September 2009

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 .

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 » | 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.

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.

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

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 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.

Leave a Comment » | America's Healthy Futures Act, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, Health Insurance Exchange, Medicaid, Medicare, Medicare Advantage, Physician, Reimbursement, Tax, Tax-Exemption | Tagged: Health Care, Health Care Policy, Health Care Provider, Health Care Reimbursement, Health Policy, Hospital, Medicare, Nonprofits, Physician, Physicians, Prescription Drugs, Public Policy, Reimbursement | Permalink
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.

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.

Leave a Comment » | America's Healthy Futures Act, Corporate Compliance, Health Care, Health Care Reform, Health Plan, Health Plans, Health Policy, Medicaid, Medicare, Medicare Advantage, Pharmacy, Prescription Drugs, Public Policy, Reimbursement | Permalink
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.

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 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.

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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

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

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

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

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

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

CMS Proposes New Prospective Payment System For Renal Dialysis Facilities

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

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

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

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

September Declared National Prostate Cancer Awareness Month, 2009

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

Recent Posts

Archives

About Cynthia Marcotte Stamer

Share this blog

Archives

Solutions Law Press Health Care Update

Share this:

Like this:

Share this:

Like this:

Share this:

Like this:

Share this:

Like this:

Share this:

Like this:

Share this:

Like this:

Share this:

Like this:

Share this:

Like this:

Share this:

Like this:

Share this:

Like this:

Share this:

Like this:

Share this:

Like this:

Share this:

Like this:

Recent Posts

Archives

About Cynthia Marcotte Stamer

Share this blog

Archives

Solutions Law Press Health Care Update