Tag: Regulations

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Texas Medical Association Says Scrap ICD-10

 

Texas doctors, through the Texas Medical Association, submitted comments to HHS (Department of Health and Human Services) recommending HHS scraps the implementation of ICD-10 completely. (International Statistical Classification of Diseases and Related Health Problems, 10th Edition).

Original article: Healthcare business news and research ModernHealthcare Article – Texas Suggests Scrapping ICD-10

The Texas Medical Association makes some really good points.

  1. ICD-10 has been around since the mid-1990?s and the US is just now getting around to ?officially? adopting them. Given that that ICD-11 is due in 2015, and the costs/benefits of going to ICD-10 are minimal vs. going straight to ICD-11, it?s just makes sense to go straight to ICD-11.
  2. ICD-11 is being revised using Web 2.0 principles and designed specifically for incorporation into electronic medical health records.
  3. Given that it?s taken more than 20 years to move from ICD-9 to ICD-10, this makes even more sense. Why adopt ICD-10 just in time to be replaced with a better standard?

Another great point, ?HHS should recognize that the costs of going to ICD-11 directly are less than incurring the remaining costs of implementing ICD-10 in 2013 and then implementing ICD-11 sometime soon thereafter.”

TMA is not alone as the American Medical Association, a host of state medical groups and medical specialty societies, submitted their own comments calling for at least a one-year delay in ICD-10 implementation.

One can always hope for common sense to prevail, can?t they? In any case, the implementation deadlines are looming and the US will be moving to a new standard; are you ready?

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Update on Sunshine Act Compliance Deadlines

Back in December I wrote a blog post about the Centers for Medicare & Medicaid Services (CMS) rule change for reporting on the Physicians Payment Sunshine Act. Original post here: http://i3.infinityinfo.com/blogs/entry/sunshine-act-compliance-deadlines-extended

The CMS had decided to extend the data collection start date from January 1, 2012 to ?some later date?. A few days ago, on May 3, the CMS provided some updated information in their blog (The CMS Blog). During the extended comment period they received over 300 comments. that?s a good thing that people are voicing their concerns.

The CMS still hasn?t issued a final date but says in their blog ?CMS will not require data collection by applicable manufacturers and applicable group purchasing organizations before January 1, 2013? and ?CMS intends to release the final rule later this year?.

Some news is better than no news. The window is closing though for companies that will be required to report this information to the FDA. Time is ticking. We have helped a number of companies ensure their systems and processes are up date and compliant. If you are struggling with these rules, give us call, we are happy to help you too!

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HHS Announces New Compliance Dates for ICD-10

In February this year we heard that Health and Human Services (HHS) was going to delay implementing ICD-10 diagnostic codes (International Statistical Classification of Diseases and Related Health Problems, 10th Revision, or ICD-10). At that time HHS did not announce a new date. You can read more from my related blog post here.

Yesterday, April 9, HHS posted that Healthcare Practitioners and Organizations would have until October 1, 2014 ? providing another year for compliance.Change to the Compliance Date for ICD-10-CM and ICD-10-PCS Medical Data. The deadline was extended in response to physician complaints about the administrative burden of converting to ICD-10.

In 2009, the Centers for Medicare and Medicaid Services (CMS) ordered the change from the ICD-9 code set, which is now in use, to ICD-10, as part of implementing the Health Insurance Portability and Accountability Act. The American Medical Association (AMA) would prefer that HHS implements a more physician friendly replacement, however, HHS has spoken?and so it shall be.  Public comments about the proposed regulations will be accepted for 30 days from publication in the Federal Register. Submit your comments to be heard.

I?m not yet convinced a change from approximately 13,000 diagnostic codes used today, to more than 68,000 codes are going to ?improve the quality of care? and “lead to improved accuracy for reimbursement for medical services, fraud detection, and historical claims and diagnosis analysis.”  In my experience, simplification (remember KISS) is the better approach. We shall see.

At least there is some common sense in this decision and gives Healthcare Practitioners a little breathing room. A year goes by very quickly though, so no time to rest for the weary.

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FDA Updates Social Media Guidelines for Pharmaceutical and Medical Device Industry

 

The FDA recently announced (some) updated social media guidelines for pharmaceutical and medical device firms. The actual title of these imageguidelines are ?Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices?.

This is still considered Draft Guidance and is an update to previously released guidance. This is, however, the first time the FDA mentions ?emerging electronic media? with specific examples related to YouTube and Twitter.

The full FDA Draft Guidance can be downloaded here: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM285145.pdf

The document is fairly short (12 pages), by government standards, and I highly recommend you read the whole thing if you are responsible for sales, marketing or customer service for pharmaceuticals or medical devices.

I will point out some important bits below, particularly, related to responses as outlined in the FDA document. This is particularly important for maintaining compliance and is a great example of why CRM systems are very important for social media interactions and staying compliant with regulations.

V. RESPONDING TO NON-PUBLIC UNSOLICITED REQUESTS FOR OFF-LABEL INFORMATION DIRECTED TO DRUG OR MEDICAL DEVICE FIRMS

1. Information distributed in response to an unsolicited request should be provided only to the individual making the request directly to the firm as a private, one-on-one communication.

2.  Information distributed in response to an unsolicited request should be tailored to answer only the specific question(s) asked.

3.  Information distributed in response to an unsolicited request should be truthful, non-misleading, accurate, and balanced.

4.  Information distributed in response to an unsolicited request should be scientific in nature.

5.  Responses to unsolicited requests for information should be generated by medical or scientific personnel independent from sales or marketing departments.

6.. Information distributed in response to an unsolicited request should be accompanied by the following:

  • A copy of the FDA-required labeling, if any, for the product (e.g., FDA-approved package insert and, if the response is for a consumer, FDA-approved patient labeling or, for new animal drugs, FDA-approved client information sheet)
  • A prominent statement notifying the recipient that FDA has not approved or cleared the product as safe and effective for the use addressed in the materials provided
  • A prominent statement disclosing the indication(s) for which FDA has approved or cleared the product
  • A prominent statement providing all important safety information including, if applicable, any boxed warning for the product
  • A complete list of references for all of the information disseminated in the response (e.g., a bibliography of publications in peer-reviewed medical journals or in medical or scientific texts; citations for data on file, for summary documents, or for abstracts)

7. A firm should maintain the following records:

  • The nature of the request for information, including the name, address, and affiliation of the requestor
  • Records regarding the information provided to the requestor
  • Any follow-up inquiries or questions from the requestor

VI. RESPONDING TO PUBLIC UNSOLICITED REQUESTS FOR OFF-LABEL INFORMATION, INCLUDING THOSE ENCOUNTERED THROUGH EMERGING ELECTRONIC MEDIA BY DRUG OR MEDICAL DEVICE FIRMS

1.  If a firm chooses to respond to public unsolicited requests for off-label information, the firm should respond only when the request pertains specifically to its own named product (and is not solely about a competitor?s product).

2.  A firm?s public response to public unsolicited requests for off-label information about its named product should be limited to providing the firm?s contact information and should not include any off-label information.

  • The firm?s public response should convey that the question pertains to an unapproved or un-cleared use of the product and state that individuals can contact the medical/scientific representative or medical affairs department with the specific unsolicited request to obtain more information.
  • The firm?s public response should provide specific contact information for the medical or scientific personnel or department (e.g., e-mail address, telephone number, facsimile) so that individuals can follow up independently with the firm to obtain specific information about the off-label use of the product through a non-public, one-on-one communication.

The customer service module within Dynamics CRM is particularly well suited to helping your team monitor, respond, and document social media interactions. We have a lot experience helping companies maintain compliance with regulations using CRM. If you need help, just call or fill out the request below and let us know.