Why heart patients in India are forced to get unnecessary stent implants
In a huge relief to heart patients, the National Pharmaceutical Pricing Authority (NPPA) in February reduced and fixed the prices of coronary stents in India.
A coronary stent is a "short wire-mesh tube" which is primarily used in survivors of heart attacks and in patients with blocked arteries. It helps in opening the blocked arteries and allows regular flow of blood from the heart.
The NPPA has capped the prices of drug-eluting stents (DES) at Rs 29,600 and the bare metal stents at Rs 7,260.
According to an NPPA order, “institutions such as hospitals/nursing homes/clinics utilising coronary stents shall specifically and separately mention the cost of the coronary stent along with its brand name, name of the manufacturer/importer/batch no. and other details, if any, in their billing to the patients or their representatives”.
Previously, the price of stents ranged anything between Rs 23,000 and Rs 2.5 lakh per piece.
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| There is very high prevalence of coronary artery disease (CAD) in India associated with high morbidity and mortality. (Credit: Reuters photo) |
Here, the highest profit margins were made by the hospitals at up to 654 per cent. Though both the varieties of stent are metal wire-mesh, the DES variety is of superior quality. It is coated with medicine which is periodically released to prevent any further arterial blockage in the heart. The DES variety covers nearly 80 per cent of the market share for coronary stents implanted in India.
As per the survey conducted by IMS Health on behalf of Advanced Medical Technology Association (AdvaMed), it was reported that stents account only for 25 per cent of an angioplasty's bill. Whereas, "about 15 per cent of the bill is the hospital margin on stents and 60 per cent-67 per cent make up for hospital charges, including the doctor's fees, etc".
During the consultative meetings with stakeholders, the NPPA had also observed, “huge unethical mark-ups are charged at each stage in the supply chain of coronary stents, resulting in irrational, restrictive and exorbitant prices”. The chairman of NPPA, Bhupinder Singh, has assured the manufacturers that the capped prices have a provision of an 8 per cent profit margin.
In July 2016, the health ministry had announced their decision to include all kinds of stents in the National List of Essential Medicines in order to bring down the prices of the product.
In April 2016, the core committee had submitted its report to the government, in which it had examined the issues relating to the essentiality of coronary stents. In the report, they had observed, “there is very high prevalence of coronary artery disease (CAD) in India associated with high morbidity and mortality; and that CAD has become a major public health problem; and that percutaneous coronary intervention (PCI) procedure requiring coronary stent implantation is an important treatment modality for the management of CAD, and hence coronary stents are "essential for public health”.
The above measures were the direct outcome of the public interest ligation, filed by an advocate Birender Sanghwan. The petition was filed because earlier drug manufacturing companies did not mention the maximum retail price on the stent packaging and neither did the hospitals mention the price of the stents in the bill.
This led to hospitals charging and extracting exorbitant prices for stent implants from their cardiac patients. Additionally, the petition had demanded for ceiling the price for all stents. Therefore, after hearing the petition in December 2016, a bench of the Delhi High Court had ordered the Centre to fix maximum retail price and a ceiling price for cardiac stents by March 1, 2017.
Artificial scarcity of stents
Following the NPPA notification, the scarcity of stents in hospitals across cities, including Mumbai have been reported. The high-end stents have been withdrawn from some hospitals to avoid price control.
Similarly, the third and fourth generation stents were unavailable to patients on the pretext of price relabelling, despite the NPPA notifying that relabelling is not required.
Also, some hospitals are being flooded with the cheaper first and second generation of stents. The state-level Food and Drug Administration (FDA) is carrying out informal surveys to ensure compliance of price capping and availability of implants at hospitals.
Moreover, it has also been reported that manufacturers and distributors of the high-end stents, such as Synergy, Alpine, Absorb etc, have informed the FDA officials that the latest stents cannot be made available within the price range fixed by the NPPA.
Therefore, following the reports of artificial stent shortages, the NPPA has notified the department of pharmaceuticals to invoke the powers of Section 3 (i) of Drug Price Control Order, 2013.
Under this section, "the government can regulate distribution and direct any manufacturer to increase production and sell products to institutions, hospitals or any agency as the case may be in case of emergency or in circumstances of urgency or in case of non-commercial use in public interest". Further, the manufacturers are required to submit a weekly report on stents produced and distributed, to NPPA and Drugs Controller General of India (DCGI).
The NPPA has also issued show-cause notices to Max Hospital, Saket (New Delhi), and Nidaan Hospital, Sonipat (Haryana), following complaints of alleged overcharging for stents. Similarly, the authorities have initiated a probe against some reputed hospitals, including PGIMER, Chandigarh, Lilavati Hospital in Mumbai; Max Hospital, Metro Hospital in Faridabad (Haryana) and Shri Ram Murti Smarak Institute of Medical Sciences in Bareilly (Uttar Pradesh).
However, the regulatory authorities will proceed further only if the preliminary investigation indicates violation. If a hospital is found guilty of overcharging for stents, "the NPPA has the power to recover the overcharged money along with 15 per cent interest under the provisions of the drugs price control order".
Unnecessary stents being implanted
The regulation and capping of the stent prices is commendable, but still a battle half won. The price regulation will only make the stent implants cheaper and affordable. But, the major concern over the practice of irrational stent implants or an angioplasty continues to persist. The use of cardiac stents in India has been growing rapidly at 25 per cent annually.
According to the Cardiology Society of India, in 2015, as many as 4,20,000 angioplasties were performed in India. Experts say in most of the cardiac patients with even 50 per cent blockage in arteries who do not require stents are implanted with stents.
A few years ago, in the US, which has better monitoring and oversight of medical procedures than India, a study had reported that only half the non-emergency cardiac stent implants were appropriate.
In India, where there is hardly or no regulation of hospitals in this regard, especially in the private sector, at least 25 per cent-30 per cent of the stent implants are inappropriate.
Hence, it indicates towards unethical stent implants being a serious concern for cardiac patients. In order to curb the unethical practice, in 2009, an expert panel of cardiologists in the US published criteria for appropriate use of stents.
This had a positive impact, and US has witnessed a remarkable decline in the number of inappropriate stent implants. Similarly, some experts are of the opinion that the Cardiology Society of India should frame similar guidelines for the appropriate use of stents in India.
According to prof BM Hegde, cardiologist and former vice-chancellor of Manipal University, the only area where angioplasty has a proven track record is during an acute heart attack, and during such times as well, the procedure has to be done within minutes. Rest of the time, it is done just to make money by instilling fear among patients and their relatives about blocks in the coronary arteries.
The measure to cap stent prices in India is commendable. However, this may also lead to increase in the overall packages by some private hospitals for stent implants in the form of hospital and surgical charges, to increase their own share of profit.
This might make the procedures unnecessarily expensive despite the stent price caps.
Moreover, as it is being reported that some hospitals are resorting to use first and second generation of stents, instead of the better third and fourth generation stents. Therefore, the state-level FDA authorities have to strictly regulate and probe the hospitals and the grievous complaints being filed by patients for overcharging and use of inferior quality of stents.
Additionally, the government needs promote and provide incentives to the Indian drug manufacturing companies to help them compete in the stent market, which is largely dominated by foreign companies.
Though having slashed the cost of stents by over 85 per cent may reduce certain percentage in the number, but still doesn't guarantee protection of patients against unnecessary stent implants in India.
The government needs to frame strict guidelines and make audits mandatory for such procedures. The doctors and hospitals involved in these unethical practices should be seriously dealt with under the law.
Unless the patients are protected from doctors and hospitals extracting unethical profits by performing unnecessary stent implants, the struggle for comprehensive healthcare for coronary artery diseases will remain incomplete.