Question : Guidelines by NPPA

Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

(a) whether patients are charged inordinately high amount for the stent device and if so, the details thereof;
(b) whether the National Pharmaceutical Pricing Authority (NPPA) has made it mandatory for hospitals to disclose the cost of the stent separately while billing a patient and if so, the details thereof;
(c) whether the NPPA has marginally increased the cost of basic cardiac stents while reducing the prices of expensive stents and if so, the details thereof;
(d) whether the Government has consulted all the stakeholders before arriving at the price and if so, the details thereof;
(e) whether the NPPA has also made it mandatory for the hospitals to provide a clear breakup of the prices levied for other items used in medical procedures and if so, the details thereof; and
(f) the steps the Government has taken to regulate and control the price of stent and make it accessible to the needy and poor patients?

MINISTER OF STATE IN THE MINISTRY OF ROAD TRANSPORT AND HIGHWAYS; MINISTRY OF SHIPPING AND MINISTRY OF CHEMICALS AND FERTILIZERS (SHRI MANSUKH L. MANDAVIYA)

(a): National Pharmaceutical Pricing Authority (NPPA) vide its notification S.O. 412(E) dated 13th February, 2017 fixed the ceiling price of the coronary stents. Institutions such as hospitals/nursing homes/clinics utilizing Coronary Stents for angioplasty are bound to abide by the ceiling prices fixed by the Government for coronary stents and NPPA has not found any actionable violation after examining about 40 complaints.

(b): Vide notification S.O. 412(E) dated 13th February, 2017 and S.O. 639(E) dated 12th February, 2018, all hospitals/nursing homes/clinics utilizing coronary stents have been instructed to mention specifically and separately the cost of the coronary stent, its category like BMS or DES, brand name, name of the manufacturer/importer/batch no./specifications and other details, if any, in their Estimate/Performa invoice/Final-billing, etc. to the patients or their representative.

(c): NPPA vide its notification S.O. 639(E) dated 12th February 2018, revised the prices of cardiac stents. The revised prices are Rs. 27,890/- for DES (Drug eluting stent) and Rs. 7,660/- for BMS (Bare metal stent) while earlier prices were Rs. 30,180/- and Rs. 7,400/- respectively.

(d): Stakeholders’ consultations with the coronary stent manufacturers, industry associations, civil society groups, hospital and nursing home associations, and eminent cardiologists both from private and public sectors were held prior to revisiting the prices of coronary stents in order to make an assessment of the actual impact of price ceiling on cardiac healthcare, the status of market of indigenous manufacturing and imports, increased affordability and access to cardiac healthcare etc.

(e): Vide Notification No. S.O. 639(E) dated 12th February, 2018, all healthcare institutions which are performing angioplasty and billing the patients have been instructed to mention cost of cardiac catheters, balloon catheter and guide wire separately along with their respective brand name, if any, name of the company, batch number and specifications in order to bring in greater transparency in the billing and monitoring of compliance with the Maximum Retail Prices (MRPs) by the NPPA under Para 20 of Drugs (Prices Control) Order, 2013 (DPCO, 2013).

(f) Government has alerted all the State Governments/UTs and State Drugs Controllers to monitor the availability of stents and to report to NPPA, in case any adverse report on availability or pricing is noticed. NPPA has also requested aggrieved persons to send verifiable information / complaint to NPPA on helpline number of NPPA and through online complaint mechanism –Pharma Jan Samadhan. Government has also directed all stent manufacturers / importers to ensure adequate supplies to hospitals and to maintain the production volume as existed prior to price fixation. Government / NPPA held discussions with the stent companies which in turn have ensured availability of stents at notified ceiling price. Further, Government has also invoked para 3 of the DPCO, 2013 directing manufacturers to maintain the production level.

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