CMS Regulations: In the Best Interest of Patient Care or the Industry?

By James Hlavenka

Suppose you are an uninsured individual who has been severely injured in a car accident.  After the accident, you are rushed to a hospital with a dedicated emergency room, subject to the requirements of the Emergency Medical Treatment and Active Labor Act of 1986 (”EMTALA”).  Upon being screened, the hospital learns that you need further, immediate treatment to be stabilized.  After admitting you as an inpatient for further stabilization purposes, the hospital discovers that you have severed a critical nerve in your spine.  The hospital is incapable of stabilizing your emergency medical condition and appropriately attempts to transfer you to an available specialty hospital two towns over that specializes in nerve repair.  Under EMTALA and the 2003 Centers for Medicare and Medicaid Services (”CMS”) regulations, there was no direct answer addressing whether the specialty hospital was required to accept your transfer from the original hospital and stabilize your emergency medical condition.

In 2008, CMS proposed rule 73 FR 23669 containing significant policy changes relating to the requirements of EMTALA to address the obligations of specialty hospitals.  Under the proposed 2008 CMS rule, the answer would have been clear: assuming the specialty hospital was subject to EMTALA, it must accept your transfer.  The proposed rule would have clarified the interaction of EMTALA’s transfer provisions with the 2003 CMS regulations that hold EMTALA obligations cease when an individual is admitted into a hospital as an inpatient.  The proposed 2008 CMS rule ensured that EMTALA’s primary purpose of patient stabilization under its transfer provisions would not be contravened by the 2003 CMS regulations.  After solicitation of comments on the proposed 2008 rule, however, CMS ultimately declined to adopt this critical policy clarification in its 2009 Final Rule, CMS-1390-F.

Background

In general, EMTALA imposes specific obligations on certain Medicare-participating hospitals to both screen and stabilize individuals who visit those hospitals’ emergency departments.  For a comprehensive, attorney-prepared EMTALA FAQ page, please click here. After a hospital screens an individual and determines that the individual has an emergency medical condition, it is obligated to provide that individual with necessary stabilizing treatment or provide an appropriate transfer to another medical facility that can achieve stabilization.

EMTALA’s transfer provisions are contained within the “specialized care” requirements of Section 1395dd(g).  Section 1395dd(g) requires a receiving hospital with specialized capabilities to accept a request to transfer an individual with an unstable emergency medical condition as long as the hospital has the capacity to treat that individual and regardless of whether the individual had been an inpatient at the admitting hospital.  These provisions would seem to answer the above hypothetical without the need for any further clarification.  In 2003, however, CMS muddied the answer with a new Final Rule.

In 2003, CMS published Final Rule 68 FR 53263 regarding the applicability of EMTALA requirements to inpatients.  The 2003 CMS rule amended section 489.24(d)(2)(i) of CMS regulations to state that a hospital’s obligations under EMTALA cease when the hospital admits an individual with an unstable emergency condition as an inpatient, so long as the admission is in good faith.  CMS reasserted that EMTALA was not intended to be a federal malpractice statute and that after admission inpatients are protected by State malpractice laws and Medicare Conditions of Participation (”CoPs”).  The 2003 CMS rule was entirely silent, however, as to how EMTALA’s specialized care requirements would continue to apply to inpatients, if EMTALA obligations cease upon admission.

As a result, in 2008, CMS proposed a rule amending Section 489.24(f) of the CMS regulations.  The amendment added a provision requiring a receiving hospital with “specialized capabilities or facilities” to accept an unstabilized inpatient with an emergency medical condition from an admitting hospital, thereby continuing the specialty hospital’s obligation under Section 1395dd(g) of EMTALA.  Thus, when the 2008 proposed CMS rule was analyzed in conjunction with the 2003 Final Rule, EMTALA obligations would not end for all hospitals once an individual is admitted as an inpatient.  Rather, EMTALA obligations would cease only at the hospital where the individual is first admitted as an inpatient.  EMTALA’s transfer provisions would continue to apply, however, to all other participating hospitals with higher levels of care, should an inpatient need to be transferred for stabilization of the original emergency medical condition.

2009 CMS Final Rule 1390-F

Upon review of solicited comments, CMS ultimately decided not to adopt the 2008 proposed rule clarifications in its 2009 Final Rule regarding transfer and inpatient care requirements under EMTALA.  Instead, in the 2009 Final Rule, CMS stated that under EMTALA individuals can only be appropriately transferred to another hospital for specialized stabilizing care where two requirements are met: (1) The individual must have an emergency medical condition that requires specialized stabilizing treatment not available at the hospital where the individual is first screened, and (2) The individual has not already been admitted as an inpatient.

Understandably, commenters disagreed about the possible effects of the proposed 2008 CMS rule.  Both opponents and proponents ultimately offered patient-centered rationales for their  policy perspectives.  When read in conjunction with EMTALA as a whole, however, those in favor of the proposed 2008 rule seem to have stayed most true to EMTALA’s original intent–to provide emergency care to all individuals who are determined to have an emergency medical condition.  The commenters’ statements below can be found within the final rule, here.

Opponents of the proposed 2008 CMS rule

The majority of the concerns raised by the dissenting commenters, which ultimately swayed CMS not to adopt the proposed 2008 rule, can be placed into three categories, each to be discussed in turn:

(1) Patient Dumping

Commenters highlighted the danger of patient dumping at hospitals with specialized facilities.  Of particular concern to one commenter was that a hospital, acting in bad faith, could choose to transfer only “medically complex patients requiring extensive lengths of stay, patients who are uninsured, and patients who have been subject to a medical error” and unresolved medical conditions.  Also of concern was that such transfers would be made as a “convenience measure and not a necessity.”  These particularly strong arguments were not overlooked by CMS when proposing the 2008 rule.  It is true that hospitals can act in bad faith, however such actions would violate both EMTALA and the CMS regulations.  Commenters also emphasized that allowing transfer of inpatients may allow hospitals to transfer unstable individuals before using all available resources in an attempt to stabilize the individual.  Again, while entirely possible, this argument is based in an assumption of bad faith, which in itself is a violation of EMTALA and medical ethics.

(2) Patient Care

Commenters expressed concern about how the proposed rule would affect patient health and safety.  Specifically, commenters were concerned that patients’ physical and psychological health could deteriorate as a result of the potential increase in inappropriate and unnecessary transfers mentioned above.  Commenters noted that referring hospitals may transfer patients who deteriorate following admission, thereby risking the life of the patient.  These arguments must raise concern, as any increase in danger to an individual already suffering an emergency medical condition is unwarranted.  These arguments do not seem overly persuasive, however, when read in conjunction with the safety measures already in place under EMTALA to ensure that transfers only occur when the benefit outweighs the risk to an individual.

(3) Futility

Commenters also asserted that the proposed 2008 rule was largely unnecessary for various reasons.  First, it was stated that it is unlikely that a hospital would knowingly admit an individual with an unstabilized emergency medical condition if the hospital did not have the capability to stabilize the individual.  This argument is not particularly strong.  While it is likely that a hospital would not knowingly do so, in daily practice errors can easily occur.  Therefore, there is no harm to ensuring that if such a mistake does occur, it will not adversely affect the suffering individual.  Along the same lines, a commenter stated that “all hospitals which have emergency departments are capable of evaluating an individual who presents to the emergency department and if the hospital does not have the capability to appropriately care for the individual, the hospital should transfer, rather than admit the individual.”  For the same reasons stated above, while a hospital may have the capability to do so, that does not mean that the hospital will make a correct decision every time.

Proponents of the proposed 2008 CMS rule

Commenters in favor of the proposed 2008 CMS rule focused upon the stabilization and safety of individuals suffering from emergency medical conditions.  Overall, commenters in favor of the proposed 2008 rule stated that the policy clarifications were in the best interests of patient care and should be implemented.  A particularly strong argument by one commenter was that inpatient admission status should be irrelevant in determining whether the individual has an emergency medical condition and whether the admitting hospital has the capability to provide the necessary care. The commenter noted that such requirements are “the only operative criteria to whether the transfer is justified under EMTALA” and as a result, EMTALA and CMS regulations must be read in harmony to achieve such a result.  The commenter stressed that EMTALA was enacted because “Congress recognized that patients needing transfers were being denied access to higher levels of care.”  This argument is very strong.  By failing to adopt the proposed 2008 rule clarifications, the will of Congress was hindered in part.

Of particular concern to other commenters were individuals who suffer emergency medical conditions in rural areas.  Such commenters stated that the proposed rule was “especially important for individuals living in rural areas because those individuals are routinely denied transfer to a regional facility for definitive care based on the conclusion that the individuals are already at a ‘hospital.’”  Given that much of our country is comprised of rural areas, such concerns should not have been minimized.  Last, a proponent addressed the concern of inappropriate transfers by suggesting that the clarified process could be adequately monitored for abuse and bad faith.  This suggestion is sound, as such monitoring is already required under the 2003 Final Rule regarding admission into hospitals to end EMTALA requirements.

Did CMS Get it Right?

CMS should have adopted the proposed 2008 rule.  Although finalizing the proposed 2008 rule may have resulted in an increase in inappropriate transfers to hospitals with specialized capabilities, arguments based on an assumption of bad faith should not outweigh the legitimate concerns voiced by many commenters.  Hypothetical risks of inappropriate transfers are always a possibility.  Regardless of whether an individual is admitted as an inpatient, both the admitting/transferring hospital and receiving hospital must comply with the stringent transfer requirements under EMTALA, namely, the requirements contained within 42 USC § 1395dd(c)(1), (2).  These provisions require a treating physician to certify that the medical benefits of the transfer to another medical facility will outweigh the increased risks to the individual.  Further, the receiving hospital must have both available space and qualified personnel for the treatment of the individual, and must have agreed to accept transfer of the individual and to provide the appropriate medical treatment.

As a result of these safeguards, the argument that individuals could suffer greater physical and psychological harm as a result of inappropriate transfers under the proposed rule equally falls flat.  If both hospitals follow the strict transfer requirements already contained within EMTALA, the risk of patient harm should be no greater or less than already present. Contrary to what CMS and industry commenters have stated, CMS has arguably increased the potential for individual physical and psychological harm by failing to adopt the proposed 2008 rule.

The primary concern of physicians within emergency departments should be focused on patient care, and not whether admitting that patient for crucial stabilizing treatment may extinguish the individual’s right under EMTALA to be transferred to an appropriate hospital.  Surely it is not always possible to give a thorough examination and attempt to stabilize a patient in the emergency room setting and thus, a hospital’s attempt to stabilize a patient through admission (even if ultimately futile because the hospital lacks the ability to do so) should not detrimentally extinguish the ability to appropriately transfer that individual under EMTALA.  As the rule currently stands, once a hospital decides to admit a patient for stabilization purposes, it automatically extinguishes its right to transfer that inpatient.  This right is extinguished even if the hospital later learns it is incapable of stabilizing a potentially life threatening emergency medical condition.

Commenters argue that a hospital should know whether or not it has the capacity to stabilize an individual prior to admission.  Theory, however, does not always equal practice.  In the fast paced, hectic setting of emergency rooms across the country, such accurate assessments may not always be possible for obvious reasons.  CMS was wrong to render this crucial transfer provision of EMTALA inoperable simply because of the technicality of inpatient admission.  Patient care and stabilization must be the focal point of this statute, and not a bright line test of patient admission and hospital liability.  CMS should reconsider harmonizing EMTALA’s original transfer provisions with its 2003 Final Rule regarding EMTALA requirements after inpatient admission.

Low Income Benchmark Methodology for Drug Plans Under Medicare

By Jason Halpin

Each year, Prescription Drug Plans (PDPs) and Medicare Advantage Prescription Drug (MA-PD) plans submit bids to the Centers for Medicare and Medicaid Services to determine what their beneficiary premia will be. And each year, Medicare calculates the Part D premium low-income subsidy (LIS or the “benchmark premium”) for low-income beneficiaries based on the new premiums.

The upshot of the annual change in both the beneficiary premium and the LIS is that one year, the subsidy could pay for a low-income beneficiary’s premium in its entirety, but the next year, the premium could increase or the subsidy could decrease, leaving the beneficiary with the possibility they could have to pay a monthly premium equal to the difference between the premium and the subsidy.

Fortunately for low-income beneficiaries, Medicare seeks to avoid this scenario. If full-benefit dual eligible beneficiaries do not actively choose a plan when they first enroll in Medicare, they are enrolled into a PDP plan where they would not pay a premium. If, in the following year, they would have to pay a premium, LIS-eligible beneficiaries may “elect,” by doing nothing, to be reassigned to a PDP with no premium. LIS-eligible beneficiaries can also choose to stay in their plan and pay a premium or pick another plan with or without a premium.

Unfortunately for low-income beneficiaries, those who are subject to reassignment may also be subject to the complexity and hassle of having to change their pharmacy and their medications, and perhaps having to get new prescriptions from their doctors. Congress and CMS, therefore, have adopted a policy of seeking mechanisms to avoid reassignment.

When establishing the guidelines for determining the LIS, Congress mandated, in 42 U.S.C. § 1395w-114(b), that weighted averages should be used, presumably to ensure that the benchmark premium accurately reflects the actual average premium for an individual PDP or MA-PD beneficiary in the region and is not skewed by outliers, such as a comparatively lightly subscribed PDP with abnormally low premiums. Maintaining stability in the benchmark premium helps to promote continuity for beneficiaries and cost predictability for the government.

Figuring out the precise formula for the benchmark premium is in the hands of CMS, pursuant to its authority to administer the Medicare program under 42 U.S.C. § 1395hh. Accordingly, on April 3, 2008, CMS issued a final rule, Modification to the Weighting Methodology Used to Calculate the Low-Income Benchmark Amount.

While 42 U.S.C. § 1395w-114(b) states that Part D premium amounts must be “weighted,” to calculate the benchmark premiums, it says nothing about what that weight should be. Prior to the promulgation of the rule the weight given a particular PDP or MA-PD plan equaled a percentage, with the numerator being the number of Part D eligible beneficiaries enrolled in the plan and the denominator being the number of Part D eligible beneficiaries enrolled in all PDP and MA-PD plans in the PDP region.

The new regulations change the formula such that the weight given a particular PDP or MA-PD plan now equals a percentage, with the numerator being the number of Part D LIS-eligible beneficiaries enrolled in the plan and the denominator being the number of Part D LIS-eligible beneficiaries enrolled in all PDP and MA-PD plans in the PDP region.

By changing the formula to reference only LIS-eligible beneficiaries, the rule gives more weight to the premiums of plans that serve more low-income beneficiaries. Proponents of this formulation argue that it stabilizes and, in general, increases the benchmark premium, thereby reducing the risk of reassignment.

As CMS suggested in its response to comments on the rule, PDPs typically support a greater share of LIS enrollment, thanks to auto and facilitated enrollment. PDPs also typically have higher premiums than MA-PDs because MA-PDs can apply Part A and B rebates to lower their Part D premiums. The rule’s proponents argued that giving more weight to the higher PDP premiums–due to their higher LIS enrollment–would push the benchmark higher, bring more plans under the line, and protect more beneficiaries from reassignment. CMS estimated that if  LIS-enrollment weighting were used in 2008, reassignments would have been reduced by 850,000 from 2.1 million.

Critics still cried foul. Because the rule, and its predecessor regulations, dictated that MA-PD post-rebate premiums (which are about $20 less than PDP premiums on average) be factored into the benchmark formula, MA-PD premiums exerted downward pressure on the benchmark regardless of the weight given PDPs, leaving more PDP plans than necessary above the line and forcing more reassignments than the critics would tolerate.

In 2009, the critics’ views were largely borne out. The predicted benchmark increases were less dramatic than anticipated; though 28 out of 34 regions experienced increases (CMS predicted 27 out of 34), the increases in six of these regions were negligible (50 cents or less). Six regions saw decreased benchmarks. In addition, 1.6 million LIS-eligible beneficiaries were reassigned to new PDPs, and 620,000 were notified they would need to either pick a new plan or start paying a premium; the anticipated reduction was not as large as CMS expected.

To its credit, however, CMS responded appropriately in 2009, establishing a Medicare Demonstration to use pre-rebate MA-PD premiums in the benchmark formula. This greatly reduces the skewing effect of low post-rebate MA-PD premiums. According to the Kaiser Family Foundation, the pre-rebate MA-PD premiums  are actually slightly higher than PDP premiums. The weight of LIS-heavy PDP premiums thus pushed benchmark premiums up in all but one region for 2010, and 1.1 million beneficiaries were reassigned.

While some critics maintain that CMS could do more to reduce reassignments, the methods they suggest have rightly been rejected by CMS. Critics suggest the similar options of either allowing plans to waive the difference between their premiums and the benchmark, or reinstituting CMS’ de minimis policy, whereby an LIS-eligible beneficiary left with a premium that is less than a de minimis amount after recalcuation and application of the subsidy would not have to pay that de minimis amount.

CMS rejected both ideas because both provide a disincentive to plans keeping their bids low. If plans knew they could reduce their premiums for LIS-eligible premiums regardless of the premium their bids produced, they would not even try to keep their bids low. Also, if a plan had to write off a large amount of its premium, the revenue estimates in its bid would be undermined.

While recrafting the benchmark formula has not eliminated all reassignments, it has been very successful in reducing them. The new formula has reduced reassignments by half since 2008 and assured that less than 10 percent of LIS-eligible beneficiaries are reassigned. While CMS must work on reducing this number further, the reformulation of the benchmark premium is a good start.

Who’s the New Guy? – Obama Announces Choice for Next CMS Director

President Obama has announced his choice for the position of director of the Centers for Medicare & Medicaid Services (CMS), Dr. Donald Berwick, a pediatrician, professor, and advocate of improving patient care.  The CMS has been without a permanent administrator since 2006.  Berwick, whose appointment must be approved by the Senate before he may assume the position, certainly has the credentials for the important role the CMS director will surely play in the coming years.  Still, whether Republican Senators will be basing their confirmation decision on credentials or resentment of health care reform’s passage is yet to be seen.

Berwick is best known for founding the Institute for Health Care Improvement.  The Institute for Health Care Improvement is a non-profit think tank that is dedicated to helping hospitals improve their patient care delivery.  As attested to by the Institute’s co-founder Dr. Paul Batalden, Berwick takes incremental approaches to improving patient care that are cost-effective and do not lead to the rationing of care.  For example, Berwick finds that reducing the prevalence of hospital-acquired infections through something as small as keeping medical equipment sterile can help to bring down the rate of medical errors.

Berwick is also a proponent of utilizing medical information sharing, and is often called blunt in regard to how he finds the American health care system inefficient in delivering patient care.  Additionally, Berwick has advocated for patient rights on numerous levels, using a philosophy of patient-centered medicine.  He wants doctors to be rewarded based on the health care outcomes of their patients instead of how many procedures a doctor has performed. Having a leader interested in implementing infrstructural changes which incentivize outcomes as opposed to procedures as paydays without regard to outcome, is, many think, a step in the right direction. It is also worth noting that Berwick himself will be taking more than a 66% pay cut if he is appointed as the director of the CMS.

While Berwick may not have functioned as the head of a health care system in his career, he is not new to the world of national health policy.  In 1998, he was on President Clinton’s advisory commission that recommended ways to reduce medical mistakes and ensure consumer protection in the American health care system.  And also served at that same time as  Chair of the agency that is now known as the Agency for Healthcare Research and Quality. Berwick has also played a part in improving Britain’s National Health Service, for which he was given an honorary knighthood by Queen Elizabeth II.

Since Obama’s health care overhaul “contemplates key roles for both programs in extending insurance coverage to 32 million people at a cost of $938 billion over 10 years,” if selected to be the CMS’s director, Berwick will certainly need to bring his A-game in helping change the way our current health care system consumes Medicare and Medicaid resources.  Many also hope that good Medicare reforms will start a trend, motivating private insurance companies to also make cost-saving changes.  Before that challenge, Berwick will have to get past a Senate confirmation.  Republican Senators are likely going to make the process a rigorous one, where they will grill Berwick on how exactly he plans to effect the new health care reform legislation.

Given the importance of the CMS and the fact that it currently has no director, it would behoove the Senate to quicken the process of Berwick’s selection, considering his credentials and commitment to the rights and needs of American patients.  As the Washington Post said, “supporters and opponents of the new health-care legislation ought to be able to agree that leaving the agency without a confirmed head is not healthy.”  The job needs to be filled, and instead of using political tactics through rehashing the health care reform debate, the Senate should focus on the many qualities that Berwick has to offer.

Rationing or Cost Effectiveness?

In today’s Wall Street Journal, Scott Gottlieb, a former senior official with both the FDA and the Centers for Medicare and Medicaid Services (CMS), warns that “Government Health Plans Always Ration Care.” Aside from recasting the same old aspersions about “rationing,” Gottlieb warns that if reform efforts can’t tame health care costs, the “government will turn to a less appealing but more familiar tool to cut costs: the regulation of access to drugs and medical services.”

Of course, “access” can mean many things. Theoretically, Americans have “access” to the best medical technologies in the world. But practically, most Americans-including those with health insurance-don’t actually access this type of care and couldn’t even if they tried. The bottom line is that every health insurer in the world, public or private, has to “ration” for the simple fact that health care resources are not unlimited. Only wealthy citizens truly have “access” to the best medical care money can buy, regardless of the country they live in or the health system they live under. That won’t change with or without major health reform.

Gottlieb is worried that reformers might formally embrace recommendations by the Medicare Payment Advisory Committee (MedPAC), which currently has a broad statutory mandate to advise Congress on the Medicare program. He also warns that rationing is “a European import,” as if no health insurer in the United States has ever had to draw the line somewhere and decide what not to pay for. For example, Gottlieb warns about organizations like the Committee for the Evaluation of Medicines in France and the Institute for Quality and Efficiency in Health Care in Germany. He doesn’t mention the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom, but it drew similar scorn after the economic stimulus package funded comparative effectiveness research here in the United States. Gottlieb cautions that European countries “aren’t shy about rationing.”

Gottlieb is correct in one aspect: these organizations are prevalent in Europe. However, he misses three important points.

First, the countries in Europe that Gottlieb warns about spend considerably less than we do on health care (and don’t suffer negative health consequences for it).

Second, wealthy residents in pretty much all of these countries can purchase services and technologies over and above what the organizations that Gottlieb warns us about approve.

And third, we’re not exactly strangers to these organizations in the United States. Gottlieb is concerned about European imports, but he’s ignoring our home grown organizations, like the Agency for Healthcare Research and Quality (AHRQ), which makes new technology assessments for Gottlieb’s old agency, CMS, and supports comparative effectiveness research. Or the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC), which also performs new technology assessments. In fact, it’s no secret in Washington that Medicare has long considered some amalgam of cost effectiveness and comparative effectiveness in its coverage decisions, even if nothing in the Medicare statute explicitly allows it to do so. (CMS has long stretched the definition of “reasonable and necessary” in section 1862(a)(1)(A) of the Social Security Act to fit its fiscal realities, even if CMS or its precursor, HCFA, haven’t been successful in cementing cost effectiveness as a formal criterion, as evidenced through failed rulemaking in 1989 (54 Fed. Reg. 4,302) and 2000 (65 Fed. Reg. 31,124)).

And just as importantly, private insurers make cost and comparative effectiveness determinations too, either by following Medicare’s lead, as expressed through national and local coverage determinations (NCDs and LCDs), or by setting up their own new technology evaluation systems, like BlueCross BlueShield has with its Technology Evaluation Center. Though the offical duties and decisionmaking processes of these organizations differ, the health care community generally understands these decisions as implicitly factoring in cost effectiveness or at least clinical effectiveness-thus doing precisely what the anti-reformers like Gottlieb warn about.

Home Health Area Especially Vulnerable To Medicare Fraud And Abuse

American Health Lawyers Association reports that the increased amount of federal spending on home health benefits has led to the rise of fraud and abuse issues.  AHLA reports that federal “spending on home health grew approximately 44% from 2002 through 2006 ….”

AHLA states:

Gaps in the Centers for Medicare and Medicaid Services’ (CMS’) administration of the $12.9 billion Medicare home health benefit have left the program vulnerable to improper payments, including payments for claims resulting from fraudulent and abusive practices, the Government Accountability Office (GAO) found in a recent report.

The opportunities for fraud and abuse issues concerning home health care are manifold.  AHLA states that  the “common types of upcoding and billing for unnecessary care in home health were: billing for outlier cases when that level of care was not required, billing for beneficiaries who were not homebound, and billing for therapy visits that may have been medically unnecessary. ”

The Department of Justice defines upcoding as “the practice of improperly assigning a diagnosis code to a patient discharge that is not supported by the medical record for the purpose of obtaining a higher level of reimbursement for that hospital discharge than the hospital would otherwise receive.”

AHLA also reports that Home Health Agencies (HHAs) “are not routinely subject to revalidation and that CMS generally does not include physicians, who are in a position to detect certain types of improper billing, in the agency’s efforts to detect improper payments.”

AHLA reports that CMS is considering adopting two of the four actions recommended by GAO:

CMS stated that it would consider two of GAO’s four recommendations–to amend regulations to expand the types of improper billing practices that are grounds for revocation of billing privileges and to provide physicians who certify or recertify plans of care with a statement of services received by beneficiaries. The agency “neither agreed nor disagreed with our other two recommendations,” GAO explained.

AHLA reports that the four recommendations for CMS are:

• Assess the feasibility of verifying the criminal history of all key officials named on an HHA enrollment application.
• Provide physicians whose identification number was used to certify or recertify a plan of care with a statement of services the HHA provided to that beneficiary based on the physician’s certification.
• Direct CMS contractors to conduct post-payment medical reviews on claims submitted by HHAs with high rates of improper billing identified through prepayment review.
• Amend current regulations to expand the types of improper billing practices that are grounds for revocation of billing privileges.

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HHS OIG Report Finds Part D Private Insurers Overcharged for Billions, Lack of CMS Oversight

According to a recent report by the Department of Health & Human Services, Office of Inspector General, private insurance companies that operate plans under the Medicare prescription drug benefit have overcharged Medicare beneficiaries and the program by several billion dollars since the program began in 2006.

According to the report, 80% of health insurers that operate plans under the Medicare prescription drug benefit overcharged the program by about $4.4 billion in 2006 alone. In addition, The McClatchy/Raleigh News & Observer reports that the Centers for Medicare & Medicaid Services (CMS) remains unaware of the total impact of the practice because of its failure to perform required audits.

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New Bill to Create Prescription Drug Benefit Through Original Medicare as CMS Expansion of Off-Label Drugs for Cancer Treatment Draws Criticism

Yesterday, Congressional Democrats introduced legislation (HR 684, S 330) that would allow Original Medicare to establish one or more plans to compete with private plans under the Part D prescription drug benefit, according to CQ HealthBeat. The legislation would also require the Secretary of Health and Human Services to negotiate directly with pharmaceutical companies for the prices of medications under Part D.

Additionally, it would strengthen the ability of Medicare beneficiaries to appeal denials of coverage for medically necessary medications under all Medicare Part D plans.

The bill was sponsored by Senate Majority Whip Richard Durbin (D-Ill.) and Reps. Marion Berry (D-Ark.) and Jan Schakowsky (D-Ill.). According to Berry, the plans established by Medicare would have the ability to obtain discounts on medications that private plans could not match.

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CMS Ruling May Pose Serious Problems for New York Seniors

Federal law protects married couples from having to choose between divorcing and becoming impoverished when one spouse needs expensive nursing home care. For 20 years, this law allowed the healthier spouse to retain income and assets while the sicker spouse is covered by Medicaid.

In New York State, the same benefit has been extended to people with illnesses like Alzheimer’s disease or cancer who receive care at home, which is both less expensive and less disruptive to relationships.

That benefit may no longer be available to the spouses of those patients receiving care at home, according to The New York Times. Last fall, the Centers for Medicare and Medicaid Services sent a letter to New York health officials outlining a legal ruling declaring that couples in which both partners live at home are not entitled to the same protection as those couples where one spouse is in a nursing home.

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Is the Medicare Advantage Program Really Advantageous

CQ Politics reports that President-elect Obama is committed to the elimination of Medicare Advantage plans. Obama told ABC’s “This Week” that Medicare Advantage plans are an example of cost-cutting government initiatives that do not work.

This is especially interesting in light of the Centers for Medicare and Medicaid Services ordering WellPoint to temporarily suspend enrollment and marketing efforts for its Medicare plans on Monday. The Los Angeles Times reports that the sanctions followed a “sharp” increase in complaints. Reportedly, some customers of WellPoint were unable to receive their prescription drugs while others were overcharged because of computer mistakes.

Along with President-elect Obama, Senate Majority Leader Harry Reid (Nev.) has signaled his intent to “scale back” the Medicare Advantage Program, according to The Hill. Medicare Advantage plans offer health insurance to more than 10 million of the 45 million Medicare beneficiaries. However, the Medicare Payment Advisory Committee reports that Medicare Advantage plans cost the government 13% more per beneficiary on average than Original Medicare in 2008.

Democrats say that $15 billion of the annual $94 billion in subsidies granted to Medicare Advantage plans are the result of “overpayments.”

Surely, any attempt to eliminate Medicare Advantage plans from the Medicare program will be met with fierce opposition from private insurance companies. In response to the threat of elimination, America’s Health Insurance Companies said that the so-called “overpayments” are used to help purchase prescription drug coverage, vision care, and chiropractic services for which Original Medicare does not pay.

There may be some merit to this argument as Original Medicare is lacking in many crucial coverage areas, including dental services which left untreated can be fatal. Thus, it is quite possible that the elimination of Medicare Advantage plans could result in many seniors facing reduced benefits, limited health care choices and higher out-of-pocket costs, according to America’s Health Insurance Companies.

CMS Physician Quality Reporting Initiative, Experience

The American Association of Family Physicians (AAFP) has authored a somewhat disturbing article on the recent Center for Medicare and Medicaid Services (CMS) report “that examines participation data from its 2007 Physicians Quality Reporting Initiative, or PQRI, and also addresses physicians’ frustrations with the program.”

According to the CMS report, Physician Quality Reporting Initiative, 2007 Reporting Experience

The Centers for Medicare & Medicaid Services (CMS) is working to transform the Medicare program from a passive payer into an active purchaser of high-quality care by linking payment to the value of care provided. Initially, CMS developed a voluntary quality reporting program in 2005, the Physician Voluntary Reporting Program (PVRP), to encourage physicians to report information on the quality of care they were delivering. As authorized by Congress, the PQRI builds on the PVRP by linking payments to reporting quality information. The PQRI is an important first step toward establishing a value-based purchasing program for physicians.

The Tax Relief and Health Care Act of 2006 (TRHCA), enacted on December 20, 2006, required the Secretary to implement less than seven months later by the start of the first reporting period on July 1, 2007, a system for the reporting of data on quality measures. CMS termed this system “PQRI.” This implementation schedule required rapid finalization of the detailed specifications for 74 clinical quality measures (covering hundreds of procedure and diagnosis codes), the development of an expanded infrastructure to support the reporting system and extensive outreach to more than 700,000 professionals about the requirements they needed to follow to submit data on quality measures.
Physicians who successfully submitted the quality information were eligible for an incentive payment capped at 1.5% “of total allowed charges for covered Medicare Physician Fee Schedule services.”

Not quite 16% of eligible physicians participated; of those who did participate, “Of the more than 14 million quality data codes submitted, 51.6 percent were submitted correctly; 48.4 percent of submissions were invalid.”

AAFP offers this summary of the Submission Data

• According to the new CMS report, the agency paid eligible providers slightly more than $36 million in incentive payments for the 2007 PQRI reporting period. The average bonus paid to individual providers was $635. The average bonus paid to practice groups was $4,700.
  Of the more than 14 million quality data codes submitted, 51.6 percent were submitted correctly; 48.4 percent of submissions were invalid.
  CMS says that nearly 16 percent of all eligible providers and groups submitted at least one quality data code during the 2007 PQRI reporting period. Of those 109,359 providers or groups,
  92.5 percent submitted at least one quality data code that was valid;
  64 percent correctly reported quality data on 80 percent of eligible cases for at least one measure;
  52 percent earned an incentive payment by successfully reporting data on one to three applicable measures for 80 percent of applicable cases; and
  1 percent were subject to the PQRI incentive cap.

In the report’s executive summary, CMS says it is “committed to a successful PQRI program,” and promises to “reduce or eliminate” the issues identified in the report. As such, among other modifications, CMS warrants to revise the analytics, redesign the physician feedback report system– registration to which was “both cumbersome and time consuming,” and increase educational outreach. In addition, “CMS has established new reporting options making it easier for EPs to participate in PQRI for 2008.”

AAFP reports that “Earlier this month AAFP Board Chair Jim King, M.D., of Selmer, Tenn., blasted CMS for its bungling of the distribution of PQRI bonus payments and told CMS Acting Administrator Kerry Weems that if problems weren’t addressed, physicians might refuse to participate in the program.”

Read the full AAFP article here.