Revision of Rates for Permission/ Reimbursement of Cost of Neuro- implants under CGHS

 F. No. Z15025/44/2023/DIR/CGHS/EHS (Comp No. 8253711)

I/3705508/2024

Government of India Ministry of Health & Family Welfare

Department of Health & Family Welfare

 

Nirman Bhawan, New Delhi

Dated 09-09-2024

 

OFFICE MEMORANDUM

 

Subject: Revision of Rates for Permission/ Reimbursement of Cost of Neuro- implants under CGHS

In supersession of the Office Memorandum dated 04.12.2008, 8.12.2014 and 09.07.2018 regarding the permission/approval for reimbursement of the cost of Neuro-implants, including Deep Brain Stimulation (DBS) Implants, Intra-thecal Pump, and Spinal Cord Stimulators for CGHS beneficiaries and those covered under CS(MA) Rules, 1944, it has now been decided to revise the rates of Neuro- implants. The terms and conditions for permission/ reimbursement are:

2.   Prescribing Authority:

 

1	DBS Implant	Neurologist of a Government Hospital
2	Intra-Thecal Pump	Any two Government specialists of concerned Specialty / Head of Department of Neurology / Neuro - Surgery.
3	Spinal Cord Stimulator

3.   Approving Authority

 

a.   CGHS - Director CGHS

b.   CS(MA) Rules, 1944 - DDG(M) or equivalent level Officer of Directorate General of Health Services

4.   Approval Process:

 

The permission for approval for DBS and other Neuro Implants shall be accorded only after the request has been approved and recommended by the respective Standing Technical Committee as given under:

 

1	Addl. DG CGHS (in case of CGHS Beneficiaries)   or DDG(M)/(P), Dte.GHS (in case of CS(MA) Rules, 1944 beneficiaries) (as the case may be)						Chairperson
2	HoD Neurology/Neuro-surgery AIIMS, Delhi						Member
3	HoD Neurology/Neuro-surgery R&R Hospital						Member
4	HoD Neurology/Neurosurgery Safadarjung Hospital						Member
5	HoD	Neurology/Neurosurgery	ABVIMS	&	Dr.	RML	Member

	Hospital
6	HoD Neurology/Neurosurgery G.B. Pant Hospital	Member
7	AD (R&H) CGHS Delhi (in case of CGHS Beneficiaries) or Addl.    DDG   (MG-II) (in case of CS(MA) Rules, 1944 beneficiaries)	Member Secretary
Instructions for Committee:   Recommendation of a Minimum of 3 subject field experts (Neurology/Neurosurgery Specialist) shall be required for justification of the case. The committee shall contain at least One Neurologist and One Neuro- surgeon. All rejections to be recorded carefully with well justified reasons.   The technical committee shall consider cases in respect of beneficiaries under CGHS/ CS(MA) Rules, 1944.

 

5.   Submission of Application:

 

The beneficiaries under CGHS/CS(MA) Rules, 1944 will submit a request for permission for DBS or other neuro implants to the Standing Technical Committee through their respective department in case of serving employees and the Additional Director, CGHS of the concerned zone or city, in case of pensioner CGHS Beneficiary.

 

 

6.   Reimbursement Criteria

 

The DBS and other neuro implants are planned surgery and therefore, prior permission has to be obtained before the surgery is undertaken. The financial approving authority shall be as per extant rules of Delegation of Financial Powers.

 

7.   Ceiling Rate

 

Device Type	Revised Cost (INR) Inclusive of GST
DBS-Non-Rechargeable Device with Non-Directional Leads (Battery Life 5-8 years)	₹8,37,497
DBS-Non-Rechargeable Device with Directional Leads (Battery Life 5-8 years)	₹10,32,586
DBS-Rechargeable Device with Non-Directional Leads (Minimum Battery Life 15 years)	₹11,24,049
DBS-Rechargeable Device with Directional Leads (Minimum Battery Life 15 years)	₹13,89,936
New Battery (Implantable Pulse Generator) (Battery Life 5-8 years)	₹5,49,450

 

Intra-thecal Pump (Minimum Battery Life 7 years)	₹5,29,898
Spinal Cord Stimulator (Minimum Battery Life 10 years)	₹13,90,243

*The above-mentioned ceiling rate does not include the cost of surgery.

 

8.   Guidelines/Indication:

 

Same as the conditions given under the section of ‘Intended use’ (Annexure-I, II and III) contained in the licence granted (Form MD-15) by the Central Drugs Standard Control Organization, under Rule 36 of Medical Devices Rules 2017.

9.   Warranty:

The company shall offer a limited warranty for one year from the date of implantation, providing free replacement in the case of battery failure or device malfunction, as reported by the concerned physician.

10.   Validity of rates:

 

The revised rates shall remain in force for a period of two years from the date of issuance of this Office Memorandum.

This issue is with the approval of competent authority and concurrence of the IFD vide C.D No. 1467 dated 16.08.2024.

(Hemlata Singh) Under Secretary to the Government of India

Tel 011-23061778

To

1.   All Ministries and Departments of the Government of India through the CGHS website

2.   Addl. Director, CGHS(HQ)/ Addl. DDG(CGHS)/ Addl. Directors, CGHS of Cities / Zone.

3.   All CGHS Wellness Centres through concerned AD, CGHS

4.   MCTC, CGHS with the request to upload the document on CGHS Website (www.cghs.gov.in).

5.   Director, AIIMS as per list; JIPMER, Puducherry; PGIMER, Chandigarh;

6.   DDG NIC Health

7.   Sh. Jitendra Singh, CDAC, Noida

8.   LACs/ ZACs through Addl. Directors, CGHS.

 

 

Copy of Information to:

1.   PPS to Secretary (H&FW), MoHFW

2.   PPS to Secretary (Personnel), DoPT, MoP,PG&P

3.   PPS to Secretary(DARPG &DoPPW), MoPPG&P

4.   PPS to AS & DG CGHS

5.   PPS to JS (MoHFW), CGHS

 

(Hemlata Singh) Under Secretary to the Government of India

Tel 011-23061778

 

 

 

Annexure I

 

 

Extract from Form MD 15 of DBS Therapy

Intended Use: DBS Therapy for Movement Disorders is indicated for stimulation of the ventral intermediate nucleus (VIM) for patients with disabling essential tremor or Parkinsonian tremor, or stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) for patients with symptoms of Parkinson's disease. Studies have shown that deep brain stimulation with the DBS Therapy system is effective in controlling essential tremor and symptoms of Parkinson's disease that are not adequately controlled with medications. Additionally, deep brain stimulation is effective in controlling dyskinesias and fluctuations associated with medical therapy for Parkinson's disease. DBS Therapy for Movement Disorders is also indicated for stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis) for individuals 7 years of age and older. DBS Therapy for Epilepsy Bilateral anterior thalamic nucleus (ANT) stimulation using the DBS System for Epilepsy is indicated as adjunctive therapy for reducing the frequency of seizures in adults diagnosed with epilepsy characterized by partial-onset seizures, with or without secondary generalization, that are refractory to antiepileptic medications

****

 

 

 

 

Annexure II

 

Extract from Form MD 15 of Spinal Cord Stimulator

Intended Use: Neurostimulation for spinal cord stimulation (SCS) - The SCS neurostimulation system is indicated for SCS as an aid in the management of the following conditions: chronic, intractable pain of the trunk and/or limbs. stable intractable Angina Pectoris in patients who are not candidates for revascularization, stable intractable Peripheral Vascular Disease of Fontaine Stage II or higher in patients who are not candidates for revascularization. Neurostimulation for Peripheral Nerve Stimulation.

****

 

 

 

 

 

Annexure III

 

Extract from Form MD 15 of Intra-Thecal Pump

Intended Use: (PNS) using percutaneous leads - A PNS neurostimulation system is indicated for PNS as an aid in the management of chronic, intractable pain of the posterior trunk. Neurostimulation for Peripheral Nerve Stimulation (PNS) using surgical leads - A PNS neurostimulation system is indicated for PNS as an aid in the management of chronic, intractable pain of the trunk and/or limbs.

****