Category Archives: Uncategorized

Dear Doctor Letter – risk evaluation & m

Dear Doctor Letter – risk evaluation & mitigation strategy for serious adverse effects from melanoma drug Yervoy is here: http://ow.ly/4uMMn

The Right to Complain – Medicare/Medicaid Rules Require More Notice

Today, the Centers for Medicare & Medicaid Services (CMS) released proposed new regulations that would expand the scope of notice that healthcare facilities are required to provide when they treat patients who are Medicare or Medicaid beneficiaries. 

As the law now stands, only hospitals where Medicare/Medicaid patients are treated as inpatients are required to let the patients know they can complain to a Quality Improvement Organization (QIO) if they take issue with the care provided to them in those facilities.  Patients might, for example, receive this notice as one of the forms they or their representatives must read and sign at the time of hospital admission.

The proposed CMS Rule requires that healthcare facilities which are not hospitals must also give patients the same notice of the right to complain.  This change would affect healthcare facilities such as ambulatory surgery centers, home health agencies, rehab facilities, hospices, long-term care facilities, physical/speech therapy centers, portable X-ray service providers and rural clinics.  Dialysis centers are exempt from this requirement.

QIOs are private organizations with doctors and other health care professionals on staff to review medical care, investigate complaints about the quality of care and implement improvements in the overall quality of care. There is at least one QIO located in every state.   The most recent listing of organizations that function as QIOs is here.

 The theory behind the new rule is that informing patients about their right to complain, not just about hospital care but about home health agencies or other forms of outpatient care as well will give the QIOs more insight into the performance of all these players in the managed care system.  In return, this should lead to better patient care and, in theory, reduce costs and eliminate waste in the Medicare/Medicaid system.  However, the  requirement to document that notice has been given might also increase the paperwork burden on small healthcare providers and perhaps expose them to cost-cutting in reimbursements that may not be justified.

The proposed rule is here

CMS is interested to know whether notice should be given after treatment as well as before treatment.  Comments from the public will be accepted until April 3, 2011.

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FDA just announced it will hold an open

FDA just announced it will hold an open public meeting on food additives. Details to follow..

The Senate passed the food safety bill t

The Senate passed the food safety bill today with a bipartisan vote of 73-25. http://ow.ly/3hJ8k

Senate just deferred the final vote on t

Senate just deferred the final vote on the Food Safety Amendments bill to tomorrow.

Senate Bill 3978: Home health agencies c

Senate Bill 3978: Home health agencies can assign 1st assessment of Medicare patients needing rehab to a skilled service. http://ow.ly/3hdL9

This group’s blog lists the alleged cam

This group’s blog lists the alleged campaign contributions made for or against the Food Safety Bill S 510: http://ow.ly/3hckC

Food safety bill: includes amendments no

Food safety bill: includes amendments not related to food, e.g tax reporting and earmarks. See next post.

FDA food safety bill goes to final Senat

FDA food safety bill goes to final Senate vote @ 6:30 pm ET. More to follow on what’s included.

NIH solicited proposals for research on

NIH solicited proposals for research on therapies for rare/neglected diseases today; applications due 12/6/10. http://ow.ly/33y0i