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Krieg DeVault Health Care Reform

CMS Issues Final DME Regulation Altering Marketing, Contracting Restrictions

Tuesday, April 10, 2012 by Thomas Hutchinson
CMS Issues Final DME Regulation Altering Marketing, Contracting Restrictions

As reported by BNA, on March 9, the Centers for Medicare & Medicaid Services released a final rule on DME supplier marketing that removes a definition of “direct solicitation” of Medicare beneficiaries that the agency said was not feasible.

CMS said that its definition of direct solicitation “was criticized as being overly broad as it covered some types of marketing activity outside the bounds of what we intended to prohibit under our regulations.”

The new rule also allows DMEPOS suppliers—including DMEPOS competitive bidding program contract suppliers—to contract with licensed agents to provide such supplies, unless prohibited by state law.

CMS also said that its final rule removes the requirement for compliance with local zoning laws and modifies certain state licensure requirement exceptions.

Previously, on Aug. 27, 2010, CMS published a final rule regarding DMEPOS supplier standards, which became effective on Sept. 27, 2010.  Under that final rule, suppliers were banned from making direct contact with Medicare beneficiaries unless they received direct permission from the beneficiary, are contacting them to schedule delivery of an item, or have provided an item within a 15-month period.

In the new final rule, CMS said that before the August 2010 rule, the definition of direct solicitation “was generally limited to telephonic contact. The August 27, 2010 final rule expanded the scope of this provision to include in-person contacts, e-mail, and instant messaging. Since publication of the August 27, 2010 final rule, we discovered that implementation of the expanded portions of this provision as written was unfeasible.”

The rule (CMS-6036-F2) was published in the March 14 Federal Register (77 Fed. Reg. 14,989).  it has an effective date of April 13.

 

Skilled Nursing Facilty Regulations: 2012 SNF PPS Final Rule

Tuesday, August 9, 2011 by Lori McLaughlin

The Centers for Medicare & Medicaid Services (CMS) released the Final Rule for SNF PPS and consolidated billing for fiscal year (FY) 2012 on Friday, July 29. An important provision included in this rule will reduce Medicare SNF PPS payments in FY 2012 by $3.87 billion, or 11.1% lower than payments for FY 2011. CMS states that the reason for this rate reduction is to correct for an unintended spike in payment levels and better align Medicare payments with costs.

CMS found that the parity adjustment made in FY 2011, which was intended to ensure that the new RUG-IV system would not change overall spending levels from the prior year, instead resulted in a significant increase in Medicare expenditures during FY 2011. This increase in spending was primarily due to shifts in the utilization of therapy modes under the new classification system differing significantly from the projections on which the original parity adjustment was based.  According to CMS, “additional data analyzed by CMS since publication of the proposed rule confirmed the extent of the overpayments that have occurred since implementation of the RUG-IV system.”  The FY 2012 recalibration of the CMIs will result in a reduction to skilled nursing facility payments of $4.47 billion or 12.6 percent.  However, this reduction would be partially offset by the FY 2012 update to Medicare payments to skilled nursing facilities.  The update — an increase of 1.7 percent or $600 million for FY 2012 — reflects a 2.7 percent increase in the prices of a “market basket” of goods and services reduced by a 1.0 percent multi-factor productivity (MFP) adjustment mandated by the Affordable Care Act.   The combined MFP-adjusted market basket increase and the FY 2012 recalibration will yield a net reduction of $3.87 billion, or 11.1 percent.

Along with recalibrating and updating the SNF PPS payment rates for FY 2012, this final rule makes a number of additional revisions aimed at enhancing SNF PPS accuracy and integrity.  The final rule also:

  • Affordable Care Act initiatives:
    • CMS is in the process of developing the SNF value based purchasing plan and will submit a report to Congress by October 1, 2011.
    • The Secretary of the Department of Health and Human Services (HHS) will evaluate the possibility of expanding the hospital-acquired condition policy from acute care hospitals to a variety of other settings, including SNFs, and will submit a report to Congress by January 1, 2012.
    • Nursing home transparency and improvement. Due to the many comments CMS received regarding disclosure of certain parties on Medicare and Medicaid facility applications and revalidations, CMS has deferred any changes in this area for now and will release a final rule sometime in fiscal year 2012. 
  • Therapy student supervision: The Final Rule will discontinue the policy requiring lineof-sight supervision of therapy students in SNFs. Instead, effective October 1, 2011, each SNF will determine for itself the appropriate manner of supervision of therapy students consistent with state and local laws and practice standards.
  • Group therapy clarifications: Effective October 1, 2011, group therapy will be defined as therapy provided simultaneously to four patients who are performing the same or similar activities, and group therapy time will be divided by four in determining the reimbursable therapy minutes for each group therapy participant and, therefore, the appropriate RUG-IV group.
  • Five- or seven-day a week therapy clarification: Elimination of the distinction between facilities regularly furnishing therapy services on a 5- or 7-day basis for purposes of setting the date for the End of Therapy (EOT) Other Medicare Required Assessment (OMRA).
  • Introduction of the End of Therapy – Resumption (EOT-R) OMRA: Effective for services provided on or after October 1, 2011, when an EOT OMRA has been completed and therapy subsequently resumes, SNFs may complete an EOT-R OMRA rather than a Start of Therapy (SOT) OMRA, in cases where the resumption of therapy date is no more than five consecutive days after the last day of therapy provided and the therapy services have resumed at the same RUG-IV level that had been in effect prior to the EOT OMRA.
  • Introduction of the Change of Therapy (COT) OMRA: Effective for services provided on or after October 1, 2011, SNFs would be required to complete a COT OMRA for patients classified into a RUG-IV therapy group whenever the intensity of therapy (that is, the total reimbursable therapy minutes provided) changes to such a degree that it would no longer reflect the RUG-IV classification and payment assigned for a given SNF resident based on that resident’s most recent assessment used for Medicare payment. The ARD of the COT OMRA would be set for day seven of a COT observation period, which is a successive seven-day window beginning on the day following the ARD set for the most recent scheduled or unscheduled PPS assessment and ending every seven calendar days thereafter.
To read the CMS press release and access the final rule, please click here.

Should you have any questions about the impact of this final rule on your facility, contact Lori McLaughlin at lmclaughlin@kdlegal.com or (219) 227-6075. 

Final Rule to Impact Hospice and Long Term Care Payments

Tuesday, August 9, 2011 by Krieg DeVault LLP

On August 5, 2011, the Department of Health and Human Services published its Final Rule implementing section 3004 of the Patient Protection and Affordable Care Act ("PPACA").  The Final Rule will impact long term care rates.  Specifically, this Section requires Long Term Care Hospitals (LTCHs), Inpatient Rehabilitation Hospitals (IRHs), and Hospice programs to submit certain quality measures information for rate year 2014 and subsequent rate years. Failure to submit the required information will result in a reduction, by 2%, of the annual update to a standard Federal Medicare rate for discharges applicable to LTCHs and IRHs, and an update to the annual Medicare market basket applicable to Hospice programs.

The Final Rule adopts the first of two quality measures that must be reported beginning in 2014:

(1) Urinary Catheter-Associated Urinary Tract Infections (CAUTI); and
(2) Pressure Ulcers that are New or Have Worsened.

Additionally, the Final Rule also discusses a third measure that HHS is currently developing and intends to propose to adopt for FY 2014 in future rulemaking. That measure will be the 30-day Comprehensive All-Cause Risk-Standardized Readmission Measure.


If you have questions about the Final Rule or other health care payment reform issues, please contact one of our health care reform lawyers, Leigh Ann O'Neill, or visit us at Health Reform Connect.  

Bed-Hold Policies: What is required of Indiana’s Long Term Care Facilities?

Monday, July 11, 2011 by Krieg DeVault LLP

Questions remain frequent among long term care providers in Indiana regarding facility-level impacts of the decision by the Indiana Office of Medicaid Policy and Planning (“OMPP”) to eliminate reimbursement for bed-hold days.  The elimination of reimbursement for bed-holds was effective February 1, 2011 (For a copy of this bulletin, click here), and the Indiana Medicaid State Plan will be amended in the coming months to finalize elimination of reimbursement.  OMPP has also posted, and periodically updated, a news summary on www.IndianaMedicaid.com that discusses the impact of the reimbursement changes on Indiana’s long term care facilities and their residents (Click here for the news summary).

More recently, requirements for long term care facilities to maintain updated bed-hold policies were discussed during a panel presentation at the 2011 Indiana Health Care Association's ("IHCA") Convention & Expo in May.  In addition to the above OMPP-issued materials, the IHCA offers the following points for long term care facilities when developing bed-hold policies. 

·         Facilities must have a bed-hold policy that states whether or not the facility allows a resident to pay to hold a bed during a leave of absence

o    Though facilities are not required to allow a resident to pay to hold a bed, facilities must still have a policy that states whether or not payment for holding a bed is permitted by the facility

·         The duration of the bed-hold period must be clearly stated in the facility policy

·         Bed-hold policies should state that Indiana Medicaid does not reimburse for bed-holds

·         Payment by residents for bed-holds must follow applicable Medicare and Medicaid guidelines regarding billing for non-covered services

·         Charges for bed-holds should be set at fair market value and must be equally applied to all residents regardless of payor source

o    Facilities may be at risk for Anti-Kickback violations related to improper inducements to government program beneficiaries if charges for bed-holds are not fair market value and equal application of those charges are not maintained.  However, an exception to the Anti-Kickback statute may apply in certain circumstances for bed-hold charges that are unable to be collected.  This exception depends on certain elements regarding facility advertisements, other relevant services and financial need of the resident. 

·         If a resident on leave is expected to return to the facility, regardless of whether they have paid to hold a bed, the facility is not required to discharge the resident

·         If a resident is discharged from a facility, however, the facility must permit the resident to return to the first available semi-private bed when (i) the resident continues to qualify for Medicaid, (ii) the resident requires nursing-level care and (iii) the facility is able to provide appropriate care for the resident.

o    A resident may be discharged from the facility for many reasons including, but not limited to, the resident’s failure to pay for a bed-hold or when the bed-hold period expires.  Facilities must follow applicable regulations and procedures when discharging a resident.

If you have questions about this article or about bed hold policies, please contact Zach Cattell at zcattell@ihca.org or 317-616-9001 or Leigh Ann O'Neill at 317-238-6346.  .

Two Examples of when the Stark Self-Referral Disclosure Protocol should not be used to Resolve Stark Violations

Wednesday, May 11, 2011 by Jason Schultz

Since the time the Stark Act Self-Referral Disclosure Protocol (“SRDP”) procedure was published by the Centers for Medicare & Medicaid Services (“CMS”) in September, 2010, providers have wondered whether the SRDP is the best method for resolving Stark violations.  With Saints Medical Center resolving their known Stark Act violations with CMS for a fraction of the total liability in the first settlement under the new SRDP protocol on February 10, 2011, the provider community has been buzzing about the potential benefits of resolving known Stark Act violations through the SRDP.  In order to assist providers in determining whether they should use the SRDP to resolve Stark violations, here are two examples of when the SRDP is not appropriate for settling Stark violations:

1.  When Stark Act violations also violate the Anti-Kickback Statute - Participation in the SRDP is limited only to violations of the Stark Act.  For conduct that violates the Stark Act and also raises possible liability under the Federal Anti-Kickback Statute or the Civil Monetary Penalty laws, providers should use the Office of the Inspector General’s (“OIG”) Self-Disclosure Protocol, and not the SRDP.  For example, if a provider has an unsigned medical director agreement with a physician that pays the physician based on the physician’s volume or value of referrals to the provider, the provider will want to use the OIG’s Self-Disclosure Protocol since the underlying conduct likely violates both the Stark Act and the Federal Anti-Kickback Statute.

2.  When only possible Stark Act violations exist - The SRDP cannot be used to obtain an advisory opinion as to whether an actual or potential violation of the Stark Act occurred.  The SRDP is only intended to resolve matters that, in the disclosing party’s assessment, are actual violations of the Stark Act.  As a result, providers should not use the SRDP unless they have discovered actual violations of the Stark Act.  For example, a provider who believes that their payments to a physician for the lease of medical equipment may have exceeded fair market value should not use the SRDP until the provider has conducted an adequate investigation and determined that the payments for the medical equipment truly exceeded fair market value.

            While the SRDP provides a promising process to settle Stark Act violations for a fraction of the total possible liability, the SRDP is not appropriate for all situations.  Providers may want to consult their attorneys about whether the SRDP is appropriate for their particular Stark Act violations.

            To see a summary of the SRDP published by CMS, see: https://www.cms.gov/PhysicianSelfReferral/Downloads/6409_SRDP_Protocol.pdf.

If you would like additional information, please contact Jason D. Schultz at jschultz@kdlegal.com or (574) 485-2003 or Robert A. Wade at bwade@kdlegal.com or (574) 485-2002.

ACO Proposed Rules Released

Monday, April 4, 2011 by Krieg DeVault LLP

On March 31, 2011, CMS released the long-awaited rules proposed to implement the provisions in PPACA, the Health Care Reform legislation enacted on March 23, 2010, referred to as the Affordable Care Act, on Accountable Care Organizations ("ACOs") and the Medicare Shared Savings Program that is designed to contract with these organizations. Likewise, the same day, the antitrust agencies, the Federal Trade Commission ("FTC") and the Antitrust Division of the Department of Justice ("DOJ"), issued proposed enforcement guidelines relating to the size, scope and ability of an ACO to contract in the commercial market and how that affects Medicare Shared Savings Program contracts as well. Additionally, the Centers for Medicare and Medicaid ("CMS") and the HHS Office of Inspector General ("OIG") proposed various waivers for standard Stark, Antikickback and Civil Money Penalty rules relating to ACO activities. Finally, the Internal Revenue Service ("IRS") issued a notice requesting comments on its existing private inurement and private benefit rules relating to tax-exempt entities and their financial relationships with "insiders".

The proposed rules are sweeping in their detail for quality metrics required of ACOs to qualify for Medicare contracts and the shared savings that may result from ACO activities. CMS has designed five "domains" containing 65 separate clinical measures to be reported and monitored to establish and assure its view of quality care for the affected Medicare beneficiaries. These five domains, or types of care and care delivery, are:

· patient experience (satisfaction)

· care coordination

· patient safety

· preventive health

· at-risk population / frail elderly health

The rules also provide for the calculation of baseline performance and continued improved performance of the ACO providers. The reward for improved performance is the ability to share 50% or 60% of the "savings" realized by the Medicare program, calculated as what the total claims paid were in a contract year compared to the "benchmark" set for that year.

There are two "Tracks" for Medicare contract participants. Track One is also called the "one-sided contract." This provides for the ACO providers to be responsible for the costs of the care for their "assigned patients" for the first two years of their three year contract, with the incentive of shared savings if the cost comes in "below budget," but with no penalties if the cost is at or above budget. The third year, the contract becomes a risk contract with the providers being responsible for the care and liable to pay back "losses" to Medicare if the total cost of care exceeds the benchmark for that year.

Track Two ( also called "two-sided ") contracts have the at-risk, loss pay - back features for all three years of a contract. The track two contracts include a higher percentage of savings (60%) as a reward for taking the risk of losses for all three years. Tract Two is explained as available for ACO networks which have more experience or resources, initially, to manage the health and the cost of care for their assigned patients.

The patients are to be assigned to ACOs based on the number and identity of the primary care physicians listed as ACO participants. The rules define "primary care" for this purpose as family practice, general practice, geriatric care and internal medicine. If a practitioner in any of these practices has a patient with more than half of his or her Medicare claims from that practitioner in a baseline or contract year, then that patient is automatically "assigned" to the ACO listing that practitioner as a participant. Patients do not "enroll" in these programs. They do not opt in or opt out. They cannot quit. They can, however, refuse to allow their protected health information to be shared around and with other ACO providers. They also have total freedom of choice and discretion as to where they receive care, from whom they receive care and the type of care that they receive. Also, notably, the ACOs are not to use traditional HMO-style managed care techniques, such as utilization management, pre-certifications and medical necessity denials, to control access to care.

While CMS and the OIG have offered to waive their traditionally strict interpretation of Stark and Anti-Kickback rules so that the Medicare Shared Savings Program payments from the ACO, which will almost always include a hospital or hospitals, to participating (referring) physicians, the antitrust agencies have indicated a real concern for an ACO becoming so large as to exercise market power in its service area, thereby having the power to raise prices, instead of reducing prices or costs for commercial health plans and their enrollees. Therefore, the FTC and DOJ have proposed a "safety zone" on the number of independent providers having common services (the same specialty or type of facility) in one ACO. These policies requires that ACOs must be non-exclusive organizations as to these contracted providers. The key percentages of the market for the affected specialties or medical services participating in an ACO are as follows:

< 30% - no review needed

30 – 50% - quick review needed

> 50% - major work needed

The impact of this thinking about inhibiting the growth of market share of the participating providers may be that, whereas most of the primary care physicians may be health system employees, and therefore considered part of a single legal entity and exempt from these concerns, many surgeons and specialists will be independent contractors needing to work in and refer to several different health systems, perhaps multiple ACOs, and so remain as independent contractors. These market share percentages will then complicate their involvement with such ACOs much more than any impact they may have on the participation of the primary care providers, as defined by this rule.

Many details, calculations, requirements, reports and controls are included in these comprehensive proposed rules and enforcement policies. Comment periods on the proposals are open until June 6 for CMS proposals and until May 31 for the antitrust enforcement policies. The CMS ACO rules are to be effective January 1, 2012.

For more information, contact

Thomas R. Neal, Krieg DeVault LLP, 12800 N. Meridian Street, Carmel, Indiana 46032.


HHS Exclusion Authority Reaches to Upper Management

Tuesday, January 18, 2011 by Krieg DeVault LLP

In recent cases, we have seen the Health and Human Services Office of Inspector General ("OIG") flexing its exclusion authority muscle, prohibiting even company CEOs from participating in Federal health care programs due to their failure to cease unlawful operations occurring within their companies.  When we think of the OIG's exclusion authority, we typically think of nurses, physicians, and other clinicians being excluded from Medicare and Medicaid participation due to serious acts such as patient neglect or abuse, or prescription drug violations.  However, in recent news we have seen upper management figures of large companies excluded from Federal health program participation for health care fraud perpetrated within their companies.  One case involved a company's false marketing of the drug Oxycontin, which resulted in the 12-year exclusion of three company executives. 

While it has been made clear that the OIG has the authority to exclude management and other administrators from Federal health care participation, such instances have been far more rare than the exclusion of clinicians.  If your health are organization does not yet have on its books an excluded provider policy, it is strongly recommended that one be implemented which would require the OIG's List of Excluded Individuals and Entities to be checked for all new hires and for all employees every 6 months.  If your organization is found to have billed Medicare or Medicaid for services provided by an excluded provider, your organization can face severe penalties, in addition to being required to return any Federal funds improperly paid that are attributable to excluded providers. 

If you have questions about the OIG's exclusion authority, or about how your organization can protect itself from penalties and subsequent exclusions, please contact Susan Ziel at 317-238-6244 or Leigh Ann O'Neill at 317-238-6346.


CMS Publishes 2011 Payment Updates and Final Rules Affecting Home Health/Hospice

Friday, November 26, 2010 by Mark Bina


On November 17, 2010 the Centers for Medicare and Medicaid Services (“CMS”) published a final rule updating the Home Health Prospective Payment System (HH PPS) rates for 2011. The final rule also imposes new ownership, capitalization, and certification requirements for Home Health agencies.

CMS is reducing Home Health PPS rates by 4.89% for 2011. This reduction stems from the health care reform legislation, wage index and market basket updates, and case-mix coding changes. Under the final rule, the current home health outlier cap becomes permanent and PPS rates are reduced an extra 2.5%. CMS provides agencies an incentive to submit certain quality data; those agencies that do not report quality data receive an additional percentage point reduction. CMS notes that it continues to study the need for future reductions and thus the likelihood of continued cuts for 2012 is uncertain. In total, CMS believes the rule will decrease Medicare reimbursements to home health agencies by approximately $960 million for fiscal year 2011.

The rule also finalizes two controversial policies announced earlier this year regarding capitalization and ownership changes. First, the rule requires a newly enrolling home health agency to furnish proof it has “sufficient” initial reserve operating funds to survive a 90 day period. CMS may revoke billing privileges for enrolled home health agencies if they do not provide supporting documentation within 30 days of a request by CMS or a contractor that the agency had sufficient funds.

The second controversial policy in the final rule involves changes of ownership. Under the new rule rule, a home health agency that changes ownership within the first 36 months of initial enrollment may not transfer its provider agreement and Medicare billing privileges to a new owner. Instead, the new owner must file a new 855A and obtain a state survey or accreditation. Bowing to industry pressure, however, CMS did slightly modify the proposed rule and carved out some exceptions to benefit legitimate owners of home health agencies. The exceptions include:

  • Change in majority ownership” is now defined as when an individual or organization acquires more than a 50% interest in a home health agency during 36 months following enrollment. A “change” also includes asset sales, stock transfer, mergers, or consolidations.
  • Publicly traded companies acquiring a home health agency in which the buyer and seller had at least 5 years of cost reports in the previous 5 years are exempt from the 36 month policy.
  • Restructuring of a current home health agency by its owners (e.g., partnership to LLC or S-Corp to LLC) are exempt where the individual owners remain the same and there is no change in majority ownership.
  • Ownership changes involving the death of an owner with 49% or less interest in the home health agency are exempt from this rule.

Finally, the rule provides some guidance on the “face to face” encounter mandate. The health care reform act requires that a physician must document that they had a face-to-face encounter with a patient before certifying a patient’s eligibility for a home health benefit. This encounter and documentation must occur at least (a) 30 days preceding the start of home health care, or (b) 14 days after the start of care if no encounter occurs which is related to the primary reason the patient needs home health care. Similarly, a hospice physician or nurse practitioner must document they had a face-to-face encounter with a hospice patient 45 days prior to any 180 day recertification and prior to each subsequent recertification.

The rule and its new requirements go into effect on January 1, 2011.

For additional information on this rule, or if you have any questions about regulations affecting home health or hospice providers, please contact Mark Bina in Krieg DeVault’s Chicago office at 312-423-9305 or mbina@kdlegal.com.

Meeting regarding Accountable Care Organizations

Thursday, September 16, 2010 by Brian Heaton
On September 13, 2010, the Federal Trade Commission (FTC) announced a public workshop jointly hosted by the FTC, Centers for Medicare & Medicaid Services (CMS), and the Office of the Inspector General (OIG) regarding the legal issues involving Accountable Care Organizations.  CMS defines Accountable Care Organizations as organizations of health care providers that agree to be accountable for the quality, cost, and overall care of Medicare beneficiaries who are enrolled in the traditional fee-for-service program who are assigned to it.  As part of the recently passed Patient Protection and Affordable Care Act (PPACA), the government will begin providing various incentives for the creation and effective use of Accountable Care Organizations.

The meeting, which will be held on October 5, 2010 in Baltimore and is also available via teleconference, will address antitrust, physician self-referral (Stark), anti-kickback, and civil monetary penalty laws and their application to the creation and operation of Accountable Care Organizations.  Another key focus of the workshop will be an assessment of how the variety of possible Accountable Care Organization structures in different markets could affect the prices and quality of health care to all consumers, whether privately insured or Medicare or Medicaid beneficiaries.

Click here for more information regarding the Accountable Care Organizations workshop.

If you would like additional information, please contact Brian M. Heaton at bheaton@kdlegal.com or (317) 238-6354.