Pharmaceuticals play a major role in today’s population health era – they can prevent and cure disease, improve or maintain wellness and slow progression of existing conditions. Yet, their promise can also be a curse if high prices limit patient access and bankrupt the healthcare providers and insurers bearing significant financial risk for patient care.
The proactive new leadership at the FDA is promoting competitive markets by combatting the abuse of well-intentioned programs and market share monopolies. Commissioner Scott Gottlieb has ramped up the FDA’s efforts to prevent drug manufacturers from “gaming the system” in a number of ways.
Accelerating generic approvals and creating transparency to stimulate competition
For the first time, the FDA made publicly available a list of off-patent, off-exclusivity branded drugs without generic competition. Using the list, Premier immediately identified a number of critical drugs for patient care and has been working with manufacturers to participate in the FDA’s new expedited review process. Additionally, Congress recently enacted legislation creating an expedited review process for generic drug applications when there are fewer than three manufacturers in the market for a given drug product. We strongly support and helped to champion these efforts, and are hopeful that the FDA will use this new authority to foster competition and curb price spikes and shortages in generic drugs where only a few players dominate.
Health Savings Accounts (HSAs) allow individuals to use pre-tax dollars to pay for high deductibles and other uncovered medical expenses. Currently, individuals are ineligible for tax-advantaged HSA contributions if they have “other” coverage in addition to a High Deductible Health Plan (HDHP.) Expanding HSAs to fund out-of-pocket expenses for routine healthcare places control directly in the hands of patients, a move that could bring down health expenditures. Large corporations are wrestling for control to direct where patients spend their hard-earned money.
A group of lawmakers recently introduced the “bipartisan” Health Savings Account Improvement Act of 2018 (H.R. 5138). This bill allegedly “expands” HSA coverage to allow use at “retail-based” (think CVS/Target) or “employer-owned” clinics (think Amazon) without losing eligibility to make tax-advantaged contributions to their HSAs. Increasing the flexibility of HSAs is a laudable goal yet, this legislation herds Americans like sheep into Minute Clinics for the benefit of corporate shareholders.
This bill should not become law. If HR 5138 passes, retail and employer-based clinics will become profit centers. Alternative legislation, known as the Primary Care Enhancement Act (H.R. 365), amends the definition of “qualified medical expenses” to include fees paid to physicians as part of a “primary care service arrangement.” This common-sense legislation flounders in Congress every year.
It starts with the CEO. Studies confirm that the single most important determinant of successful workplace wellbeing programs is the active, passionate, and persistent involvement of the CEO.
The CEO is taken very seriously. When the CEO wants something, people notice. When the CEO is passionate about something, it gets elevated to extreme importance. The sort of paradigm and cultural change needed to create a culture of employee wellbeing simply cannot occur without the full, passionate, focused, and persistent involvement of the CEO. I was a CEO, and one has to have been one to understand the full implications of CEOship. It IS different. This is not elitism. It’s fact.
While I was CEO of Blue Cross & Blue Shield of RI, I made my singular focus ethics and integrity. Why? Because my predecessor became top-of-the-fold news, and our organization quickly gained a reputation for unethical behavior. We had to change that, and I made ethics and integrity part of every speech, virtually every piece of written material I sent to employees, a part of fully half of my weekly newsletters to employees, etc. And over time, it worked. No cutting corners; full compliance; a strong reporting system, etc. And we became recognized, rather quickly, for having ethics “in our DNA.”
I wish I had brought the same passion to the wellbeing of my employees. I didn’t, and now part of my mission in life is correct that by inspiring CEOs, Boards, and C-Suites to do just that.
A somewhat cynical CEO might ask: “Why is this my responsibility?” Or, “Why can’t employees just do what they should be doing?” Or, “Am I also supposed to cure world hunger and take on the responsibility for employees’ happiness?” “Where does it end?”
These are understandable questions. The short answers are, yes, this is your responsibility for many reasons, the chief of which is that it is a strategic imperative for operational success. It’s also the right thing ethically and morally. And no, employees often need help, and the workplace is the best venue to give and receive such help.
Artificial Intelligence is at peak buzzword: it elicits either the euphoria of a technological paradise with anthropomorphic robots to tidy up after us, or fears of hostile machines breaking the human spirit in a world without hope. Both are fiction.
The Artificial Intelligences of our reality are those of Machine Learning and Deep Learning. Let’s make it simple: both are AI – but not the AI of fiction. Instead, these are limited intelligences capable of only the task they are created for: “weak” or “narrow” AI. Machine Learning is essentially applied Statistics, excellently explained in Hastie and Tibshirani’s Introduction to Statistical Learning. Machine Learning is a more mature field, with more practitioners, and a deeper body of evidence and experience.
Deep Learning is a different animal – a hybrid of Computer Science and Statistics, using networks defined in computer code. Deep Learning isn’t entirely new – Yann LeCun’s 1998 LeNet network was used for optically recognizing 10% of US checks. But the compute power necessary for other image recognition tasks would require an additional decade. Sensationalism by overly optimistic press releases co-exists with establishment inertia and claims of “black box” opacity. For the non-practitioner, it is very difficult to know what to believe, with confusion the rule.
Access to basic healthcare services is a cardinal human right, enshrined in the World Health Organization’s Constitution, which envisions the “highest attainable standard of health as a fundamental right of every human being”. Comprehensive, quality healthcare services are critical not only for treatment, but also prevention and management of illnesses which culminates in reducing unnecessary death and injuries and increasing overall life expectancy.
Globally, millions of people face challenges accessing adequate healthcare services, with those living in rural settings the most affected. One of the key components of healthcare is timeliness in availing these services, including access to a location with adequate healthcare provisions. More recently, the Sustainable Development Goals have also emphasised the importance of expedient access in Goal 3.8 which seeks to provide “access to quality essential healthcare services”.
In general, there are three types of delays in a healthcare system which can negatively affect the patient’s life. These include a delay in decision to seek care; delay in reaching a health facility; and delay in receiving appropriate treatment. These blockages in the system are almost always prevalent in countries with poor socioeconomic conditions, such as Bangladesh.
Many states have been looking for alternatives to reimbursing Medicaid providers piecemeal on a fee-for-service (FFS) basis. Increasingly they have been moving beneficiaries into Medicaid managed care plans. Today 39 states contract with managed care organizations to care for at least some Medicaid beneficiaries. States have been slower to integrate drug benefits with managed care, however. The Medicaid Drug Rebate Program requires drug manufacturers to rebate a portion of the drug costs to states and the federal government. Prior to the Affordable Care Act states did not qualify for drug maker rebates unless states managed their own Medicaid drug program on a FFS basis. States can now receive rebates for drugs purchased by Medicaid managed-care plans as well.
Medicaid is a partnership between the federal government and the states. Regardless of whether states manage Medicaid drug benefits, enrollees fill their prescriptions at local pharmacies. Pharmacies are reimbursed for the cost of each prescription, plus a dispensing fee. If the state manages Medicaid drug benefits, the state agency sets fees and reimburses pharmacies.
Today 26 states have transitioned at least some Medicaid beneficiaries away from FFS drug programs into drug plans integrated with managed care. Yet, recent legislative initiatives are bucking this trend for political reasons. Senate Bill 5 in the Kentucky legislature (and similar proposals in Ohio and Arkansas) would require the state to manage Medicaid drug benefits on a FSS basis. Indeed, nearly half of states still hang on to outdated FFS drug programs for political reasons.
The study that changed everything was published last week. An alien visiting the national cardiology meeting in Orlando may have thought that the trial of note was the one that featured the culmination of one hundred years of lipid research to develop an inhibitor of the enzyme PCSK9 (Proprotein convertase subtilisin/kexin type 9) that lowers lipids and reduces the risk of future heart attacks.
The Martian would be wrong.
The trial that has cardiologists across the land choking back tears is a hypertension study done in black barbershops. The idea is fairly simple. Black men have the highest rates of disability related to uncontrolled hypertension, in large part related to a difficulty in engaging black men with the health care system. The end result of poorly controlled hypertension in this community was on full display where I did much of my medical training as a student and resident in the heart of North Philadelphia. Ensconced in the walls of Temple we learned to manage the end organs ravaged by hypertension. I have to say I never stopped to think what we could have done to interrupt this process even though we were located in the heart of an underserved black community.
Luckily, Ronald Victor has been thinking about this problem for some time. A Cedars Sinai physician, his research focuses on community interventions to rectify health care disparities. His first study in 2007 sought to examine the feasibility of blood pressure screenings in black barbershops because this was where black men congregated and may be susceptible to influence by important peer influencers: barbers.
The 2007 study by Victor proved that it was feasible to enlist barbers to measure blood pressures, correctly stage hypertension, and make a referral to a clinician for treatment. This opened up funding for the next step in the process- actually affect blood pressure control in barbershops. The trial was wildly positive. In stark contrast to the multibillion dollars of research that lead to a $1000/month PCSK9 inhibitor that gives us a 15% relative risk reduction of a composite outcome of stroke/death/heart attack, the Victor barbershop protocol resulted in a staggering average 27mmHg blood pressure drop in 6 months. The potential ramifications are large for a 20mmHg drop – a 30% reduction in risk of a heart attack or a 40% reduction in risk of a stroke.
A critical test in Congress comes this week in year 2 of the ACA wars. Will lawmakers do the right thing?
It’s up in the air—again. Congress has until this Friday at midnight to pass a budget bill to fund the government through Sept. 30. That bill is widely considered to be the last “must-pass” legislation before the mid-term elections.
As such, it’s probably the last chance lawmakers will have to enact measures aimed at stabilizing the ACA marketplaces for 2019. Health plans start pulling their bids together in May and June and the deadline for final submissions is in September.
As of this writing, it’s unclear whether House Republican leaders will even include an ACA stabilization provision in their version of the budget bill. In the Senate Lamar Alexander (R-TN) and Susan Collins (R-ME) have submitted a proposal and are pressing hard for inclusion and a vote. (See details of the bill below.)
According to media reports, President Trump told the two Republicans on Saturday he would support their effort. And Senate leader McConnell is also said to be supportive. But as drafted, the measure contains a poison pill: a provision that would forbid the use of federal dollars to help pay for insurance policies that provide abortions. Democrats say that’s a deal-breaker.
The renewed push now for ACA marketplace stabilization comes primarily because the repeal of the individual mandate penalty takes affect on Jan. 1, 2019. That’s projected to trigger premium increases of between 7 and 15 percent, varying by state. But, on top of that, the Trump administration has proposed policy changes that experts predict will spur additional premium increases—that, in turn will lead to coverage losses. Continue reading…
This is the last installment in a three-part series that asks why we need both an insurance industry and an ACO industry. We are now stuck with the worst of all possible worlds – an inefficient insurance industry layered on top of an inefficient ACO industry.
I noted in Part I of this series that ACOs’ inability to cut costs explains why 90 percent of Medicare ACOs refuse to accept anything resembling insurance risk. In Part II I discussed ACO proponents’ expectation that many ACOs would accept full insurance risk, and I described the Medicare Payment Advisory Commission’s (MedPAC’s) reaction to ACOs’ inability to cut costs and their unwillingness to accept insurance risk. We saw that MedPAC attempted to design a plan called “premium support” that would generate competition between Medicare ACOs, Medicare Advantage plans, and the traditional Medicare fee-for-service program, and, after four years of trying (and even after dropping the FFS program from the project), gave up.
In this last installment I review a nearly identical attempt by Minnesota’s Medicaid program to set Medicaid ACOs and HMOs on a level playing field. I will close with a prediction of where the ACO industry is headed.
Last week, House Representatives failed to pass “Right to Try” (RTT) legislation, a bill that purported to help terminally ill patients access experimental medications. Opponents of this legislation, including these authors, have long argued that RTT does nothing to bring potentially life-saving medications to patients who are in dire need and, potentially, puts desperate individuals at risk. With the bill’s failure, Republican leaders should rewrite the draft legislation in a collaborative fashion, taking input from the FDA, the biopharmaceutical industry, patients, patient advocates, and bioethicists who are experts in the field of pre-approval access, working to craft legislation that will actually bring help to patients in need.
The failed RTT bill was fraught with errors, poorly written, and lacked any concrete action to give access to potentially life-saving treatments for terminally ill patients outside of clinical trials. Currently, thirty-eight states, representing 83% of the population in the USA, have already signed Right to Try bills into law. These bills align with the model legislation crafted by libertarian think tank, The Goldwater Institute. Promoted as providing “immediate access to the medical treatments” for terminally ill patients, the cruel reality with Right to Try legislation is that it will not grant patients the immediate access to treatments they desperately need – and it never has. Although over 270 million Americans are currently living within the boundaries governed with Right to Try laws, there continues to be no evidence of a patient ever receiving a life-saving medication under Right to Try legislations that they otherwise wouldn’t have received under the FDA’s current Expanded Access Program. The legislation simply doesn’t work, and it never will, for numerous reasons.