Categories

Above the Fold

Coronary Stent Price Control in India: Two Years and Counting

By SOMALARAM VENKATESH MD

With a stated intent of bringing social justice and financial relief to hundreds of thousands of patients undergoing coronary angioplasty in the country every year, the Government of India capped the sale price of coronary stents in Feb 2017. Stent prices fell by as much as 80% with this populist move, seen as anti-trade within the industry circles. It is tempting for a practising interventional cardiologist to look at two years of this government control on medical device prices in a market economy.

Before price-capping, angioplasty patients were indeed getting a raw deal. There was no uniformity in price among stents of similar class/generation made by different manufacturers. The cost of the only bioabsorbable stent then available in India, to the patient, was 200,000 Indian Rupees (a little under USD 3000), whereas the US or European-manufactured (“Imported”) drug eluting stents (DES) would cost anywhere between INR 85,000 to 160,000. Stents manufactured within India (“Indigenous”) were cheaper. The real cost of manufacture or import was hidden from public view. It was left to the eventual vendor, with alleged involvement of the user hospitals, to determine the Maximum Retail Price (MRP). It was speculated that a huge margin was worked into it, and the profit was split between manufacturers, distributors, and hospitals. Allegedly, some unscrupulous physicians received kickbacks for implanting these devices. Even in government-run hospitals, foul play was suspected.

By a single stroke of the pen, Prime Minister Narendra Modi government slashed stent prices substantially. The bioabsorbable stent cost, to the patient, was capped at INR 60,000 (< USD 1000). Bare metal stents (BMS) and Drug-eluting stents (DES) were capped at INR 7500 and 30,000, respectively. The government seemed to have done its homework: these figures were arrived at from industry-supplied figures on manufacturing or import costs. The cosy network of coronary stent food chain was set on fire with this move: with sudden diminution of profit margins, it was feared that multinational companies would cut Indian workforce; stent distributors & vendors (especially small vendors) were expected to be wiped out or cut in size; doctors worried that with low profitability, multinational stent manufacturers would exit the country or at least, stop importing newer technologies; and hospitals feared revenue loss.

Following this, Industry and Hospital-chain representatives are said to have had series of discussions with the government. Rumours were that the Central Government was arm-twisting traders and that it would relent and raise price limits after these ‘talks.’ The National Pharmaceutical Pricing Authority (NPPA) promised a price revision, one year after the price cap. Meanwhile, some multinationals informed the government that they would withdraw some of their ‘top-end products’ from the Indian market, citing financial nonviability, obviously to put pressure on the government. The Bioresorbable Scaffold from Abbott actually disappeared from Cath lab shelves.

Continue reading…

Health in 2 Point 00, Episode 71 | Livongo’s SIGNUM 2019, Bobblehead Edition!

Today on Health in 2 Point 00, Jess and I are at Livongo’s SIGNUM 2019 conference in San Francisco—in bobblehead form. In this episode, Jess asks me about my key takeaways from the conference, which focused on chronic condition solutions. It was really exciting to hear how the experience of patients with chronic conditions has been changed. We heard some fun stuff from Seth Stephens-Davidowitz about his book Everybody Lies and Daniel H. Pink’s When: The Scientific Secrets of Perfect Timing, and from Stephen Klasko of Jefferson University and Mark Ganz of Cambia Health about the importance of proper partnerships and innovation from traditional healthcare companies. At the end of the day, at a relatively small scale we’ve made a difference in the lives of people with chronic illness—but can we deliver this at a huge scale? —Matthew Holt 

“Public Charge” is a Public Health Disaster in the Making

By PHUOC LE MD 

I was born in a rural village outside of Hue, Vietnam in 1976, a year after Saigon fell and the war ended. My family of four struggled to survive in the post-war shambles, and in 1981, my mother had no choice but to flee Vietnam by boat with my older sister and myself. Through the support of the refugee resettlement program, we began our lives in the United States in 1982, wearing all of our belongings on our backs and not knowing a word of English.

Though we struggled for years to make ends meet, we sustained ourselves through public benefit programs: food stamps, Medicaid, Section 8 Housing, and cash aid. These programs were lifelines that enabled me to focus on my education, and they allowed me to be the physician and public health expert that I am today. Looking back, I firmly believe that the more we invest in the lives and livelihoods of immigrants, the more we invest in the United States, its ideals, and its future.

So, when I first learned of the current administration’s plan to make it harder for immigrants with lower socioeconomic statuses to gain permanent U.S. residence, the so-called changes to the “Public Charge” rule, I felt outraged and baffled by its short-sightedness.
Continue reading…

The Business Case for Social Determinants of Health

By JESSICA DaMASSA, WTF HEALTH

How can understanding the underlying social risks impacting patient populations improve health outcomes AND save health plans some serious per-member-per-month costs? You’re probably familiar with the concept of ‘Social Determinants of Health’ (SDOH) but Dr. Trenor Williams and his team at health startup Socially Determined are building a business around it.

By looking at data around what Trenor calls ‘the Significant 7’ social determinants (social isolation, food insecurity, housing, transportation, health literacy, and crime & violence) he and his team are working to help health plans intervene with their most vulnerable populations and bring down costs.

What kind of data is Socially Determined looking at? Everything from publicly available data on housing prices and air quality, to commercial datasets on buying preferences and more. Plus, with help from their health plan partners, they’re using clinical and claims data to create a complete picture of health care spend, utilization, and outcomes.

Trenor walks through some very specific examples in this interview to help illustrate his point. In one, Socially Determined was able to identify how Medicaid could better help asthmatics manage their asthma AND save a thousand dollars per affected member each month. Another project in Ohio identified that a mother with a history of housing eviction was 40% more likely to give birth to a baby requiring NICU care – opening up myriad opportunities for early intervention and the potential to positively impact the lifetime health of both mother and child.

As healthcare continues to realize its ‘data play’ – and look beyond the typical data sets available to healthcare companies – the opportunities for real and meaningful impact are tremendous. Listen in to hear more about what Trenor sees as the new opportunity for Social Determinants of Health.

Filmed at AHIP’s Consumer Experience & Digital Health Forum in December 2018.

Get a glimpse of the future of healthcare by meeting the people who are going to change it. Find more WTF Health interviews here or check out www.wtf.health

Interoperability and Data Blocking | Part 1: Fostering Innovation

By DAVE LEVIN MD 

The Office of the National Coordinator (ONC) and the Centers for Medicare and Medicaid (CMS) have published proposed final rules on interoperability and data blocking as part of implementing the 21st Century Cures act. In this series we will explore the ideas behind the rules, why they are necessary and the expected impact. Given that these are complex, controversial topics, and open to interpretation, we invite readers to respond with their own ideas, corrections, and opinions.

_____________

Health IT 1.0, the basic digitalization of health care, succeeded in getting health care to stop using pens and start using keyboards. Now, Health IT 2.0 is emerging and will build on this foundation by providing better, more diverse applications. Health care is following the example set by the rest of the modern digital economy and starting to leverage existing monolithic applications like electronic health records (EHRs) to create platforms that support a robust application ecosystem. Think “App Store” for healthcare and you can see where we are headed.

This is why interoperability and data blocking are two of the biggest issues in health IT today. Interoperability – the ability of applications to connect to the health IT ecosystem, exchange data and collaborate – is a key driver of the pace and breadth of innovation. Free flowing, rich clinical data sets are essential to building powerful, user-friendly applications.  Making it easy to install or switch applications reduces the cost of deployment and fosters healthy competition. Conversely, when data exchange is restricted (data blocking) or integration is difficult, innovation is stifled.

Given the importance of health IT in enabling the larger transformation of our health system, the stakes could hardly be higher. Congress recognized this when it passed the 21st Century Cures Act in 2016. Title IV of the act contains specific provisions designed to “advance interoperability and support the access, exchange, and use of electronic health information; and address occurrences of information blocking”. In February 2019, ONC and CMS simultaneously published proposed rules to implement these provisions.

Continue reading…

Our Dead on Every Shore

By MAYURA DESHPANDE 

I once made a serious error. The patient had taken an overdose of paracetamol, but because I was single-handedly covering three inpatient acute psychiatric wards due to sickness of two other trainees which medical HR had been unable to cover, with a lot of agency nurses who did not know any of the patients well at all, and also because this patient frequently said she had taken overdoses when she had not, and declined to let me take bloods to test for paracetamol levels, I believed she was crying wolf. She collapsed several hours later, and died. I was overwhelmed with feelings of guilt, inadequacy, but also fear – was this the end of my career? I was a trainee psychiatrist at the time – and was immensely fortunate in that my supervising consultant was robust in his defence of me, supported me, whilst fronting the complaint from the patient’s family and attending the inquest. He had been covering two outpatient clinics himself while I was on the ward.

The patient was only 26 years old. Her parents were very angry with me, and not unreasonably so; at the time, it seemed to me that they wanted me to suffer. Twenty years later, I believe they wanted to understand how I made the decision I did. Eventually, the consultant arranged for me to meet the parents. They were very kind to me, all of them, I realise that now. I wasn’t able to give them the answers they wanted. I just cried and said I was sorry.

The mother sent the consultant a letter afterwards which he gave me when I was about to complete that training placement. I did not read it for many months. When I did, I cried. The mother described her daughter’s childhood, the family’s loss, and her own incomprehension that the NHS – which she and generations of her family had venerated as a great institution – could have failed her child. It said very little about me, certainly didn’t seek to blame me, but said a few times that she wanted justice for her daughter. It was an exploration of grief by a bereft mother.

I often think about the mother – I cannot recall the face of the 26 year old patient – but remember perfectly well the mother, who said very little, didn’t even cry, leaving her husband to talk incoherently about justice and a referral to the GMC and the police (they did not do any of these things). And I often ponder the nature of justice they wanted. This was well before the advent of Duty of Candour and rigorously completed serious incident investigations.

Did they get justice? The coroner returned a verdict of suicide, but failed to acknowledge the systemic problems of lack of staff, merely noting that there had a “gap in clinical assessment”. It was not untrue, yet I experienced it as unfair. The consultant reminded me that I was fortunate that the family had not made more fuss. So I let it be. Until the case of Dr Bawa-Garba.

Continue reading…

Advance Practice vs Primary Care

By SAURABH JHA MD SAURABH JHA

In this episode of Radiology Firing Line Podcast, Danny Huges and I discuss a JAMA paper: A comparison of diagnostic imaging ordering patterns between advanced practice clinicians and primary care physicians following office-based evaluation and management visits.

Listen to our conversation on Radiology Firing Line here.

Saurabh Jha is a contributing editor to THCB and host of Radiology Firing Line Podcast of the Journal of American College of Radiology, sponsored by Healthcare Administrative Partner

ONC’s Proposed Rule is a Breakthrough in Patient Empowerment

By ADRIAN GROPPER

Imagine solving wicked problems of patient matching, consent, and a patient-centered longitudinal health record while also enabling a world of new healthcare services for patients and physicians to use. The long-awaited Notice of Proposed Rulemaking (NPRM) on information blocking from the Office of the National Coordinator for Health Information Technology (ONC) promises nothing less.

Having data automatically follow the patient is a laudable goal but difficult for reasons of privacy, security, and institutional workflow. The privacy issues are clear if you use surveillance as the mechanism to follow the patient. Do patients know they’re under surveillance? By whom? Is there one surveillance agency or are there dozens in real-world practice? Can a patient choose who does the surveillance and which health encounters, including behavioral health, social relationships, location, and finance are excluded from the surveillance?

The security issues are pretty obvious if one uses the National Institutes of Standards and Technology (NIST) definition of security versus privacy: Security breaches, as opposed to privacy breaches, are unintentional — typically the result of hacks or bugs in the system. Institutional workflow issues also pose a major difficulty due to the risk of taking responsibility for information coming into a practice from uncontrolled sources. Whose job is it to validate incoming information and potentially alter the workflow? Can this step be automated with acceptable risk?

It’s not hard to see how surveillance as the basis for health information sharing would be contentious and risk the trust that’s fundamental to both individual and public health. Nowhere is this more apparent than in the various legislative efforts currently underway to expand HIPAA to include behavioral health and social determinants of health, preempt state privacy laws, grant data brokers HIPAA Covered Entity status, and limit transparency of how personal data is privately used for “predictive analytics”, machine learning, and artificial intelligence.

Continue reading…

Running an RCT – A Conversation With the Investigators of the REGAIN Trial

By SAURABH JHA MD SAURABH JHA

It is easy for armchair activists to bash randomized controlled trials (RCTs) with clever methodological critiques. However, it takes a lot of effort and coordination to pull off an RCT successfully. In this episode of Radiology Firing Line, I speak with Dr. Mark Neuman and Lakisha Gaskins, principal investigator and research project manager of the REGAIN trial, respectively, about the logic, challenges and intricacies of conducting an RCT. The Regional versus General Anesthesia for Promoting Independence After Hip Surgery (REGAIN) trial is an ongoing pragmatic, multi-center RCT, funded by PCORI, which randomizes patients with hip fractures to regional or general anesthesia.

Guests: Mark Neuman MD MSc, is an Associate Professor of Anesthesiology and Critical Care at the University of Pennsylvania. He is a senior fellow at the Leonard Davis Institute of Health Economics. He’s a former RWJ Scholar. Lakisha Gaskins is a research coordinator with extensive experience recruiting patients for RCTs.

Listen to our conversation on Radiology Firing Line Podcast here.

Saurabh Jha is a contributing editor to THCB and host of Radiology Firing Line Podcast of the Journal of American College of Radiology, sponsored by Healthcare Administrative Partner.

For Your Radar — Huge Implications for Healthcare in Pending Privacy Legislation

By VINCE KURAITIS and DEVEN McGRAW

Two years ago we wouldn’t have believed it — the U.S. Congress is considering broad privacy and data protection legislation in 2019. There is some bipartisan support and a strong possibility that legislation will be passed. Two recent articles in The Washington Post and AP News will help you get up to speed.

Federal privacy legislation would have a huge impact on all healthcare stakeholders, including patients.  Here’s an overview of the ground we’ll cover in this post:

  • Why Now?
  • Six Key Issues for Healthcare
  • What’s Next?

We are aware of at least 5 proposed Congressional bills and 16 Privacy Frameworks/Principles. These are listed in the Appendix below; please feel free to update these lists in your comments.  In this post we’ll focus on providing background and describing issues. In a future post we will compare and contrast specific legislative proposals.

Continue reading…

Registration

Forgotten Password?