Research for Vulnerable PopulationsGrant # 2T32HS022242