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Renal Dialysis Faculties Encouraged to Review Current Protocols for Administering Erthropoiesis-Stimulating Agents

November 6, 2009

Renal Dialysis Facilities are encouraged to review and consider the advisability for further tightening of their current practices in light of the Renal Dialysis Facilities’ Dosage Protocols for Administering Erthropoiesis-Stimulating Agents, (OEI-03-09-00010), posted by the OIG this week.

According to the report, OIG conducted the report in response to a request from Chairman Fortney Pete Stark of the Subcommittee on Health, Committee on Ways and Means, U.S. House of Representatives in response to reported concerns by some members of Congress that dialysis facilities’ protocols for administering ESAs may not be consistent with the current boxed warning for these drugs.

OIG found that 93 percent of Medicare-certified dialysis facilities had protocols in place for administering erythropoiesis-stimulating agents (ESA), but only 56 percent of the facilities’ protocols explicitly state a target hemoglobin range. OIG could not determine whether the remaining 44 percent of protocols were consistent with the boxed warning and Medicare’s benefit policy because they do not specify a target hemoglobin range. Of the protocols that state a target hemoglobin range, 94 percent are consistent with the boxed warning on FDA-approved labeling and the Medicare benefit policy for ESAs.

While noting they are not required to do so, OIG commented that dialysis facilities may develop their own protocols for administering ESAs to patients with chronic kidney failure. The protocols may define target hemoglobin levels and dosage instructions for administering ESAs. According to the boxed warning on ESAs’ labels, maintaining higher rather than lower hemoglobin levels in a patient with chronic kidney failure can adversely affect the patient’s health and increase the risk of death. Specifically, the boxed warning states that providers should administer ESAs “to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.” The Medicare benefit policy for ESAs reflects the target hemoglobin range specified in the boxed warning. A separate Medicare policy for monitoring ESA payments states that CMS will reduce reported dosages upon which ESA claims are paid when patients’ hemoglobin levels exceed 13g/dL.

OIG reported its review of protocols to determine whether they are consistent with selected guidelines on ESAs’ labels revealed that some protocols contain information that differs from labeling guidelines regarding starting doses, dose adjustments, and withholding ESA doses. OIG also found that all of the protocols that include a target hemoglobin range or level at which to increase ESA doses conform with CMS’s monitoring policy.

OIG concluded that although its review does not address the amount of ESAs that providers actually administer to patients at their dialysis facilities, it does demonstrate that just over half of facilities’ protocols for administering ESAs are consistent with the boxed warning and Medicare’s benefit policy for ESAs. However, since almost half of the dialysis facilities either did not have protocols or did not specify a target hemoglobin range in their protocols, OIG reported it could not determine whether these facilities’ policies target the hemoglobin range outlined in the boxed warning that FDA requires on ESA labels.

For More Information

We hope that this information is useful to you. If you need assistance with these or other health care public policy, regulatory, compliance, risk management, workforce and other staffing, transactional or operational concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270‑2402, cstamer@cttlegal.com. Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health industry and other reimbursement, operations, internal controls and risk management matters. You can review other recent health care and related resources and additional information about the health industry and other experience of Ms. Stamer here.

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here or e-mailing this information here, by subscribing to receive these updates in blog form here and/or by participating in the SLP Health Care Risk Management & Operations Group on LinkedIn. To unsubscribe, e-mail here.

Leave a Comment » | Evidence Based Medicine, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Hospital, Medicaid, Medicare, OIG, Reimbursement, Stark | Tagged: Dialysis, Health Care, HHS, Kidney, OCR, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer

North Texas Healthcare Compliance Professional Association Meets Nov. 10 At Medical City

November 6, 2009

Note New Meeting Time And Change Of Room Location!!!

November 10, 2009 Meeting Announcement & Agenda

3:00 – 5:00 p.m.

Medical City Hospital Cafetorium in Building A next to the Cafeteria

7777 Forrest Lane, Dallas, Texas

The North Texas Healthcare Compliance Professional Association invites members and other interested health industry compliance professionals to its November 10, 2009 meeting to be held from 3:00 – 5:00 p.m. in the Cafetorium located in Building A next to the cafeteria at Medical City, 7777 Forrest Lane, Dallas, Texas. Please note the adjusted time and room location for this meeting!

Topics to be discussed include:

An update on modifications/upgrades in Group One’s Compliance Check and the ability to use the Data Initiative to pull RAC specific indicators and a dashboard in development for Compliance Officer use from Kristin Jenkins of the Dallas/Hospital Council; and
An update on “Emerging Issues & Trends in Medical Practice Valuations” by Don Barbo, Health Care Valuation Services Director, MidAmerica, Deloitte Financial Advisory Services, LLP.

Complementary participation in the meeting is open to all NTHCPA members and other interested health care compliance professionals. Please feel free to share this invitation with others who may be interested.

NTHCPA thanks Texas Health Resources for hosting the October 13, 2009 Meeting and Medical City for hosting the November 10, 2009 meeting.

If you are interested in hosting one of the upcoming meetings, wish to suggest topics or speakers, or wish to obtain or share other information, please contact NTHCPA Vice-President Cynthia Marcotte Stamer at (214) 270-2402 or by e-mail at cstamer@solutionslawyer.net.

We look forward to seeing you at the meeting!

About the NTHCPA

The vision of NTHCPA is to be a pre-eminent compliance and ethics group promoting lasting success and integrity of organizations within North Texas.

To register or update your registration or to receive notice of future meetings, e-mail here.

This communication may be considered a marketing communication for certain purposes. If you wish to update your e-mail for purposes of or would prefer not to receive future e-mail concerning meetings or other activities of the North Texas Healthcare Compliance Professionals Association or other marketing and promotional mailings from it, please send an email with the word “unsubscribe” in its subject heading here.

Leave a Comment » | Health Care, Health Care Fraud, Health Care Provider | Tagged: Health Care, Health Care Compliance | Permalink
Posted by Cynthia Marcotte Stamer

2010 Medicare Part B Monthly Premium Rate, Annual Part B Deductible & Actuarial RatesAnnounced

October 27, 2009

The Centers for Medicare & Medicaid Services recently announced that the monthly premiums, actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program that will apply for calendar year 2010.

The rates announced here in the Federal Register on October 22, 2009 are as follows:

The monthly actuarial rates for 2010 are $221.00 for aged enrollees and $270.40 for disabled enrollees. The standard monthly Part B premium rate for 2010 is $110.50, which is up from the 2009
standard premium rate of $96.40.)
The Part B deductible for 2010 is set at $155.00 for all Part B beneficiaries.

A beneficiary who has to pay an income-related monthly adjustment may have to pay a total monthly premium of roughly 35, 50, 65 or 80 percent of the total cost of Part B coverage.

For More Information

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here or e-mailing this information here and/or by participating in the SLP Health Care Risk Management & Operations Group on LinkedIn. To unsubscribe, e-mail here.

Leave a Comment » | Health Care, Health Care Finance, Medicare, Physician, Uncategorized | Tagged: Health Insurance, Medicare, Medicare Part B, Physician, Physicians, Prescription Drugs | Permalink
Posted by Cynthia Marcotte Stamer

2010 Medicare Hospital (Part A) Premiums, Inpatient Deductibles & Copays Announced

October 27, 2009

The Centers for Medicare & Medicaid Services (CMS) recently announced that the Medicare Hospital Insurance (Part A) premium for uninsured enrollees in calendar year (CY) 2010 for the 12-month period beginning January 1, 2010 will be $461. This premium is paid by enrollees age 65 and over who are not otherwise eligible for benefits under Medicare Part A (hereafter known as the “uninsured aged”) and by certain disabled individuals who have exhausted other entitlement. In some instances, certain of these individuals may qualify for a reduced premium of $254. You can read more about the uninsured enrollee premium here.

Concurrently, CMS also announced that the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year (CY) 2010 under Medicare’s Hospital Insurance Program (Medicare Part A). For CY 2010, these amounts are as follows:

The inpatient hospital deductible will be $1,100.
The daily coinsurance amounts for CY 2010 will be:

ü $275 for the 61st through 90th day of hospitalization in a benefit period;

ü 550 for lifetime reserve days; and

ü 137.50 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.

The Social Security Act (the Act) requires the subtraction of an inpatient hospital deductible and certain coinsurance amounts from the amount otherwise payable under Medicare Part A. The coinsurance and deductible amounts are calculated based on a statutory formula. You can review the CMS announcement of these copayment and deductible amounts here.

Leave a Comment » | Health Care, Health Care Finance, Health Care Provider, Hospital, Medicare | Tagged: Copayments, Deductible, Hospital, Medicare, Medicare Part A, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer

CMS Renews Community Health Accreditation Program Authority To Accredit Hospices

October 24, 2009

The Centers for Medicare & Medicaid Services will continue to recognize the Community Health Accreditation Program (CHAP) as a national accreditation program for hospices seeking to participate in the Medicare or Medicaid programs for the period from November 20, 2009 though November 20, 2012. CMS announced its decision to conditionally approve the continuation of CHAP’s accreditation status with a 180-day probationary period on October 23, 2009 here.

For More Information

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here or e-mailing this information here and/or by participating in the SLP Health Care Risk Management & Operations Group on LinkedIn. To unsubscribe, e-mail here.

Leave a Comment » | Health Care, Health Care Finance, Health Care Provider, Health Care Quality | Permalink
Posted by Cynthia Marcotte Stamer

Senate Finance Committee Releases Statutory Language of America’s Healthy Future Act To Present To Full Senate

October 22, 2009

Americans finally have a chance to read the actual statutory language of the painfully negotiated package of proposed health care reforms that the Senate Finance Committee proposes for adoption. The Senate Finance Committee leadership finally finished drafting has posted the 1506 page long text of the proposed statutory language of the health care reform provisions of the “America’s Healthy Future Act” on its website here.

When the Senate Finance Committee vote passing the America’s Health Future Act, members of the Senate Finance Committee had not yet had the opportunity to review the actual statutory language to be proposed to implement the package of heatlh care reforms painfully hashed out in their committee. As the actual statutory language had not been completed at the time a majority of the Democrats and one Republican Senator serving on the Senate Finance Committee voted to send the legislation to the the full Senate, the vote actually was taken based on a narative description of the intended reforms set forth in a revised draft of the “Chairman’s Mark” of the legislation. Since that time Senate Finance Committee Chairman Max Baucus and other key Democrat Senators on the Senate Finance Committee have worked behind closed doors to prepare the actual statutory language to be presented to the full Senate.

As proposed, the America’s Healthy Future Act would require sweeping changes to the U.S. health care systems that if adopted will radically impact the roles and responsibilities of every patient, health care provider, health care payor, employer and other American. Because of the potential implications on the way health care is financed, delivered and administered and the projections that the legislation will cost approximately $1 Trillion, all parties are urged to carefully review the complex and lengthy legislation to gain an understanding of the legislation and to act quickly to make any concerns known to elected leaders in Congress.

For More Information

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here or e-mailing this information here and/or by participating in the SLP Health Care Risk Management & Operations Group on LinkedIn. To unsubscribe, e-mail here.

Leave a Comment » | America's Healthy Futures Act, Anti-KickBack, ASC, Childrens Health Insurance Program, Consumer Driven Health Care, Doctor, Electronic Medical Records, Employer, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, Health Insurance Exchange, Health IT, Health Plan, Health Plans, Hospital, Indian Health, Inpatient Rehabilitation Facility, Medicaid, Medical Licensure, Medical Malpractice, Medicare, Medicare Advantage, Mental Heatlh, OIG, Physician, Prescription Drugs, Reimbursement, Rural Health Care | Permalink
Posted by Cynthia Marcotte Stamer

CMS Proposes Changes To Medicare Advantage and Medicare Prescription Drug Program Rules

October 22, 2009

December 8, 2009 is the deadline for interested persons to submit comments on proposed changes to Medicare Advantage (MA) program (Part C) and prescription drug benefit program (Part D) regulations published by the Centers For Medicare & Medicaid Services (CMS) in today’s (October 22, 2009) Federal Register. If adopted as proposed, the Proposed Regulations would:

Clarify various program participation requirements;
Implement changes CMS intends to strengthen beneficiary protections and ensure that plan offerings to beneficiaries include meaningful differences;
Change plan payment rules and processes; and
Implement a new Part D formulary policy and other policy changes.

To review the Proposed Regulations or for instructions on submitting comments, see here. If you need assistance with these or other Medicare Advantage or other health care public policy, regulatory, compliance, risk management, workforce and other staffing, transactional or operational concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270 2402, cstamer@cttlegal.com, Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health industry and other reimbursement, operations, internal controls and risk management matters. We hope that this information is useful to you. If you found this information of interest, you also may be interested in reviewing some of the following recent Solution Law Press Health Care Updates available online here. You also can review other recent health care and related resources and additional information about the health industry and other experience of Ms. Stamer here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here, or e-mailing this information to cstamer@cttlegal.com, and/or by participating in the SLP Health Care Risk Management & Operations Group on LinkedIn. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here or e-mailing this information here. To unsubscribe, e-mail here. ©2009 Cynthia Marcotte Stamer. All rights reserved.

Leave a Comment » | Employer, Health Care, Medicare Advantage, Medicare Prescription Drug Program | Tagged: Health Care Policy, Health Care Reimbursement, Medicare, Prescription Drugs | Permalink
Posted by Cynthia Marcotte Stamer

Forms & Instructions To Provide HITECH Act-Required Notice To OCR Of Breach of Unsecured Protected Health Information Posted

October 15, 2009

The Department of Health and Human Services (HHS) Office of Civil Rights (OCR) recently posted online forms and instructions for submitting notice of breaches of unsecured protected health information to OCR required under new protected health information breach notification rules enacted under the Health Information Technology for Economic and Clinical Health (HITECH) Act.

Under Section 13402 of the Health Information Technology for Economic and Clinical Health (HITECH) Act as implemented by the Interim Final Breach Notification Regulations published by OCR in August, health care providers, health plans, and health care clearinghouses (covered entities) and their business associates within the meaning of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) must provide certain notifications within 60 days following discovery of a breach of unsecured protected health information to individuals whose protected health information was breached, OCR, and certain other parties. The new breach notification requirements apply to breaches occurring after September 23, 2009.

The required form to submit notice to and deadline for submitting notice to OCR depends on the number of affected individuals. For breaches affecting 500 or more individuals, notice of the breach must be submitted without unreasonable delay and no later than 60 days from the discovery of the breach. In other cases, notice to affected individuals still must be provided without unreasonable delay and within 60 days of discovery; but notification to CMS may be provided within 60 days of the end of the calendar year of discovery of the breach.

The author of this update, Curran Tomko Tarski LLP Partner Cynthia Marcotte Stamer has extensive experience advising covered entities, their business associates and others about HIPAA and other privacy and data security matters affecting covered entities and their business associates and has conducted training on the breach notification and other new HITECH Act rules and other HIPAA Privacy and Security matters. You can review her experience, learn how to access recordings of her presentations and other details here.

Other Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Solution Law Press Health Care Updates available online by clicking on the article title below:

For More Information

We hope that this information is useful to you. If you need assistance with these or other health care public policy, regulatory, compliance, risk management, workforce and other staffing, transactional or operational concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270‑2402, cstamer@cttlegal.com, Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health industry and other reimbursement, operations, internal controls and risk management matters.

Ms. Stamer has extensive experience in these and other health industry related representation. You can review other recent health care and related resources and additional information about the health industry and other experience of Ms. Stamer here.

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here, or e-mailing this information to cstamer@cttlegal.com, and/or by participating in the SLP Health Care Risk Management & Operations Group

Leave a Comment » | ARRA, Electronic Health Records, Health Care, Health IT, Health Plan, Health Plans, Health Policy, HIPAA, HITECH Act | Tagged: Data Breach, Health Care, HIPAA, HITECH Act, Unsecured Protected Health Information | Permalink
Posted by Cynthia Marcotte Stamer

North Texas Healthcare Compliance Professional Association Meets October 13

October 12, 2009

October 13, 2009 Meeting Invitation/Reminder & Updated Meeting Agenda

North Texas Health Care Compliance Professional Association’s invites you to its October 13, 2009 Meeting from 2:00 – 4:00 p.m. at the Texas Health Resources Pavilion.

The first portion of the program will feature a discussion by Kristin Jenkins from DFW Hospital Council of:

Modifications/upgrades in Group One’s Compliance Check processes; and
The ability to use the Data Initiative to pull RAC specific indicators and a dashboard in development for Compliance Officer use.

The second portion of the program will be a participatory Health Care Compliance Roundtable Discussion of Hot Topics moderated by the Erma E. Lee, JPS Health Network District Compliance Officer and NTPCA President. Topics to be discussed include:

HIPAA Data Breach;
Red Flag & Other Evolving Privacy & Data Security Obligations & Risks;
Office of Civil Rights Health Industry Disability & Other Civil Rights Enforcement;
Tax-Exemption Issues Including Proposed Form 990 and Exemption Reforms In Health Care Reform;
Health Care Fraud Enforcement; and
Other Hot Developments

NTHCPA invites interested persons to come catch up on these and other new developments and exchange thoughts and insights with other Health Care Compliance Professionals on Tuesday, October 13, 2009 from 2:00 – 4:00 p.m. in Classroom B of the Texas Health Resources Pavilion located at 612 E. Lamar Blvd., Arlington, TX. NTHCPA thanks Texas Health Resources for hosting this month’s meeting. For additional information, please contact NTHCPA Vice-President Cynthia Marcotte Stamer at (214) 270-2402 or by e-mail at cstamer@solutionslawyer.net. NTHCPA looks forward to seeing you there! About the NTHCPA NTHCPA exists to champion ethical practice and compliance standards and to provide the necessary resources for ethics and compliance Professionals and others in North Texas who share these principles. The vision of NTHCPA is to be a pre-eminent compliance and ethics group promoting lasting success and integrity of organizations within North Texas. To register or update your registration or to receive notice of future meetings, e-mail here . This communication may be considered a marketing communication for certain purposes. If you wish to update your e-mail for purposes of or would prefer not to receive future e-mail concerning meetings or other activities of the North Texas Healthcare Compliance Professionals Association or other marketing and promotional mailings from it, please send an email with the word “unsubscribe” in its subject heading to here.

Leave a Comment » | Health Care, Health Care Fraud, Health Care Provider, Health Care Quality, Uncategorized | Permalink
Posted by Cynthia Marcotte Stamer

North Texas Healthcare Compliance Association Meets October 13 at 2 p.m.

October 12, 2009

October 13, 2009 Meeting Invitation/Reminder & Updated Meeting Agenda

North Texas Health Care Compliance Professional Association’s invites you to join us for our October 13, 2009 Meeting from 2:00 – 4:00 p.m. at the Texas Health Resources Pavilion.

The first portion of the program will feature a discussion by Kristin Jenkins from DFW Hospital Council of:

Modifications/upgrades in Group One’s Compliance Check processes;
The ability to use the Data Initiative to pull RAC specific indicators and a dashboard in development for Compliance Officer use; and

HIPAA Data Breach, Red Flag & Other Evolving Privacy & Data Security Obligations & Risks
Office of Civil Rights Health Industry Disability & Other Civil Rights Enforcement
Tax-Exemption Issues Including Proposed Form 990 and Exemption Reforms In Health Care Reform
Health Care Fraud Enforcement
Other Hot Developments

NTHCPA thanks Texas Health Resources for hosting this month’s meeting. For additional information, please contact NTHCPA Vice-President Cynthia Marcotte Stamer at (214) 270-2402 or by e-mail at cstamer@solutionslawyer.net.

NTHCPA looks forward to seeing you there!

About the NTHCPA

The vision of NTHCPA is to be a pre-eminent compliance and ethics group promoting lasting success and integrity of organizations within North Texas.

To register or update your registration or to receive notice of future meetings, e-mail here .

Leave a Comment » | Uncategorized | Permalink
Posted by Cynthia Marcotte Stamer

North Texas Healthcare Compliance Professional Association To Meet At Texas Health Resources On October 13

September 29, 2009

NORTH TEXAS HEALTHCARE COMPLIANCE PROFESSIONAL ASSOCIATION

October 13, 2009 Meeting Reminder

2:00 – 4:00 p.m. at the Texas Health Resources Pavilion

North Texas Health Care Compliance Professional Association’s October 13, 2009 Meeting will feature a participatory Health Care Compliance Roundtable Discussion of Hot Topics moderated by the Erma E. Lee, JPS Health Network District Compliance Officer and NTPCA President on Tuesday, October 13, 2009 from 2:00 – 4:00 p.m at the Texas Health Resources Pavilion located at 612 E. Lamar Blvd., Arlington, TX. Topics to be discussed include:

HIPAA Data Breach, Red Flag & Other Evolving Privacy & Data Security Obligations & Risks
Office of Civil Rights Health Industry Disability & Other Civil Rights Enforcement
Tax-Exemption Issues Including Proposed Form 990 and Exemption Reforms In Health Care Reform
Health Care Fraud Enforcement
Other Hot Developments

Come catch up on these and other new developments and exchange thoughts and insights with other Health Care Compliance Professionals!

NTHCPA thanks Texas Health Resources for hosting this month’s meeting.

For additional information, please contact NTHCPA Vice-President Cynthia Marcotte Stamer at (214) 270-2402 or by e-mail at cstamer@solutionslawyer.net.

We look forward to seeing you there!

About the NTHCPA

The vision of NTHCPA is to be a pre-eminent compliance and ethics group promoting lasting success and integrity of organizations within North Texas.

To register or update your registration or to receive notice of future meetings, e-mail here .

Leave a Comment » | Anti-KickBack, ARRA, Disability Discrimination, Discrimination, Doctor, Electronic Health Records, Electronic Medical Records, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health IT, Health Policy, HIPAA, HITECH Act, Medicaid, Medicare, OCR, OIG, Physician, Privacy, Reimbursement, Tax, Tax-Exemption, Technology | Tagged: Data Security, Doctor, Events, false claims act, Form 990, Health Care, Health Care Compliance, Health Care Discrimination, Health Care Fraud, Health Care Policy, Health Care Reform, Health Care Reimbursement, Health Policy, HIPAA, HITECH Act, Hospital, North Texas Health Care Compliance Professionals Association, Physician, Red Flag Rules, Reimbursement, Tax-Exemption | Permalink
Posted by Cynthia Marcotte Stamer

HIT Committee To Meet October 14 In Washington, D.C.

September 29, 2009

The next meeting of the HIT Standards Committee of the Office of the National Coordinator for Health Information Technology (ONC) will be held on October 14, 2009, from 9 a.m. to 3 p.m./Eastern Time at the Omni Shoreham Hotel, 2500 Calvert Street, NW., Washington, DC. The hotel telephone number is 202-234-0700. Interested members of the public are invited to attend.

Created under the American Recovery and Reinvestment Act of 2009 (ARRA), the HIT Standards Committee is charged with making recommendations to the Office of National Coordinator for Health Information Technology (ONC) on standards, implementation specifications, and certification criteria for the electronic exchange and use of health information consistent with the implementation of the Federal Health IT Strategic Plan, and in accordance with policies developed by the HIT Policy Committee. Even as Congress debates further reforms, the activities of the HIT Committee and other components of the ONC are key actors in the continuing efforts of the Obama Administration to promote health care efficiency by reengineering health care technology.

During a previous meeting on August 20, 2009, the HIT Committee finalized certain recommendations concerning meaningful use of electronic medical records, clinical quality, and privacy and security of protected health information, which are available for review here.

According to the ONC announcement regarding the upcoming meeting in today’s (September 29, 2009) Federal Register available here, the Committee plans during the meeting to:

Discuss reports from its Clinical Operations, Clinical Quality, and Privacy and Security Workgroups
Take testimony from invited experts in the field of security as it relates to health information technology

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before October 6, 2009. Oral comments from the public will be scheduled between approximately 2:30 p.m. to 3 p.m. Time allotted for each presentation may be limited. If the number of speakers requesting to comment is greater than can be reasonably accommodated during the scheduled open public hearing session, ONC will take written comments after the meeting until close of business.

ONC hopes to make background material available to the public at least two (2) business days prior to the meeting. However, if ONC is unable to post the background material on its Web site before the meeting, it will make that material publicly available at the location of the advisory committee meeting, and post the background material on ONC’s web site after the meeting here.

The designated person to contact for additional information is Jonathan Ishee, Office of the National Coordinator, HHS, 200 Independence Ave, SW., Room 729-G, Washington, DC 20201, 202-205-8493, Fax: 202-690-6079, e-mail: jonathan.ishee@hhs.gov.

If you need assistance preparing or presenting comments to the HIT Standards Committee or with monitoring or responding to other health care IT, privacy and data security, regulatory, operational, public policy or other health care concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Chair and Partner Cynthia Marcotte Stamer at (214) 270-2402 or via e-mail at CStamer@CTTLegal.com.

Other Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Solution Law Press Updates available online by clicking on the applicable article title below:

For More Information

We hope that this information is useful to you. If you need assistance with auditing or defending these or other health care compliance, risk management, transaction or operation concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270‑2402, cstamer@cttlegal.com, Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health industry and other reimbursement, operations, internal controls and risk management matters.

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here, registering to receive updates in blog form here or e-mailing this information to support@solutionslawyer.net.

Leave a Comment » | ARRA, Doctor, Electronic Health Records, Electronic Medical Records, Health Care, Health Care Finance, Health Care Provider, Health Care Quality, Health Care Reform, Health IT, Health Plan, Health Plans, HIPAA, HITECH Act, Hospital, Laws, Medicaid, Medicare, Medicare Advantage, Outcomes Data, Physician, Technology | Tagged: ARRA, Health Care, Health Care Policy, Health Care Provider, Health Care Reform, Health Care Reimbursement, Health Insurance, Health IT, Health Plans, Health Policy, Health Technology, HHS, HIPAA, Hospital, Identity Theft, Medicare, Medicare Part B, PBMs, Privacy, Public Policy, Reimbursement, Technology | Permalink
Posted by Cynthia Marcotte Stamer

Baucus Health Care Reform Proposal Calls For Significant Tightening In Tax-Exemption Rules

September 22, 2009

Senate Finance Set To Begin Markup Sessions Today – Repeal of Rebuttable Presumption Rule In Reasonable Compensation Rules, Other Tightening of Requirements Threatened

With Senate Finance Committee meetings to mark up Chairman Max Baucus’ health care reform proposal as outlined in his 220-page “Chairman’s Mark of America’s Healthy Future Act of 2009” (the “Baucus Proposal”) scheduled to begin today (September 22, 2009), tax-exempt health care and other non-profit organizations should evaluate carefully proposed amendments that could impact their tax-exempt status or related obligations. The proposed amendments have serious implications for non-profits within and beyond the health care industry.

Markup Scheduled To Begin Tuesday

The Senate Committee on Finance began meeting today (September 22, 2009) to negotiate how to convert into proposed legislation the Baucus Proposal introduced by Committee Chairman Max Baucus on September 16, 2009, the text of which may be reviewed here.

Since no text of the proposed legislation itself has been released yet, it is impossible to fully evaluate the specific nature and implications of the Baucus Proposal. While this week’s planned Senate Finance Committee mark up will further clarify these matters, a review of the description of changes proposed by Chairman Baucus in the Baucus Proposals nevertheless provides significant insight of what health care organizations can expect to be discussed and, in all likelihood incorporated into the draft legislation ultimately proposed in some form. Accordingly, tax-exempt health care organizations should carefully evaluate and act promptly to share their input with members of the Senate Finance Committee and other members of Congress about a series of proposed amendments that would impact their tax-treatment and other responsibilities.

All Tax-Exempts Should Monitor Proposals To Shift Burden Of Proof On Compensation Reasonability & Expanded IRS Powers

Among a multitude of proposed tax amendments, tax-exempt organizations inside and outside the health care industry will want to keep a a close eye on discussions and proposals to amend the Baucus Proposal to further modify the tax-exemption requirements for tax-exempt hospitals and other tax-exempt organizations. Late last week, Ranking Member Senator Chuck Grassley submitted a proposal to amend the Baucus Proposal to further tighten tax-exemption requirements in two material respects likely to generally concern tax-exempt organizations:

For the stated purpose of avoiding wasteful legal challenges to the management and governance questions on the revised Form 990, to specifically grant statutory authority to the Internal Revenue Service to ask management and governance questions on the Form 990; and
To make it easier for the Internal Revenue Service to challenge as unreasonable compensation payments made by tax-exempt entities by shifting the burden to the taxpayer of proving the reasonability of compensation and removing the burden currently borne by the Internal Revenue Service of going forward with the evidence on comparability. This would be accomplished by overruling the rebuttable presumption of reasonableness currently set forth in Treasury Regulation § 53.4958-6 of the intermediate sanctions rules and replacing it with a requirement that public charities due diligence demonstrate that their compensation payments meet the 3 current elements of the presumption:
- Review by an authorized body made of members without a conflict of interest
- Use of appropriate data as to comparability and
- Adequate and contemporaneous documentation. This amendment is expected to raise revenue, according to the summary.

Given the potential implications of these proposed amendments, tax-exempt health care and other organizations should keep a close eye on proposed tax provisions of the Baucus Proposal and other related proposals.

Proposal To Tighten Other Tax-Exemption & Reporting Requirements For Tax-Exempt Hospitals

While the Senate Finance Committee as of yet has not released text of the proposed legislation itself, a review of the description of changes proposed by Chairman Baucus in the Baucus Proposals and other subsequently proposed amendments to the Baucus Proposal reveal other plans to materially change the tax-exemption qualification, governance and reporting requirements for tax-exempt hospitals beyond the proposal to create CO-OPs. Among other things, the Baucus Proposal calls for the Internal Revenue Code § 501(c)(3) and its related provisions to be amended to require tax-exempt hospitals:

To conduct or participate in and share with the public a community-needs analysis with input from a broad cross section of the community at least once every 3 years and thereafter to report on its implementation, including explaining where applicable why identified needs were unaddressed. These additional requirements would supplement rather than replace existing community benefit standards already generally applicable to charitable entities
To provide non-discriminatory emergency care
To have, implement and widely disseminate a written financial assistance policy defining among other things:
- The rules for determining who qualifies for financial assistance
- How the hospital determines amounts to be billed to patients in manner that provides for patient discounts to be based on Medicare rates, “best” commercial rates or other approved statutory measures rather than “chargemaster rates”
- Require hospital to notify patients of the financial assistance policy on admission, on bills and in telephone calls of its financial assistance policy before initiating various collection actions or reporting the account to a credit rating agency
To make its audited financial statements (and where applicable, the consolidated financial report of any entity of which it is a part) available widely
The Internal Revenue Service (IRS) to conduct a SEC-type review of each 501(c)(3) hospital’s community benefit activities at least once every three years based on data reported on Schedule H of the Form 990
The IRS and the Department of Health and Human Services (HHS) to report annually to Congress on community benefit activities of non-governmental tax-exempt hospitals, charity care, bad debt, and unreimbursed costs of government programs (means-tested and non-means-tested) incurred by tax-exempt, taxable, and governmental hospitals.

CO-Ops As Health Coverage Alternative

Much more widely discussed is the Chairman’s CO-OP proposal. The Baucus Proposal calls for the creation of a new vehicle to provide an alternative source of health care coverage called “CO-Ops.” As contemplated by the Baucus Proposal, CO-Ops would be associations controlled by a beneficiary board unrelated to existing organizations providing health insurance as of July 16, 2009. Subject to their meeting non-inurement and other common existing requirements for charitable status as well as other conditions, CO-Ops would be able to apply for tax-exempt status as well as federal funding.

New Taxes and Fees On Insurers & Others

The Baucus Proposal proposes to finance its health care reforms through a variety of mechanisms including, excise taxes and penalties on employers and individuals that fail to purchase the government specified health care package, taxes on premiums paid for health insurance coverage in excess of certain specified annual limits, the imposition of certain premium taxes and “sector fees” on healthcare insurers (with some exceptions possible under certain circumstances for certain 501(c)(3) and (c)(4) HMOs not providing commercial-type insurance within the meaning of Section 501(m)).

Other Baucus Proposal Highlights

In its current summary form, the 220-page Baucus Proposal includes a host of other sweeping reforms, which are certain to be further expanded and refined during this week’s scheduled Senate Finance Committee markup session. Many of these other proposed reforms were highlighted in an overview of the Baucus Proposal published here. You can join the discussion of these and other proposed health care forms and exchange updates and other resources about health care reform and related concerns by registering to participate in the Coalition For Responsible Health Care Policy Group on Linkedin.

Other Recent Developments

For More Information

We hope that this information is useful to you. If you need assistance with health care compliance, risk management, reimbursement, staffing, credentialing, transactional, operational or public policy concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270‑2402, cstamer@cttlegal.com or your other favorite Curran Tomko Tarski LLP Partner. Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health industry and related matters.

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here, by e-mailing this information to support@cttlegal.com or by participating in the SLP Health Care Risk Management & Operations Group on LinkedIn.

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Posted by Cynthia Marcotte Stamer

Medicare Cautions Medicare-Contracted Insurance Companies & Drug Plans About Health Care Reform Advocacy Mailings As Investigation Opened Into Humana, Inc. Reform Related Communications To Beneficiaries

September 21, 2009

The Centers for Medicare & Medicaid Services (CMS) is considering taking action against Humana, Inc. based on communications about health care reform it sent to enrollees in its Medicare Advantage Plans and calling on other Medicare-contracted health insurance and prescription drug plans to suspend potentially misleading mailings to beneficiaries about health care and insurance reform.

According to a CMS announcement distributed today, CMS is investigating whether Humana, Inc. acted improperly in connection with its communications with enrollees in its plans about health care reform. The CMS investigation reportedly initiated at the request of Senate Finance Chair Max Baucus (D-Mont.) questions the propriety of letters sent by Humana, Inc. to Medicare enrollees alleging that they could lose their benefits under healthcare reform bills moving through Congress.

According to CMS, CMS learned that Humana had been contacting enrollees in one or more of its plans and, in mailings that CMS obtained, made claims that current health care reform legislation affecting Medicare could hurt Medicare beneficiaries. The message from Humana urges enrollees to contact their congressional representatives to protest the actions referenced in the letter.

The Humana Letter allegedly letter told beneficiaries that “millions of seniors and disabled individuals could lose many of the important benefits and services that make Medicare Advantage health plans so valuable” and urged enrollees to contact their congressional representatives and protest the possible changes. Humana, Inc. sent the letter in an envelope stating that the envelop contained ‘important information about beneficiaries’ plans.’

CMS has commenced an investigation into whether the Humana, Inc. mailings violate Federal laws. Specifically, CMS is investigating whether Humana inappropriately used the lists of Medicare enrollees for unauthorized purposes or violated regulations requiring CMS prior approval of advertisements to beneficiaries.

Late last week, CMS requested that Humana, Inc. end similar mailings and remove related communications from its website pending the completion of its investigation. CMS reports that Humana has agreed to do so.

In an announcement e-mailed to members of its list-serve today, CMS notified other Medicare contracted health insurance and prescription drug plans of the investigation and urged them to abstain from engaging in similar communications. “We are concerned that the materials Humana sent to our beneficiaries may violate Medicare rules by appearing to contain Medicare Advantage and prescription drug benefit information, which must be submitted to CMS for review” said Jonathan Blum, acting director of CMS’ Center for Drug and Health Plan Choices. “We also are asking that no other plan sponsors are mailing similar materials while we investigate whether a potential violation has occurred.”

Other Recent Developments

For More Information

We hope that this information is useful to you. If you need assistance with these or other Medicare Advantage or other health care public policy, regulatory, compliance, risk management, workforce and other staffing, transactional or operational concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270‑2402, cstamer@cttlegal.com, Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health industry and other reimbursement, operations, internal controls and risk management matters.

Ms. Stamer has extensive experience in these and other health industry related representation including specific experience assisting Medicare/Medicaid Advantage and other health plans, their outsourcers and others about regulatory compliance, contracting and other risk management and public policy matters. You can review other recent health care and related resources and additional information about the health industry and other experience of Ms. Stamer here.

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here, or e-mailing this information to cstamer@cttlegal.com, and/or by participating in the SLP Health Care Risk Management & Operations Group on LinkedIn.

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Posted by Cynthia Marcotte Stamer

Baucus’ America’s Healthy Future Act of 2009 Calls For Significant Tightening of Tax Exemption Rules

September 21, 2009

Senate Finance Set To Begin Markup Session Proposal September 22 – Repeal of Rebuttable Presumption Rule In Reasonable Compensation Rules, Other Tightening of Requirements Threatened

With Senate Finance Committee meetings to mark up Chairman Max Baucus’ health care reform proposal as outlined in his 220-page “Chairman’s Mark of America’s Healthy Future Act of 2009” (the “Baucus Proposal”) scheduled to begin tomorrow (September 22, 2009), tax-exempt health care and other non-profit organizations should evaluate carefully proposed amendments that could impact their tax-exempt status or related obligations in addition to the widely-discussed proposal to create “Consumer Operated and Oriented Plans (CO-OPs).

Markup Scheduled To Begin Tuesday

The Senate Committee on Finance plans on Tuesday, September 22, 2009 to hash out how to convert into proposed legislation the health care reform proposal outlined in the “Chairman’s Mark America’s Healthy Future Act of 2009” introduced by Committee Chairman Max Baucus on September 16, 2009, the text of which may be reviewed here.

Since no text of the proposed legislation itself has been released yet, it is impossible to fully evaluate the specific nature and implications of the Baucus Proposal. While this week’s planned Senate Finance Committee mark up will further clarify these matters, a review of the description of changes proposed by Chairman Baucus in the Baucus Proposals nevertheless provides significant insight of what health care organizations can expect to be discussed and, in all likelihood incorporated into the draft legislation ultimately proposed. Accordingly, tax-exempt health care organizations should carefully evaluate and act promptly to share their input with members of the Senate Finance Committee and other members of Congress about a series of proposed amendments that would impact their tax-treatment and other responsibilities.

Proposal To Tighten Tax-Exemption & Reporting

Requirements For Tax-Exempt Hospitals

While the Senate Finance Committee as of yet has not released text of the proposed legislation itself, a review of the description of changes proposed by Chairman Baucus in the Baucus Proposals and other subsequently proposed amendments to the Baucus Proposal reveal plans to materially change the tax-exemption qualification, governance and reporting requirements for tax-exempt hospitals beyond the proposal to create CO-OPs. Among other things, the Baucus Proposal calls for the Internal Revenue Code § 50!(c)(3) and its related provisions to be amended to require:

The hospital to conduct or participate in and share with the public a community-needs analysis with input from a broad cross section of the community at least once every 3 years and thereafter to report on its implementation, including explaining where applicable why identified needs were unaddressed. These additional requirements would supplement rather than replace existing community benefit standards already generally applicable to charitable entities
The hospital to provide non-discriminatory emergency care
The hospital to have, implement and widely disseminate a written financial assistance policy defining among other things:
- The rules for determining who qualifies for financial assistance
- How the hospital determines amounts to be billed to patients in manner that provides for patient discounts to be based on Medicare rates, “best” commercial rates or other approved statutory measures rather than “chargemaster rates”
- Require hospital to notify patients of the financial assistance policy on admission, on bills and in telephone calls of its financial assistance policy before initiating various collection actions or reporting the account to a credit rating agency
The hospital make its audited financial statements (and where applicable, the consolidated financial report of any entity of which it is a part) available widely
The Internal Revenue Service (IRS) to conduct a SEC-type review of each 501(c)(3) hospital’s community benefit activities at least once every three years based on data reported on Schedule H of the Form 990
The IRS and the Department of Health and Human Services (HHS) to report annually to Congress on community benefit activities of non-governmental tax-exempt hospitals, charity care, bad debt, and unreimbursed costs of government programs (means-tested and non-means-tested) incurred by tax-exempt, taxable, and governmental hospitals.

In addition to the proposed amendments included in the Baucus Proposal as originally introduced, health care organizations also will need a close eye on discussions and proposals to amend the Baucus Proposal to further modify the tax-exemption requirements for tax-exempt hospitals and other health care organizations. For instance, late last week, Ranking Member Senator Chuck Grassley submitted a proposal to amend the Baucus Proposal to further tighten requirements for tax-exempt health care organizations:

For the stated purpose of avoiding wasteful legal challenges to the management and governance questions on the revised Form 990, to specifically grant statutory authority to the Internal Revenue Service to ask management and governance questions on the Form 990; and
To make it easier for the Internal Revenue Service to challenge as unreasonable compensation payments made by tax-exempt entities by shifting the burden to the taxpayer of proving the reasonability of compensation and removing the burden currently borne by the Internal Revenue Service of going forward with the evidence on comparability. This would be accomplished by overruling the rebuttable presumption of reasonableness currently set forth in Treasury Regulation § 53.4958-6 of the intermediate sanctions rules and replacing it with a requirement that public charities due diligence demonstrate that their compensation payments meet the 3 current elements of the presumption:
- Review by an authorized body made of members without a conflict of interest
- Use of appropriate data as to comparability and
- Adequate and contemporaneous documentation. This amendment is expected to raise revenue, according to the summary.

With these provisions already targeting their tax-exempt status, tax-exempt hospitals and other non-profits and others likely to surface as the legislative discussion proceeds, tax-exempt health care and other organizations should keep a close eye on proposed tax provisions of the Baucus Proposal and other related proposals.

CO-Ops As Health Coverage Alternative

New Taxes and Fees On Insurers & Others

Other Baucus Proposal Highlights

Other Recent Developments

For More Information

We hope that this information is useful to you. If you need assistance with these or other health care public policy, regulatory, compliance, risk management, workforce and other staffing, transactional or operational concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270‑2402, cstamer@cttlegal.com, Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health industry and other reimbursement, operations, internal controls and risk management matters.

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here, or e-mailing this information to cstamer@cttlegal.com, and/or by participating in the SLP Health Care Risk Management & Operations Group on LinkedIn.

Leave a Comment » | Corporate Compliance, Health Care, Health Care Finance, Health Care Provider, Health Care Reform, Health Insurance Exchange, Health Plan, Health Plans, Hospital, Reimbursement, Rural Health Care, Tax-Exemption | Tagged: America's Healthy Future Act, Doctor, Health Care, Health Care Policy, Health Care Provider, Health Care Reform, Health Care Reimbursement, Health Insurance, Hospital, Medicare, Nonprofits, Public Policy | Permalink
Posted by Cynthia Marcotte Stamer

Senate Finance To Begin Markup Session on Baucus Health Care Reform Proposal On September 22

September 18, 2009

The Senate Committee on Finance plans on Tuesday, September 22, 2009 to being meetings to hash out how to convert into proposed legislation the health care reform proposal outlined in the “Chairman’s Mark America’s Healthy Future Act of 2009” introduced by Committee Chairman Max Baucus on September 16, 2009, the text of which may be reviewed here.

While the Chairman’s Markup outlining the health care reform elements that Chairman Baucus’ proposes for adoption by Congress, the specific legislation that the Chairman proposes to be used to implement these proposals has not yet been introduced. Deciding the language and other features of such legislation -i.e., actually drafting the statutory language – is a primary purpose of the September 22, 2009 meeting.

Until actually reduced to specific legislative language, it is difficult for members of Congress and the Americans they represent to know and assess the changes proposed and their potential implications. However, a review of the proposal outlined in the Chairman’s Markup indicates that the adoption of the proposed would impose significant burdens and costs on employers and their employees, while substantially curtailing their health coverage choices. For instance, the Chairman’s Markup would:

Set up insurance “exchanges” through which some individuals and families could receive federal subsidies topurchase coverage;
Allow for the creation of “CO-OPs” as an alternative source of coverage
Mandate that most legal residents of the United States obtain health insurance and impose an income based penalty for Americans failing to secure that coverage;
While not explicitly requiring employers to offer health insurance, the Chairman’s markup would among other things subject businesses with more than 50 workers that did not offer coverage to a penalty for any workers who obtained subsidized coverage through the insurance exchanges also to be established under the legislation. As a rule, full-time employees who were offered coverage from their employer would not be eligible to obtain subsidies via the exchanges but an exception to that “firewall” would be allowed for workers who had to pay more than 13 percent of their income for their employer’s insurance (in which case the employer would also be penalized). Under certain circumstances, firms with relatively few employees and relatively low average wages would also be eligible for tax credits to cover up to half of their contributions toward health insurance premiums.
Deter employers and their employees from investing in higher grade coverage that might otherwise be available for purchase in the marketplace by subjecting insurance policies with relatively high total premiums to a 35 percent excise tax on the amount by which the premiums exceeded a specified threshold. In general, that threshold would be set initially at $8,000 for single policies and $21,000 for family policies; after 2013, those amounts would be indexed to overall inflation.
Significantly expand eligibility for Medicaid;
Significantly tighten tax-exemption requirements for hospitals and other charitable health care organizations;
Radically reduce the growth of Medicare’s payment rates for most services (relative to the growth rates projected under current law) and make various other changes to the Medicaid and Medicare programs and the federal tax code to reduce government program costs. The Congressional Budget Office projects that among the proposed provisions that would result in the largest budget savings are:
- Make permanent reductions in the annual updates to Medicare’s payment rates for most services in the fee-for-service sector (other than physicians’ services)
- Set payment rates in the Medicare Advantage program based on the average of the bids submitted by Medicare Advantage plans in each market
- Reduce Medicare and Medicaid payments to hospitals that serve a large number of low-income patients, known as disproportionate share (DSH) hospitals
- Establish a Medicare Commission, which would be required, under certain circumstances, to recommend changes to the Medicare program to limit the rate of growth in that program’s spending. Those recommendations would go into effect automatically unless blocked by subsequent legislative action. Before 2019, such recommendations would be required if the Medicare Trustees project that Medicare spending per beneficiary will grow more rapidly than a measure of inflation (the average of the growth rates of the consumer price index for medical services and the overall index for all urban consumers). After 2019, recommendations would be required if projected growth exceeded the rate of increase in gross domestic product (GDP) per capita plus 1 percentage point. Because the proposal would prohibit the Commission from modifying eligibility or benefits, its recommendations probably would focus on changes to payment rates or methodologies. The Commission would develop its first set of recommendations during 2013 for implementation in 2015.

Other Recent Developments

For More Information

We hope that this information is useful to you. If you need assistance with these or other health care public policy, regulatory, compliance, risk management, workforce and other staffing, transactional or operational concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270‑2402, cstamer@cttlegal.com, Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health industry and other reimbursement, operations, internal controls and risk management matters.

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here, or e-mailing this information to cstamer@cttlegal.com, and/or by participating in the SLP Health Care Risk Management & Operations Group

Leave a Comment » | Disease Management, Doctor, Employer, false claims act, Health Care, Health Care Finance, Health Care Quality, Health Care Reform, Health Plan, Health Plans, Hospital, Inpatient Rehabilitation Facility, Medicaid, Medicare, Medicare Advantage, Pharmacy, Physician, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer

CMS Proposes New Prospective Payment System For Renal Dialysis Facilities

September 15, 2009

November 16, 2009 is the deadline to comment on a new prospective payment system (PPS) for facilities that provide dialysis services to Medicare beneficiaries who have end-stage renal disease (ESRD) proposed by the Centers for Medicare & Medicaid Services (CMS) today (9/15/09). Interested persons can review the proposed rule here.

Currently, ESRD is the only category for Medicare eligibility that is based on a specific diagnosis, without regard to the age of the patient. Patients diagnosed with ESRD must rely on dialysis or receive a kidney transplant for survival. ESRD services are furnished on an outpatient basis in independent or hospital-based dialysis facilities. Currently, Medicare pays for certain dialysis services under a partial bundled rate, referred to as the composite rate. Payments for these composite rate services represent about 60 percent of total Medicare payments to ESRD facilities. The remainder of Medicare spending for dialysis services is for separately billed items such as drugs, but may also include laboratory services, supplies and blood products.

Today’s notice proposes three quality measures that CMS plans to use for its quality incentive program (QIP) and lays out a conceptual model for public comment.

Quality Improvement Measures

The ESRD PPS proposed rule proposes the following specific measures that will apply to the initial performance period of the Quality Incentive Program:

Hemodialysis Adequacy: Achieved urea reduction ratio (URR) of 65 percent or more;
Anemia Management: Controlled anemia, as shown in two measures:
- The percentage of patients at a facility whose hemoglobin levels were less than 10 grams per deciliter (g/dL), and
- The percentage of patients at a facility whose hemoglobin levels were greater than 12 g/dL.

CMS reports the proposed measures were chosen because dialysis facilities have used them since 2001. These measures are currently collected from Medicare dialysis facility claims so there is no need for separate reporting. Finally, CMS already has data on these measures which it can use to develop and test models for the operation of the QIP.

As required by law, CMS plans to establish performance standards for each of the measures and facilities would be scored based on their adherence to the measures. Providers and facilities that do not meet or exceed the total performance score during a performance period would see up to a two percent reduction from their payment rates in the succeeding year.

CMS will accept comments on this conceptual QIP model in the ESRD PPS proposed rule through November and will is

The ESRD PPS proposed rule proposes the following specific measures that will apply to the initial performance period of the Quality Incentive Program:

Hemodialysis Adequacy: Achieved urea reduction ratio (URR) of 65 percent or more;
Anemia Management: Controlled anemia, as shown in two measures:
- The percentage of patients at a facility whose hemoglobin levels were less than 10 grams per deciliter (g/dL), and
- The percentage of patients at a facility whose hemoglobin levels were greater than 12 g/dL.

Proposed PPS Model

The proposed PPS would provide a single bundled payment to dialysis facilities that would cover the items and services used in providing outpatient such services, including the dialysis treatment, prescription drugs, and clinical laboratory tests.

Under the proposed rule, CMS would establish a base bundled payment rate of $198.64 for all of the services related to a dialysis session, including the services in the current composite rate as well as items, including oral drugs that are billed separately. CMS reports the proposed base rate was derived from 2007 claims data for both composite rate and separately billable services and updated to reflect projected 2011 prices. CMS would adjust this base rate for case mix factors such as the patient’s age, gender, body size, and time on dialysis. A special case-mix adjustment would apply to pediatric patients. Additional adjustments to the payment rate would be made for specific conditions, or co-morbidities that have a significant impact on a course of treatment. By accounting for more characteristics of patients, the new PPS would target payments more appropriately, paying higher rates to those facilities with the most costly patients. The base rate would also be adjusted to reflect geographic differences in labor costs. In addition, CMS is proposing to provide an adjustment for low-volume facilities, as well as an outlier policy that would make an adjustment for particularly expensive cases.

The following are highlights of the proposed mechanics of the proposed new PPS:

ESRD Base Rate and Bundle of Services: CMS is proposing to pay a base rate of $198.64 per dialysis treatment, representing the average Medicare allowable payment per treatment for composite rate and separately billable services, including training and home dialysis costs, laboratory services and all ESRD-related Part B and former Part D drugs. The proposed base rate would be adjusted to reflect patient- and facility-specific differences in case-mix and other adjustments as required by MIPPA.

To arrive at a base rate, CMS is proposing to adjust the average payment per treatment using 2007 claims data adjusted to reflect 2011 projected prices. The rate will not include positive adjustments for case-mix and the wage index as those will be introduced into the payment formula at a later time. This standardized amount must then be reduced by 1.0 percent to fund the proposed outlier policy, and reduced by the percentage required by MIPPA to reflect 98 percent of the estimated payments that would have been made absent the statutory changes.

Proposed Standardized Amount: Based on 2007 claims data, total per treatment payments in CY 2011 are projected to be $261.58. To eliminate the overall positive effects of the proposed case-mix and geographic adjustments, CMS is proposing a 21.73 percent reduction, yielding a standardized amount of $204.74.

Proposed Outlier Adjustment: CMS is proposing to reduce the standardized amount by 1.0 percent for outlier payments for cases requiring unusually high amounts of drugs or other services that are separately payable under the current payment system. This 1.0 percent reduction lowers the standardized amount of $204.74 to $202.69.

MIPPA Required 98 Percent Adjustment: As required by MIPPA, CMS is also proposing to adjust the reduce the standardized amount by 2.0 percent to ensure that estimated total Medicare payments to ESRD facilities in CY 2011 are 98 percent of what they would have been under the existing system. This additional reduction yields a proposed base rate of $198.64.

Transition Budget Neutrality Adjustment: Also required by MIPPA, CMS is proposing that a transition budget neutrality adjustment factor (a 3.0 percent reduction) be applied to all payments during the four-year phase-in and would make payments under the transition the same as they would have been had there not been a transition. As part of this transition budget neutrality adjustment, during the transition, CMS is proposing to apply a $14 per treatment adjustment to the composite rate portion of the blended payment amount to reflect ESRD-related Part D drugs.

Patient-Level Adjustments: As authorized by MIPPA, CMS is proposing to adjust the base rate for case mix using a variety of factors which have been found to affect costs. Under the existing payment system, the composite rate is adjusted for age, body surface area (BSA), body mass index (BMI), and pediatric status. The proposed rule would add adjustments for patient sex (female patients) and certain co-morbidities, as well as a “new patient adjustment” that recognizes that patients have higher costs in their first four months of maintenance dialysis. In addition, special payment adjusters would apply for providers of pediatric services. CMS is specifically seeking comment about these and other patient characteristics that may affect costs of treatment and for which a payment adjustment may be appropriate.

Facility-Level Adjustments: MIPPA specifically requires CMS to adopt an adjustment for low-volume facilities and gives the HHS secretary discretion to adopt additional facility-level adjustments. Based on an analysis of ESRD data, CMS is proposing to define low-volume facilities as those facilities that: (1) furnished fewer than 3,000 treatments in each of the three years preceding the payment year; and (2) have not opened, closed, nor received a new provider number due to a change in ownership during the three years preceding the payment year. Other definitions may be added to include geographic restrictions. CMS is also proposing to continue to apply a wage index adjustment using the core-based statistical area (CBSA) definitions. The index would be based on the most current hospital wage data, prior to application of the rural floor and occupational mix adjustments, and geographic reclassifications.

Outlier Policy: MIPPA requires CMS to make adjustments for high cost patients, called outlier payments, to ESRD facilities that treat patients who use more than the predicted amount of services, including the amount of erythropoietin stimulating agents (ESAs) used to manage dialysis-related anemia. As noted previously, CMS is proposing to reduce the standardized amount for all dialysis treatments by 1.0 percent, to fund the proposed 1.0 percent policy under the new ESRD PPS. CMS is proposing a fixed loss dollar amount of $134.96 for adult and $174.31 for pediatric dialysis patients. Once the fixed dollar amount is met, CMS would pay 80 percent of the ESRD facility’s outlier service costs. CMS projects that approximately 5.3 percent of adult and 2.6 percent of pediatric patient months would qualify for outlier payments.

Annual Payment Rate Updates: As required by MIPPA, beginning in CY 2012 the ESRD PPS base rate will be updated annually by an ESRD market basket index minus one percentage point. The proposed rule includes a discussion of how the ESRD market basket would be calculated.

Beneficiary Coinsurance: CMS is proposing that the beneficiary coinsurance amount be 20 percent of the ESRD bundled payment amount, including applicable case-mix adjustments and outlier payments. CMS will accept comments on the proposed rule through November 2009, and will respond to them in a final rule to be issued in 2010. The new payment system would apply to renal dialysis services furnished to Medicare beneficiaries on or after January 1, 2011.

Required by the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), CMS reports the new payment system set forth in the proposed rule is designed to improve the efficiency of care, while promoting high quality services.

CMS will accept comments on the proposed rule through November 16, 2009, and will respond to them in a final rule to be issued in 2010. The new payment system would apply to dialysis services furnished to Medicare beneficiaries on or after January 1, 2011.

If you need assistance with auditing, updating or defending your organizations HIPAA and other privacy and data security practices, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Leader Cynthia Marcotte Stamer at (214) 270-2402 or via e-mail at CStamer@CTTLegal.com. The former Compliance Committee Chair of the National Kidney Foundation of North Texas, Ms. Stamer has extensive experience advising nephrology, dialysis and other health care providers about gainsharing and other reimbursement, quality, regulatory and compliance, risk management, workforce and staffing and other operational matters.

Other Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Solutions Law Press Health Care Updates available online by clicking on the article title:

For More Information

We hope that this information is useful to you. If you need assistance with auditing or defending these or other health care compliance, risk management, transaction or operation concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270‑2402, cstamer@cttlegal.com. Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health industry and other internal controls and risk management matters.

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here or e-mailing this information to cstamer@cttlegal.com.

Leave a Comment » | Disease Management, Doctor, Health Care, Health Care Finance, Health Care Provider, Health Care Quality, Medicaid, Medicare, Outpatient, Physician, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer

ONC Shares HIT Committee August Meeting Recommendations, Announcements Opportunity To Comment On Recommendations At September 15 HIT Committee Meeting

September 9, 2009

Register here to Participate In September 17 Briefing On New HIPAA Data Breach Rules

As part of the American Recovery and Reinvestment Act of 2009 (ARRA), the Office of the National Coordinator for Health Information Technology (ONC) is required to publicize the Health Information Technology Standards Committee (Committee) recommendations in the Federal Register and provide for public input.

During its August 20, 2009 meeting, ONC reports that the Committee’s recommendations focused on the following areas:

Clinical Quality
Clinical Operations
Privacy and Security.

Individuals wishing to make comments on the Committee’s August 20, 2009, recommendations may present oral comments at the Committee’s next meeting on September 15, 2009, from approximately 1:00 p.m. to 2:00 p.m. Eastern Time, at the Omni Shoreham Hotel, 2500 Calvert Street, NW, Washington, DC, 20008. Comments will be limited to two (2) minutes per person.

All recommendations from the August 20, 2009 meeting may be found here. In addition, specific URLs for each recommendation have been listed below.

Clinical Quality

The Clinical Quality recommendations pertain to the appropriate standardized performance measures that correspond to the HIT Policy Committee’s 2011 Meaningful Use Measures. The recommendations include 30 quality performance measures and the data types required for each, of which National Quality Forum (NQF)-endorsed measures can either be retooled for use in an Electronic Health Record (EHR) or will require attestation for the foreseeable future. The Clinical Recommendations of the Committee appear here.

Clinical Operations

The Clinical Operations recommendations focus on standards for 2011 Meaningful Use, including quality data reporting, messaging formats, and all the vocabularies necessary for semantic interoperability. The Clinical Operations recommendations appear here.

Privacy and Security

The Privacy and Security recommendations focus on authentication, authorization, auditing and secure data transmission standards as well as Meaningful Use measures related to HIPAA compliance. The Privacy & Security recommendations appear here.

Procedure

A separate notice announcing this meeting has been published in the Federal Register and provides additional information.

Other Recent Developments

If you need assistance with auditing, updating or defending your organizations HIPAA and other privacy and data security practices, or addressing other HITECH Act or related health care matters, please contact Curran Tomko Tarski LLP Partner Cynthia Marcotte Stamer at (214) 270-2402 or via e-mail at CStamer@CTTLegal.com.

Register Now For Upcoming September Health Industry Update Programs

If you found this information of interest, you also may be interested in one of the following upcoming health industry programs to be presented by Ms. Stamer during September:

How to Ensure That Your Organization Is In Compliance With Regulations Governing Discrimination — What You Should Be Doing To Be Prepared for the New, Stepped Up Enforcement Actions on September 10, 2009 hosted via teleconference by Health Resources Publishing
Health Information Security & Data Breach Under HITECH Act on September 17, 2009 hosted via teleconference by the Health Care Compliance Association

To register or for other details about these and other upcoming programs and presentations by Ms. Stamer and other Curran Tomko Tarski members, see here.

Other Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Health Care Updates available online by clicking on the article title:

For More Information

We hope that this information is useful to you. If you need assistance with auditing or defending these or other health care compliance, risk management, transaction or operation concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270‑2402, cstamer@cttlegal.com, Edwin J. Tomko at (214) 270-1405 or another Curran Tomko Tarski LLP Partner of your choice. Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health industry and other internal controls and risk management matters.

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here or e-mailing this information to cstamer@cttlegal.com.

Leave a Comment » | Electronic Health Records, Health Care, Health IT, HITECH Act | Permalink
Posted by Cynthia Marcotte Stamer

DEA Seeks Comments on Standardization of Code Number For Institutionally Based Practitioners Dispensing Controlled Substances

September 9, 2009

Midnight on November 9, 2009 is the deadline to respond to request for comments of the Drug Enforcement Administration (DEA) on how best to standardize the specific internal code number associated with each individual practitioner permitted by the hospital or other institutional practitioner to administer, dispense, or prescribe controlled substances using that institution’s DEA registration.

DEA is soliciting public input in response to comments received to its Notice of Proposed Rulemaking “Electronic Prescriptions for Controlled Substances” regarding electronic prescriptions for controlled substances published on June 27, 2008, 73 FR 36722. In that Notice, DEA proposed:

That pharmacy applications receiving electronic prescriptions for controlled substances be capable of reading and retaining the full DEA registration number, including any extensions, or other identification numbers used under 21 CFR 1306.05(c).
That the full number including extensions must be retained in the prescription record.
That the pharmacy application must verify that the practitioner’s DEA registration was valid at the time the prescription was signed by checking the DEA CSA database or by having another entity check the DEA CSA database during transmission and indicate on the record that the check has occurred and the registration is valid.
That the pharmacy application must reject prescriptions signed by practitioners without valid DEA registrations.
Every person who dispenses controlled substances is required to obtain a DEA registration under the Comprehensive Drug Abuse Prevention and Control Act of 1970, often referred to as the Controlled Substances Act (CSA) and the Controlled Substances Import and Export Act (21 U.S.C. 801-971), (CSA).
An individual practitioner who is an agent or employee of a hospital or other institution registered with DEA may use the DEA registration of that hospital or other institution to administer, dispense, or prescribe controlled substances in accordance with the regulations (21 CFR 1301.22(c)). Specifically, an individual practitioner who is an agent or employee of a hospital or other institution may, when acting in the normal course of business or employment, administer, dispense, or prescribe controlled substances under the registration of the hospital or other institution which is registered in lieu of being registered himself if:
The dispensing, administering or prescribing is done in the usual course of his professional practice;
The individual practitioner is authorized or permitted to do so by the jurisdiction in which he is practicing;
The hospital or other institution by whom he is employed has verified that the individual practitioner is so permitted to dispense, administer, or prescribe drugs within the jurisdiction;
The individual practitioner is acting only within the scope of his employment in the hospital or institution;
The hospital or other institution authorizes the individual practitioner to administer, dispense or prescribe under the hospital registration and designates a specific internal code number for each individual practitioner so authorized consisting of numbers, letters, or a combination thereof and shall be a suffix to the institution’s DEA registration number, preceded by a hyphen; and
A current list of internal codes and the corresponding individual practitioners is kept by the hospital or other institution and is made available at all times to other registrants and law enforcement agencies upon request for the purpose of verifying the authority of the prescribing individual practitioner. See 21 CFR 1301.22(c).

In response to the comments on these proposed provisions, DEA has determined standardization of the internal code numbers assigned by institutional practitioners to the individual practitioners they permit to use their registration to administer, dispense, and prescribe controlled substances is essential for DEA to require pharmacy systems to retain this information.

Since this number has never been standardized, however, DEA anticipates that institutional practitioner registrants have established a variety of internal code number systems. Accordingly, DEA is soliciting information from the regulated industry and other interested members of the public regarding current methods used and how best to implement industry standardization in this area. Specifically, DEA seeks the following information:

Information regarding formats used by institutional practitioners when establishing internal code numbers for individual practitioners permitted to use the institution’s registration number;
Estimates of the number of individual practitioners using internal code numbers for identification purposes;
Estimates of the number of individual practitioners using internal code numbers for identification purposes in a particular institutional practitioner;
Estimates of costs to institutional practitioners if code numbers for individual practitioners were to be standardized and what changes would be associated with those costs;
Formats pharmacy applications could accommodate or would prefer, recognizing that pharmacy applications may need to be reprogrammed to accept this information;
Estimates of the costs to pharmacies and/or pharmacy application providers for such reprogramming;
Comments regarding whether pharmacies have had difficulty obtaining information from institutional practitioners regarding individual practitioners’ internal code numbers and, if so, any proposed solutions.

Persons wishing to address the above topics or provide other information relative to these proposed rules should submit their comments by Midnight on November 9, 2009 in accordance with the instructions contained in the Notice available for review here.

Register Now For Upcoming September Health Industry Update Programs

If you found this information of interest, you also may be interested in one of the following upcoming health industry programs to be presented by Ms. Stamer during September:

How to Ensure That Your Organization Is In Compliance With Regulations Governing Discrimination — What You Should Be Doing To Be Prepared for the New, Stepped Up Enforcement Actions on September 10, 2009 hosted via teleconference by Health Resources Publishing
Health Information Security & Data Breach Under HITECH Act on September 17, 2009 hosted via teleconference by the Health Care Compliance Association

To register or for other details about these and other upcoming programs and presentations by Ms. Stamer and other Curran Tomko Tarski members, see here.

Other Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Health Care Updates available online by clicking on the article title:

For More Information

We hope that this information is useful to you. If you need assistance with auditing or defending health care fraud concerns or other health care compliance, risk management, transaction or operation concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270‑2402, cstamer@cttlegal.com, Edwin J. Tomko at (214) 270-1405 or another Curran Tomko Tarski LLP Partner of your choice. Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health industry and other internal controls and risk management matters.

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here or e-mailing this information to cstamer@cttlegal.com.

Leave a Comment » | Controlled Substances, DEA, Doctor, Electronic Health Records, Electronic Medical Records, FDA, Health Care, Health IT, HIPAA, Hospital, Pharmacy, Physician, Physician Licensing | Permalink
Posted by Cynthia Marcotte Stamer

Two Recent Criminal Prosecutions For HIPAA Privacy Rule Violations Signal Rising Criminal Enforcement Risks

September 8, 2009

Register here To Participate In September 9 or September 17 Briefings on New HIPAA Data Breach Rules

September 8, 2009

Two recent separate criminal actions against hospital workers for wrongfully accessed medical records in violation of the medical privacy provisions of the Health Insurance Portability & Accountability Act of 1996, as amended (HIPAA) are the latest reminders to health care providers, health plans, health care clearinghouses, their business associates and members of their workforce that the criminal provisions of the HIPAA Privacy Rules have teeth.

Palmetto General Hospital Employee And Accomplice Indicted For Stealing Patient Records As Part Of Fraud

In Miami-Dade County, federal felony charges are pending against Jacquettia L. Brown, 29, and Tear Renee Barbary, 25, prosecution on for offenses relating to the theft of patient profile records from Palmetto General Hospital to further a fraud scheme.

A seven-count Indictment announced by the Department of Justice on May 26, 2009 charges Brown and Barbary with conspiracy to commit access device fraud in violation of Title 18, United States Code, Section 1029(b)(2), and criminal violations of HIPAA. In addition, Brown is charged with aggravated identity theft, in violation of Title 18, United States Code, Section 1028A(a)(1). If convicted, the defendants face a statutory maximum of five (5) years’ imprisonment on Count 1, and a statutory maximum of ten (10) years’ imprisonment as to each of Counts 2, 3, and 7. As to Counts 4-6, Brown faces a two (2) year mandatory prison sentence per count.

According to the Indictment, Brown, a medical records employee of Palmetto General Hospital, took records containing personal profile information of Palmetto General Hospital patients. Defendant Brown and Barbary then used the stolen personal information to further a credit card fraud conspiracy. The patient profile records that Brown stole included personal identifying information, such as patients’ names, birthdates, Social Security numbers, addresses, driver’s license numbers, and next of kin contacts. Brown used the stolen identifying information to obtain patients’ credit card account numbers. She gave patient profile records and credit card account numbers to Barbary, who used the information to make unauthorized credit card purchases. When law enforcement officials disrupted the scheme, Brown was in possession of 41 patient profile records and Barbary was in possession of six patient profile records.

Curiosity Check of Medical Records Results In Arkansas Doctor, 2 Former Hospital Employees Guilty Plea To HIPAA Violation

Three Arkansas health care workers could be sentenced to up to 1 year in prison, a fine of not more than $50,000, or both after pleading guilty in July, 2009 to misdemeanor violations of the health information privacy provisions of HIPAA for accessing a patient’s record without any legitimate purpose.

United States Magistrate Judge Henry L. Jones, Jr. accepted the guilty pleas of Dr. Jay Holland, age 56, of Little Rock, Arkansas; Sarah Elizabeth Miller, age 28, of England Arkansas; and Candida Griffin, age 34 of Little Rock, Arkansas after each admitted to accessing patient records to satisfy their own curiosity.

Dr. Holland, Medical Director of Select Specialty Hospital, located on the 6 floor of the St. Vincent Infirmary Medical Center (SVIMC), admitted that after watching news reports on television, he logged on to the SVIMC patient records from his computer at home and accessed a patient’s files to determine if the news reports were accurate. He admitted he accessed the file because he was curious even though he had had HIPAA training and understood he was violating HIPAA when he accessed the file. SVIMC suspended Dr. Holland’s privileges for two weeks and required him to complete on-line HIPAA training.

Sarah Elizabeth Miller, formerly an account representative at SVIMC, Sherwood Campus, was responsible for checking patients in and out of the clinic and for processing patient billing. In order to perform her duties, she had access to the SVIMC patient records program which includes all locations, not just that of the Sherwood clinic. Miller admitted that on October 20 and 21, 2008, she accessed a patient’s files approximately 12 times out of curiosity. She admitted that she accessed the records without any legitimate purpose. Records show that Miller was trained on HIPAA privacy laws by SVIMC. SVIMC fired Miller from her position.

Candida Griffin was the emergency room unit coordinator at SVIMC. Her responsibilities were to order patient tests, perform data entry into electronic patient files for patients and perform other secretarial functions in the emergency room. Griffin admitted that on October 20, 2008, she was told by the charge nurse to set-up an alias for a particular patient admitted to the emergency room. On October 21, 2008, after the patient had been moved to ICU, Griffin admitted that she became curious about the patient’s status and accessed the medical chart to find out if the patient was still living. Although Griffin did not inform anyone about accessing the chart, hospital records show that the patient’s records were accessed three times that day by Ms. Griffin. SVIMC records show that Griffin was trained on HIPAA privacy laws. SVIMC fired Griffin from her position.

Pursuant to plea agreements with the United States, Holland, Miller and Griffin pleaded guilty to a misdemeanor a violation of the health information privacy provisions of HIPAA based on their accessing a patient’s record without any legitimate purpose. Each faces a maximum penalty of 1 year imprisonment, a fine of not more than $50,000, or both. A sentencing date has not yet been set, but is expected within the next few weeks.

Criminal Referral and Enforcement Continues

Together with the HIPAA-related criminal convictions of in 2008 of David Gibson, Ferando Ferrer, Jr. and Andrea Smith discussed here, these new Arkansas and Florida criminal actions document the willingness of Justice Department attorneys to investigate and prosecute certain criminal violations. Because they involved the theft of health information for use in furtherance of other health care fraud schemes, many have viewed as predictable and understandable the prosecution of Gibson, Ferrer, Brown and Barbary. In contrast, the willingness of Jane W. Duke, United States Attorney for the Eastern District of Arkansas, to prosecute criminally the wrongful access by the SVIMC health care workers and Andrea Smith in the absence of other health care fraud motives challenges the perception widely held among certain segments of the health care and health plan industry that the criminal provisions of HIPAA have little teeth. Since U.S. Attorney Duke pursued both the SVIMC and Smith prosecutions, it remains to be seen whether other U.S. Attorneys will be equally willing to pursue prosecution of HIPAA violations in the absence of evidence of other federal health care crimes.

Less speculative is the growing readiness of the Department of Health & Human Services Office of Civil Rights to pursue civil remedies for HIPAA violations. On February 18, 2009, for instance, OCR and the Federal Trade Commission (“FTC”) issued a joint announcement (the “Announcement”) ordering CVS Pharmacy, Inc., the nation’s largest retail pharmacy chain, to pay the U.S. government a $2.25 million settlement and to take other corrective action to ensure that it does not violate the privacy rights patients under HIPAA when disposing of patient information such as identifying information on pill bottle labels. In a coordinated action, CVS Caremark Corp., the parent company of the pharmacy chain, also signed a consent order and agreed to a settlement with the FTC to settle potential violations of the FTC Act. The investigation resulting in the settlement marks the first instance where the OCR formally coordinated on investigation and resolution of a case with the FTC.

Coming as new data breach notification requirements for HIPAA-covered entities are set to take effect on September 23, 2009, these and other stepped up oversight and enforcement activities make it critical that all health care providers, health plans, health care clearinghouses and their business associates need to update their policies and practices, tighten their compliance and data breach monitoring processes, and strengthen their internal controls, compliance in preparation for defending their actions under the newly strengthened Privacy Rules. Covered entities and their business associates more than ever must ensure their ability to demonstrate to federal regulators the effectiveness of their HIPAA compliance efforts by both adopting the written policies and procedures required by HIPAA and continuously monitoring and administering these safeguards. Covered entities should consider reviewing the adequacy of their current HIPAA Privacy and Security compliance practices taking into consideration the Corrective Action Plan, published OCR noncompliance and enforcement statistics, their own and reports of other security and privacy breaches and near misses, and other developments to determine if additional steps are necessary or advisable.

If you need assistance with auditing, updating or defending your organizations HIPAA and other privacy and data security practices, please contact Curran Tomko Tarski LLP Partner Cynthia Marcotte Stamer at (214) 270-2402 or via e-mail at CStamer@CTTLegal.com.

Register Now For Upcoming September Health Industry Update Programs

If you found this information of interest, you also may be interested in one of the following upcoming health industry programs to be presented by Ms. Stamer during September:

HITECH ACT Health Data Security & Breach Update on September 9, 2009 hosted live or via teleconference by Curran Tomko Tarski LLP
How to Ensure That Your Organization Is In Compliance With Regulations Governing Discrimination — What You Should Be Doing To Be Prepared for the New, Stepped Up Enforcement Actions on September 10, 2009 hosted via teleconference by Health Resources Publishing
Health Information Security & Data Breach Under HITECH Act on September 17, 2009 hosted via teleconference by the Health Care Compliance Association

To register or for other details about these and other upcoming programs and presentations by Ms. Stamer and other Curran Tomko Tarski members, see here.

Other Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Curran Tomko Tarski LLP Latest in Health Care Updates available online by clicking on the article title:

For More Information

We hope that this information is useful to you. If you need assistance with auditing or defending these or other health care compliance, risk management, transaction or operation concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270‑2402, cstamer@cttlegal.com, Edwin J. Tomko at (214) 270-1405 or another Curran Tomko Tarski LLP Partner of your choice. Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health industry and other internal controls and risk management matters.

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here or e-mailing this information to cstamer@cttlegal.com.

Leave a Comment » | Corporate Compliance, Electronic Medical Records, FACTA, Health Care, Health Care Provider, Health IT, Health Plan, Health Plans, HIPAA, OCR | Tagged: ARRA, Doctor, Federal Sentencing Guidelines, Health Care, Health Care Provider, Health Insurance, HIPAA, Hospital, Identity Theft, Physician, Physicians, Privacy | Permalink
Posted by Cynthia Marcotte Stamer

North Texas Healthcare Compliance Professional Association September 8 Meeting Covers Provider Outreach Activities, New Data Breach Rules.

September 4, 2009

NORTH TEXAS HEALTHCARE COMPLIANCE PROFESSIONAL ASSOCIATION

September 8, 2009 Meeting Reminder

North Texas Health Care Compliance Professional Association’s September, 2009 Meeting will feature a discussion by Adele Culpepper, Health Integrity, on Provider Outreach Activities, followed by a discussion of the new HIPAA Data Breach Regulations scheduled to take effect this month.

Date: Tuesday, September 8, 2009, 2:00 – 4:00 p.m.

Location: Offices of Curran Tomko Tarski LLP, 2001 Bryan Street, Suite 2050, Dallas TX 76011. Click here for a map and driving directions.

For additional information, please contact Cynthia Stamer at (214) 270-2402 or by e-mail at cstamer@solutionslawyer.net. We look forward to seeing you there!

About the NTHCPA

NTHCPA exists to champion ethical practice and compliance standards and to provide the necessary resources for ethics and compliance Professionals and others in North Texas who share these principles. The vision of NTHCPA is to be a pre-eminent compliance and ethics group promoting lasting success and integrity of organizations within North Texas.

To register or update your registration or to receive notice of future meetings, e-mail here . There is no charge to participate.

Leave a Comment » | Uncategorized | Tagged: Health Care, Health Care Provider, Health Care Reimbursement, Hospital, Meeting, North Texas Healthare Compliance Professional Association, Physicians | Permalink
Posted by Cynthia Marcotte Stamer

September Declared National Prostate Cancer Awareness Month, 2009

September 3, 2009

September, 2009 has been designated National Prostate Cancer Awareness Month, 2009 under a Proclaimation issued by President Obama on August 31, 2009. 
TYpically highly treatable when detected early, prostate cancer affects both those stricken with the disease and their families, often occurring when they least expect it. 
You can read the Proclaimation http://edocket.access.gpo.gov/2009/E9-21502.htm.
Help celebrate by encouraging friends and families to seek appropriate testing.

Leave a Comment » | Uncategorized | Permalink
Posted by Cynthia Marcotte Stamer

Pfizer To Pay $2.3 Billion For Fraudulent Marketing In Largest DOJ Health Care Fraud Settlement

September 2, 2009

Announcement Highlights Growing Fraud Prosecution Risks of Health Industry Businesses

Today’s announcement that Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. (collectively “Pfizer”) will pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability for alleged illegal promotion of certain pharmaceutical products and other stepped up oversight and enforcement activities make it critical that all health industry organizations strengthen their internal controls, compliance and audit activities as well as be prepared to defend their actions against the rising tide of federal and state oversight and enforcement.

The pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. have agreed to pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability arising from the alleged illegal promotion of certain pharmaceutical products, the Justice Department (DOJ) announced today (September 2, 2009).

According to DOJ, Pharmacia & Upjohn Company agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud or mislead. Bextra is an anti-inflammatory drug that Pfizer pulled from the market in 2005.

The Food, Drug and Cosmetic Act requires that a company specify the intended uses of a product in its new drug application to FDA. Once approved, the drug may not be marketed or promoted for so-called “off-label” uses – i.e., any use not specified in an application and approved by FDA. DOJ charged Pfizer promoted the sale of Bextra for several uses and dosages that the FDA specifically declined to approve due to safety concerns. Under the announced settlement, Pfizer will pay a criminal fine of $1.195 billion, the largest criminal fine ever imposed in the United States for any matter. Pharmacia & Upjohn will also forfeit $105 million, for a total criminal resolution of $1.3 billion.

In addition, Pfizer agreed to pay $1 billion to resolve allegations under the civil False Claims Act that the company illegally promoted four drugs – Bextra; Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug – and caused false claims to be submitted to government health care programs for uses that were not medically accepted indications and therefore not covered by those programs. The civil settlement also resolves allegations that Pfizer paid kickbacks to health care providers to induce them to prescribe these, as well as other, drugs. The federal share of the civil settlement is $668,514,830 and the state Medicaid share of the civil settlement is $331,485,170. This is the largest civil fraud settlement in history against a pharmaceutical company.

As part of the settlement, Pfizer also has agreed to enter into an expansive corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services. That agreement provides for procedures and reviews to be put in place to avoid and promptly detect conduct similar to that which gave rise to this matter.

Whistleblower lawsuits filed under the qui tam provisions of the False Claims Act that are pending in the District of Massachusetts, the Eastern District of Pennsylvania and the Eastern District of Kentucky triggered this investigation. As a part of today’s resolution, six whistleblowers will receive payments totaling more than $102 million from the federal share of the civil recovery.

Today’s announcement of this historic settlement emphasizes the continuing and growing government commitment to, coordination and sophistication in the investigation and prosecution of health care crimes by pharmaceutical industry and other health care providers. The Obama Administration has made investigation and prosecution of health care fraud laws a key element of its strategy to manage U.S. health care program costs. Recently enacted changes in the False Claims Act and other laws are making it easier for federal prosecutors to successfully prosecute these and other health care fraud cases.

The enhanced coordination among agencies central to this strategy is reflected in the collaboration among the many agencies involved in the investigation leading to these charges. The U.S. Attorney’s offices for the District of Massachusetts, the Eastern District of Pennsylvania, and the Eastern District of Kentucky, and the Civil Division of the Department of Justice handled these cases. The U.S. Attorney’s Office for the District of Massachusetts led the criminal investigation of Bextra. The investigation was conducted by the Office of Inspector General for the Department of Health and Human Services (HHS), the FBI, the Defense Criminal Investigative Service (DCIS), the Office of Criminal Investigations for the Food and Drug Administration (FDA), the Veterans’ Administration’s (VA) Office of Criminal Investigations, the Office of the Inspector General for the Office of Personnel Management (OPM), the Office of the Inspector General for the United States Postal Service (USPS), the National Association of Medicaid Fraud Control Units and the offices of various state Attorneys General.

These and other stepped up oversight and enforcement activities make it critical that all health industry organizations strengthen their internal controls, compliance and audit activities as well as be prepared to defend their actions against the rising tide of federal and state oversight and enforcement.

Register Now For Upcoming September Health Industry Update Programs

If you found this information of interest, you also may be interested in one of the following upcoming health industry programs to be presented by Ms. Stamer during September:

HITECH ACT Health Data Security & Breach Update on September 9, 2009 hosted live or via teleconference by Curran Tomko Tarski LLP
How to Ensure That Your Organization Is In Compliance With Regulations Governing Discrimination — What You Should Be Doing To Be Prepared for the New, Stepped Up Enforcement Actions on September 10, 2009 hosted via teleconference by Health Resources Publishing
Health Information Security & Data Breach Under HITECH Act on September 17, 2009 hosted via teleconference by the Health Care Compliance Association

To register or for other details about these and other upcoming programs and presentations by Ms. Stamer and other Curran Tomko Tarski members, see here.

Other Recent Developments

For More Information

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here or e-mailing this information to cstamer@cttlegal.com.

Leave a Comment » | Corporate Compliance, Doctor, false claims act, FDA, Federal Sentencing Guidelines, Health Care, Health Care Fraud, Health Care Provider, Hospital, Medicare, OIG, Physician, Reimbursement | Tagged: Corporate Compliance, Doctor, false claims act, FDA, Federal Sentencing Guidelines, Fraud, Health Care, Health Care Provider, Health Care Reimbursement, HHS, Hospital, Off-label marketing, Pharma, Pharmaceudical, Prescription Drugs | Permalink
Posted by Cynthia Marcotte Stamer

Maximum Penalty For Patient Protection Act Confidentiality Breaches To Rise To $11,000

August 30, 2009

The maximum civil money penalty for violations of the confidentiality provisions of the Patient Safety and Quality Improvement Act of 2005[i] (Patient Safety Act) will rise to $11,000 on November 24, 2009 unless the Department of Health & Human Services (HHS) Office of Civil Rights (OCR) receives comments impacting a new final rule (Final Rule) published on August 25, 2009. You can read the Final Rule here.

The Patient Safety Act created a voluntary program through which health care providers can share information related to patient safety events and concerns with patient safety work product organizations (PSOs) for the purpose of improving patient safety and the quality of care nationwide. The Patient Safety Act provides that PSWP is both privileged and confidential. While participation in the patient safety program is voluntary, a violation of the Patient Safety Act’s confidentiality requirements currently is subject to a civil money penalty (CMP) of up to $10,000.[ii] Under Section § 3.404 of the current HHS Patient Safety Act Regulations,[iii], a person who discloses identifiable PSWP in knowing or reckless violation of the Patient Safety Act is subject to a CMP of not more than $10,000 for each act constituting a violation.

The Federal Civil Penalties Inflation Adjustment Act of 1990 (Inflation Adjustment Act) requires HHS to adjust for inflation the Patient Safety Act’s civil money penalty amount at least once every four years, beginning from the Patient Safety Act’s date of enactment, which was July 29, 2005. Issued along with a proposed rule providing for the same adjustment, the Final Rule provides for the maximum civil money penalty amount for a violation of the confidentiality provisions of the Patient Safety and Quality Improvement Act to increase from $10,000 to $11,000.

The Final Rule and a simultaneously published Proposed Rule allow the public 30 days to comment on the Final Rule and its accompanying proposed rule. If no adverse comments are received, the direct final rule will go into effect 90 days after publication, and the proposed rule with be withdrawn. If, however, adverse comments are received during the comment period, HHS states it will withdraw the direct final rule.

For More Information

We hope that this information is useful to you. If you need assistance with Patient Protection Act or other health care compliance, risk management, transaction or operation concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270‑2402, cstamer@cttlegal.com or your other favorite Curran Tomko Tarski LLP Partner. Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health care privacy and data security and related matters.

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here or e-mailing this information to cstamer@cttlegal.com.

[i] 42 U.S.C. 299b–21 to 299b–26.

[ii] 42 U.S.C. 299b–22(f).

[iii] 42 CFR part 3.

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Posted by Cynthia Marcotte Stamer

Health Care Providers & Other HIPAA Covered Entities Must Comply With New Data Breach Rules By September 23

August 26, 2009

Health care providers, health clearinghouses, health plans and their business associates generally must start complying with new federal data breach notification rules on September 23, 2009.

The new “Breach Notification For Unsecured Protected Health Information” regulation (Breach Regulation) published here in today’s Federal Register requires health care providers, health plans, health care clearinghouses and their business associates (Covered Entities) covered under the personal health information privacy and security rules of the Health Insurance Portability & Accountability Act (HIPAA) to notify affected individuals following a “breach” of “unsecured” protected health information. The Breach Regulation is part of a series of guidance that HHS is issuing to implement new and stricter personal health information privacy and data security requirements for Covered Entities added to HIPAA under the Health Information Technology for Economic and Clinical Health (HITECH) Act signed into law on February 17, 2009 as part of American Recovery and Reinvestment Act of 2009 (ARRA).

HITECH Act Data Breach and Unsecured PHI Rules

Published in the Federal Register on August 24, 2009, the new Breach Regulation implements the HITECH Act requirement that Covered Entities and their business associates notify affected individuals, the Secretary of HHS, and in some cases, the media, when a breach of “unsecured protected health information” happens and the form, manner, and timing of that notification. Covered Entities must begin complying with the new Breach Regulation on September 23, 2009.

Part of a series of new HHS rules implementing recent changes to HIPAA enacted under the HITECH Act to strengthen existing federally mandates requiring Covered Entities to safeguard protected health information, the Breach Regulation will obligate Covered Entities and business associates to provide certain notifications following a breach of “protected health information” that not secured at the time of the breach through the use of a technology or methodology meeting minimum standards issued by HHS pursuant to other provisions of the HITECH Act.

Under the HITECH Act, the breach notification obligations contained in the Breach Notification only apply to a breach of “unsecured protected health information.” The Breach Regulation exempts breaches of protected health information that qualify as “secured” under separately issued HHS and Federal Trade Commission (FTC) standards for encryption and destruction of protected health information from its breach notification requirements.

For purposes of the HITECH Act, electronic protected health information is considered “unsecured” unless the Covered Entity has satisfied certain minimum standards for the protection of that data established pursuant to the HITECH Act. Earlier this year, HHS and the FTC issued interim rules defining the minimum encryption and destruction technologies and methodologies that Covered Entities must use to render protected health information unusable, unreadable, or indecipherable to unauthorized individuals for purposes of determining when protected health information is “unsecured” for purposes of the HITECH Act. Concurrent with its publication of the Breach Regulation, HHS also released guidance updating and clarifying this previously issued guidance.

Read the Breach Regulation here. To review the HITECH Act Breach Notification Guidance and Request for Information, see here.

OCR officials are continuing to work on other guidance concerning the amendments to HIPAA’s privacy and security rules enacted under the HITECH Act and the Genetic Information and Nondiscrimination Act (GINA). Differences in the effective dates of certain requirements generally will necessitate that Covered Entitites and their business associates move forward to comply with the Breach Regulations and other aspects of these changes before some of these other rules or guidance relating to them takes effect.

About The Author

The author of this update, Curran Tomko Tarski LLP Health Practice Leader Cynthia Marcotte Stamer is nationally known for her work, publications and presentations on privacy and security of health and other sensitive information in health and managed care, employment, employee benefits, financial services, education and other contexts.

Vice President of the North Texas Health Care Compliance Professionals Association and Past Chair of the ABA Health Law Section Managed Care & Insurance Section, and Former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 20 years experience advising clients about health and other privacy and security matters. A popular lecturer and widely published author on privacy and data security and other related health care and health plan matters, Ms. Stamer is the Editor in Chief of the forthcoming 2010 edition of the Information Security Guide to be published by the American Bar Association Information Security Committee in 2010, as well as the author of “Protecting & Using Patient Data In Disease Management: Opportunities, Liabilities And Prescriptions,” “Privacy Invasions of Medical Care-An Emerging Perspective,” “Cybercrime and Identity Theft: Health Information Security Beyond HIPAA,” and a host of other highly regarded publications. She has continuously advises employers, health care providers, health insurers and administrators, health plan sponsors, employee benefit plan fiduciaries, schools, financial services providers, governments and others about privacy and data security, health care, insurance, human resources, technology, and other legal and operational concerns. Ms. Stamer also publishes and speaks extensively on health and managed care industry privacy, data security and other technology, regulatory and operational risk management matters. Her insights on health care, health insurance, human resources and related matters appear in the Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Managed Healthcare, Health Leaders, and a many other national and local publications. For additional information about Ms. Stamer, her experience, involvements, programs or publications, see here.

We hope that this information is useful to you. If you need assistance monitoring, evaluating or responding to these or other compliance, risk management, transaction or operation concerns, please contact the author of this update, Cynthia Marcotte Stamer, at (214) 270-2402, cstamer@cttlegal.com or another Curran Tomko Tarski LLP Partner of your choice.

Other Helpful Resources & Other Information

If you found this updates of interest, you also be interested in one or more of the following other recent articles published on our electronic Curran Tomko Tarski LLP publications available for review here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail- by creating or updating your profile at here. You can access other recent updates and other informative publications and resources provided by Curran Tomko Tarski LLP attorneys and get information about its attorneys’ experience, briefings, speeches and other credentials here.

For important information concerning this communication click here. If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to support@cttlegal.net.

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Posted by Cynthia Marcotte Stamer

CDC Healthcare Infection Control Practices Advisory Committee Schedules Teleconference on Draft Guideline for Prevention of Catheter-Associated Urinary Tract Infections 2008

August 25, 2009

The Centers for Disease Control and Prevention Healthcare Infection Control Practices Advisory Committee (HICPAC) plans to hold a public meeting by teleconference on September 9, 2009 from 2 p.m.-3 p.m. Eastern Time on the Draft Guideline for Prevention of Catheter-Associated Urinary Tract Infections 2008, available at here. Members of the public can participate in the teleconference meeting subject to the availability of telephone ports. To participate in the teleconference, dial 1-888-324-8568 and enter conference code 7126207. HICPAC announced the planned meeting in the August 25, 2009 Federal Register. Agenda items are subject to change as priorities dictate.

HICPAC is charged with providing advice and guidance to Health & Human Services, the Centers for Disease Control and the National Center for Preparedness, Detection, and Control of Infectious Diseases (NCPDCID), regarding: (1) The practice of hospital infection control; (2) strategies for surveillance, prevention, and control of infections (e.g., nosocomial infections), antimicrobial resistance, and related events in settings where healthcare is provided; and (3) periodic updating of guidelines and other policy statements regarding prevention of healthcare-associated infections and healthcare-related conditions.

For more information, contact: Wendy Vance, HICPAC, Division of Healthcare Quality Promotion, NCPDCID, CDC, 1600 Clifton Road, NE., Mailstop A-07, Atlanta, Georgia 30333.

Other Helpful Resources & Other Information

We hope that this information is useful to you. If you need assistance monitoring, evaluating or responding to these or other health industry, public policy, staffing and workforce, regulatory and compliance, risk management, transactional or operational concerns, please contact the author of this update, Cynthia Marcotte Stamer, at (214) 270-2402, cstamer@cttlegal.com or another Curran Tomko Tarski LLP Partner of your choice.

If you found these updates of interest, you also be interested in one or more of the following other recent articles published on our electronic Curran Tomko Tarski LLP publications available for review here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail- by creating or updating your profile at here. You can access other recent updates and other informative publications and resources provided by Curran Tomko Tarski LLP attorneys and get information about its attorneys’ experience, briefings, speeches and other credentials here.

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Posted by Cynthia Marcotte Stamer

HHS Secretary Sebelius Announces Intent to Appoint Dr. Helene Gayle as Chair of the Presidential Advisory Council on HIV/AIDS

August 24, 2009

Secretary of Health and Human Services (HHS) Kathleen Sebelius today (August 24, 2009) announced her intent to appoint Helene Gayle, MD, MPH to serve as the Chair of the Presidential Advisory Council on HIV/AIDS. Secretary Sebelius made the announcement in Atlanta at the 2009 National HIV Prevention Conference.

The Presidential Advisory Council on HIV/AIDS (PACHA) provides advice, information, and recommendations to the Secretary of Health and Human Service and the President regarding programs and policies intended to promote effective prevention of HIV disease, to advance research on HIV and AIDS, and to promote quality services to persons living with HIV and AIDS. The role of the Council is solely advisory. The Secretary provides the President with copies of all written reports provided to the Secretary by the Council.

Helene D. Gayle is president and CEO of CARE USA, and is an internationally recognized expert on health, global development and humanitarian issues. Dr. Gayle spent 20 years with the Centers for Disease Control and Prevention (CDC), focused primarily on combating HIV/AIDS, in a variety of roles involving research, programs and policy. She was appointed as the first director of the National Center for HIV, STD and TB Prevention and achieved the rank of Rear Admiral and Assistant Surgeon General in the U.S. Public Health Service. On assignment from the CDC, Dr. Gayle also served as the AIDS coordinator and chief of the HIV/AIDS division for the U.S. Agency for International Development (USAID). Dr. Gayle then directed the HIV, TB and Reproductive Health Program at the Bill & Melinda Gates Foundation, where she was responsible for programs related to HIV/AIDS, sexually transmitted diseases, reproductive health issues and tuberculosis. In April 2006, she joined CARE, an international humanitarian organization with programs in nearly 70 countries to end poverty. Dr. Gayle earned a B.A. in psychology at Barnard College, an M.D. from the University of Pennsylvania and an M.P.H. from Johns Hopkins University. She is board certified in pediatrics, completing a residency in pediatric medicine at the Children’s Hospital National Medical Center in Washington, DC. She has been honored with awards from Johns Hopkins University, Columbia University, Cable Positive, the Eleanor Roosevelt Center at Val-Kill, the Arthur Ashe Institute for Urban Health and the U.S. Public Health Service, among others. She holds faculty appointments at the University of Washington School of Public Health and Emory University School of Medicine.

The author of this publication. Curran Tomko Tarski LLP Partner Cynthia Marcotte Stamer,is nationally known for her work, advocacy, publications and presentations on health care privacy and security of health and other sensitive information in health and managed care, employment, employee benefits, financial services, education and other contexts.

Other Helpful Resources & Other Information

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Posted by Cynthia Marcotte Stamer

Border Health Care Study Sheds Some Light of Health Care Utilization, Needs & Costs

August 24, 2009

Health care costs, care concerns and other health care utilization and risk patterns are a common issue of discussion in the continuing health care reform discussion by health care providers and policymakers in Border States or elsewhere. Meanwhile, employers, who employ a significant number of migrant workers frequently express interest in more information about the health care and disability care and benefit needs, understanding and utilization patterns of migrant families for purposes of planning benefit and human resources practices. A new report published by the Texas Department of State Health Services may shed some light on these issues.

The Texas Department of State Health Services 2007 Health Risk Factors in the Texas-Mexico Border report presents a summary of health-related risk factors and trends among residents of fifteen Texas counties along the US-Mexico border. Its findings are based on data collected through the 2007 Behavioral Risk Factor Surveillance System (BRFSS), a nation-wide telephone-based survey of randomly-selected adults that gathers information on many conditions and behaviors known to influence personal health. Data from the fifteen counties were clustered into five areas: the Lower Rio Grande Valley – commonly known as ‘The Valley’ – (Hidalgo, Starr, and Cameron Counties), Webb and Zapata Counties, Val Verde and Maverick Counties, the Big Bend area (Brewster, Culberson, Hudspeth, Jeff Davis, Pecos, Presidio, and Terrell Counties), and El Paso County. For the purposes of this analysis, “the border” refers to these five areas.

Interested persons can review this report here.

About The Author

Past Chair of the ABA Health Law Section Managed Care & Insurance Section and currently the Chair of the American Bar Association (ABA) RPTE Employee Benefits & Other Compensation Section and a Council Representative of the ABA Joint Committee On Employee Benefits, Ms. Stamer has more than 20 years experience advising health industry and other clients about labor and employment, health and other employee benefits, public policy and other health care and workforce matters. A primary drafter of the Bolivian Social Security Privatization law, Ms. Stamer also frequently provides input domestically and internationally on workforce, health care, migration and other policies. A popular lecturer and widely published author on these and other matters, she frequently writes and speaks about health and workforce issues of special populations including migrant workers, ex pats, and others. Her insights on health care, health insurance, human resources and related matters appear in the Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Managed Healthcare, Health Leaders, and a many other national and local publications. For additional information about Ms. Stamer, her experience, involvements, programs or publications, see here.

We hope that this information is useful to you. If you need assistance responding to these or other compliance, risk management, transaction or operation concerns, please contact the author of this update, Cynthia Marcotte Stamer, at (214) 270-2402, cstamer@cttlegal.com or another Curran Tomko Tarski LLP Partner of your choice.

Other Helpful Resources & Other Information

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Posted by Cynthia Marcotte Stamer

Health Care Providers & Other HIPAA-Covered Entities & Their Business Associates Must Comply With New HHS Health Information Data Breach Rules By September 24

August 24, 2009

Register Now To Participate in September 9 “HITECH Act Health Data Security & Breach Update”

Health care providers, health clearinghouses, health plans and their business associates generally must start complying with new federal data breach notification rules on September 24, 2009.

You are invited to catch up on what these new rules mean for your organization and how it must respond by participating in the “HITECH Act Health Data Security & Breach Update” on Wednesday, September 9, 2009 from Noon to 1:30 P.M. Central Time.

HITECH Act Data Breach and Unsecured PHI Rules

Scheduled for publication in the Federal Register on August 24, 2009, the new Breach Regulation implements the HITECH Act requirement that Covered Entities and their business associates notify affected individuals, the Secretary of HHS, and in some cases, the media, when a breach of “unsecured protected health information” happens and the form, manner, and timing of that notification. Covered Entities must begin complying with the new Breach Regulation on September 24, 2009.

Read the Breach Regulation here. To review the HITECH Act Breach Notification Guidance and Request for Information, see here.

September 9 “HITECH Act Health Data Security & Breach Update” Briefing

Interested persons are invited to register here now to learn what these new rules mean for your organization and how it must respond by participating in the “HITECH Act Health Data Security & Breach Update” on Wednesday, September 9, 2009 from Noon to 1:30 P.M. Central Time. For a registration fee of $45.00, registrants will have the option to participate via teleconference or in person at the offices of Curran Tomko Tarski LLP, 2001 Bryan Street, Suite 2050, Dallas Texas 75201. For information about registering for this program or other questions here.

Conducted by Curran Tomko and Tarski LLP Partner Cynthia Marcotte Stamer, the briefing will cover:

Who must comply
What your organization must do
How to qualify protected health information as exempt from the breach regulations as “secure” protected health information
What is considered a breach of unsecured protected health information
What steps must a covered entity take if a breach of unsecured protected information happens
What liabilities do covered entities face for non-compliance
What new contractual requirements, policies and procedures Covered Entities and Business Associates will need
How the Breach Regulation, the Privacy Regulation, impending FTC red flag rules and state data breach and privacy rules interrelate
Other recent developments
Practical tips for assessing, planning, moving to and defending compliance
Participant questions
More

About The Presenter

The program will be presented by Curran Tomko Tarski LLP Partner Cynthia Marcotte Stamer. Ms. Stamer is nationally known for her work, publications and presentations on privacy and security of health and other sensitive information in health and managed care, employment, employee benefits, financial services, education and other contexts.

Other Helpful Resources & Other Information

Leave a Comment » | ARRA, Disease Management, Doctor, Electronic Health Records, Electronic Medical Records, Employer, FACTA, FDA, Health Care, Health IT, Health Plan, Health Plans, HIPAA, Hospital, Indian Health, Inpatient Rehabilitation Facility, Medicaid, Medical Licensure, Medical Malpractice, Medicare, Medicare Advantage, Mental Heatlh, OCR, Outcomes Data, Peer Review, Physician, Prescription Drugs, Privacy, Reimbursement, Tax | Tagged: ARRA, Corporate Compliance, Data Security, Doctor, Health Care, Health Care Provider, Health Care Reimbursement, HHS, HIPAA, Hospital, Identity Theft, Long Term Care Hospital, Medicare, Medicare Part B, Physician, Physicians, Privacy, public health, Public Policy, Red Flag Rules, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer

HHS Issues Interim Final Requiring Health Care Provider, Health Plans & Other Covered Entities To Give Breach Notifications When Certain Personal Health Information Breached Beginning In September; Register to Participate In September 10th Briefing on New Rules In Person or Via Telephone

August 20, 2009

The U.S. Department of Health and Human Services (HHS) yesterday (August 19, 2009) issued “breach notification” regulations requiring health care providers, health plans and other covered entities (Covered Entities) under the personal health information privacy and security rules of the Health Insurance Portability & Accountability (HIPAA) to notify affected individuals following a “breach” of “unsecured” protected health information. Scheduled for publication in the Federal Register on August 24, 2009, the new breach notification regulations are part of a series of new rules that implement new electronic personal health information data security and data breach notification requirements for Covered Entities added to HIPAA under the Health Information Technology for Economic and Clinical Health (HITECH) Act signed into law on February 17, 2009 as part of American Recovery and Reinvestment Act of 2009 (ARRA). Covered entities must begin complying with the new rules no later than September 24, 2009.

Curran Tomko Tarski, LLP Health Practice leader Cynthia Marcotte Stamer will conduct a briefing on these new protected health information data security and data breach rules on Thursday, September 10, 2009 from Noon to 1:30 P.M. Central Time. For a registration fee of $45.00, registrants will have the option to participate via teleconference or in person at the offices of Curran Tomko Tarski LLP, 2001 Bryan Street, Suite 2050, Dallas Texas 75201. For more information, e-mail here.

HITECH Act Data Breach and Unsecured PHI Rules

The new data breach notification rules are part of a series of recent HIPAA enacted under the HITECH Act to strengthen the federal rules requiring HIPAA covered entities to safeguard electronic and certain other protected health information. Enhanced data security and data breach rules added as part of these HITECH Act amendments obligate covered entities and business associates to provide certain notifications following a breach of “unsecured” “protected health information” within the meaning of HIPAA, as amended. “Unsecured protected health information” is defined as protected health information that is not secured through the use of a technology or methodology specified by the HHS Secretary.

The new data breach regulations implement the HITECH Act requirement that Covered Entities and their business associates notify affected individuals, the Secretary of HHS, and in some cases, the media, of a breach and the form, manner, and timing of that notification. For purposes of the HITECH Act, electronic protected health information is considered “unsecured” unless the covered entity has satisfied certain minimum standards for the protection of that data established pursuant to the HITECH Act. HHS and the Federal Trade Commission previously issued certain initial guidance concerning the HITECH Act standards for determining when electronic personal health information qualifies as secure. To help further define when electronic health information is treated as “unsecured” and therefore subject to the breach notification requirements, the data breach rules also update and clarify the previously issued existing HHS guidance specifying encryption and destruction as the technologies and methodologies that render protected health information unusable, unreadable, or indecipherable to unauthorized individuals published earlier this year by HHS to for purposes of determining when protected health information will be considered “unsecured” for purposes of the HITECH Act data breach rules. Entities subject to the HHS and FTC regulations that secure health information as specified by the guidance through encryption or destruction are relieved from having to notify in the event of a breach of such information.

The HHS interim final regulations are effective September 24, 2009, which is the date 30 days after the date they will be published on the Federal Register and include a 60-day public comment period. To review the interim final data breach regulations, see here. To review the HITECH Act Breach Notification Guidance and Request for Information, see here.

For More Information

The author of this article, Curran Tomko and Tarski LLP Health Care Practice Chair Cynthia Marcotte Stamer has extensive experience advising and assisting health care providers, payors and their business associates about HIPAA and other privacy and data security matters, as well as a diverse range of health care policy, regulatory, compliance, risk management and operational concerns.

Past chair of the American Bar Association Health Law Section Managed Care & Insurance Section, Martindale Hubble AV-rated and recognized in International Who’s Who of Professionals, Ms. Stamer continuously advises health care providers, health care payers and administrators, employers, governments and others about health care, insurance, human resources, privacy and data security, technology, and other legal and operational concerns. A popular lecturer and widely published author on privacy and data security and other related health care and health plan matters, Ms. Stamer also writes and speaks extensively on health and managed care industry privacy, data security and other technology, regulatory and operational risk management matters. She currently serves as the Editor in Chief of the forthcoming 2010 edition of the Information Security Guide to be published by the American Bar Association Information Security Committee in 2010. Examples of her other works include “Protecting & Using Patient Data In Disease Management: Opportunities, Liabilities And Prescriptions,” “Privacy Invasions of Medical Care-An Emerging Perspective,” “Cybercrime and Identity Theft: Health Information Security Beyond HIPAA,” and a host of others. Her insights on health care, health insurance, human resources and related matters appear in the Atlantic Information Service Privacy Report, The Wall Street Journal, Business Insurance, the Dallas Morning News, Managed Healthcare, Health Leaders, and a various other national and local publications. For additional information about Ms. Stamer, her experience, involvements, programs or publications, see here.

We hope that this information is useful to you. If you need assistance monitoring, evaluating or responding to these or other proposed health care or other regulatory reforms or with other health care compliance, risk management, transaction or operation concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270-2402, cstamer@cttlegal.com or your other favorite Curran Tomko Tarski LLP Partner.

Other Helpful Resources & Other Information

We hope that this information is useful to you. If you found these updates of interest, you also be interested in one or more of the following other recent articles published on our electronic Solutions Law Press Health Care Update publication available here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please register to receive this Solutions Law Press Health Care Update here and be sure that we have your current contact information – including your preferred e-mail- by creating or updating your profile at here. You can access other recent updates and other informative publications and resources provided by Curran Tomko Tarski LLP attorneys and get information about its attorneys’ experience, briefings, speeches and other credentials here.

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Posted by Cynthia Marcotte Stamer

CMS Publishes Updated FY 2010 Inpatient Rehabilitation Facility Prospective Payment System Final Rule

August 7, 2009

On August 6, 2009, the Center for Medicare & Medicaid Services (CMS) published its updated final rule governing the payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2010. The provisions of the final rule generally are effective October 1, 2009 and will apply to IRF discharges occurring on or after October 1, 2009 and on or before September 30, 2010 (FY 2010). However, amendments to Sections 412.23, 412.29, and 412.622 don’t take effect until January 1, 2010.

Among other things, the final rule:

Updates the FY 2010 IRF PPS relative weights and average length of stay values using the most current and complete Medicare claims and cost report data in a budget neutral manner;
Updates the FY 2010 IRF facility level adjustments (rural, LIP, and teaching status adjustments) using the most current and complete Medicare claims and cost report data in a budget neutral manner;
Updates the FY 2010 IRF PPS payment rates by the proposed market basket;
Updates the FY 2010 IRF PPS payment rates by the wage index and labor-related share in a budget neutral manner;
Updates the outlier threshold amount for FY 2010;
Updates the cost-to-charge ratio ceiling and the national average urban and rural cost-to-charge ratios for purposes of determining the outlier payments under the IRF PPS for FY 2010;
Removes the words “or assessment” from Sections 412.23(b)(3) and 412.29(b) to indicate that CMS is no longer providing for a 3 to 10 day inpatient assessment period after admission to an IRF to assess the appropriateness of the IRF admission;
Amends paragraphs Section 412.23(b)(4) and Section 412.29(c) to require that IRFs “furnish, through the use of qualified personnel, rehabilitation nursing, physical therapy, and occupational therapy, plus, as needed, speech-language pathology, social services, psychological services (including neuropsychological services), and orthotic and prosthetic services;”
Replaces the word “multidisciplinary” with the word “interdisciplinary” in Section 412.23(b)(7) and Section 412.29(e) to make the terminology consistent with the new IRF coverage criteria in Section 412.622(a);
Requires in both Section 412.23(b)(7) and Section 412.29(e) that the interdisciplinary team meetings occur at least once per week (rather than once every two weeks) to be consistent with the new IRF coverage criteria in Section 412.622(a);
Adds new paragraphs (3), (4), and (5) to Section 412.622(a) to implement new IRF coverage requirements;
With respect to Sections 412.604, 412.606, 412.610, 412.614 and 412.618, removes from Section 412.614(a) current subparagraph (3); and
In Section 412.614(d), makes a technical correction to the paragraph formerly designated as paragraph and assigns the revised language to a new paragraph (1)(a), redesignates paragraph (2) as (1)(b), and adds a new paragraph (2).

You can review the actual text of the final rule here.

For More Information

The author of this article, Curran Tomko and Tarski LLP Health Care Practice Chair Cynthia Marcotte Stamer has extensive experience advising and assisting health industry clients and others about a diverse range of health care policy, regulatory, compliance, risk management and operational concerns. You can get more information about her health industry experience here.

Other Helpful Resources & Other Information

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Posted by Cynthia Marcotte Stamer

House Democratic Leaders Work To Resolve Differences In Committee Versions of Health Care Reform Legislation and Build Public Support During August Recess

August 5, 2009

Democratic Leaders in the House of Representatives plan to hammer out differences three versions of the America’s Affordable Health Choices Act (H.R. 3200) as separately passed by three key House Committees in July before House members return from their August recess in hopes of bringing the agreed to version of H.R. 3200 to the full house in September. Regardless of which version ultimately emerges, the enactment of H.R. 3200 would result in sweeping new regulation and federal control over health care providers, health care payers, employers, and individuals.

After negotiating a last minute pre-August recess deal with certain Blue Dog Democrat Committee members, the House Energy and Commerce Committee on July 31, 2009 passed its version of H.R. 3200, the America’s Affordable Health Choices Act (H.R. 3200). The version of H.R. 3200 passed by the House Energy and Commerce Committee incorporates a series of amendments to the language of H.R. 3200 as originally introduced. For instance, this version of H.R. 3200 provides incentives for states to adopt certain tort reforms, provides for a public plan option that would reimburse physicians based on negotiated rates rather Medicare rates, and would allow states to offer both state-based heath insurance exchanges and health insurance co-ops. To review H.R. 3200 as amended by the House Energy and Commerce Committee, see here.

The approval by the Energy and Commerce Committee of its version of H.R. 3200 follows the July 17, 2009 approval by the House Ways and Means Committee and Education and Labor Committee of their own versions of H.R. 3200. For details on the version of H.R. 3200 approved by the House Ways and Means Committee, see here. For details on the version of H.R. 3200 approved by the House Education and Labor Committee, see here.

Leading House Democrats have announced their intention to work to resolve differences between these three versions of H.R. 3200 as passed by these Committees during August recess in hopes of bringing the agreed to version of H.R. 3200 to a vote of the full House of Representatives in September.

Meanwhile, House members from both parties also generally are using the August recess as an opportunity to reconnect with local constituents on health care reform and other core issues.

For More Information

Other Helpful Resources & Other Information

Leave a Comment » | Disease Management, Electronic Health Records, Evidence Based Medicine, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Qulity, Health Care Reform, Health Insurance Exchange, Health IT, Health Plan, Health Plans, Health Policy, HIPAA, Hospital, Indian Health, Medicaid, Medical Malpractice, Medicare, Medicare Advantage, Outcomes Data, Physician, Prescription Drugs, Reimbursement, Rural Health Care, Tax, Wellness | Tagged: Affordable Health Choices Act, America's Affordable Health Choices Act, Doctor, Employer, Health Care, Health Care Policy, Health Care Provider, Health Care Reform, Health Care Reimbursement, Health Insurance, Health Plans, Health Policy, HHS, Hospital, Medicare, Medicare Part B, Nonprofits, Physician, Physicians, Prescription Drugs, public health, Public Policy, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer

HHS Hiring to Expand its Health Information Enforcement Team Again

August 4, 2009

The Department of Health and Human Services (HHS) this week announced additional job openings on its Office For Civil Rights (OCR) Health Information Privacy Enforcement Team.

These new positions are located in the OCR Office of the Deputy Director Health Information Privacy (ODDHIP). OCR provides the oversight, leadership, and coordination necessary to ensure that individuals have nondiscriminatory access to HHS services or programs and that the privacy of their health information is protected. The Division of Health Information Privacy enforces the HIPAA Privacy Rule and the confidentiality provisions of the Patient Safety and Quality Improvement Act.

For more information on these available positions, go here and enter the corresponding job announcement number applicable to the position of interest below.

Health Information Privacy Specialist, GS-301-13/14 HHS-OS-14-2009-0012

Health Information Privacy Specialist, GS-301-13/14 HHS-OS-14-2009-0013

The open period for these positions is Friday, July 31, 2009 to Thursday, August 13, 2009.

For More Information

We hope that this information is useful to you. If you need assistance with EMR or other health care technology, privacy or other health care compliance, risk management, transaction or operation concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270-2402, cstamer@cttlegal.com or your other favorite Curran Tomko Tarski LLP Partner.

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here or e-mailing this information to cstamer@cttlegal.com.

Leave a Comment » | Electronic Health Records, Health Care, Health IT, Health Plan, Health Plans, HIPAA, Hospital, Physician, Privacy | Permalink
Posted by Cynthia Marcotte Stamer

Reassignment of HIPAA Security Rule Enforcement Signals Growing Seriousness About Enforcing HIPAA

August 4, 2009

The Department of Health & Human Services (HHS) today (August 3, 2009) transferred authority for the administration and enforcement of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule to the Office for Civil Rights (OCR). Prior to this announcement, responsibility for interpretation and enforcement of the Security Rule rested with the Centers for Medicare & Medicaid Services (CMS). The change reflects the growing seriousness of HHS and others about enforcing federal privacy and data security mandates for health information. HHS anticipates the transfer of authority will eliminate duplication and increase efficiencies in how the department ensures that Americans’ health information privacy is protected.

HHS has the authority for administration and enforcement of the federal standards for health information privacy called for in HIPAA. The Privacy Rule provides federal protections for personal health information held by covered entities and gives patients an array of rights with respect to that information. OCR has been responsible for enforcement of the Privacy Rule since 2003. The Security Rule specifies a series of administrative, technical, and physical security procedures for covered entities to use to assure the confidentiality of electronic protected health information. The Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act of 2009 (ARRA), mandated improved enforcement of the Privacy Rule and the Security Rule.

Through a separate delegation, CMS continues to have authority for administration and enforcement of the HIPAA Administrative Simplification regulations, other than privacy and security of health information.

The transfer of Security Rule enforcement authority comes as guidance about new data breach rules for electronic protected health information is impending. This impending guidance relates to the implementation of new breach notification rules for covered entities and their business associates concerning their obligation to use of technologies and methodologies that render protected health information unusable, unreadable, or indecipherable to unauthorized individuals, as required by amendments to HIPAA enacted under the Health Information Technology for Economic and Clinical Health (HITECH) Act passed as part of the American Recovery and Reinvestment Act of 2009 (ARRA) last February. OCR officials have stated that they are working to publish the next set of regulations regarding these new breach notifications before the end of August, 2009.

In addition to adding the breach notification requirements, the HITECH Act also tightened the HIPAA mandates in several other respects. Among other things, it amended HIPAA to:

Broaden the applicability of the HIPAA’s Privacy Rules and penalties to include business associates;
Clarify that HIPAA’s criminal sanctions apply to employees or other individuals that wrongfully use or access PHI held by a covered entity;
Increase criminal and civil penalties for HIPAA Privacy Rules violators;
Allow State Attorneys General to bring civil damages actions on behalf of certain state citizens who are victims of HIPAA Privacy and Security Rule violations;
Modify certain HIPAA use and disclosure and accounting requirements and risks;
Prohibits sales of PHI without prior consent;
Tighten certain other HIPAA restrictions on uses or disclosures;
Tighten certain HIPAA accounting for disclosure requirements;
Clarify the definition of health care operations to excludes certain promotional communications; and
Expand the Business Associates Agreement Requirements.

These and other developments make it imperative HIPAA covered entities and their business associates take prompt action to immediately review and update their data security and privacy practices to guard against growing liability exposures under HIPAA and other federal and state laws. Covered entities must update policies and practices to avoid these growing liabilities. Business associates that have not already done so also must appoint privacy officers and adopt and implement privacy and data security policies and procedures fully compliant with HIPAA and other applicable federal and state rules, including amendments enacted as part of the American Recovery and Reinvestment Act of 2009 signed into law on February 17, 2009.

For more information about today’s announcement, see here. See here for the initial guidance and request for comments issued by HHS regarding these new security standards.

For More Information

We hope that this information is useful to you. If you need assistance with health care privacy and data security, technology, or other health care compliance, risk management, transaction or operation concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270-2402, cstamer@cttlegal.com or your other favorite Curran Tomko Tarski LLP Partner. Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health care privacy and data security and related matters.

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here or e-mailing this information to cstamer@cttlegal.com.

Leave a Comment » | Doctor, Electronic Health Records, Electronic Medical Records, Health Care, Health Care Reform, Health IT, Health Plan, Health Plans, HIPAA, Hospital, Physician, Privacy, Technology | Tagged: Data Security, Health Care, Health Care Provider, Health Insurance, Health Plans, HIPAA, Hospital, Identity Theft, Nonprofits, Personal Health Information, PHI, Physicians, Privacy, Red Flag Rules | Permalink
Posted by Cynthia Marcotte Stamer

Where To Read & Share Your Feedback About The Health Care Reform Legislation

August 1, 2009

As the health care reform policy debate continues, Americans increasingly are asking where to read the text of the health care reform legislation that members of Congress are debating and how to share their input.

While numerous alternatives presently are pending before Congress, much of recent discussion and debate has focused around one of the following bills:

H.R. 3200: America’s Affordable Health Choices Act of 2009, introduced in the House by Rep Dingell, John D. on July 14, 2009 the text of which as originally introduced may be reviewed here. It has been the focus of significant mark up negotiation through out July before the following House Energy and Commerce, House Ways & Means, and House Education & Labor Committees; and
S. __, the Affordable Health Choices Act approved by the Senate Committee on Health, Education, Labor and Pensions, the text of which as approved may be reviewed here.

When reviewing these bills, Americans should keep in mind that members of Congress are engaged in ongoing negotiations about the specific provisions and language of these bills, as well as other legislation. Official developments generally may be monitored here.

Many American businesses and individuals also are asking about how and where to share their views, how to organize others to do the same and other questions about getting the word out. Here a some quick ideas. We encourage others to share.

The Coalition For Patient Empowerment and the Coalition for Responsible Health Care Reform linkedin group are two one of many resources where individuals are sharing information about these matters.
Concerned individuals should share their views both by faxing, e-mailing or telephoning key decisionmakers in Congress, as well as joining and participating in activities of other individuals and groups that share their concerns. Contact and get involved with this and other groups that share your concerns.
Contact the offices of your Congressional representatives in the House and Senate as well as other members of Congress that support your views and ask them about other groups and ways that you can share your views. They will welcome your input and involvement.
If you are aware of or involved in a group that shares your views, we encourage you to share it on the Coalition for Responsible Health Care Reform linkedin group. If you or others are planning a town hall or other health care reform meeting, use this or other linked in groups to spread the word.
If you are interested in volunteering to plan events in your region, let us know.

When communicating, consider targeting your messages to members of Congress whose votes are likely to be impacted by your communications.

For instance, with both the House and Senate in the majority in Congress, Democrats generally have greater control over what legislation moves forward. The Democratic Leadership of the House and Sentate generally can get legislation passed by their members as long as they can maintain consensus among the members of their parties. In connection with the health care reform proposals, however, cost and other considerations have made maintaining a consensus more difficult than on other legislation. Certain fiscally moderate members of the Democratic Party have expressed concern about the expense and other aspects of their Leadership proposed health care reform proposals. These Democrats in Congress generally the members of Congress whose votes are most likely to be impacted by public input and feedback generally and from voters in their districts and contributors specifically.

In the House of Representatives, these members likely are the “Blue Dog Democrats.” Read about Blue Dog Democrats here.

The fiscal conservatism of Blue Dog Democrats makes them more likely to listen to concerns about the cost and other concerns relating to the health care reform bills touted by the Democrat Leadership in the House and Senate. In fact, many Blue Dog Democrats already are speaking out about their concerns about the cost and other aspects of the Bill.

Contact from voters and contributors in their districts and others could make a major difference in the ability that the House Democrat Leadership needs to pass their Bill. Immediately contacting these members and getting others – particularly voters and contributors in the districts that elect these members – is one of the most important steps that concerned Americans can do to position their concerns to be heard.

For most concerned voters, telephone or fax contact is the best means to convey these messages. To minimize spam, most members only accept e-mail submitted through their website links. Security concerns can delay receipt of written correspondence for weeks.

For persons interested in making their voices heard and sharing information with others who wish to do the same, the following contact information may be of interest:

The number of the Capital Switchboard is 202-224-3121.

The Blue Dog Leadership Team and there telephone and fax numbers are:

Rep. Stephanie Herseth Sandlin (SD), Blue Dog Co-Chair for Administration, Telephone: 202.225.2801 , Fax: 202.225.5823

Rep. Baron Hill (IN-09), Blue Dog Co-Chair for Policy,Telephone: 202-225-4031, Fax: (202) 226-6866

Rep. Charlie Melancon (LA-03), Blue Dog Co-Chair for Communications, Telephone: 202-225-4031, Fax: (202) 226-3944

Rep. Heath Shuler (NC-11), Blue Dog Whip, Telephone: 202-225-6401, Fax: (202) 226-6422

The Blue Dog Members and their telephone numbers are :

Altmire, Jason (PA-04),(202)225-2565
Arcuri, Mike (NY-24), (202)225-3665
Baca, Joe (CA-43),(202)225-6161
Barrow, John (GA-12), (202) 225-2823
Berry, Marion (AR-01), (202) 225-4076
Bishop, Sanford (GA-02), (202) 225-3631
Boren, Dan (OK-02), (202) 225-2701
Boswell, Leonard (IA-03), (202) 225-3806
Boyd, Allen (FL-02), (202) 225-5235
Bright, Bobby (AL-02), (202) 225-2901
Cardoza, Dennis (CA-18), (202) 225-6131
Carney, Christopher (PA-10), (202) 225-3731
Chandler, Ben (KY-06), (202) 225-4706
Childers, Travis (MS-01), (202) 225-4306
Cooper, Jim (TN 5^th), (202) 225-4311
Costa, Jim (CA 20^th), (202) 225-3341
Cuellar, Henry (TX 28^th), (202) 225-1640
Dahlkemper, Kathleen A. (PA 3^rd), (202) 225-5406
Davis, Lincoln (TN 4^th),(202) 225-6831
Donnelly, Joe (IN 2^nd), (202) 225-3915
Ellsworth, Brad (IN 8^th), (202) 225-4636
Giffords, Gabrielle (AZ 8^th), (202) 225-2542
Gordon, Bart (TN 6^th), (202) 225-4231
Griffith, Parker (AL 5^th), (202) 225-4801
Harman, Jane (CA 36^th), (202) 225-8220
Herseth Sandlin, Stephanie (SD At Large), (202) 225-2801
Hill, Baron P. (IN 9^th), (202) 225-5315
Holden, Tim (PA 17^th), (202) 225-5546
Kratovil, Frank Jr. (MD 1^st), (202) 225-5311
McIntyre, Mike (NC 7^th), (202) 225-2731
Marshall, Jim (GA 8^th), (202) 225-6531
Matheson, Jim (UT 2^nd), (202) 225-3011
Melancon, Charlie (LA 3^rd), (202) 225-4031
Michaud, Michael H. (ME 2^nd), (202) 225-6306
Minnick, Walt (ID 1^st), (202) 225-6611
Mitchell, Harry E. (AZ 5^th), (202) 225-2190
Moore, Dennis (KS 3^rd), (202) 225-2865
Murphy, Patrick J. (PA 8^th), (202) 225-4276
Nye, Glenn C. (VA 2^nd), (202) 225-4215
Peterson, Collin C. (MN 7^th), (202) 225-2165
Pomeroy, Earl (ND At Large), (202) 225-2611
Ross, Mike (AR 4^th), (202) 225-3772
Salazar, John T. (CO 3^rd), (202) 225-4761
Sanchez, Loretta (CA 47^th), (202) 225-2965
Schiff, Adam B. (CA 29^th), (202) 225-4176
Scott, David (GA 13^th), (202) 225-2939
Shuler, Heath (NC 11^th), (202) 225-6401
Space, Zachary T. (OH 18^th), (202) 225-6265
Tanner, John S. (TN 8^th), (202) 225-4714
Taylor, Gene (MS 4^th), (202) 225-5772
Thompson, Mike (CA 1^st), (202) 225-3311
Wilson, Charles (OH-06), (202) 225-5705

We also encourage you and others to join the discussion about these and other health care reform proposals and concerns by joining the Coalition for Responsible Health Care Reform Group on Linkedin, registering to receive these updates here The author of this article, Curran Tomko and Tarski LLP Health Care Practice Chair Cynthia Marcotte Stamer has extensive experience advising and assisting health industry clients and others about a diverse range of health care policy, regulatory, compliance, risk management and operational concerns. You can get more information about her health industry experience here.

If you need assistance evaluating or formulating comments on the proposed reforms contained in the House Bill or on other health industry matters please contact Cynthia Marcotte Stamer, CTT Health Care Practice Group Chair, at cstamer@cttlegal.com, 214.270.2402 or your other favorite Curran Tomko Tarski LLP attorney.

Other Helpful Resources & Other Information

Leave a Comment » | Consumer Driven Health Care, Employer, Health Care, Health Care Provider, Health Care Quality, Health Care Reform, Health Plan, Health Plans, Patient Empowerment, Public Policy | Tagged: Affordable Health Choices Act, American's Affordable Health Choices Act, Doctor, Employer, false claims act, Health Care, Health Care Policy, Health Care Provider, Health Care Reform, Health Care Reimbursement, Health Insurance, Health Plans, Health Policy, Hospital, Medicare, Medicare Part B, PBMs, Physician, Physicians, Prescription Drugs, Privacy, public health, Public Policy, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer

25 States Awarded Grants Totaling $190 Million For Strategic Substance Abuse & Mental Health Strategic Prevention Planning

July 26, 2009

The Substance Abuse and Mental Health Services Administration (SAMHSA) Friday (July 24, 2009) announced 25 grants totaling up to $190 million over five years to implement the Strategic Prevention Framework State Incentive Grants to advance community-based programs for substance abuse prevention to recipients in Alaska, Arizona, District of Columbia, Delaware, Iowa, Maryland, Michigan, Minnesota, Montana, Nebraska, New York, Ohio, Oklahoma, Oregon, Puerto Rico, South Carolina, South Dakota, Virgin Islands. Each state grantee will receive up to $2.135 million per year for five years. SAMHSA’s Center for Substance Abuse Prevention will administer the grants.

The SAMHSA grants are built on a community-based risk and protective factors approach to prevention by addressing issues like family conflict, low school readiness, and poor social skills that increase the risk for delinquency and violence. These grants are intended to assist programs in providing leadership, technical support and monitoring to their communities.

Recipients are to use the grant funds will be used to implement a five-step planning process known to support positive youth development, reduce risk-taking behaviors, build on assets, and prevent problem behaviors. The five steps are: (1) conduct needs assessments; (2) build state and local capacity; (3) develop a comprehensive strategic plan; (4) implement evidence-based prevention policies, programs and practices; and (5) monitor and evaluate program effectiveness, sustaining what has worked well. SAMHSA says the success of the grants will be indicated by specific measurable outcomes, among them: abstinence from drug use and alcohol abuse, reduction in substance abuse-related crime, attainment of employment or enrollment in school, increased stability in family and living conditions, increased access to services, and increased social connectedness. For more information, see here.

We hope that this information is useful to you. If you need assistance with EMR or other health care technology, privacy or other health care compliance, risk management, transaction or operation concerns, please contact Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270-2402, cstamer@cttlegal.com or your other favorite Curran Tomko Tarski LLP Partner.

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here or e-mailing this information to cstamer@cttlegal.com.

Leave a Comment » | Disease Management | Permalink
Posted by Cynthia Marcotte Stamer

Blue Dog Democrats Hold Key Voice On House Democrats Proposed Health Care Reform Plan; Contact Numbers Here

July 20, 2009

Health care providers and others concerned about the “American’s Affordable Health Care Choices Act of 2009” health care reform proposal introduced by the House Democratic Leadership should target their input on the Democrats in Congress most likely to listen to those concerns. In the House of Representatives, these members likely are the “Blue Dog Democrats” in the House. Read about Blue Dog Democrats here.

For persons interested in making their voices heard and sharing information with others who wish to do the same, the following contact information may be of interest:

The number of the Capital Switchboard is 202-224-3121.

The Blue Dog Leadership Team and there telephone and fax numbers are:

Rep. Stephanie Herseth Sandlin (SD), Blue Dog Co-Chair for Administration, Telephone: 202.225.2801 , Fax: 202.225.5823

Rep. Baron Hill (IN-09), Blue Dog Co-Chair for Policy,Telephone: 202-225-4031, Fax: (202) 226-6866

Rep. Charlie Melancon (LA-03), Blue Dog Co-Chair for Communications, Telephone: 202-225-4031, Fax: (202) 226-3944

Rep. Heath Shuler (NC-11), Blue Dog Whip, Telephone: 202-225-6401, Fax: (202) 226-6422

The Blue Dog Members and their telephone numbers are :

Altmire, Jason (PA-04),(202)225-2565

Arcuri, Mike (NY-24), (202)225-3665

Baca, Joe (CA-43),(202)225-6161

Barrow, John (GA-12), (202) 225-2823

Berry, Marion (AR-01), (202) 225-4076

Bishop, Sanford (GA-02), (202) 225-3631

Boren, Dan (OK-02), (202) 225-2701

Boswell, Leonard (IA-03), (202) 225-3806

Boyd, Allen (FL-02), (202) 225-5235

Bright, Bobby (AL-02), (202) 225-2901

Cardoza, Dennis (CA-18), (202) 225-6131

Carney, Christopher (PA-10), (202) 225-3731

Chandler, Ben (KY-06), (202) 225-4706

Childers, Travis (MS-01), (202) 225-4306

Cooper, Jim (TN 5^th), (202) 225-4311

Costa, Jim (CA 20^th), (202) 225-3341

Cuellar, Henry (TX 28^th), (202) 225-1640

Dahlkemper, Kathleen A. (PA 3^rd), (202) 225-5406

Davis, Lincoln (TN 4^th),(202) 225-6831

Donnelly, Joe (IN 2^nd), (202) 225-3915

Ellsworth, Brad (IN 8^th), (202) 225-4636

Giffords, Gabrielle (AZ 8^th), (202) 225-2542

Gordon, Bart (TN 6^th), (202) 225-4231

Griffith, Parker (AL 5^th), (202) 225-4801

Harman, Jane (CA 36^th), (202) 225-8220

Herseth Sandlin, Stephanie (SD At Large), (202) 225-2801

Hill, Baron P. (IN 9^th), (202) 225-5315

Holden, Tim (PA 17^th), (202) 225-5546

Kratovil, Frank Jr. (MD 1^st), (202) 225-5311

McIntyre, Mike (NC 7^th), (202) 225-2731

Marshall, Jim (GA 8^th), (202) 225-6531

Matheson, Jim (UT 2^nd), (202) 225-3011

Melancon, Charlie (LA 3^rd), (202) 225-4031

Michaud, Michael H. (ME 2^nd), (202) 225-6306

Minnick, Walt (ID 1^st), (202) 225-6611

Mitchell, Harry E. (AZ 5^th), (202) 225-2190

Moore, Dennis (KS 3^rd), (202) 225-2865

Murphy, Patrick J. (PA 8^th), (202) 225-4276

Nye, Glenn C. (VA 2^nd), (202) 225-4215

Peterson, Collin C. (MN 7^th), (202) 225-2165

Pomeroy, Earl (ND At Large), (202) 225-2611

Ross, Mike (AR 4^th), (202) 225-3772

Salazar, John T. (CO 3^rd), (202) 225-4761
Sanchez, Loretta (CA 47^th), (202) 225-2965

Schiff, Adam B. (CA 29^th), (202) 225-4176
Scott, David (GA 13^th), (202) 225-2939

Shuler, Heath (NC 11^th), (202) 225-6401

Space, Zachary T. (OH 18^th), (202) 225-6265

Tanner, John S. (TN 8^th), (202) 225-4714

Taylor, Gene (MS 4^th), (202) 225-5772

Thompson, Mike (CA 1^st), (202) 225-3311

Wilson, Charles (OH-06), (202) 225-5705

Other Helpful Resources & Other Information

Leave a Comment » | American's Affordable Health Choices Act, Childrens Health Insurance Program, Consumer Driven Health Care, Doctor, Electronic Medical Records, Evidence Based Medicine, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, Health Insurance Exchange, Health Plan, Health Plans, Health Policy, Hospital, Indian Health, Medicaid, Medical Malpractice, Medicare, Medicare Advantage, Outcomes Data, Outpatient, Physician, Prescription Drugs, Reimbursement, Rural Health Care, Stark, Uncategorized, Veterans Health, Veterans Health Care | Tagged: American's Affordable Health Care Choices act of 2009, Health Care, Health Care Policy, Health Care Provider, Health Care Reimbursement, Health Insurance, Health Plans, Health Policy, HHS, Hospital, House Democrat Majority, Long Term Care Hospital, Medicare, Medicare Part B, Physician, Physicians, Prescription Drugs, public health, Public Policy, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer

August 31 Deadline To Comment On CMS Proposed Changes To Hospital, ASC Payment Rules

July 20, 2009

August 31, 2009 at 5:00 p.m. E.S.T is the deadline to comment on the “Proposed Changes to the Hospital Outpatient Prospective Payment System and CY 2010 Payment Rates; Proposed Changes to the Ambulatory Surgical Center Payment System and CY 2010 Payment” rules published by the Centers for Medicare & Medicaid Services (CMS) in the Federal Register today (July 20, 2009).

The Proposed Rule would revise the Medicare hospital outpatient prospective payment system (OPPS) to implement applicable statutory requirements that CMS proposes to apply to services furnished on or after January 1, 2010. It also would update the revised Medicare ambulatory surgical center (ASC) payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. If also sets for the applicable relative payment weights and amounts for services furnished in ASCs, specific HCPCS codes to which these proposed changes would apply, and other pertinent rate setting information for the CY 2010 ASC payment system.

To review the proposed rule and for instructions about how to submit comments, see here.

The author of this article, Curran Tomko and Tarski LLP Health Care Practice Chair Cynthia Marcotte Stamer has extensive experience advising and assisting health care providers to evaluate and comment on health care industry reimbursement and other health industry legislation and regulations, as well as a diverse range of other health care reimbursement, and other legal and operational risk concerns. She also writes and speaks extensively on these issues. You can get more information about her health industry experience here.

If you need assistance investigating the adequacy of your current compliance efforts, with these or other compliance concerns, wish to inquire about arranging for compliance audit or training, or need legal representation on other matters please contact Cynthia Marcotte Stamer, CTT Health Care Practice Group Chair, at cstamer@cttlegal.com, 214.270.2402 or your other favorite Curran Tomko Tarski LLP attorney.

Other Helpful Resources & Other Information

Leave a Comment » | ASC, Doctor, Outpatient, Uncategorized | Tagged: ASC, Centers for Medicare & Medicaid Servicces, CMS, Doctor, Health Care, Health Care Policy, Health Care Provider, Health Care Reimbursement, HHS, Hospital, Medicare, Medicare Part B, Physician, Physicians, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer

Contact House Blue Dog Democrats About Health Care Reform Bill Concerns

July 17, 2009

Individuals concerned about the “American’s Affordable Health Care Choices Act of 2009” health care reform proposal introduced by the House Democratic Leadership earlier this week should target their input on the Democrats in Congress most likely to listen to those concerns. In the House of Representatives, these members likely are the “Blue Dog Democrats” in the House. Read about Blue Dog Democrats here.

For persons interested in making their voices heard and sharing information with others who wish to do the same, the following contact information may be of interest:

The number of the Capital Switchboard is 202-224-3121.

The Blue Dog Leadership Team and there telephone and fax numbers are:

Rep. Stephanie Herseth Sandlin (SD), Blue Dog Co-Chair for Administration

Telephone: 202.225.2801 , Fax: 202.225.5823

Rep. Baron Hill (IN-09), Blue Dog Co-Chair for Policy

Telephone: 202-225-4031, Fax: (202) 226-6866

Rep. Charlie Melancon (LA-03), Blue Dog Co-Chair for Communications

Telephone: 202-225-4031, Fax: (202) 226-3944

Rep. Heath Shuler (NC-11), Blue Dog Whip

Telephone: 202-225-6401, Fax: (202) 226-6422

The Blue Dog Members and their telephone numbers are :

Altmire, Jason (PA-04),(202)225-2565

Arcuri, Mike (NY-24), (202)225-3665

Baca, Joe (CA-43),(202)225-6161

Barrow, John (GA-12), (202) 225-2823

Berry, Marion (AR-01), (202) 225-4076

Bishop, Sanford (GA-02), (202) 225-3631

Boren, Dan (OK-02), (202) 225-2701

Boswell, Leonard (IA-03), (202) 225-3806

Boyd, Allen (FL-02), (202) 225-5235

Bright, Bobby (AL-02), (202) 225-2901

Cardoza, Dennis (CA-18), (202) 225-6131

Carney, Christopher (PA-10), (202) 225-3731

Chandler, Ben (KY-06), (202) 225-4706

Childers, Travis (MS-01), (202) 225-4306

Cooper, Jim (TN 5^th), (202) 225-4311

Costa, Jim (CA 20^th), (202) 225-3341

Cuellar, Henry (TX 28^th), (202) 225-1640

Dahlkemper, Kathleen A. (PA 3^rd), (202) 225-5406

Davis, Lincoln (TN 4^th),(202) 225-6831

Donnelly, Joe (IN 2^nd), (202) 225-3915

Ellsworth, Brad (IN 8^th), (202) 225-4636

Giffords, Gabrielle (AZ 8^th), (202) 225-2542

Gordon, Bart (TN 6^th), (202) 225-4231

Griffith, Parker (AL 5^th), (202) 225-4801

Harman, Jane (CA 36^th), (202) 225-8220

Herseth Sandlin, Stephanie (SD At Large), (202) 225-2801

Hill, Baron P. (IN 9^th), (202) 225-5315

Holden, Tim (PA 17^th), (202) 225-5546

Kratovil, Frank Jr. (MD 1^st), (202) 225-5311

McIntyre, Mike (NC 7^th), (202) 225-2731

Marshall, Jim (GA 8^th), (202) 225-6531

Matheson, Jim (UT 2^nd), (202) 225-3011

Melancon, Charlie (LA 3^rd), (202) 225-4031

Michaud, Michael H. (ME 2^nd), (202) 225-6306

Minnick, Walt (ID 1^st), (202) 225-6611

Mitchell, Harry E. (AZ 5^th), (202) 225-2190

Moore, Dennis (KS 3^rd), (202) 225-2865

Murphy, Patrick J. (PA 8^th), (202) 225-4276

Nye, Glenn C. (VA 2^nd), (202) 225-4215

Peterson, Collin C. (MN 7^th), (202) 225-2165

Pomeroy, Earl (ND At Large), (202) 225-2611

Ross, Mike (AR 4^th), (202) 225-3772

Salazar, John T. (CO 3^rd), (202) 225-4761
Sanchez, Loretta (CA 47^th), (202) 225-2965

Schiff, Adam B. (CA 29^th), (202) 225-4176
Scott, David (GA 13^th), (202) 225-2939

Shuler, Heath (NC 11^th), (202) 225-6401

Space, Zachary T. (OH 18^th), (202) 225-6265

Tanner, John S. (TN 8^th), (202) 225-4714

Taylor, Gene (MS 4^th), (202) 225-5772

Thompson, Mike (CA 1^st), (202) 225-3311

Wilson, Charles (OH-06), (202) 225-5705

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Posted by Cynthia Marcotte Stamer

August 14 Comment Deadline On Newly Proposed Rules To Implement Medicaid Eligibility Quality Control & Payment Error Rate Measurement Provisions of CHIP Reauthorization Ac

July 15, 2009

August 14, 2009 is the deadline to submit comments on to the Centers for Medicare & Medicaid Services (CMS) on proposed rules to implement the Medicaid Eligibility Quality Control (MEQC) and Payment Error Rate Measurement (PERM) programs provisions from the Children’s Health Insurance Program Reauthorization Act of 2009 (CHIPRA) (Pub. L. 111-3) published in today’s (July 15, 2009) Federal Register. The Proposed Regulations also would codify several procedural aspects of the process for estimating improper payments in Medicaid and the Children’s Health Insurance Program (CHIP).

The Proposed Regulations also would codify several procedural aspects of the process for estimating improper payments in Medicaid and the Children’s Health Insurance Program (CHIP).

Interested persons may review a copy of the regulation on the Internet here.

To be assured consideration by CMS, CMS must receive comments no later than 5 p.m. on August 14, 2009 in accordance with the instructions published along with the proposed regulations.

The author of this article, Curran Tomko and Tarski LLP Health Care Practice Chair Cynthia Marcotte Stamer has extensive experience advising and assisting health care providers to evaluate and comment on health care industry reimbursement and other health industry legislation and regulations, as well as a diverse range of other health care reimbursement, and other legal and operational risk concerns. She also writes and speaks extensively on these issues. You can get more information about her health industry experience here.

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Posted by Cynthia Marcotte Stamer

House Democrats Introduce the “American’s Affordable Health Care Choices Act of 2009”

July 15, 2009

House Democrats introduced their proposal for health care reform this afternoon (July 14, 2009), the “America’s Affordable Health Choices Act of 2009 (the “House Bill”). Introduced under the sponsorship of three key House committees — Energy and Commerce, Ways and Means, and Education and Labor — the 1018 page House Bill details the sweeping and comprehensive health care reforms touted by House Democrat Leaders.. A copy of the House Bill as introduced may be reviewed here.

The House Bill proposes sweeping reforms built around the establishment of a public plan option while technically continuing to permit private plans to operate but in a federally regulated form allowing for little meaningful plan design control to private payers, health care providers or the individuals choosing among the plan options. The Congressional Budget Office estimates that the coverage side of the bill will cost $1 trillion and cover 97 percent of the legal population within 10 years.

The following is a brief overview of certain key provisions of the House Bill drawn mostly from a series of high level summaries released by House Democrats along with the House Bill. Long on politically comforting phrasing and short on details, you can read these summaries here.

Public Plan Option. The House Bill proposes the establishment of a public health insurance option that would compete with allowable private plans, both of which would be subject to sweeping federal controls. Democrat House co-sponsors represent the House Bill:

Provides a public health insurance option that would compete with private insurers within the Health Insurance Exchange.
The public health insurance option would be made available in the new Health Insurance Exchange (Exchange) along with private health insurance plans that comply with the design dictates established in the House Bill.
The public health insurance option and private plan options meet the same benefit requirements and comply with the same insurance market reforms
The public option’s premiums would be established for the local market areas designated by the Exchange.
Individuals with affordability credits could choose among the private carriers and the public option.
Require that the public health plan and private health plan options and private options each must be financially self-sustaining
Promote primary care, encourage coordinated care and shared accountability, and improve quality.
Institute new payment structures and incentives to promote these critical reforms.
Specify health care provider participation in the plans will be voluntary; Medicare providers are presumed to be participating unless they opt out.
Provides for provider reimbursements for services from the plans initially will be established using “rates similar to those used in Medicare with greater flexibility to vary payments.
Speaker of the House Nancy Pelosi has announced plans to proceed immediately on mark up on the House Bill with the intention to of scheduling a vote on the House Bill by the end of July. Assuming that House leaders adhere to this schedule, the planned timetable leaves little opportunity for critical evaluation and input by members of Congress or the public who may have questions or concerns about the proposed legislation. Prompt and coordinated action is required for individuals with concerns about any of the proposed reforms.

Federal Mandates Health Plan Benefits. In order to achieve affordable, quality health care for all, the House Bill would impose federal standards regulating the benefits that the public health plan and private health plans would be required and permitted to offer. Under these provisions, the House Bill would:

Establish a standardized benefit package that covers essential health services.
Vest the power in the Secretary of Health & Human Services to decide the coverage that would be included in this mandated standardize benefit package.
Eliminate cost-sharing for preventive care (including well baby and well child care)
Impose caps annual out-of-pocket spending for individuals and families.
Create a new independent Benefits Advisory to recommend to the Secretary and update the core package of benefits.
Provide for the public health plan option to offer four tiers of benefit packages from which consumers can choose to best meet their health care needs. Each allowable plan would be required to provide the dictated core benefits.
- The Basic Plan would include the federally mandated core set of covered benefits and cost sharing protections;
- The Enhanced Plan would include the federally mandated core set of covered benefits with more generous cost sharing protections than the Basic plan;
- The Premium Plan would include the federally mandated core set of covered benefits with more generous cost sharing protections than the Enhanced plan; and
- The Premium Plus Plan would include the federally mandated core set of covered benefits, the more generous cost sharing protections of the Premium plan, and additional covered benefits (e.g., oral health coverage for adults, gym membership, etc.) that will vary per plan. In this category, insurers must disclose the separate cost of the additional benefits so consumers know what they’re paying for and can choose among plans accordingly.

The House Bill empowers the Secretary of Health & Human Services to decide the federally dictated, required core set of benefits provides coverage with input from a newly created Benefits Advisory Commission. These core benefits are intended to include inpatient hospital services, outpatient hospital services, physician services, equipment and supplies incident to physician services, preventive services, maternity services, prescription drugs, rehabilitative and habilitative services, well baby and well child visits and oral health, vision, and hearing services for children and mental health and substance abuse services. However, the particular, terms and scope of these benefits is left to HHS to define.

Health Insurance Exchange. The House Bill also calls for the establishment of a “Health Insurance Exchange” meeting federal mandates through which low income individuals initially, and certain small businesses would be offered the option to purchase health care coverage through federally mandated purchasing groups. In the first year, the House Bill provides for the Health Insurance Exchange to accept those without health insurance, those who are buying health insurance on their own, and small businesses with fewer than 10 people. In the second year, the Health Insurance Exchange could accept small businesses with fewer than 20 people. After that, “larger employers as permitted by the Commissioner.” In other words, expansion is discretionary, not mandated.

Affordability & Subsidies. The House Bill provides sliding-scale affordability credits for individuals and families with incomes above the Medicaid thresholds but below 400% of poverty and imposes a cap on total out-of-pocket spending for individuals and families covered under the plans regardless of income. In addition, the House Bill would broaden Medicaid coverage to include individuals and families with incomes below 133% of poverty.

Effective 2013, sliding scale affordability credits would be provided provided to individuals and families between 133% to 400% of poverty. That means the credits phase out completely for an individual with $43,320 in income and a family of four with $88,200 in income (2009).

The sliding scale credits limit individual family spending on premiums for the essential benefit package to no more than 1.5% of income for those with the lowest income and phasing up to no more than 11% of income for those at 400% of poverty.

The affordability credits also subsidize cost sharing on a sliding scale basis, phasing out at 400% of poverty, ensuring that covered benefits are accessible.

The Health Insurance Exchange would administer the affordability credits in relationship with other federal and state entities, such as local Social Security offices and Medicaid agencies.

The essential benefit package, and all other benefit options, limit exposure to catastrophic costs with a cap on total out of pocket spending for covered benefits. Special provisions would apply to Medicaid.

Effective 2013, individuals with family income at or below 133% of poverty ($14,400 for an individual in 2009) are eligible for Medicaid. State Medicaid programs would continue to cover those individuals with incomes above 133% of poverty, using the eligibility rules states now have in place.

Paying The Tab. House Democrats propose to finance approximately half of the estimated $1 trillion bill for their proposed reforms through projected $500 billion or so in savings from Medicare and Medicaid achieved by a variety of reimbursement and benefit cutbacks and other reforms. The rest of the financing would come from a combination of revenue expections from employer and individual mandates (an estimated $200 billion over 10 years) and a surtax on the richest 1.5 percent of Americans. The surtax is 1 percent on income between $350,000 and $500,000; 1.5 percent on income between $500,000 and $1,000,000; and 5.4 percent in income above $1,000,000. The House Bill permits the amount of this surtax to vary if the bill is less or more expensive than initially anticipated.

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Leave a Comment » | Anti-KickBack, Centers For Disease Control, Childrens Health Insurance Program, Consumer Driven Health Care, Corporate Compliance, Disease Management, Doctor, Electronic Health Records, Electronic Medical Records, Employer, Evidence Based Medicine, false claims act, FDA, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, Health IT, Health Plan, Health Plans, Health Policy, HIPAA, Hospital, Indian Health, Medicaid, Medical Malpractice, Medicare, Medicare Advantage, OCR, OIG, Outcomes Data, Patient Empowerment, Peer Review, Physician, Prescription Drugs, Public Policy, Reimbursement, Rural Health Care, Stark, Tax, Veterans Health, Veterans Health Care, Wellness | Tagged: Corporate Compliance, Doctor, Health Care Policy, Health Care Provider, Health Care Reform, Health Care Reimbursement, Health Insurance, HIPAA, Hospital, Medicare, Medicare Part B, PBMs, Physician, Physicians, Prescription Drugs, Privacy, public health, Public Policy, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer

CMS Expands, Revises Hospital Compare Website Mortality, Readmission Data On 4000+ U.S. Hospitals As Part of Continuing Emphasis on Health Care Quality Improvement

July 14, 2009

Effort Seeks To Use Consumer Market Pressure To Pressure Hospital Quality Improvement, Cost Savings

The Centers for Medicare & Medicaid Services last week (July 9, 2009) expanded the information included on the Hospital Compare Website, a CMS resource that reports how frequently patients return to a hospital after being discharged and other selected quality data.

By sharing data through Hospital Compare, CMS seeks to pressure hospitals to improve quality by creating market pressure from consumers empowered with hospital quality data. The initiative is one of many government and private efforts to promote quality and reduce costs by tapping the power of health care consumers.

According to CMS, Hospital Compare now provides “better” data on the previously posted mortality rates for individual hospitals, as well as new data on 30-day readmissions for heart attack, heart failure, and pneumonia. Previously, Hospital Compare had provided only mortality rates for these three conditions.

The Hospital Compare Web site will show a hospital’s mortality or readmissions rate is “Better than,” “No different from,” or “Worse than” the U.S. national rate. This data information includes each hospital’s risk-standardized mortality rate (RSMR), an estimate of the rate’s certainty (also known as the interval estimate), and the number of eligible cases for each hospital. By posting hospital RSMRs, interval estimates, and the number of eligible cases, CMS is giving consumers and communities additional insight into the performance of their local hospitals in hopes that this will prompt all hospitals to work toward achieving the level of the top-performing hospitals in the country.

Reducing the rate of hospital readmissions to improve quality and achieve savings are key components of President Obama’s health care reform agenda. Administration officials indicate that hospital readmissions are reducing the quality of health care while increasing hospital costs. CMS officials hope posting of this expanded health care outcome data will help consumers make more informed health care choices.

According to CMS data, on average 1 in 5 Medicare beneficiaries who are discharged from a hospital today will re-enter the hospital within a month. Hospital Compare data show that for patients admitted to a hospital for heart attack treatment, 19.9 percent of them will return to the hospital within 30 days, 24.5 percent of patients admitted for heart failure will return to the hospital within 30 days, and 18.2 percent of patients admitted for pneumonia will return to the hospital within 30 days. Both the mortality and the readmissions measures have been endorsed by the National Quality Forum (NQF) and are supported by the Hospital Quality Alliance (HQA). CMS says both sets of measures are risk-adjusted and take into account previous health problems to “level the playing field” among hospitals and to help ensure accuracy in performance reporting.

“Providing readmission rates by hospital will give consumers even better information with which to compare local providers,” said Charlene Frizzera, CMS Acting Administrator. “Readmission rates will help consumers identify those providers in the community who are furnishing high-value healthcare with the best results.”

CMS has been tracking selected hospital outcomes data since 2007, when Hospital Compare debuted 30-day mortality rates for heart attack and heart failure. Thirty-day mortality rates for pneumonia were added to the Website in 2008. Hospital Compare also includes 10 measures that capture patient satisfaction with hospital care, 25 process of care measures, and two children’s asthma care measures. The site also features information about the number of selected elective hospital procedures provided to patients and what Medicare pays for those services.

According to CMS, public reporting of these and other measures is intended to empower patients and their families with information they need to engage their local hospitals and physicians in active discussions about quality of care. CMS officials assert that all hospitals, regardless of their readmission and mortality rates, should use the data available in these free, detailed reports to find ways to continually improve the care they deliver.”

This year, CMS has changed the way it calculates the mortality data to provide even better information to consumers. In 2007 and 2008, Medicare used only one year of claims data to compute mortality, while the rates added to the Web site today encompass three full years of claims data (from July 1, 2005 – June 30, 2008). Although this means that consumers cannot compare data from last year’s rate with this year’s rate, CMS officials believe the expanded data set should provide a clearer picture of how well hospitals are performing.

Using the three-year data method, CMS estimates that the national 30-day mortality rate for patients originally admitted for heart attack care is 16.6 percent. For heart failure patients, the national 30-day mortality rate is 11.1 percent, and for pneumonia patients the national rate is 11.5 percent.

According to CMS, Hospital Compare readmissions and mortality measures are risk-adjusted measures and were developed by a team of clinical and statistical experts from Yale and Harvard Universities under the direction of CMS and are endorsed by the NQF. The model CMS uses to assess hospital readmissions and mortality rates is based on claims data and has been validated by models based on clinical data. It takes into account medical care received during the year prior to each patient’s hospital admission, as well as the number of admissions at each hospital. The model uses this information to adjust for differences in each hospital’s patient mix, so that hospitals that care for older, sicker patients are on a “level playing field” with those whose patients would be expected to be at less risk of dying within 30 days of admission.

The author of this article, Curran Tomko and Tarski LLP Health Care Practice Chair Cynthia Marcotte Stamer has extensive experience advising and assisting health care providers and payers establish, administer health care quality assurance and other programs. Former Chair of the American Bar Association Health Law Section Managed Care & Insurance Interest Group, Ms. Stamer advises and represents health care payers and providers with a diverse array of quality assurance and other legal and operational risk management initiatives and writes and speaks extensively on these issues. Her many publications and presentations on health care quality include “Making Gainsharing Work: Contracting & Managing Physician Performance To Promote Quality, Manage Costs,“ “Payment (or Not) For Never Events,” “Practical Solutions for Achieving Clinical Quality & Financial Efficiency in an Evolving Health Care Arena,” “Building Your Patient Empowerment Toolkit,” “Selected Thoughts About Medical Judgment-Based Coverage Decisions Under ERISA-Covered Health Plans After Davila” and numerous other quality improvement workshops for medical societies, health care systems, and others. You can get more information about her health industry experience here.

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Posted by Cynthia Marcotte Stamer

OCR Requires Health Care Providers To Improve Services for Limited English Speakers, Hearing Impaired As HHS Steps Up Enforcement of Federal Discrimination Laws

July 14, 2009

Health care providers should review the adequacy of translation and other mechanisms required to allow limited English speakers, hearing impaired, and other language limited populations effective access to services in light of recent enforcement actions taken by Department of Health and Human Services (HHS) Office of Civil Rights (OCR) against health care providers for discrimination under Title VI of the Civil Rights Act of 1964 (Title VII), the Americans With Disabilities Act (ADA) and other federal discrimination laws.

As part of a broader Obama Administration initiative to make prevention and redress prohibited national origin, disabilities and other discrimination in employment, public services, public accommodations and telecommunications a priority, HHS has announced that OCR will hold health care providers accountable for ensuring effective and adequate access by individuals seeking services having limited English language proficiency, hearing loss or other language or communication restrictions impacting on their ability to access care and services.

Medco Health Solutions, Inc. National Origination Settlement

On June 22, 2009, OCR announced that national pharmacy benefit management company Medco Health Solutions, Inc. had agreed to implement a multi-faceted plan to improve services to limited and non-English speaking members in 2009.

The commitment to take corrective action by the nation’s largest mail-order pharmacy operation arose from OCR’s investigation of a complaint filed with OCR on behalf of a Spanish-speaking member. The complaint alleged that Medco violated Title VI of the Civil Rights Act of 1964 (Title VII) by failing to provide limited English proficiency members (LEP members) with meaningful access to mail-order pharmacy services and other pharmacy benefit management services.

Under Title VI, health care providers and other recipients of federal financial assistance are required to take reasonable steps to provide meaningful access to their programs by limited English proficient individuals who are eligible to receive their services.

Under the commitment letter, Medco agreed to implement a number of measures to strengthen its provision of language assistance services to LEP members starting with those for Spanish-speaking members in 2009. The corrective actions agreed to by Medco include:

Expanding its pool of bilingual customer service representatives who speak Spanish
Revising its systems to enhance its ability to route Spanish-speaking members who need help with prescription drug questions or problems directly to bilingual staff, including pharmacists where possible and appropriate
Continuing to use a telephonic interpreter service available for more than 150 other languages to communicate with other non-English speakers.
Implementing a critical improvement in Medco’s internal computer systems that will flag language preference on an ongoing basis to aid effective communication with limited English proficient persons during member-Medco contact.
Continuing to improve its ability to identify and track individuals’ language preferences so that important written communications and outbound telephone calls are placed to members in their primary language.
Reviewing how best to notify limited English proficient members that language assistance services are available.
Developing an evaluation process with respect to interpreter competency. Staff at call centers and pharmacies expected to communicate directly with members in languages other than English will be assessed as to language proficiency, and those serving as interpreters will be assessed for interpreting competency.
Training all relevant staff on system changes intended to improve access to limited English proficient members, and will monitor the results of these efforts through periodic assessments.

Read the Medco Commitment Letter here.

Scottsdale Healthcare – Osborn (SHO) Voluntary Resolution Agreement

The Medico Commitment Letter follows OCR’s April, 2008 announcement that d a signed Resolution Agreement that requiring Scottsdale Healthcare – Osborn (“SHO”) a 337–bed full–service Arizona hospital to improve access to sign language interpreters and other services required for hearing impaired patients to effectively access services. The SHO VRA resolves a disability discrimination complaint against SHO brought by a patient with severe hearing loss, who reported that she was denied a sign language interpreter when treated in the SHO emergency room and intensive care unit.

Following OCR’s investigation of the complaint, SHO among other things agreed to: (1) affirm its compliance with Section 504 of the Rehabilitation Act of 1973, 29 U.S.C. § 794; (2) issue and post revised policies to ensure that appropriate auxiliary aids, including sign language interpreters or video interpretation services, are provided to deaf or hard-of-hearing patients or companions within a two hour time period; (3) develop procedures to assess the sign language interpreter needs of patients or companions; (4) train hospital personnel and physicians on its revised policies and procedures to ensure effective communication; (5) place TTY lines throughout its facility; (6) maintain a centralized telecommunication number 24-hours per day, 7-days per week for sign language interpreter requests; and (7) provide regular compliance reports to OCR. Read SHO VRA here

Health Care Providers Should Act To Manage Risks As Obama Administration Makes Enhanced Investigation and Enforcement of Federal Discrimination Laws A Priority

Health care providers and other businesses covered by Title VII, the Americans with Disabilities Act and other federal discrimination laws should heed the Medco and SHO actions of the advisability of taking prompt action to review and if necessary, strengthen the adequacy of reasonable accommodations necessary to enable individuals with limited English proficiency, hearing or other language impairments to access services.

Beyond the adequacy of services to address language impairments, health care providers and others also generally should anticipate that the willingness by the OCR under the Obama Administration to act on the Medco and SHO complaints reflects a heightened willingness by federal agencies to investigate and enforce disabilities, national origin and charges of federal discrimination violations by health care providers and others by OCR and other federal agencies under the Obama Administration. Review Obama Administration Civil Rights Enforcement Agenda here. While OCR took a series of enforcement actions under the predecessor Bush Administration, this announced renewed emphasis on federal discrimination law enforcement coupled by the series of actions taken by OCR and other federal agencies since January, 2009 reflects that OCR and other agencies are acting on the direction of President Obama to make prevention and redress of disabilities and other discrimination in employment, public services, public accommodations and telecommunications a priority. Read about other recent OCR federal discrimination enforcement activates here. See also, e.g., recent discrimination policies and enforcement activities by Department of Justice, the Equal Employment Opportunity Commission, the Department of Housing and Urban Development.

The Medco and SHO actions, as well as a series of other recently announced enforcement actions reflect that OCR and other federal agencies are likely to continue to expand investigation and enforcement of disability and other violations by health care providers of federal disability and other discrimination laws in recent months. Health care providers and others regulated by these federal discrimination laws should consider auditing the adequacy of existing practices, reaffirming their commitment to compliance to workforce members and constituents, retraining workforce and taking other appropriate steps to help prevent illegal discrimination within their organization and to position their organization to respond and defend against potential discrimination investigations or charges.

The author of this article, Curran Tomko and Tarski LLP Health Care Practice Chair Cynthia Marcotte Stamer has extensive experience advising and assisting health care practitioners and other businesses and business leaders to establish, administer, investigate and federal and state discrimination and other compliance and internal control policies and practices to reduce risk under federal and state health care, discrimination and other laws. Board Certified in Labor and Employment Law by the Texas Board of Legal Specialization, Ms. Stamer’s practice emphasizes assisting health industry clients to monitor compliance and other legal and operational risks and to design, administer and defend internal controls and other risk management practices to mitigate these exposures. You can get more information about her health industry experience here.

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Leave a Comment » | ADA, Corporate Compliance, Disability Discrimination, Discrimination, Doctor, Employer, Health Care, Health Care Provider, Health Policy, Medicaid, Medicare, Medicare Advantage, OCR, Physician, Rehabilitation Act | Tagged: ADA, Corporate Compliance, Disability Discrimination, Doctor, English as A Second Language, Health Care, Health Care Provider, Health Care Reimbursement, Health Insurance, Health Policy, Hearing Impairment, HHS, Hospital, Limited English Proficiency, Medicare, Medicare Part B, National Origin Discrimination, Physician, Physicians, Prescription Drugs, Public Policy, Rehabilitation Act, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer

“Health Care Government Relations and Legislative Update” Focus On July 14 North Texas Healthcare Compliance Professional Association Meeting

July 13, 2009

NORTH TEXAS HEALTHCARE COMPLIANCE PROFESSIONAL ASSOCIATION

July 14, 2009 Meeting Reminder

Congress and federal regulators are making health care regulation and reform their latest priority. The NTHCPA invites interested health care compliance and ethics professionals to join us on July 14, 2009 for a lively discussion about “Health Care Government Relations and Legislative Update” lead by as Sandy Pappas, from Congressman Pete Session’s Office and Cynthia Marcotte Stamer from Curran Tomko Tarski LLP.

Date: Tuesday, July 14, 2009

Time: 2:00 p.m.

Location: Texas Health Resources, 612 E. Lamar Blvd., Arlington, TX 76011

For additional information, please contact Cynthia Stamer at (214) 270-2402 or by e-mail at cstamer@solutionslawyer.net.

About the NTHCPA

The vision of NTHCPA is to be a pre-eminent compliance and ethics group promoting lasting success and integrity of organizations within North Texas.

To register or update your registration to receive notice of other upcoming events, e-mail your contact information to lfigueroa@cttlegal.com.

Leave a Comment » | Anti-KickBack, Centers For Disease Control, Childrens Health Insurance Program, Corporate Compliance, Disability Discrimination, Discrimination, Doctor, Electronic Health Records, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Reform, Health IT, Licensing, Medicaid, Medical Licensure, Medical Malpractice, Medicare, Medicare Advantage, OIG, Peer Review, Physician, Physician Licensing, Prescription Drugs, Reimbursement, Rural Health Care, Veterans Health, Veterans Health Care | Tagged: Antitrust, Doctor, Health Care, Health Care Policy, Health Care Provider, Health Care Reform, Health Care Reimbursement, Health Insurance, Health Policy, HHS, HIPAA, Hospital, Long Term Care Hospital, Medicare, Medicare Part B, Physician, Physicians, Prescription Drugs, public health, Red Flag Rules, Reimbursement, retaliation, Retalitory Discharge | Permalink
Posted by Cynthia Marcotte Stamer

HHS Rescinds Key Medicaid Regulations

June 29, 2009

Department of Health and Human Services (HHS) Secretary Kathleen Sebelius today (June 29, 2009) announced that the administration will rescind all or part of three Medicaid regulations that were previously issued and delay the enforcement of a fourth regulation. Each of these rules, in whole or in part, had been subject to Congressional moratoria set to expire on July 1, 2009.

Specifically, the Centers for Medicare & Medicaid Services (CMS) and HHS are:

Rescinding a final rule, published December 28, 2007, that would have eliminated reimbursement for school-based administrative costs and costs of transportation to and from schools. The rescission reflects concern that the rule could limit the Medicaid administrative outreach activities of schools, and that the overall budgetary impact on schools could potentially impact their ability to offer Medicaid services to students.
Rescinding a rule, published November 7, 2008, that would have limited the outpatient hospital and clinic service benefit for Medicaid beneficiaries to the scope of services recognized as an outpatient hospital service under Medicare. This rule was rescinded because CMS became aware that coverage beyond that scope could not be easily moved to other benefit categories, resulting in great impact than previously anticipated.
Rescinding provisions of an interim final rule published December 4, 2007, which would have restricted beneficiary access to case management services. These provisions appeared to, in practice, restrict beneficiary access to needed covered case management services, and limit state flexibility in determining efficient and effective delivery systems for case management services.
Delaying until June 30, 2010, the enforcement of portions of a regulation that clarified limitations on health care related tax programs so that CMS could determine whether states need additional clarification or guidance. CMS may also further review the potential impact of the regulation, and give additional consideration to alternative approaches.

Announcing the rescission, Secretary Sebelius said “By rescinding these rules, we can expect that children will continue receiving services through their schools, beneficiaries will be able to access all available case management resources to help them better manage their health care, and outpatient hospital and clinic services can continue to be covered in the most efficient manner.”

Solutions Law Press author and Curran Tomko and Tarski LLP Health Care Practice Chair Cynthia Marcotte Stamer has extensive experience advising and assisting health care practitioners and other businesses and business leaders to establish, administer, investigate and defend health care fraud and other compliance and internal control policies and practices to reduce risk under federal and state health care and other laws. You can get more information about her health industry experience here.

If you need assistance with these or other compliance concerns, wish to inquire about arranging for compliance audit or training, or need legal representation on other matters please contact Cynthia Marcotte Stamer, CTT Health Care Practice Group Chair, at cstamer@cttlegal.com, 214.270.2402 or your other favorite Curran Tomko Tarski LLP attorney.

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Posted by Cynthia Marcotte Stamer

8 Miami-Area Residents Charged, Assets Frozen in $22 Million Home Health Medicare Fraud Scheme

June 29, 2009

Eight Miami-Dade County, Florida residents have been indicted in connection with an alleged $22 million Medicare fraud scheme operated out of Miami businesses purporting to specialize in home health care services and the assets of those charged and their companies frozen as part of a joint Department of Justice (DOJ) and Department of Health & Human Services (HHS) Medicare Fraud Strike Force operation.

DOJ and HHS officials jointly announced the Florida indictments and injunction action on June 26, 2009, just two days after their June 24, 2009 joint announcement of that a Detroit Medicare Fraud Strike Force had secured indictments against 53 people for schemes to submit more than $50 million in false Medicare claims.

Both the Florida and Detroit actions arose from health care fraud conducted by Medicare Fraud Strike Force teams acting as part of a recently formalized and expanded Health Care Fraud Prevention & Enforcement Action Team (HEAT) jointly announced by the DOJ and HHS on May 20, 2009. The Florida and Detroit actions announced last week reflect the growing commitment of federal officials to investigate and prosecute Medicare and other alleged heath care fraud.

8 Florida Indictments

The Florida indictments announced June 26, 2009 charge Gladys Zambrana, Javier Zambrana, Enrique Perez, Alejandro Hernandez Quiros aka Alex Hernandez, Vanessa Estrada, Vicenta Tellechea, Modesto Hidalgo and Carlos Castaneda conspiracy to commit health care fraud. Gladys Zambrana was also charged with four counts of health care fraud. Gladys Zambrana and Hernandez Quiros were charged with three counts each of paying health care kickbacks, while Perez, Hidalgo and Tellechea were charged with one count each of paying health care kickbacks. Gladys Zambrana, Perez, Alejandro Quiros, Tellechea and Castaneda were also charged with conspiracy to launder health care fraud proceeds.

According to the indictment, Gladys Zambrana, Perez and Hernandez Quiros operated ABC Home Health Care Inc. (ABC), listing Javier Zambrana as the owner; and Gladys Zambrana and Castaneda operated Florida Home Health Care Providers Inc. (Florida Home Health), listing Tellechea as the owner. Both ABC and Florida Home Health purported to be home health agencies that catered to Medicare beneficiaries. The indictment alleges that at both agencies, beneficiaries were recruited and paid kickbacks and bribes to arrange for their Medicare beneficiary numbers to be used by their co-conspirators to file claims with Medicare for purported home health care services. The indictment alleges that the services were not provided and were not medically necessary.

The indictment alleges that in addition to exerting ownership and control of the home health agencies, Hernandez Quiros and Castaneda acted as Medicare beneficiary recruiters for ABC and Florida Home Health, respectively; and Hidalgo, a medical assistant, falsified medical tests and records to make it appear that the services were needed. The indictment alleges that ABC billed more than $17 million to the Medicare program for services provided from January 2006 through December 2008 that were medically unnecessary and were not actually provided. During that time frame, Medicare paid more than $11 million on those fraudulent claims submitted by ABC. The indictment also alleges that from October 2007 through March 2009, Florida Home Health billed more than $5 million to the Medicare program for services that were medically unnecessary and not actually provided. During that time frame, Medicare paid more than $4 million on those fraudulent claims submitted by Florida Home Health.

The charge of conspiracy to commit health care fraud carries a maximum prison sentence of 10 years. Each charged count of health care fraud carries a maximum prison sentence of 10 years and each count of paying health care kickbacks carries a maximum prison sentence of five years. Conspiracy to launder health care fraud proceeds carries a maximum prison sentence of 10 years per count.

In conjunction with the criminal case, on June 24, 2009, the U.S. Attorney’s Office filed a civil complaint for injunctive relief under the fraud injunction statute and obtained a temporary restraining order freezing the assets of ABC, Florida Home Health, Gladys Zambrana, Javier Zambrana, Perez, Hernandez Quiros, Castaneda and Tellechea. In addition, that temporary restraining order also freezes certain financial assets of four other companies the defendants owned or controlled and allegedly used to launder money fraudulently obtained from Medicare. The temporary restraining order is intended to preserve the remaining proceeds of the fraud for recovery by the United States as part of the criminal case and any related civil proceedings.

53 Indicted In Detroit June 24

The announcement of the Florida indictment comes just 2 days after DOJ, HHS and FBI officials announced that a Detroit Medicare Fraud Strike Force had secured indictments against 53 people for their involvement in alleged schemes to submit false Medicare claims. The indictments unsealed June 24, 2009 returned by a grand jury in Detroit resulted in arrests in Miami, New York City and Detroit resulted from a concentrated effort by the Detroit Medicare Fraud Strike Force targeting infusion therapy and physical/occupational therapy providers involved in schemes orchestrated to defraud the Medicare program.

Collectively, the Detroit indictment accuses the physicians, medical assistants, patients, company owners and executives charged in the indictments of conspiring to submit more than $50 million in false claims to the Medicare program. According to the indictments, the defendants participated in schemes to submit claims to Medicare for treatments that were in fact medically unnecessary and oftentimes, never provided. In many cases, indictments also allege that beneficiaries accepted cash kickbacks in return for allowing providers to submit forms saying they had received the unnecessary and not provided treatments.

Federal Officials Turning On The HEAT on Health Care Fraud

The Florida and Detroit indictments reflect the growing commitment and cooperation among federal and state officials to investigation and prosecution of health care fraud using Medicare Fraud Task Forces operating as part of HEAT. Drawing upon successful experiences gained from Medicare Fraud Task Forces operating in Miami and Los Angeles since 2007, HEAT is an expanded multi-agency effort jointly announced by HHS and DOJ in May, 2009 that uses a multi-agency team of federal, state and local investigators to investigate and combat Medicare fraud through the use of Medicare data analysis techniques and an increased focus on community policing. Since strike force operations began in March 2007, DOJ officials report that the Medicare Fraud Task Forces already have resulted in the indictment of 257 defendants in 115 cases for their allegedly fraudulently billing Medicare for more than $600 million.

Before the May 20, 2009 HEAT announcement, Medicare Fraud Strike Forces operating demonstration projects in South Florida and Los Angeles already had produced a number of indictments. The Medicare Fraud Strike Force team operating in South Florida has already convicted 146 defendants and secured $186 million in criminal fines and civil recoveries. After the success of operations in South Florida, the Medicare Fraud Strike Force expanded in May 2008 to phase two in Los Angeles, where 37 defendants have been charged with criminal health care fraud offenses. To date in the Los Angeles cases, more than $55 million has been ordered in restitution to the Medicare program. DOJ and HHS officials have indicated that the success of these demonstration projects lies behind the founding of the HEAT initiative.

The heightened emphasis on enforcement of federal health care fraud laws reflected in the HEAT program the enactment of recent amendments to the False Claims Act, 31 U.S.C. § 3729 (FCA) under the “Fraud Enforcement and Recovery Act of 2009”(FERA). The FERA amendments increase the likelihood both that whistleblowers will turn in health care providers and other individuals and organizations that file false claims in violation of the FCA and the liability that violators may incur for that misconduct.

The FERA amendments and the HEAT Team and Strike Force activities are part of a broader emphasis in the enforcement of federal health care fraud laws by both the Administration and Congress. President Obama’s proposed Fiscal Year 2010 budget seeks to further increase funding for fraud prevention and enforcement by investing $311 million — a 50 percent increase from 2009 funding — to strengthen program integrity activities within the Medicare and Medicaid programs. The Obama Administration anticipates that all combined, the anti-fraud efforts in the President’s budget could save $2.7 billion over five years by improving oversight and stopping fraud in the Medicare and Medicaid programs, including the Medicare Advantage and Medicare prescription drug programs. Many state agencies also are stepping up their health care fraud investigations and enforcement.

In light of this new emphasis upon health care fraud detection and enforcement, health care providers now more than ever need to prepare to demonstrate the appropriateness and defensibility of their health care billing and other compliance efforts.

Curran Tomko and Tarski LLP Health Care Practice Chair Cynthia Marcotte Stamer has extensive experience advising and assisting health care practitioners and other businesses and business leaders to establish, administer, investigate and defend health care fraud and other compliance and internal control policies and practices to reduce risk under federal and state health care and other laws. You can get more information about her health industry experience here.

Other Helpful Resources & Other Information

We hope that this information is useful to you. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail- by creating or updating your profile at here. You can access other recent updates and other informative publications and resources provided by Curran Tomko Tarski LLP attorneys and get information about its attorneys’ experience, briefings, speeches and other credentials here.

Leave a Comment » | Anti-KickBack, Doctor, false claims act, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Hospital, Medicaid, Medicare, OIG, Physician | Tagged: Corporate Compliance, DME, false claims act, Federal Sentencing Guidelines, Fraud, Health Care, Health Care Reimbursement, HEAT, HHS, home health, Hospital, IV-infusion, Medicare, Medicare Fraud, Medicare Part B, Physician, Physicians, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer

53 Doctors, Health Care Executives & Beneficiaries Indicted For Involvement In A $50 Million Alleged False Billing Ring

June 24, 2009

Fifty-three people have been indicted for schemes to submit more than $50 million in false Medicare claims in the continuing operation of the Medicare Fraud Strike Force in Detroit, Attorney General Eric Holder, Department of Health and Human Services (HHS) Secretary Kathleen Sebelius, and FBI Director Robert Mueller announced today (June 24, 2009).

The charges were unsealed today against the 53 individuals who are accused of various Medicare fraud offenses, including conspiracy to defraud the Medicare program, criminal false claims and violations of the anti-kickback statutes. The indictments returned by a grand jury in Detroit resulted in arrests in Miami, New York City and Detroit.

According to the DOJ, federal agents from the FBI and the HHS Office of Inspector General (HHS-OIG) began executing arrest warrants and made arrests in Detroit, Miami and New York City earlier today as part of a concentrated effort targeting infusion therapy and physical/occupational therapy providers involved in schemes orchestrated to defraud the Medicare program.

Collectively, the indictment accuses the physicians, medical assistants, patients, company owners and executives charged in the indictments of conspiring to submit more than $50 million in false claims to the Medicare program. According to the indictments, the defendants participated in schemes to submit claims to Medicare for treatments that were in fact medically unnecessary and oftentimes, never provided. In many cases, indictments also allege that beneficiaries accepted cash kickbacks in return for allowing providers to submit forms saying they had received the unnecessary and not provided treatments. An indictment is merely an allegation, and defendants are presumed innocent until and unless proven guilty.

The investigation and enforcement action that lead to today’s indictment was conducted as part of the continuing activities of the new interagency Health Care Fraud Prevention and Enforcement Action Team (HEAT) that DOJ and HHS jointly announced last month. On May 20, 2009, DOJ and HHS jointly announced they were combining forces to find and prosecute health care fraud through the HEAT and identified Detroit and Houston as cities targeted for Medicare Fraud Strike Force attention.

Before the May 20, 2009 HEAT announcement, Medicare Fraud Strike Forces operating demonstration projects in South Florida and Los Angeles already had produced a number of indictments. The Medicare Fraud Strike Force team operating in South Florida has already convicted 146 defendants and secured $186 million in criminal fines and civil recoveries. After the success of operations in South Florida, the Medicare Fraud Strike Force expanded in May 2008 to phase two in Los Angeles, where 37 defendants have been charged with criminal health care fraud offenses. To date in the Los Angeles cases, more than $55 million has been ordered in restitution to the Medicare program. The success of these demonstration projects lies behind the founding of the HEAT initiative.

Other Helpful Resources & Other Information

Leave a Comment » | Anti-KickBack, Corporate Compliance, Doctor, false claims act, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Hospital, Medicaid, Medicare, Medicare Advantage, OIG, Physician, Reimbursement | Tagged: Corporate Compliance, false claims act, Federal Sentencing Guidelines, Fraud, Health Care, Health Care Provider, Health Care Reimbursement, heatlh care fraud, Hospital, Medicare, Medicare Part B, Physician, Physicians, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer

Veterans’ Rural Health Advisory Committee July 16, 2009 Telephone Meeting Open To Public

June 24, 2009

Health care providers and other interested members of the public can participate in a telephone meeting of the Department of Veterans Affairs (VA) Veterans’ Rural Health Advisory Committee from 2 p.m. to 3:30 p.m. Eastern on Thursday, July 16, 2009.

The Committee is scheduled to meet to discuss the current status of the Office of Rural Health operations, progress towards completion of the Committee’s first report to the Secretary and upcoming meeting dates.

The Committee advises the Secretary of Veterans Affairs on health care issues affecting enrolled Veterans residing in rural areas. It examines programs and policies that impact the provision of VA health care to enrolled Veterans residing in rural areas.

The July 16, 2009 meeting is open to the public. The toll free number for the meeting is 1-866-802-4355, and the access code is 1372672. The Committee has indicated that a 15 minute period will be reserved at 3:15 p.m. Eastern for public comments. Members of the public may also submit a one page summary of their comments for inclusion in the official meeting record. For additional information, see the Committee Meeting Notice or contact Kara Hawthorne, Designated Federal Officer, at rural.health.inquiry@va.gov or (202) 461-7100.

For More Information

We hope that this information is useful to you. If you need assistance with EMR or other health care technology, privacy or other health care compliance, risk management, transaction or operation concerns, please contact Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer at (214) 270-2402, CStamer@CTTLegal.com or your other favorite Curan Tomko Tarski LLP Partner.

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here or e-mailing this information to CStamer@CTTLegal.com.

Leave a Comment » | Doctor, Health Care, Hospital, Veterans Health | Tagged: Rural Health Care, VA, Veterans Health | Permalink
Posted by Cynthia Marcotte Stamer

FDA Schedules Three Public Seminars on The Essentials of Medical Device Regulations:

June 24, 2009

The Food and Drug Administration plans to present a public seminars on FDA medical device regulations to introduce startup and small device manufacturers and their suppliers to the essentials of medical device regulations on three dates during July and August. The seminars to be hosted in three different cities will cover include:

Doing business in a regulated industry;
Organizational structure of FDA;
Overview of the quality system regulation;
Design controls;
Documents, records, and change control;
Purchasing controls and acceptance activities;
Production and process control;
Corrective and preventive actions;
Complaints, medical device reports, corrections, and
recalls;
Compliance issues;
Management responsibility;
Interacting with FDA–Where do you go for assistance?
General question and answer session;
Manufacturers and suppliers–The chain regulatory
responsibility;
Reimbursement of medical technology;
The AdvaMed code of ethics; and
Fraud and abuse.

The 2-day seminars to be hosted in cooperation with AdvaMed’s Medical Technology Learning Institute are scheduled on:

July 14-15, 2009 in Coronado, CA
August 4- 5, 2009 in Nashville, TN and
August 12-13, 2009 in San Juan

The registration fee is $650 per person per seminar. For additional details, see the FDA Announcement in the June 24, 2009 Federal Register.

For More Information

We hope that this information is useful to you. If you need assistance with EMR or other health care technology, privacy or other health care compliance, risk management, transaction or operation concerns, please contact Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer at (214) 270-2402, CStamer@CTTLegal.com or your other favorite Curan Tomko Tarski LLP Partner.

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here or e-mailing this information to CStamer@CTTLegal.com.

Leave a Comment » | FDA, Health Care | Permalink
Posted by Cynthia Marcotte Stamer

Comments On Definition of Meaningful Use of EMR For Purposes of HITECH Act Provider Incentives Due June 26

June 16, 2009

Friday, June 26, 2009 at 5:00 p.m. Eastern Time is the deadline to submit comments to the Office of the National Coordinator for Health Information Technology (ONC) on the recommendations about what should be considered the term “meaningful use” of electronic health records (EHRs) presented to the Health Information Technology Policy Committee today (June 16, 2009) available for review here. Comments will be received by the Committee for consideration and further recommendations to the National Coordinator of Health Information Technology on the elements and measures of Meaningful Use of a certified EHR.

The HIT Policy Committee is a Federal Advisory Committee (FACA) to the U.S. Department of Health and Human Services (HHS). The American Recovery and Reinvestment Act of 2009 (ARRA”) provides for Medicare and Medicaid incentive payments for eligible providers, such as physicians and hospitals, in order to promote the adoption of EHRs. To receive the incentive payments, providers must demonstrate “meaningful use” of a certified EHR. Building upon the work of the HIT Policy Committee, HHS anticipates developing a proposed rule that provides greater detail on the incentive programs and “meaningful use.” HHS expects to issue the proposed rule in late 2009, which will be followed by a comment period.

How OCR decides to define meaningful use of EMR is likely to play a central role in determining how effective provider incentives to use EMR included in ARRA’s HITECH Act provisions work and ultimately influence how effectively those provisions and other OCR efforts to accelerate EMR and other health information technology use to promote health care efficiency and quality work.

For instructions on how to comment or additional information, see here.

For More Information

We hope that this information is useful to you. If you need assistance with EMR or other health care technology, privacy or other health care compliance, risk management, transaction or operation concerns, please contact Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer at (214) 270-2402, CStamer@CTTLegal.com or your other favorite Curan Tomko Tarski LLP Partner.

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here or e-mailing this information to CStamer@CTTLegal.com.

Leave a Comment » | ARRA Funding, Corporate Compliance, Doctor, Health Care, Health Care Finance, Health Care Provider, Health Care Reform, Health Plan, HIPAA, Hospital, Nonprofits | Tagged: ARRA, Data Security, Health Care Policy, Health Care Provider, Health Care Reform, Health Care Reimbursement, Health Insurance, Health Plans, Health Policy, HIPAA, Hospital, Medicare, Physician, Physicians, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer

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