“We have observed that in 200 to 300 cases of cardiac stent overcharging, violations were in the form of not mentioning the stent price in the medical bill and billing it as angioplasty charges or cath lab charges, not mentioning brand name and company of the stents in the medical bills and also not mentioning clearly also the batch number and expiry dates of the stents thus misleading the patients and fleecing the patients in a major way,” explained NPPA chairman Bhupendra Singh.
This comes at a time when cardiac stent manufacturers have raised concern around ensuring consistent supply of latest generation stents on ground of commercial unviability and applied to the drug pricing regulator for its redressal.
While rejecting pleas of Abbott and Medtronic for withdrawing high-end stents from the market, the NPPA has provided an escape clause that the companies can seek regulatory approval to revise prices as per the provisions of the Drug Price Control Order (DPCO) if they can prove superiority of these stents over others.
Abbott had sought permission to withdraw its ‘alpine drug eluting’ stent and ‘absorb dissolving’ stent, while Medtronic had also sought to withdraw its Onyx Zotarolimus eluting stents. Another major multinational stent maker Boston Scientific has already filed an application with NPPA to let it sell some stents in India at “special prices” higher than the mandated ceiling prices.
“The issues that companies raising now are the same issues raised before and they can seek price revision based on certain conditions as per the law of land. There is a legal provision under which there is a method of examining the case and we will do it on case to case basis if it comes to us,” informed Singh.
“Medtronic’s application for the withdrawal of Resolute Onyx was not accepted by the NPPA on the basis of incomplete paperwork. We intend to resubmit the application, and until it is re-submitted and approved we will continue to supply the Resolute Onyx stent in India. All decisions to withdraw or introduce products to the market are made only after taking into consideration all guidelines and norms set by the government and applicable legal and regulatory requirements,” Medtronic said in an email statement.
On 21 February, the government had invoked an emergency clause under the Drug Price Control Order, citing public interest, and asked stent makers to maintain supplies of their products for six months. In a notification on April 26, 2017 the NPPA said during this period no such request from the companies to withdraw their products could be entertained.
The Gujarat Food and Drug Control Administration (FDCA) has recovered Rs.52 Lakh of overcharged amount from around 20 hospitals for non-compliance to National Pharmaceutical Pricing Authority (NPPA) ceiling price norms on cardiac stents. The cases were detected in Baroda, Mehsana, Surat, Rajkot, Anand and Ahmedabad as a part of its inspections on 60 cardiac centres across the state to check price compliance at the point of care.
Most of these hospitals where such cases have been detected are private and corporate hospitals. The FDCA had earlier detected 8 private hospitals in Ahmedabad alone for non-compliance to NPPA ceiling price norms which stipulate prices of coronary stents at Rs.7,260 for bare metal ones and Rs.29,600 for drug eluting variety with effect from February 14, 2017.
Gujarat FDCA's inspections aimed at checking whether hospitals and cardiac centres across the state are complying to ceiling price norms stipulated as per the order so that patients are not overcharged.
“Subsequent to cases being detected, the state regulator had directed the concerned hospitals to refund the overcharged amount through cheque and RTGS and almost all of them have refunded the overcharged amount as per the NPPA price capping exercise. Around 119 stents were used in 79 patients in these 20 hospitals as a part of the angioplsty procedures,” said Gujarat FDCA Commissioner Dr H G Koshia.
On February 14, 2017, NPPA announced cut in prices of coronary stents by up to 85% by capping them at Rs.7,260 for bare metal ones and Rs.29,600 for drug eluting variety.The step was taken to fix a standardised specification of stent and its MRP to stop fleecing patients.
Meanwhile, advocate Birender Sangwan, whose PIL led to slashing prices of cardiac stents this year in February, has filed another set of PILs at the Delhi High Court (HC) against 38 hospitals on whom complaints of overcharging have been received at the drug pricing regulator NPPA office.
However, Maharashtra Food and Drug Administration (FDA) recently in its verification reports have ascertained that no hospital in Mumbai, Pune and Nashik were found violating the ceiling prices for cardiac stents as stipulated by the drug pricing regulator NPPA.
The state regulator had stepped up its vigilance as a part of its larger plan to detect overpricing of stents in government and private hospitals subsequent to NPPA receiving complaints about stents being sold at higher prices at KEM Hospital, Lilavati Hospital and a few hospitals in Pune and Nashik.
This was following 2 complaints of overcharging received recently against KEM hospital, Mumbai. The first complaint was received on February 26, followed by another complaint on March 1, 2017. The other hospitals include Lilavati Hospital, Bandra, the complaint of which was received on February 23, 2017 and Bhaktivedanta Hospital, Mira Road, Thane, the complaint of which was received on March 4, 2017.
Two other hospitals in Maharashtra against whom complaints were received include Pune Hospital and Research Centre, Pune, the complaint of which was received on March 4, 2017 and Six Sigma Medicare and Research Ltd, Nashik, the complaint of which was received on February 25, 2017.
NPPA has directed hospitals/nursing homes/clinics utilizing coronary stents shall specifically and separately mention the cost of the coronary stent along with its brand name, name of the manufacturer/importer/batch number. and other details, if any, in their billing to the patients or their representatives.