Sunshine Act to Begin August 1, 2013

Print This Post

Medical device manufacturers will be tracking and reporting financial interactions with licensed physicians and teaching hospitals. Starting on August 1, 2013 all payments or other transfers of value exceeding $10.00 to covered recipients (physicians and teaching hospitals) must be reported to CMS. Follow the link for additional information.

http://www.jdsupra.com/legalnews/getting-ready-for-the-physician-payment-63094/

CMS is Proposing Major Changes to its coverage of IDE Trials

Print This Post

The proposed change was announced in the 2014 Proposed Physician Fee Schedule. While some of the changes are beguiling, the heart of the change makes it quite likely that FDA clinical trials of the type that you have done historically will no longer be covered.

The beguiling part is that CMS is proposing to centralize review of coverage requests. This could mean no more dealing with the individual MACs and (possibly) dealing directly with CMS instead of through sites and investigators.

However, the standards for coverage which CMS is proposing have rarely, if ever, been met in the IDE trials with which we are familiar. There are two standards of particular note.

The first is proposed section 405.212(a)(1), which says that to be eligible for coverage, “The principle purpose of the study is to test whether the item or service meaningfully improves health outcomes of patients who are represented by Medicare-enrolled subjects.” This standard is problematic for several reasons including that IDE trials as they have been conducted to date would not meet it.

The second is CMS preference for “superiority” clinical trial design. While its not clear that only “superiority” trials will be covered, the proposed regulation stats a clear preference for them. In the regulation it states that trials having superiority design (and meeting all other conditions) “are covered,” but states only that trials meeting all other conditions “may be covered.”

We believe these proposed new standards essentially change the game from one in which CMS covers most IDE trials to one in which CMS is attempting to change the nature of an IDE trial in order to qualify for coverage. The changed nature of the trial may not even satisfy the FDA purposes for doing the trial. We think these changes would disrupt the medical device innovation process indefinitely.

If you agree with us we urge you to make your opinion known to CMS via the formal comment process. Comments are due September 6, 2013. Comments should be made in response to the 2014 Proposed Physician Fee Schedule. You may submit comments is one of the following ways:

Electronically: you may submit electronic comments on this regulation to http://www.regulations.gov. Follow the instructions for “submitting a comment.”

By Regular Mail: You may submit written comments to the following address only:

Centers for Medicare & Medicaid Services,
Department of Health and Human Services.
Attention: CMS-1600-P,
P.O. Box 8016,
Baltimore, MD 21244-8016

By Express or Overnight Mail: You may send written comments via express or overnight mail to the following address ONLY:

Centers for Medicare & Medicaid,
Department of Health and Human Services.
Attention: CMS-1600-P,
Mail Stop C4-26-05,
7500 Security Boulevard,
Baltimore, MD 21244-1850

Please contact us for more information.

Comments for PFS, HOPD/ASC Proposed Regs. Due to CMS 9/6/2013

Print This Post

You may submit your comments for the PFS  Proposed Rule in one of these ways (no duplicated please):

Electronically:  You may (and we encourage you to) submit electronic comments on this regulation to http://www.regulations.gov.  Follow the instructions under the “submit a comment” tab.

By Regular Mail:  You may mail written comments to the following address ONLY:

Centers for Medicare and Medicaid Services,
Department of Health and Human Services.
Attention: CMS-1600-P,
P.O. Box 8016,
Baltimore, MD 21244-8016

By Express or Overnight Mail:  You may send written comments via express or overnight mail to the following address ONLY:

Centers for Medicare and Medicaid Services,
Department of Health and Human Services.
Attention: CMS-1600-P,
Mail Stop C4-26-05,
7500 Security Boulevard,
Baltimore, MD 21244-1850

You may submit your comments for the  HOPD/ASC Proposed Rule in one of these ways (no duplicates please):

Electronically: You may (and we encourage you to) submit electronic comments on this regulation to http://www.regulations.gov.  Follow the instructions under the “submit a comment” tab.

By Regular Mail: You may mail written comments to the follow address ONLY:

Centers for Medicare & Medicaid Services,
Department of Health and Human Services.
Attention: CMS-1601-P,
P.O. Box 8013,
Baltimore, MD 21244-1850

By Express or Overnight Mail: You may send written comments via express or overnight mail to the following address ONLY:

Centers for Medicare & Medicaid Services,
Department of Health and Human Services.
Attention: CMS-1601-P,
Mail Stop C4-26-05,
7500 Security Boulevard,
Baltimore, MD 21244-1850

Proposed Rule for 2014 Payment Rates

Print This Post

CMS has released the proposed rule for 2014 payment rates for Outpatient Hospital, Ambulatory Surgery Center and Physician. Comments are due 9/6/2013. For more information, contact Reimbursement Principles or visit the CMS website: www.cms.gov

Implementation of the Award for the Jurisdiction E Medicare Administrative Contractor

Print This Post
The Centers for Medicare & Medicaid Services (CMS) has awarded the jurisdiction E (JE) A/B Medicare administrative contractor (MAC) contract for the administration of the Part A and Part B Medicare fee-for-service claims in the states and territories of California, Hawaii, Nevada, American Samoa, Guam and the Northern Marianas to Noridian Administrative Services, LLC (NAS). The JE workloads (known as jurisdiction 1) are currently being processed by Palmetto Government Benefit Authorizers (PGBA). NAS’ address is:
Noridian Administrative Services, LLC
900 42nd Street
South Fargo, North Dakota 58103
For more information about this change, here is the link to the CR 8226 external pdf file.

ICD-9-CM Coordination & Maintenance Committee Meeting

Print This Post

Registration for the March 5, 2013 ICD-9-CM Coordination and Maintenance Committee meeting is open.  You can register at the following link:

https://www.cms.gov/apps/events/upcomingevents.asp?strOrderBy=1&type=3

AMA Lobbying Policy and CPT Code Criteria

Print This Post

AMA’s lobbying policy and criteria for CPT code applications are now in effect; for more detail go to the AMA website:

http://www.ama-assn.org/ama/pub/physician-resources/solutions-managing-your-practice/coding-billing-insurance/cpt/applying-cpt-codes.page

Advisory Panel on HOPPS

Print This Post

Registration for the March 11-12, 2013 ICD-9-CM Advisory Panel on Hospital Outpatient Payment (HOP Panel) meeting is open.  You can register at the following link:

https://www.cms.gov/apps/events/upcomingevents.asp?strOrderBy=1&type=3

2013 Physician Fee Schedule

Print This Post

The Centers for Medicare and Medicaid Services (CMS) issued a final rule with comment period on November 1, 2012 for Medicare’s payments for physician fees for 2013.  It includes a new policy to pay a patient’s physician or practitioner to coordinate the patient’s care in the 30 days following a hospital or skilled nursing facility stay.  For additional information on this release, please contact us.

The 2.3% Excise Tax on Medical Devices

Print This Post

On January 1, 2013, the 2.3% excise tax on certain medical devices will take effect.  The tax was imposed as part of the Affordable Care Act and primarily applies to medical device manufacturers and distributors.  Please contact Reimbursement Principles for more information regarding the tax and the effects it will have on your business.

http://www.mddionline.com/article/medical-device-tax-101

Page 4 of 512345