Increased Medical Access May Increase LEP Patient Legal Claims

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The U.S. Census Bureau recently reported that over 57 million people in the United States spoke a language other than English in their home during 2009, a rate that will exceed 66 million people --  or 20 percent of the United States population -- by 2020.   The related increases in the limited English proficiency (LEP) population will require health care providers reimbursed by the Medicare, Medicaid and other government programs to heed the applicable requirements published by the Health and Human Services’ Office of Civil Rights (OCR) here and the Agency for Healthcare Research and Quality here in order to provide meaningful access to services.  To learn more about these requirements, visit the OCR’s LEP website here or contact Susan Ziel at 

HHS Refuses to Adopt District Court Decision on 340B Orphan Drugs

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In a June 18, 2014 statement, the Department of Health and Human Services (HHS) and the Health Resources and Services Administration (HRSA) announced their intentions to continue allowing hospitals participating in the 340B program to purchase “orphan drugs” (pharmaceuticals used to fight rare diseases or conditions) at discounted rates so long as the pharmaceuticals are not being used to treat the disease or condition that gave them their “orphan” status. This move comes in spite of a May, 2014 U.S. District Court for the District of Columbia decision holding that HHS does not have the requisite statutory authority to issue a final legislative rule narrowing the exclusion of orphan drugs from the 340B program.[1] 

Under the 340B program, drug manufacturers who participate in Medicaid must sell “covered outpatient drugs” to critical access hospitals, free-standing cancer hospitals, sole community hospitals, and rural referral centers at discounted prices as set by the Centers for Medicare and Medicaid Services. However, Section 7101 of the Affordable Care Act (ACA) bars hospitals covered under 340B from receiving discounts on “a drug designated for a rare disease or condition”.  The rational for that policy is that drugs with relatively small markets are unlikely to be very profitable; discounting them further would decrease the drug manufacturers’ ability to earn back the large amount of money necessary to research and develop orphan drugs. However, some orphan drugs are also approved for conditions that are not rare. HHS’ invalidated final legislative rule narrowed the ACA provision by mandating that orphan drugs be sold to the qualifying hospitals at their discounted prices, provided they were not being used for one of these “common” purposes.

HHS asserts that while the District Court invalidated its orphan drug final legislative rule, it did not invalidate its interpretation of federal law. Accordingly, HHS has the option to issue an interpretive rule or an interpretive guidance which would allow the agency to define statutory terms in a way which would allow the continued discounting of orphan drugs prices. To support its position, HHS pointed to Kelley v. U.S. Environmental Protection Agency wherein the Court invalidated a legislative rule, but invited the EPA to “try again” by issuing an interpretive rule. 

HRSA also issued a recent statement declaring that if manufacturers do not continue to sell orphan drugs at the discounted rates, they will not only be required to refund the hospitals and clinics, but their Pharmaceutical Pricing Agreements (PPA) may be terminated by the government. PPAs are typically required by the government if drug manufacturers desire to have their products covered by the Medicaid programs.

Should you have any questions regarding this matter, please do not hesitate to contact Charles MacKelvie at or at (312) 235-1117 

[1] Pharm. Research & Mfrs. of Am. v. United States HHS, 2014 U.S. Dist. LEXIS 70894 (D.D.C. May 23, 2014)

The National Association For Home Care And Hospice And Two Other Advocacy Organizations File A Lawsuit Contesting The Department Of Labor’s Companionship And Live–In Rules

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On  June 6, 2014, the National Association for  Home Care & Hospice (“NAHC”), the Home Care Association of American and the International Franchise Association filed a lawsuit seeking declaratory and injunctive relief against the Department of Labor seeking to overturn the new Department  rules restricting the application of companionship services and live-in exceptions to minimum wage and overtime compensation requirements.  The lawsuit was filed in the United States District Court for the District of Columbia.  The new rules are scheduled to take effect on January 1, 2015.

Under the Department of Labor’s new companionship rule, “companionship services” has been redefined to be limited to “fellowship” “protection” and personal care.  Personal care-related services are limited to no more than 20 percent of the hours worked.  Under this definition, the vast majority of Medicaid personal services will be subject to minimum wage and overtime requirements.  It is highly likely that virtually all private pay home care services will be affected by the new rule.

The revised standards for the exemptions will exclude application to employees employed by home care agencies (“third-party employers”).  The modified “companionship services” exemption, combined with the live-in domestic services exemption, will apply to workers directly employed by a client or family member.  According to the lawsuit, the rule change will reduce consumer’s care options , increase their costs and limit the availability of essential care workers.  Home care workers will be harmed as well, relegated to part time work even if they seek full-time employment.

The lawsuit asserts that the new rule, if enacted, will destabilize the entire home care industry while creating serious access to care problems for the seniors and persons with disabilities.  According to the lawsuit, the DoL’s new definition  will essentially force home care patients to become employers , causing them to take on the myriad of complex tasks that employers face such as compliance with tax laws, workers compensation, unemployment compensation and the Fair Labor Standards Act.   In essence,  the lawsuit alleges, that the home-bound, elderly,  infirm, sick, dying and people with severe physical or mental disabilities will be required to become small businesses.

Should you seek additional information on this matter, please contact Charles MacKelvie at (312) 235-1117 or or Meghan Linvill McNab at or (317) 808-5863.

National Association For Home Care And Hospice Files Lawsuit Challenging CMS Rule On Face To Face Encounters

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On June 5, 2014, the National Association for Home Care & Hospice (“NAHC”) filed a lawsuit in the United States District Court for the District of Columbia challenging the administration of the physician face-to-face encounter (“F2F”) documentation requirements developed and administered by the Centers for Medicare and Medicaid Services (“CMS”).  According to NAHC,  the F2F regulations have caused a dramatic upsurge in the retroactive denials of home care patient claims under Medicare.  These denials are not based on the CMS allegations that physicians have failed to see patients and certify their care; but because physicians did not supply sufficient paperwork to express a narrative, explanation, or their judgment that the patients are homebound or in need of skilled nursing or physical therapy. 

NAHC asserts that CMS violated Medicare law in three aspects

1.        The authorizing statute only requires that the physician document that the F2F encounter occurred, not that the physician provides a narrative explaining why a patient is home bound and in need of skilled care. 

2.       By failing to provide adequate, reasonable and clear guidance on the standards for compliance, CMS has failed to explain what constitutes ”sufficient” narratives.  This  violates both the United States Constitution and the Medicare Act.

3.       Authorizing  CMS’ contractors to solely use the physician’s narrative to deny payments retroactively, without review  of the entire patient record to determine whether the patient is home bound and in need of skilled care is a further violation of Medicare law.

NAHC has also sought a suspension of retroactive reviews of physician narratives until CMS has revised its rules.  NAHC has filed for a preliminary injunction seeking expedited court review and will seek  summary judgment, asserting that CMS does not have authorization to require the physician narratives.  Concurrently, NAHC will work with members of Congress to seek a legislative remedy.

For further questions, please contact Charles MacKelvie at (312) 235-1117 or or Meghan Linvill McNab at or (317) 808-5863.

Deadline Approaches for CMS Open Payment Registration

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As discussed in a previous article, specific deadlines related to the Physician Payment Sunshine Act are approaching.  The Physician Payment Sunshine Act is a national transparency program in which certain manufacturers of drugs, devices, biologicals, and medical supplies and government purchasing organizations (“GPOs”) are required to disclose certain financial relationships with teaching hospitals and physicians.

The Phase 2 deadline is June 30th for applicable manufacturers and GPOs.  As required under this law, manufacturers of covered products and entities under common ownership with those manufacturers must, on an annual basis, report payments or other transfers of value made to teaching hospitals and physicians. Further, GPOs are required to report payments or other transfers of value made to physician owners or investors.

The Phase 2 deadline allows applicable manufacturers and GPOs to complete registration for themselves and their reporting entity, confirm the accuracy of the data submitted, and to delegate roles for users.  It is worth noting that both physicians and teaching hospitals should ensure they are registered prior to July 1st to ensure they receive the full 45 days to review any information submitted by applicable manufacturers and GPOs.

If you have any questions regarding the registration process or the compliance issues related to the Sunshine Act, feel free to contact Alex T. Krouse at (574) 485-2003 or Susan E. Ziel at (612) 564-1927 or.

New On-Line Guide To Protect Elderly From Financial Abuse

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The Consumer Financial Protection Bureau (CFPB) was established by Congress to carry out Federal laws concerned with consumer financial protection.  On June 19th, the CFPB published an on-line manual entitled  “Protecting Residents From Financial Exploitation: A Manual For Assisted Living and Nursing Facilities.”  The 44-page manual reviews the applicable requirements and presents a series of action-oriented tools, including a model response protocol, that can be used by all health care organizations that service the elderly, including but not limited to assisted living and nursing facilities, to protect this vulnerable population from financial abuse.    For additional information, please contact Susan Ziel at  

Physicians and Teaching Hospitals - Register to Track and Dispute Publicly Available Payment Disclosures from Drug and Device Manufacturers

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In the coming months, all direct or indirect payments to physicians and teaching hospitals from drug and device manufacturers will be publicly available.  It is imperative physicians and teaching hospitals register to ensure accuracy of these payments and to track the number of payments individuals or organizations are receiving from drug and device manufacturers.

Section 6002 of  the Patient Protection and Affordable Care Act required the Centers for Medicare and Medicaid Services (“CMS”) to implement transparency programs as it pertains to physician ownership and investment interests. The result of this section is the open payments program, also known as the Physician Payment Sunshine Act, which is a national transparency program requiring certain manufacturers of drugs, devices, biologicals, and medical supplies and government purchasing organizations (“GPOs”) to disclose certain financial relationships with teaching hospitals and physicians.

Manufacturers of covered products and entities under common ownership with those manufacturers must, on an annual basis, report payments or other transfers of value made to teaching hospitals and physicians. Further, GPOs are required to report payments or other transfers of value made to physician owners or investors. It is worth noting that such ownership or investment interests also include physician’s immediate family members, which includes the broad definition of “immediate family members” under the Stark Act.

The information and data that will be submitted by these organizations will include general payments, research payments, and ownership and investment interests. The types of payments that will be reported include both direct and indirect payments to both physicians and teaching hospitals. Further CMS will also collect any information on payments which have been designated by the teaching hospital or physician to other third parties.

Currently, CMS is in the registration phase of the process. This means that manufacturers and GPOs have been registering and submitting information on payments or transfers of value to physicians and teaching hospitals throughout the past few months. However, on June 1st physicians and teaching hospitals are able to register with CMS so they can receive notifications on information submitted by those organizations. Once registered, physicians and teaching hospitals will be able to review information for accuracy and they will be able to dispute any inaccurate data which has been reported by manufacturers or GPOs.

Once the data has been submitted, CMS will make this data publicly available.  To manage this public data, CMS allows physicians and teaching hospitals to register in order to track and dispute payments.  Physicians and teaching hospitals should take a proactive approach to limit risks of this data being released.  Earlier this year, CMS released Medicare payment data on over 800,000 medical professionals substantially increasing risks for those individuals under the False Claims Act.  It is possible this information could have a similar effect, therefore it is advisable that individuals and entities register.

If you have any questions about the risks of this data being released, or the registration process, please feel free to contact Robert A. Wade at (574) 485-2002 or Alex T. Krouse at (574) 485-2003.

CMS Permits Unified and Integrated Medical Staff in Revised Conditions of Participation

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The Centers for Medicare & Medicaid Services (“CMS”) published a Final Rule on May 12, 2014, making modifications to the Medicare Conditions of Participation (“CoP”). Specifically, updates were published to revisit the CofP with respect to the medical staff of multiple hospital systems. Under the Final Rule, CMS will no longer prohibit a multi-hospital system from establishing a unified and integrated medical staff after receiving numerous comments and agreeing that a unified system may be best for standardization of practices in some hospital settings. CMS provided the following guidelines for such integration while recognizing the related parameters and limitations should be left to the hospitals.   
(1) Medical Staff Members Must Vote
All medical staff members practicing at each separately certified hospital must have voted by majority to either accept and incorporate a unified and integrated medical staff structure or to reject such structure and maintain a separate and distinct medical staff.
(2) Opt-Out Provisions Must be Included in Bylaws
Bylaws, rules, and requirements must exist to document several processes, including the ability for members of the medical staff to opt-out of the unified and integrated structure after a majority vote by the members and, conversely, to maintain a separate and distinct medical staff for the respective hospital.
(3) Medical Staff Must Acknowledge Unique Circumstances, Populations, and Services of Hospitals
The unified and integrated medical staff must be established to consider each hospital’s unique circumstances, including differences in patient populations or services offered in each hospital. Examples of patient population differences include, among others, low income or minority populations and rural populations. Furthermore, services offered include, among others, emergency, psychiatric, pediatric, long term acute care, organ transplant, and dialysis.
(4) Hospitals Must Give Due Consideration
Each hospital must give consideration to the needs and concerns of each medical staff member and mechanics must be created to ensure issues are considered and addressed.
Please note that hospitals may choose to exercise this flexibility only after determining such decision is in accordance with all applicable state and local laws. Additionally, please note that these modifications become effective on July 11, 2014.   
For additional information, or to obtain a complete summary of all modifications, please consult the Federal Registry at or contact Susan Ziel at

PSWP Privilege Prevails According to a Federal District Court in Kentucky

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In early May 2014, the United States District Court for the Western District of Kentucky issued an order denying the production of Patient Safety Work Product (PSWP) privileged documents in a wrongful termination lawsuit.  This unprecedented decision extended the application of the Patient Safety Work Product (PSWP) privilege beyond medical malpractice actions to all federal, state or local civil, criminal or administrative proceedings with narrow exceptions.

In the lawsuit, a former employer resisted production of root cause analysis records and other documents, claiming that the PSWP privilege applied to discovery in the federal discrimination action.  After reviewing the information in-camera, the court agreed and held that the PSWP privilege applied to the withheld documents.  The court also found that the basic information set forth in the former employer’s privilege log satisfied Rule 26(b)(5)(A)(ii) of the Federal Rules of Civil Procedure and the plain language of the PSWP privilege’s statutory elements.
The Quality Improvement Act of 2005 at 42 U.S.C. §§ 299b-21(7) and 229b-22 sets forth the PSWP privilege.  Although the original intent of the privilege was to limit malpractice exposure, this recent order provides clarity as to the PSWP privilege’s widespread application when its elements are proved.  The decision also gives health care providers an additional incentive to report patient safety information to certified patient safety organizations in order to secure the use of the prevailing PSWP privilege.

If you would like more information, please contact Susan E. Ziel.  Thank you.

1 Narrow exceptions to the PSWP privilege are set forth in 42 U.S.C.§ 299-b22(c).


Medicare Survey and Certification Letter Addresses Reportable Infection Control Breaches Applicable to All Certified Providers

click here to learn more...Medicare regulations for various certified providers/suppliers require adherence to generally recognized infection control standards.  Surveyors evaluate the implementation of these requirements during facility surveys.

When a State Agency (SA) or accrediting organization (AO) confirms that evidence of one or more of the breaches described below has been identified, in addition to taking appropriate enforcement action to ensure correction of the deficient practice, the SA or AO should also make the responsible State public health authority aware of the identified breach.

·         Breaches to Be Referred

§  Using the same needle for more than one individual;

§  Using the same (pre-filled/manufactured/insulin or any other) syringe, pen or injection device for more than one individual;

§  Re-using a needle or syringe which has already been used to administer medication to an individual to subsequently enter a medication container (e.g., vial, bag), and then using contents from that medication container for another individual;

§  Using the same lancing/fingerstick device for more than one individual, even if the lancet is changed.
SAs may refer infection additional control breaches if recommended by their State public health authorities. AOs also have discretion to refer additional breaches they believe require public health assessment and management. The Centers for Disease Control & Prevention (CDC) works with States on HAI prevention activities; many States have designated HAI Prevention Coordinators.

For a copy of the CMS Survey and Certification letter click here.  For more information, contact any member of the Krieg DeVault Health Care Practice Group. 

If you would like more information, please contact Lori McLaughlin.  Thank you.

CMS Proposes Significant Changes to Filing/Pursing Cost Report Appeals

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On May 15, 2014, the Centers for Medicare and Medicaid Services (“CMS”) issued the fiscal year (FY) 2015 Hospital Inpatient Prospective Payment Systems Proposed Rule (“Proposed Rule”).  This Proposed Rule includes suggested changes to the cost report regulations in 42 CFR Part 413, Subpart B.  This change would require a provider to include an appropriate claim for a specific item in its Medicare cost report in order to receive or potentially qualify for Medicare payment for the specific item.   Under the Proposed Rule, if the claim is not included in the Medicare cost report, payment will not be included in the Notice of Program Reimbursement (“NPR”) or in any decision or order issued by a reviewing entity in an administrative appeal.  The Proposed Rule also suggests adding specific procedures for the Provider Reimbursement Review Board’s (“PRRB”) review of whether the provider’s cost report meets the suggested new requirement that it include an appropriate claim for a specific item.  If these changes are adopted in the Final Rule, it will make the process of filing cost reports and protecting provider appeal rights more complex, with an increased need for attention to ensure appeal rights are fully preserved and protected starting from the point the cost report is filed until the appeal is resolved. 

For more information on these proposed changes, please contact Charles MacKelvie at or Meghan McNab at