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New MA and Part D policy changes proposed
CMS has issued a Proposed rule containing policy
and technical changes to the Medicare Advantage (MA) and Part D prescription
drug plans. The proposed changes are designed to strengthen MA and
Part D performance requirements, extend greater protections to enrollees,
and ensure that companies offering more than one drug or health plan
in the same areas offer meaningful differences between those plans.
Three specific proposals
When the Medicare Modernization Act (PubLNo 108-173) required
that the Part D benefit afford each enrollee a minimum of two choices
in each plan region, CMS did not envision that each enrollee would
have a choice from among dozens of plans with various benefit packages.
With so many plans to choose from, many beneficiaries find the annual
task of selecting one plan overwhelming and confusing. Moreover, organizations
submitting bids with multiple plans have not consistently submitted
plan benefit designs that are significantly different from each other,
which adds to beneficiary confusion. Consequently, many Part D beneficiaries
do not necessarily enroll in the lowest cost plan and many eligible
individuals are not enrolled in the low-income subsidy program. Finally,
once beneficiaries have chosen a plan, they tend to remain in those
plans, despite changes in medication use or premium increases.
As a result, CMS is making three specific proposals to simplify
the programs for beneficiaries:
to require sponsors to ensure that when they provide multiple
plan offerings, those offerings sufficiently differ and thereby provide
beneficiaries meaningful options;
to eliminate plans with persistently low enrollments,
since these can add complexity to choices without adding value; and
to require sponsors to use standardized "templates" in
their beneficiary communication materials (such as the Annual Notice
of Changes (ANOC) and the Evidence of Coverage (EOC) notices), so
that beneficiaries can understand how their current benefits and cost-sharing
requirements will be changing and more easily compare their current
plan with other plan options.
Additional proposals
Improving sponsor performance. Existing program
rules and regulations have limited CMS actions to improve sponsoring
organization performance. As a result, CMS is proposing to limit the
number of plan offerings by eliminating duplicative bids, and strengthen
program participation requirements.
Strengthening beneficiary protections. CMS
is proposing a number of provisions aimed at strengthening existing
beneficiary protections, such as strengthening the plan transition
process requirements to ensure maximum transparency regarding CMS
expectations of Part D plans with respect to enrollees transitioning
to the plan from other drug coverage and to ensure that current subregulatory
practices are codified in regulation.
Data collection expansion. CMS is proposing
another set of provisions that are aimed at improving payment rules
and processes, and improving data collection for oversight and quality
assessment. This set of provisions would expand the collection of
prescription drug event data currently limited to research and other
non-payment related purposes. This additional data, would provide
additional information to conduct analyses that may be used to improve
policies and assist in monitoring of Part D plan sponsors. In addition,
the proposal would clarify that, by 2011, both the Part C and D plans
will be expected to pay for the data collection costs associated with
the annual Consumer Assessment of Healthcare Providers and Systems
(CAHPS) enrollee satisfaction surveys performed by independent contractors.
Formulary policy. A significant new Part D
formulary policy is proposed in this rule. CMS proposes a regulatory
interpretation of the Medicare Improvements for Patients and Providers
Act (MIPPA) (PubLNo 110-273) protected drug categories and classes
provision previously addressed in a January 16, 2009 Interim
final rule (IFR) with comment period (74 FR 2881, ¶180,883). Based on comments to that IFC, CMS believes that interpretation
of statutory terms is needed, along with clarification of the process
used to identify the protected categories and classes of drugs that
must be listed on all Part D plan formularies.
Comments on the Proposed rule may be submitted
through December 8, 2009.
2010 Medicare premiums, deductibles announced
As required by law, CMS is announcing 2010 Medicare Part A deductibles
and Part B premium amounts. Most Medicare beneficiaries will not see
a Part B monthly premium increase in 2010 as a result of a "hold
harmless" provision in the current law. The "hold harmless"
provision states that when there is no cost-of-living allowance (COLA)
increase for Social Security there is no increase in the Part B premium.
This provision allows for 73 percent of Medicare beneficiaries to
be protected from an increase that will raise the 2010 Part B monthly
premiums from $96.40 to $110.50.
Part A premium and deductible
Medicare Part A pays for inpatient hospital, skilled nursing
facility, hospice, and certain home health care services. The Part
A deductible for 2010 is $1,100, up from $1,068 in 2009. Beneficiaries
must pay an additional $275 per day for days 61 through 90 in 2010,
and $550 for lifetime reserve days. The corresponding amounts in 2009
are $267 and $534, respectively. Daily coinsurance for the 21st through
100th day in a skilled nursing facility will be $137.50 in 2010, up
from $133.50 in 2009. The Part A premium will be $461 per month for
2010, an increase of $18 from 2009. A reduced premium applies in
the case of individuals with 30 to 39 quarters of coverage, who will
pay a premium of $254 in 2010, compared to $244 in 2009.
Part B deductible
The Part B deductible was increased to $110 in 2005 and, as
a result of the Medicare Modernization Act, is currently indexed to
the annual percentage increase in the Part B actuarial rate for aged
beneficiaries. In 2010, the Part B deductible will be $155.
Part B premiums
The Part B premium a beneficiary pays each month is based on
his or her annual income. Specifically, if a beneficiary's "modified
adjusted gross income" is greater than the legislated threshold
amounts ($85,000 in 2010 for a beneficiary filing an individual income
tax return or married and filing a separate return, and $170,000 for
a beneficiary filing a joint tax return) the beneficiary is responsible
for a larger portion of the estimated total cost of Part B benefit
coverage. In addition to the standard 25 percent premium, such beneficiaries
now pay an income-related monthly adjustment amount.
Implementation of Part D e-prescribing examined
by OIG
As required by the Medicare Prescription Drug, Improvement,
and Modernization Act of 2003 (PubLNo 108-173), CMS has established
electronic prescribing standards to facilitate the communication of
prescription information among prescribers (e.g., physicians), Part
D plan sponsors, and dispensers (e.g., pharmacies).
CMS standards and implementation
schedule
Three of these standards enable the flow of eligibility, medication
history, and formulary and benefits information between plan sponsors
and prescribers at the point of care. These plan-to-prescriber standards
are (1) Accredited Standards Committee X12N 270/271, (2) SCRIPT 8.1,
and (3) Formulary & Benefits Standard 1.0.
The Formulary & Benefits Standard 1.0 consists of four components:
(1) Formulary Status List, (2) Formulary Alternatives List, (3) Coverage
List, and (4) Copayment List.
CMS required that plan sponsors implement two standards by January
2006 and the remaining standard by April 2009. Between August and
September 2008, the Office of Inspector General (OIG) surveyed all
Part D plan sponsors for plan year 2008 to determine the extent of
their implementation of the standards. The OIG received responses
from 262 plan sponsors for a 94 percent response rate.
OIG findings and recommendations
The OIG survey found that: (1) nearly 80 percent of plan sponsors
reported at least partial plan-to-prescriber connectivity but few
reported complete connectivity; (2) problems implementing Formulary &
Benefits Standard 1.0 limit complete plan-to-prescriber connectivity;
and (3) only 5.0 percent of plan sponsors reported no plan-to-dispenser
connectivity.
OIG recommends that CMS ensure that plan sponsors completely
implement the plan-to-prescriber and plan-to-dispenser standards.
To achieve this, CMS could continue to educate plan sponsors about
e-prescribing requirements, clarify e-prescribing standards exemptions,
or use corrective action plans and civil monetary penalties to bring
plan sponsors into compliance. OIG also recommends that CMS collaborate
with plan sponsors, pharmaceutical benefits managers, and standards-development
organizations to address batch-processing problems. CMS could also
consider pilot-testing a real-time standard that enables plan sponsors
to transmit beneficiary-specific formulary and benefits information.
OIG Report, No. OEI-05-08-00320, Oct.
2009, ¶53,164.
HHS Secretary's misinterprets 2003 Medicare
Act
The United States District Court for the District of North Dakota,
recently held that the Secretary of HHS' administrative interpretation
of the 2003 Medicare Act, which created a significant change in the
policy that required a hospital to pay for "all or substantially
all" the costs of a residency training program in order
to be reimbursed, was neither reasonable or fair.
The Secretary had argued there was a significant change in policy
between 1998 and 2003 that either the hospital or the qualified non-hospital
must pay for "all or substantially all"
the costs for the entire residency training program. The Secretary
also argued the 1998 revised regulations gave notice to the hospitals
that they were prohibited from splitting the costs of a residency
training program.
Before the Secretary announced this new administrative interpretation
in 2003, hospitals were allowed to split the costs of a residency
training program and were reimbursed the direct and indirect costs
of training their own residents. Two hospitals in North Dakota each
submitted cost reports for 1999, 2000, and 2001, but the fiscal intermediary
(FI) disallowed their costs for direct and indirect graduate medical
education citing the new administrative interpretation.
In this case, a review of the 1998 revised regulations indicated
hospitals were not prohibited from splitting the total costs of a
medical residency training program. The history of the two hospitals
shows that for over 20 years the FI for these two hospitals had been
aware the hospitals shared costs and reimbursed them separately for
the costs of training their residents. The FI's practice of reimbursing
the hospitals the costs incurred in training their residents established
compliance towards interpreting the statute.
The language in 42 C.F.R. §413.86(f)(4) (2000)
did not change this practice nor provide substantial notice of a policy
change to require either hospital to incur "all or substantially
all" of the costs for the entire residency training
program. The first notice of this administrative change was in the
preamble of the inpatient prospective payment system (IPPS) Final rule for FY 2004 (see ¶180,363).
The Secretary's 2003 administrative interpretation was neither
reasonable nor plausible because there was no change in the payment
structure under the Medicare Act and the existing regulations. Furthermore,
the Secretary's application of this 2003 administrative interpretation
was retroactive, arbitrary and capricious as applied to the hospitals'
cost reports for the years 1999, 2000, and 2001. The Administrator's
decision was reversed and summary judgment for the hospitals was granted.
Medcenter One Health Systems and St. Alexius
Medical Center v. Leavitt, D. N.D., Oct. 13, 2009, ¶303,143.
Tort reform would reduce health care utilization,
CBO
The Congressional Budget Office (CBO) re-analyzed the effects
of several medical malpractice (tort reform) proposals to limit health
care costs at the request of Senator Orrin Hatch (R-Utah). Current
law permits individuals to bring civil claims against physicians and
providers for negligence resulting in personal injury. Tort reform
has been proposed to place a cap on payments that individuals may
receive and limit those that may be found liable for the torts. Many
of the proposals presented have included caps on noneconomic damage
awards and punitive damages, allowing evidence of income from other
sources to be introduced at trial, limiting the statute of limitations
period and doing away with joint-and-several liability.
According to the CBO, by implementing these proposals such as
these nationwide, national premiums for medical liability insurance
would decrease by approximately 10 percent, and considering that providers
will spend about $35 billion for medical malpractice liability for
2009, total health care expenditures would reduce by 0.2 percent.
Further, recent research has found that additional savings may result
from a reduction in the utilization of health care services. The current
liability system encourages providers to provide more, and more intense,
health care services, but tort reform may lessen that burden on providers.
Current analysis shows that the implementation of the proposals would
reduce national health care spending by 0.5 percent, 0.2 percent from
lower premiums and 0.3 percent from lower utilization. The proposals
would also reduce spending for Medicare, Medicaid, the Children's
Health Insurance Program, and the Federal Employees Health Benefits
program by $41 billion in the next 10 years.
CBO Letter to Senator Hatch, Oct. 9,
2009, ¶53,163.
Decisions and Developments
CMS Manuals
Magnetic resonance imaging national coverage
determination updated to remove non-covered status for blood flow
determination
Medicare National Coverage Determinations
Manual, Pub. 100-03, Transmittal No. 107, Oct. 16, 2009, ¶158,487.
New two part coverage framework for positron
emission tomography imaging for solid tumors and myeloma
Medicare National Coverage Determinations Manual, Pub. 100-03, Transmittal No. 108, Oct. 16, 2009, ¶158,488.
Annual update to the clotting factor furnishing
fee
Medicare Claims Processing Manual, Pub. 100-04, Transmittal No. 1829, Oct. 16, 2009, ¶158,489.
Annual update to type of service indicators
Medicare Claims Processing Manual, Pub. 100-04,
Transmittal No. 1830, Oct. 16, 2009, ¶158,490.
Magnetic resonance imaging national coverage
determination updated to remove non-covered status for blood flow
determination
Medicare Claims Processing
Manual, Pub. 100-04, Transmittal No. 1831, Oct. 16, 2009, ¶158,491.
New two part coverage framework for positron
emission tomography imaging for solid tumors and myeloma
Medicare Claims Processing Manual, Pub. 100-04,
Transmittal No. 1833, Oct. 16, 2009, ¶158,492.
Interest rate for overpayments and underpayments
during the first quarter of fiscal year 2010 set at 10.875 percent
Medicare Financial Management Manual, Pub.
100-06, Transmittal No. 160, Oct. 15, 2009, ¶158,485.
Contractors to collect data from providers
requesting physician quality reporting initiative and E-prescribing
feedback reports
One-Time Notification Manual, Pub. 100-20, Transmittal No. 529, Aug. 7, 2009, ¶158,486.
Procedures for determining compliance with
Office of Civil Rights requirements during a change in ownership
State Operations Provider Certification Manual, Pub. 100-07, Transmittal No. 53, Oct. 16, 2009, ¶158,493.
New business segment indicator to facilitate
the Intermediary/Carrier merger to a Medicare Administrative Contractor
in jurisdiction 13
One-Time Notification
Manual, Pub. 100-20, Transmittal No. 576, Oct. 16, 2009, ¶158,494.
Updating Health Care Claim/Payment Advice
and Standard Paper Remit to conform to new Health Insurance Portability
and Accountability Act of 1996 requirements
One-Time Notification Manual, Pub. 100-20, Transmittal
No. 577, Oct. 16, 2009, ¶158,495.
Business functions to be addressed by the
durable medical contractor common electronic data interchange receipt
of inbound transaction submissions
One-Time
Notification Manual, Pub. 100-20, Transmittal No. 578, Oct.
16, 2009, ¶158,496.
DAB Decisions
Abuse prevention
A skilled
nursing facility (SNF) was in violation of conditions of participation
because it failed to fully implement its abuse prevention policy,
although the scope of the facility's residents' exposure to immediate
jeopardy was limited to one day. Therefore, a civil money penalty
(CMP) of $3,050 for one day was reasonable. The surveyor's determination
that the SNF was in violation of conditions of participation for a
longer period of time was erroneous, because the SNF's abuse prevention
policy had all the elements required by regulation and suggested by
the State Operations Manual. The SNF was further
subject to a CMP of $50 per day for a period from February 6 to March
7, 2007, for failing to follow a care plan for one resident.
Gateway Nursing Center v. CMS, HHS Departmental Appeals
Board, Civil Remedies Division, Doc. No. C-07-419, Dec. No. CR1963,
June 24, 2009, ¶121,915.
Accessible for inspection
A
medical equipment supplier was not in compliance with supplier standards,
and CMS' revocation of its supplier number was appropriate. CMS' allegation
that the facility was not open or accessible for an on-site inspection
to ascertain compliance with requirements was supported by the evidence.
An inspector visited the supplier twice, and on both occasions the
business facility was not operational, open or accessible at either
location during its posted business hours. While the owner claimed
that he was present and in a meeting during the attempted inspection,
the doors were locked and the staff was unavailable at the facility
during business hours. CMS requires that suppliers must (1) be accessible
during reasonable business hours to both beneficiaries and CMS, (2)
permit CMS to conduct on-site inspections, and (3) maintain a visible
sign and posted hours of operation. As the supplier was not accessible
or open during the posted hours of operation on two consecutive days,
the revocation of the supplier number was appropriate.
Uzzie
Medical Supply, LLC v. CMS, HHS Departmental Appeals Board,
Civil Remedies Division, Doc. No. C-09-300, Dec. No. CR1984, August
7, 2009, ¶121,927.
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CAH participation
A hospital
failed to qualify for critical access hospital (CAH) status because
it was not located beyond the minimum distance from another hospital
as required by Soc. Sec. Act §1820(c)(2)(B)(i)(I). The statute requires that a hospital be "located more than
a 35-mile drive (or in the case of mountainous terrain or in areas
with only secondary roads available, a 15-mile drive) from a hospital,
or another [CAH]." The definition of a "secondary
road" is not present in the Act or implementing regulation,
but the State Operations Manual [SOM] defines
a "primary road" as either a numbered federal highway
or a numbered state highway with 2 or more lanes in each direction.
Further, the SOM elaborates by stating that if more than 15 of the
total miles of the distance consists of roads not meeting the primary
road definition, the CAH may qualify. The hospital is located 31.14
miles from another hospital, only 13.92 of which are secondary roads.
The hospital claims that not only is the SOM not binding but
fails to take into account the realities of driving between rural
facilities. It argues that CMS should look at driving time, rather
than distance, in determining CAH status. However, the hospital's
argument was unpersuasive to find that the SOM is inconsistent with
the Act or regulations, and the driving time test is not present in
the Act or regulations.
Missouri Baptist Hopsital - Sullivan
v. CMS, HHS Departmental Appeals Board, Civil Remedies Division,
Doc. No. C-09-108, Dec. No. CR1987, Aug. 11, 2009, ¶121,928.
Certification date
CMS properly
certified an acute care hospital's participation in the Medicare
program eight days later than the date sought by the hospital, finding
that it did not meet all conditions for participation until the later
date, when it was finally accredited. The hospital had chosen to be
deemed by CMS as qualified for Medicare participation based on accreditation
by a national accrediting organization. The accrediting organization,
the Joint Commission on the Accreditation of Healthcare Organizations,
used an "early survey" (two survey) process wherein it
granted a preliminary accreditation after a first survey and before
it conducted a second survey; it then granted accreditation to the
hospital eight days later, after the second survey was completed.
The hospital argued that: (1) it should have been certified
after the preliminary survey because it had a track record of sustained
clinical performance; (2) it was misled by CMS, the accrediting organization,
and the state bed registration agency about the accreditation date;
(3) a special rule permitted Medicare reimbursement; and (4) equity
should have allowed it to recoup over $500,000 for services rendered
during those eight days because it detrimentally relied upon information
from government employees.
The hospital did not meet all Medicare participation requirements
until the later second-survey date, when it actually was accredited;
its previous status as a satellite outpatient facility was irrelevant
to it meeting acute care hospital program requirements. The special
rule ( 42 C.F.R. §489.13(d)(2)) permitting a Medicare retroactive
effective date was inapplicable because the rule only applies to hospitals
that are already properly certified. The administrative law judge
did not have authority to base his decision on equitable principles;
the case law is clear that an equity case cannot be pursued against
the government, even when erroneous information is received from government
employees. CMS' motion for summary judgment was granted.
Humility
of Mary Health Partners d/b/a St. Elizabeth Boardman Health Center
v. CMS, HHS Departmental Appeals Board, Civil Remedies Division,
Doc. No. C-08-676, Dec. No. CR1965, June 24, 2009, ¶121,917.
Civil money penalties
A long
term care facility (LTC) failed to follows its own elopement prevention
policies and to adequately supervise and mitigate foreseeable harm
when a resident eloped the facility unsupervised. Quality of care
issues are addressed by 42 C.F.R. §483.25(h), including
the prevention of injury from accidents by preventing elopements.
The residents care plan required "constant observation"
and a personal alarm device that would lock or set off the LTC's door
alarms when she approached. On February 20, 2008, the resident was
found walking on the shoulder of a highway. That day an alarm company
installed a new system but turned off the old one enabling her to
leave undetected. It was completely foreseeable that the resident
needed heightened supervision because of the work on the facility's
exit doors. The use of an alarm device on the resident was not a substitute
for adequate staff supervision.
The LTC facility failed to produce evidence as to the frequency
or means by which the staff supervised the resident prior to the time
her elopement was discovered. The record suggests the staff relied
solely on the alarm device to protect her. The imposition of a civil
money penalty in the amount of $5,000 was reasonable and summary judgment
is granted to CMS.
Cedar Lake Nursing Home v. CMS, HHS Departmental Appeals Board, Civil Remedies Division, Doc. No.
C-08-500, Dec. No. CR1967, June 24, 2009, ¶121,919.
Civil money penalties
A skilled
nursing facility (SNF) was properly assessed with civil monetary penalties
(CMPs) in the amount of $500 per day due to its noncompliance with
Medicare participation requirements. During a survey of the facility,
it was determined that the SNF failed to (1) comply with 42
C.F.R. §483.20(b)(2)(ii), requiring a comprehensive assessment
be performed when significant changes to the resident's condition
occurs; (2) 42 C.F.R. §483.25(e)(2), requiring
that residents with limited range of motion receive appropriate treatment;
(3) 42 C.F.R. §483.75(e)(8), mandating that a performance
review be conducted for each nurses aide at least every 12 months;
and (4) 42 C.F.R. §483.25(a)(1), requiring that resident's daily
living abilities do not diminish unless unavoidable. Because the facility
failed to offer any evidence or arguments challenging the first three
allegations, they are administratively final as they were unopposed.
The last allegation stemmed from a resident whose condition
allegedly deteriorated so that she became entirely dependent on the
staff for daily activities. Despite the SNF's argument that the resident
was stable, the resident's record of care does not indicate that she
received any type of restorative care. Further, the CMPs imposed were
reasonable as the deficiencies posed a potential of harm to residents
and the deficiencies were sufficiently severe to justify the penalties.
Rosewood Care Center of St. Charles v. CMS, HHS Departmental
Appeals Board, Civil Remedies Division, Doc. No. C-08-487, Dec. No.
CR1962, June 18, 2009, ¶121,913.
Coverage of transfer factor therapy
A local coverage determination (LCD) denying coverage of transfer
factor therapy was upheld. Under 42 C.F.R. §426.450(a), after
the administrative law judge (ALJ) or the Departmental Appeals Board
(DAB) determines that the LCD record is complete, the only issue is
whether the LCD is reasonable based in light of the record, the law
and the regulations. The LCD must be upheld if a rational person reviewing
applicable law and the record could reach the same conclusion. The
law and regulations do not require a particular procedure for LCDs,
and failure to follow procedure is not a legal basis for holding the
LCD to be invalid. The LCD is reasonable because there was no double-blind
study in which the effects of the therapy were compared to a control
group that received a placebo. In addition, there had been no research
on the therapy for nearly 20 years, and the texts and experts consulted
did not include the therapy among the potentially effective treatments.
Further, there was no evidence presented that the therapy had been
effective in the treatment of any of the 11 patients.
In re
CMS LCD Complaint: Homeopathic Medicine and Transfer Factor, HHS Departmental Appeals Board, Civil Remedies Division, Doc. No.
Doc. No. C-08-72, Dec. No. CR1989, Aug. 11, 2009, ¶121,911.
DME supplier number
A durable
medical equipment, prosthetics, orthotics, and supplies (DMEPOS) supplier
did not comply with supplier standards of participation 9 and 12 ,
and therefore its Medicare supplier number was properly revoked. A
DMEPOS supplier must meet 25 standards in order for it to qualify
for billing privileges as a Medicare supplier, 42 C.F.R. §424.57.
The DMEPOS supplier argued it had complied with standard 9 and standard
12. Standard number 9 states, a supplier must maintain a primary business
telephone number listed under the business' name and the exclusive
use of a facsimile machine which may not be used as the primary telephone
number for the purposes of this regulation. CMS also prohibited the
exclusive use of a cell phone number as the primary business number.
In this case, the evidence supports the surveyor's conclusion
that the DMEPOS phone numbers were a cell phone and fax number that
were used as the business' primary contact numbers. Neither the cell
phone number nor the fax number meet the requirements of standard
9. Further, the evidence provided by the DMEPOS supplier does not
support its assertion that it complied with standard 12. The documents
the DMEPOS supplier produced did not address the period in dispute,
the time after May 29, 2008, inspection. Since there were no genuine
issues of material fact CMS' motion for summary judgment is granted.
1866ICPayday.com, L.L.C. v. CMS, HHS Departmental Appeals
Board, Civil Remedies Division, Doc. No. No. C-09-259, Dec. No. CR1976,
July 21, 2009, ¶121,923.
Immediate jeopardy
A long
term care facility was not in substantial compliance with requirements
to provide residents with care and services necessary, and CMS' determination
that the facility posted immediate jeopardy to resident health and
safety was appropriate. The nursing staff and physicians failed to
provide necessary care and services in significant respects to a resident,
leading to severe dehydration and acute renal failure. The staff at
the facility did not recognize the symptoms of dehydration, nor did
they appropriately or consistently monitor intake and output of fluids.
There was also a five day lapse between ordering laboratory tests
and having them done, which created a delay in treatment options for
the resident. Facilities are required to provide or obtain laboratory
services that meet the needs of the residents. The decision by CMS
determining that the facility was substantially noncompliant and placed
residents in immediate jeopardy was appropriate and supported by the
evidence.
Golden Living Center- Frankfurt, v. CMS, HHS Departmental Appeals Board, Civil Remedies Division, Doc. No.
C-08-363, Dec. No. CR1981, July 29, 2009, ¶121,926.
Non-physician practitioner
A certified first assistant was not included in the recognized category
of non-physician practitioners who are eligible to enroll in Medicare
as individual practitioners; accordingly he did not qualify for a
Medicare billing number. The assignment of a Medicare billing number
allows an individual to bill Medicare directly and receive payment
for services under the Medicare program. The certified first assistant
argued: (1) he is a health care provider; (2) the Medicare regulations
and the Health Insurance Portability and Accountability Act (HIPAA)
(PubLNo 104-191) are in conflict, therefore, HIPAA should control
the definition of health care provider; and (3) and the Medicare
Program Integrity Manual, Chapter 10, must be amended to
reflect Congress' intent for administrative simplification under HIPAA.
Certified first assistants are not recognized as non-physician
practitioners as defined in 42 C.F.R. §405.400, which specifically
lists the recognized professions that qualify as non-physician practitioners.
There are no conflicts between Medicare regulations and HIPAA. HIPAA
was enacted to protect private health information but its broad definition
does not affect the requirements for Medicare enrollment or reimbursement.
Finally, the Departmental Appeals Board has no authority to amend
the Medicare Program Integrity Manual, which was
created to protect Medicare against fraud, waste and abuse.
McCambridge v. CMS, HHS Departmental Appeals Board, Civil
Remedies Division, Doc. No. C-09-215, Dec. No. CR1961, June 16, 2009, ¶121,914.
Prevention of accidents
A skilled
nursing facility violated the requirement of 42 C.F.R. §483.25(h)to protect residents from foreseeable accidents by failing to investigate
the reasons for two residents' repeated falls and making appropriate
adjustments to their plans of care. Because the SNF assessed one resident
as having cognitive impairments similar to Alzheimers, unable to recognize
her room or SNF staff, reminders to use her call light and her walker
were inadequate protection. The resident's falls occurred at night
near her bathroom. Although the SNF contended that it rejected a toileting
schedule for the resident because she would be uncooperative, nothing
in the records documented any reason to anticipate noncooperation.
As to both residents, the SNF failed to consider any options between
restraint and inadequate supervision. Sanctions of civil money penalties
of $3,000 per instance and denial of payment for new admissions for
a period of 12 days were reasonable.
Lompoc Healthcare District
Convalescent Care Center v. CMS, HHS Departmental Appeals
Board, Civil Remedies Division, Doc. No. C-08-568, Dec. No. CR1978,
July 22, 2009, ¶121,924.
Right to hearing
A community
mental health center that participates in the Medicare program as
a provider of services in one location was notified by CMS that it
could not bill for services at another location under its current
provider agreement. The CMS determination that the health center must
apply for a separate provider agreement for the new site is not an initial determination" that would trigger a right to an administrative
law judge hearing under 42 C.F.R. §498.3(b). The health
center's request for review of the CMS decision, accordingly, must
be dismissed.
St. Pete Behavioral Health Center, Inc. v. CMS, HHS Departmental Appeals Board, Civil Remedies
Division, Doc. No. C-08-654, Dec. No. CR1968, June 24, 2009, ¶121,920.
SNF noncompliance
CMS properly
found that a skilled nursing facility (SNF) failed to comply substantially
with Medicare participation requirements, posed an immediate jeopardy
to its residents, and warranted civil money penalties (CMP), when
it failed to: (1) consult with residents' physicians concerning significant
changes in the residents' medical conditions, (2) provide services
that met professional standards of quality, (3) provide its residents
with the necessary care to maintain the highest well-being in accordance
with the resident's plan of care, (4) ensure that its residents were
free from significant medication errors, and (5) administer itself
in a manner that enabled it to use its resources effectively to maintain
the well-being of its residents.
The evidence established that, among other things, the nursing
staff ignored the SNF's protocol for notifying residents' treating
physicians when certain residents exhibited dangerously abnormal blood
sugar levels, on occasion took matters into their own hands to address
medical crises without physician input, and made significant medication
errors, such as administering the wrong dose of medication to residents,
resulting in grave, life-threatening health risks.
CMS' determination that the SNF failed to meet the professional
standards of quality was properly based on the professional opinions
of two surveyors who were both nurses and a physician, in light of
their knowledge, experience and professional training. The SNF's pervasive
deficiencies evidenced its failure to administer itself effectively
or efficiently, and was the proper basis for CMS' determination of
immediate jeopardy, given the high probability that residents would
suffer serious harm. Finally, the imposition of a CMP was reasonable
in light of the seriousness of the SNF's noncompliance.
Life Care Center of Tullahoma v. CMS, HHS Departmental Appeals
Board, Civil Remedies Division, Doc. No. C-08-253, Dec. No. CR1964,
June 24, 2009, ¶121,916.
State license requirement
The
termination of a hospices Medicare agreement was supported by Medicare
law and regulations. The hospice had allowed its state license as
a hospice to expire and submitted a request for renewal two weeks
after the license expiration date. The state decided not to renew
the hospice license and recommended that CMS terminate the hospice's
Medicare agreement. Under 42 C.F.R. §418.116, if state
or local law provides for licensing of hospices, a hospice must be
licensed as a condition of participation in the Medicare program as
a provider of hospice services.
The evidence presented by the hospice described a somewhat contentious
inspection process conducted by representatives of the state licensing
agency during the period immediately prior to the expiration of its
hospice license on June 30, 2008. The details of the inspection process
are not relevant here, however, because of the undisputed fact that
the hospice's license expired on June 30, 2008, and was not
renewed thereafter. The choice to terminate Medicare participation
lies within CMS' discretion, according to 42 C.F.R. §489.53(a)(3). The CMS decision was affirmed.
Emmanuel Ridge Hospice Ministry
v. CMS, DAB Civil Remedies Division, Doc. No. C-09-324, Dec.
No. CR1974, July 14, 2009, ¶121,922.
Pressure sores
A skilled nursing
facility (SNF) was not in substantial compliance with conditions of
participation at a security level that involved actual harm, but its
lack of compliance did not amount to immediate jeopardy. The SNF failed
to carry out physician orders for the treatment of existing pressure
sores on a resident which the physician deemed important to promote
healing and fight infection, as required by 42 C.F.R. §483.25(c)(2); the resident suffered actual harm due to this lack of treatment.
Civil money penalties in daily amounts of $200 for each day of a period
from March 17, 2008, through June 8, 2008, (84 days) were sustained.
Embassy Health Care Center v. CMS, HHS Departmental Appeals
Board, Civil Remedies Division, Doc. No. C-08-505, Dec. No. CR1980,
July 24, 2009, ¶121,925.
Return to compliance
CMS' imposition
of denial of payment for new admissions (DPNA) was improper because
the skilled nursing facility (SNF) returned to substantial compliance
with conditions of participation four days before the effective date
of the DPNA. Although Soc. Sec. Act §1819(h)(2)requires a DPNA if a SNF has not returned to substantial compliance
three months after the last day of the survey finding noncompliance,
a SNF has the right to administrative review of any determination
that results in an enforcement remedy. The policy statement in State Operations Manual, Pub. 100-07, §7317B, that the date of the third revisit survey is
the date a SNF returned to compliance, cannot preclude the facility
from establishing an earlier date when the date is the basis for an
enforcement remedy because it is inconsistent with 42 C.F.R. §488.417(c), which provides that payments may resume on the date that the facility
establishes by credible written evidence that it has returned to and
can maintain substantial compliance.
Foxwood Springs Living
Center v. CMS, HHS Departmental Appeals Board, Civil Remedies
Division, Doc. No. C-07-401, Dec. No. CR1966, June 24, 2009, ¶121,918.
Untimely hearing request
A
skilled nursing facility (SNF) was not entitled to a hearing given
that it neither filed a timely request for a hearing nor showed good
cause for its failure to file a timely hearing request. A state survey
agency conducted a compliance survey of the SNF and notified the SNF
that it was noncompliant with federal participation requirements.
CMS later imposed a $3,000 civil money penalty based on the SNF's
noncompliance, and advised the SNF of its right to a hearing; specifically,
CMS notified the SNF that a written request for a hearing must be
filed no later than 60 calendar days from the receipt of the notice.
The SNF did not file a hearing request until 62 days after its
receipt of CMS' notice letter. Therefore, the request was untimely
filed. However, an ALJ may grant additional time for a facility to
file a hearing request if it can show good cause, i.e., circumstances
beyond its control. The SNF argued that it could not specify the exact
date of receipt of the notice letter given the SNF's extensive mail
disbursement process, and therefore it had good cause for filing its
request after 60 days. However, the SNF's own process for disbursing
mail was not a circumstance outside the SNF's own control. Therefore,
no good cause existed to extend the time for filing.
Marian
Estates v. CMS, HHS Departmental Appeals Board, Civil Remedies
Division, Doc. No. C-09-241, Dec. No. CR1960, June 19, 2009, ¶121,912.
Untimely hearing request
A
long-term care facility was not entitled to a hearing given that it
neither filed a timely request for a hearing nor showed good cause
for its failure to file a timely hearing request. A state survey agency
conducted a compliance survey of the facility, and notified the facility
that it was noncompliant with federal participation requirements for
nursing homes and that it was recommending various remedies. CMS later
notified the facility that (1) CMS concurred with the recommendations;
(2) that it was imposing, among other remedies, a civil money penalty
of $10,000 per instance of noncompliance; and (3) if the SNF disagreed
with the determination, it must file a written request for a hearing
before an administrative law judge (ALJ) no later than 60 calendar
days from the receipt of the notice.
The facility did not file a hearing request until 260 days after
its receipt of CMS' notice letter. Therefore, the request was untimely
filed. However, an ALJ may grant additional time for a facility to
file a hearing request if it can show good cause, i.e., circumstances
beyond its control. The facility argued that good cause existed because
the state survey agency's letter was ambiguous, which led to a series
of misunderstandings that caused the facility to file after the time
period lapsed. However, the notice letters and regulatory language
unambiguously stated the SNF had to file an appeal within 60 days
of the notice. Therefore, no good cause existed to extend the time
for filing.
Shields Richmond Nursing Center v. CMS, HHS Departmental Appeals Board, Civil Remedies Division, Doc. No.
C-08-371, Dec. No. CR1973, July 10, 2009, ¶121,921.
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