Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.
Below are the abstracts/summaries for papers identified from the month of July. The selections feature topics ranging from the price increases of protected-class drugs in Medicare Part D, to the impact of price regulation on the availability of new drugs in Germany, to the association between FDA advisory committee recommendations and agency actions. A full posting of abstracts/summaries of these articles may be found on our website.
If you rely on a pacemaker, an implanted defibrillator, a prosthetic hip, wear contacts or need an MRI, then you should be concerned about the constant threat and imposition of tariffs on Chinese imports by the Trump Administration. Using Section 301 of the Trade Act of 1974, President Donald Trump imposed new tariffs on an array of Chinese imports based on the assertion that they were stealing United States intellectual properties. The first volley occurred in July 2018 when the administration applied tariffs of 25% to over $34 billion in Chinese imports, and then again in August 2018 when it added another $16 billion in products to the list.
In an ongoing tit-for-tat, on May 10, 2019, the United States raised tariffs from 10% to 25% on an additional $200 billion worth of Chinese goods, including many health care products, from surgical gloves to chemical reagents. While medical supplies are only a small, biopsy-sized sample of the goods that will face these tariffs, they are sure to have some impact on an already financially burdened health care delivery system here in the United States. This will result in higher prices for health care products, devices, and components that are all passed off to the consumer.
Massachusetts and Oregon expanded insurance coverage during previous periods of federal inaction, and with solutions unlikely to come from a politically divided Washington D.C., how will states tackle the problem of health insurance becoming increasingly unaffordable and unattainable for many families?
Is there a role for the government to play a greater role in making health insurance affordable and accessible? As public support for action on health care grows, what options are available to states now?
I spoke to former Petrie-Flom Student Fellow and Medicaid policy scholar Emma Sandoe about states that have begun to explore Medicaid Buy-In policies, which allow people to purchase government backed health insurance or Medicaid-like plans. Read More
Recently, there has been a lot of media attention on galling price hikes of generic drugs.
Historically, the social contract in pharmaceutical pricing has been tolerating expensive brand-name drugs while they have been on patent (a government-granted monopoly), followed by allowing low cost generics to rush to market after patent expiration. Yet these norms are now being challenged in the setting of increased generic manufacturer consolidation and single-source generic drugs.
Probably the most well known example is the case of Martin Shkreli (the so-called “Pharma Bro”) and Turing Pharmaceuticals, which bought out the rights of pyrimethamine (Daraprim), a key treatment for Toxoplasmosis and other infectious diseases, raising the price from $13.50 per pill to $750 per pill.
Note that even the pre-price hike price is significantly more than people other countries pay. In the UK it costs only $0.66 per pill and in Australia it is $0.18 per pill.
Short-term, limited-duration insurance was designed as a temporary gap-filler while a person transitions from one kind of health insurance to a different plan or coverage. In 2016, recognizing its serious limitations, an Obama Administration rule mandated that coverage of short-term, limited-duration insurance be limited to three months, including any period of renewal.
Recently there has been a shift in popular parlance toward referring to PCPs as primary health care providers. Not primary health care physicians or practitioners, but providers.
This change seems to have increased in popularity after the original passage of the ACA, specifically with the opening of the health insurance marketplaces.
But it was particularly jarring, as a Canadian, to become accustomed to terminology that reframes physicians as providers, and patients as consumers.
Ostensibly, this language comes from a movement to empower patients to be more engaged in their health care rather than to accept passively that the “doctor knows best.” It is an effort to shift away from health care delivery by paternalistic doctors of the past, and toward the contemporary active patients who take ownership of their health and participate in making decisions. As a result, doctors are framed as service providers who cater to the needs of their consumers.
Happy World Trade Month! While health policy is often seen as something particularly domestic, trade can have an impact on health policy here at home.
Just a day before President Trump’s speech outlining the administration’s approach to rising drug costs, the Pharmaceutical Research and Manufacturers of America (PhRMA) declared May as a time to “celebrate the many American companies exporting products around the world.” However, PhRMA also warned that “Americans should not subsidize the medicine costs in other wealthy countries.”
Although drug formularies are ubiquitous in Medicare and the private insurance market, they’re absent in Medicaid. By law, state Medicaid programs that offer prescription drug coverage (as they all do) must cover all drugs approved by the U.S. Food and Drug Administration, however expensive they are and however slim their clinical benefits may be.
Massachusetts would like to change all that. In a recent waiver proposal, Massachusetts asked the Centers for Medicare and Medicaid Services (CMS) to allow it to adopt a closed formulary in Medicaid. That would allow Massachusetts to exclude certain brand-name drugs from Medicaid, increasing its leverage in price negotiations beyond what it can achieve through existing utilization management techniques like prior authorization.
Among Medicaid advocates, the proposal is controversial. Some fear that state budgets would be balanced on the backs of Medicaid beneficiaries, who could be denied access to expensive therapies. But Massachusetts thinks there’s room to drive down drug spending without threatening access to needed medications. In any event, the state has to do something. Drug spending in Massachusetts has increased, on average, 13 percent annually since 2010, threatening to “crowd out important spending on health care and other critical programs.”
By all rights, CMS should welcome Massachusetts’s proposal. Closed drug formularies are tried-and-true, market-based approaches to fostering competition over drug prices, and the Trump administration’s Council on Economic Advisers recently released a report saying that “government policy should induce price competition” in Medicaid. If Secretary of Health and Human Services (HHS) Alex Azar means it when he says that “drug prices are too high,” letting Massachusetts try out a formulary makes a ton of sense. […]
Value-based health care is one of the most pressing topics in health care finance and policy today. Value-based payment structures are widely touted as critical to controlling runaway health care costs, but are often difficult for health care entities to incorporate into their existing infrastructures. Because value-based health care initiatives have bipartisan support, it is likely that these programs will continue to play a major role in both the public and private health insurance systems. As such, there is a pressing need to evaluate the implementation of these initiatives thus far and to discuss the direction that American health care financing will take in the coming years.
To explore this important issue, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is collaborating with Ropes & Gray LLP to host a one-day conference on value-based health care. This event will bring together scholars, health law practitioners, and health care entities to evaluate the impact of value-based health care on the American health care system.
This event is free and open to the public, but seating is limited and registration is required. Register now!