HHS Invites Comments On Health Center Program Federal Tort Claims Policy Manual

July 1, 2010

The Federal Tort Claims Act (FTCA) Policy Manual (Manual) posted here that the Department of Health & Human Services intends to serve as the primary policy source for information on FTCA for Health Center Program grantees funded under section 330 (Section 330) of the Public Health Service (PHS) Act. August 6, 2010 is the deadline to share feedback on the Manual in response to an invitation from HHS published in the July 1, 2010 Federal Register. See here.  

The Manual is intended to consolidate, update and replace a variety of guidance previously issued by HHS about the FTCA Medical Malpractice program for participating Health Center Program grantees. HHS previously has issued numerous Program Information Notices (PINs) and Program Assistance Letters (PALs) related to the Health Center FTCA Medical Malpractice Program. HHS consolidated these PINs and PALs to create the Manual. HHS intends for the Manual to convey guidance about existing policy and current processes, and to serve as the principal policy resource on FTCA matters for Health Center Program grantees and related stakeholders. HHS going forward plans to update the Manual as it issues new policy and program guidance.

The Health Center Program supports more than 1,100 organizations operating almost 8,000 health care delivery sites, including community health centers, migrant health centers, health care for the homeless centers, and public housing primary care centers. Health centers serve medically underserved communities delivering preventive and primary care services to patients regardless of their ability to pay.

Health Center Program grantees funded under section 330 of the PHS Act, including Community Health Centers, Migrant Health Centers, Health Care for the Homeless Health Centers, and Public Housing Primary Care Health Centers, have access to medical malpractice coverage under the FTCA. FTCA is the legal mechanism for compensating people who have suffered personal injury due to the negligent or wrongful action of employees of the U.S. Government.

Under section 224 of the PHS Act, as amended by the Federally Supported Health Centers Assistance Act (FSHCAA) of 1992 and 1995, a section 330-funded health center, as well as its officers, directors, employees, and certain contractors, may be considered deemed to be Federal employees for the purpose of medical malpractice coverage under the FTCA. Accordingly, they are immune from personal liability for claims of medical malpractice arising from their deemed employment, contract for services, or duties as an officer or director of the deemed health center. FSHCAA requires health centers to apply for deemed status in order for FTCA coverage to be effective.

The author of this update, attorney Cynthia Marcotte Stamer, has extensive experience advising and assisting health care providers and other health industry clients with reimbursement, compliance, public policy, regulatory, staffing, and other operations and risk management matters. You can get more information about her health industry experience here.  If you need assistance with these or other compliance concerns, wish to inquire about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here. 

Other Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent 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 evaluating or responding to the Health Care Reform Law or health care compliance, risk management, transactional, operational, reimbursement, or public policy concerns, please contact the author of this update, Cynthia Marcotte Stamer, at (469) 767-8872, cstamer@Solutionslawyer.net.

Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 23 years experience advising health industry clients about these and other matters. A popular lecturer and widely published author on health industry and human resources matters, Ms. Stamer continuously advises health industry clients about health industry and other related concerns. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. For additional information about Ms. Stamer, her experience, involvements, programs or publications, see here.

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 here. To unsubscribe, e-mail here.

©2010 Solutions Law Press. All rights reserved.

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Posted by Cynthia Marcotte Stamer

NCPDP SCRIPT 10.6 Approved As Medicare Part D/Advantage E-Prescribing Option

July 1, 2010

The Centers for Medicare & Medicaid Services (CMS) today (July 1, 2010) issued an interim final rule (Rule) that permits the voluntary use of the National Council for the Prescription Drug Programs (NCPDP) Prescriber/Pharmacist Interface SCRIPT standard, Implementation Guide, Version 10, Release 6 (Version 10.6) (NCPDP SCRIPT 10.6) for conducting certain e-prescribing transactions for the Medicare Part D electronic prescription drug program. Review the Rule here.

Prior to the adoption the Rule, only NCPDP SCRIPT 8.1 was authorized for use in communicating Medicare Part D medication history among sponsors, prescribers and dispensers. The Rule revises Regulation §423.160(b)(4) to specify that entities now may use either NCPDP SCRIPT 10.6 or 8.1 for the communication of Medicare Part D medication history among sponsors, prescribers, and dispensers.

Along with the rule, CMS issued a request for comments on the Rule.  The deadline for interested parties to comment is 5 p.m. Eastern Daylight Time on August 30, 2010.

Section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) requires that Prescription Drug Plan (PDP) sponsors, Medicare Advantage (MA) organizations offering Medicare Advantage-Prescription Drug Plans  and other Medicare Part D sponsors (Plans) provide for electronic transmittal the prescribing provider, dispensing pharmacy and the dispenser of information about:

  • Eligibility,
  • Benefits (including drugs included in the applicable formulary, any tiered formulary structure and any requirements for prior authorization),
  • The drug being prescribed or dispensed and other drugs listed in the medication history,
  • The availability of lower cost, therapeutically appropriate alternatives (if any) for the drug prescribed, and
  • Certain other information.

Before the Rule, CMS had approved NCPDP SCRIPT 8.1 for conducting these electronic transmittals.

As a consequence of the Rule, Plans, prescribers and dispensers now may use either NCPDP SCRIPT 10.6 or 8.1 when conducting e-Prescribing to conduct:

  • Get message transaction.
  • Status response transaction.
  • Error response transaction.
  • New prescription transaction.
  • Prescription change request transaction.
  • Prescription change response transaction.
  • Refill prescription request transaction.
  • Refill prescription response transaction.
  • Verification transaction.
  • Password change transaction.
  • Cancel prescription request transaction.
  • Cancel prescription response transaction.
  • Fill status notification transaction.
  • For the communication of Medicare Part D medication history among sponsors, prescribers, and dispensers.

The MMD does not require that prescribers or dispensers implement e-Prescribing, prescribers and dispensers who electronically transmit prescription and certain other prescription-related information for Medicare Part D covered drugs prescribed for Medicare Part D eligible individuals, directly or through an intermediary, must comply with any applicable final standards that are in effect.  The Rule provides new choices on how to accomplish this.

The author of this update, attorney Cynthia Marcotte Stamer, has extensive experience advising and assisting health care providers and other health industry clients with reimbursement, compliance, public policy, regulatory, staffing, and other operations and risk management matters. You can get more information about her health industry experience here.   If you need help with these or other compliance concerns, wish to ask about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here. 

Other Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent 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 evaluating or responding to the Health Care Reform Law or health care compliance, risk management, transactional, operational, reimbursement, or public policy concerns, please contact the author of this update, Cynthia Marcotte Stamer, at (469) 767-8872, cstamer@Solutionslawyer.net.

Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 23 years experience advising health industry clients about these and other matters.  A popular lecturer and widely published author on health industry and human resources matters, Ms. Stamer continuously advises health industry clients about these and other related concerns.  Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, and other operations and risk management concerns.  Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  For additional information about Ms. Stamer, her experience, involvements, programs or publications, see here.  

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 here. To unsubscribe, e-mail here.

©2010 Solutions Law Press.  All rights reserved.

Leave a Comment » | Controlled Substances, DEA, Doctor, Electronic Health Records, Electronic Medical Records, Health Care, Health Care Provider, Health IT, Health Plan, Health Plans, Hospital, Hospital, Meaningful Use, Medicare, Medicare Advantage, Pharmacy, Physician, Prescription Drugs, Privacy, Reimbursement, Telemedicine | Tagged: , , , , , , , | Permalink
Posted by Cynthia Marcotte Stamer

Proposed Medicare Rules Will Require Hospitals Honor Patient Visitation Preferences

June 23, 2010

A new Condition of Participation rule proposed by the Centers for Medicare & Medicaid Services (CMS) would require hospitals to protect and honor patients’ rights to choose their own visitors during a hospital stay.  The new proposed rule will implement an April 15, 2010, Presidential memorandum directing HHS to develop standards requiring Medicare- and Medicaid-participating hospitals (including critical access hospitals) to allow patients to choose who may visit them when they are inpatients of a facility.

The proposed rule would add the new requirement as an addition Condition of Participation for Medicare- and Medicaid-participating hospitals and critical access hospitals.  To meet the Condition, the proposed rules would require every hospital to have written policies and procedures detailing patients’ visitation rights, as well as instances when the hospital may restrict patient access to visitors based on reasonable clinical needs.  Among other things, the proposed rule specifically would require:

  • Visitors chosen by the patient (or his or her representative) be able to enjoy visitation privileges that are no more restrictive than those for immediate family members; and
  • Require hospitals and critical access hospitals to explain to all patients their right to choose who may visit them during their inpatient stay, regardless of whether the visitor is a family member, a spouse, or a domestic partner (including a same-sex domestic partner), as well as the right to withdraw such consent at any time. 

The proposed rules expected to be published in the Federal Register this week will be available for public comment for 60 days.  CMS plans to finalize the proposed rule after CMS has read and considered the comments.  More information about the proposed rule see CMS’ website here and here.

The proposed new requirement would add to the already existing safety and other Conditions of Participation that hospitals must meet to participate in Medicare and would operate in addition to otherwise applicable patient’s visitation rights standards imposed by Joint Commission and other rules.  The author of this update, attorney Cynthia Marcotte Stamer, has extensive experience advising and assisting hospitals and other health care providers to estalish and administer patient’s rights and other policies to comply with Conditions of Participation and other applicable laws, regulations and standards. You can get more information about her health industry experience here.   If you need assistance with these or other compliance concerns, wish to inquire about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here. 

Other Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent 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 evaluating or responding to the Health Care Reform Law or health care compliance, risk management, transactional, operational, reimbursement, or public policy concerns, please contact the author of this update, Cynthia Marcotte Stamer, at (469) 767-8872, or e-mail here.

Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 22 years experience advising health industry clients about these and other matters.  A popular lecturer and widely published author on health industry and human resources matters, Ms. Stamer continuously advises health industry clients about these and other related concerns.  Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, and other operations and risk management concerns.  Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  For additional information about Ms. Stamer, her experience, involvements, programs or publications, see here.  

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 here. To unsubscribe, e-mail here.

©2010 Solutions Law Press.  All rights reserved.

Leave a Comment » | Conditions of Participation, Consumer Driven Health Care, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Hospital, Hospital, Medical Licensure, Medicare, Medicare Advantage | Permalink
Posted by Cynthia Marcotte Stamer

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