AAPS Comments Submitted Regarding PECOS

To the Centers for Medicare and Medicaid Services
Department of Health and Human Services
ATTN: CMS-6010/IFC
P.O. Box 8013
Baltimore, Maryland 21244-8013 Submitted by e-mail at www.regulations.gov

This concerns the interim final rule, 42CFR parts 424 and 431 concerning changes in provider and supplier enrollment, ordering and referring, and documentation requirements; and changes in provider agreements.

Comments are submitted by the Association of American Physicians and Surgeons, a nationwide association of thousands of physicians in all specialties, founded in 1943.

In general, this rule requires that physicians and eligible professionals must be enrolled in Medicare in order to order and refer covered items and services for Medicare beneficiaries. This requirement and others restricts the right of patients who are enrolled in Medicare to receive goods and services of their choice from licensed professionals who choose not to enroll in Medicare, whether or not Medicare pays any part of the bill. It has the effect of denying the benefits for which they have been forced to pay all their working lives to Medicare beneficiaries for any items that are provided by non-enrolled professionals. In addition, it attempts to deny access to services that a patient is willing and able to pay for, which may actually enhance or even prolong his life, even if no claim is made to the federal treasury for reimbursement.

Because of the insolvency of the Medicare program and the likelihood of draconian rationing of goods and services, this subjects Medicare beneficiaries to premature death, disability, and pain that could be obviated by medical services that they are willing and able to purchase but for the Medicare restrictions. This amounts to unconstitutionally depriving these citizens of life, liberty, and property without due process of the law, in violation of the 5th Amendment to the U.S. Constitution. It means that once a person accepts and entitlement for which he has been forced to pay, he becomes totally dependent upon the government for all medical services. Despite years of hard work and frugality, he is not allowed to use his savings to enhance or prolong his final years.

While Medicare has the discretion to condition enrollment upon whatever requirements it chooses to impose, it does not have the constitutional or statutory authority to prohibit the practice of medicine by professionals who are qualified and licensed in their respective states, or to force them to restrict their practice to persons who are not enrolled in a federal program. Billing Medicare is said to be a privilege, as is the receipt of entitlement benefits; however, the liberty to use one�s own property to extend one�s own life is a right guaranteed by the U.S. Constitution, not a privilege that can be denied at the whim of a federal bureaucrat.

As it states on page 24439, it may well be that Medicare has permitted the enrollment of under-qualified or even fraudulent providers. This does not, however, give it the constitutional or statutory authority to prevent physicians, who are qualified and regulated under the laws of their respective states and chosen freely by their patients, from practicing medicine.

It is stated that the requirements are �to protect beneficiaries and the Medicare Trust Fund by preventing unqualified, fraudulent, or excluded providers and suppliers from providing items or services to Medicare beneficiaries or from billing the Medicare program or its beneficiaries.� Medicare beneficiaries, however, are individual American citizens, not a ward of the Medicare trust fund. They do not relinquish their right to make their own decisions about their medical care by enrolling in a benefits program. The trust fund is in no way harmed by beneficiaries choosing to buy items and services for which the Fund does not pay. In fact, the demands on the insolvent Trust Fund could well be substantially relieved by beneficiaries who choose to receive medical items and services that are fully paid for privately.

It is stated that the National Provider Identifier (NPI) requirement will �strengthen cross-program integrity efforts.� There is no need or justification, however, for program integrity efforts to extend to nonparticipants in the program. In fact, it only dilutes the efforts to protect the program.

It is stated that the NPI is required so that providers can �be identified, as required, in the claims for the covered items that they have ordered and referred.� There is no need, however, for the program to identify providers who are not ordering services through the program and therefore not submitting any claims for these services. Such providers are identified by those who are paying for the goods and services, namely the patient or conceivably some private plan. Patients and private companies have found ways of identifying people since time immemorial as by name, signature, facial and voice identification, or numerical identifiers such as DEA registration number or state license number. CMS has no responsibility for the patient�s identification of his physician, and hence no right to dictate how that recognition is to be made when it is paying no part of the bill.

On page 24411, the rules state that �our policy has not been to permit all of the eligible professionals�to order and refer.� Section 640(c) of the Affordable Care Act gives the Secretary the discretion to determine the professions that can order and refer for all covered items and services under Title 18�. This Act does not give any authority to the Secretary to determine who may order or refer for items that are not covered and for which payment will not be made under a federal insurance plan. The jurisdiction of the Secretary does not extend to fully private transactions. The scope of practice of professionals is defined by state medical practice acts. Thus it appears that these regulations are creating a federalism issue.

On page 24444, it is stated that �we believe that these requirements will promote quality healthcare services for Medicare beneficiaries because orders and referrals would be written by qualified physicians and eligible professionals, as their credentials would have been verified by part of the Medicare provider/supplier enrollment process.� The credentials of physicians, of course, have already been verified by the state licensure boards. Additional verification by the Medicare program is redundant and a waste of taxpayer money as well as professionals� time.

The real purpose appears to be stated in another paragraph that �our requirements will enable us to know the identity of the individual who ordered or referred and, if appropriate, we could establish edits to check for over-ordering specific items or services, over-referring specific services, and/or over-ordering or over-referring to specific providers of services and suppliers.� It appears that having credentials to be a qualified provider is insufficient to assure that a provider does not �over-order.� It appears that the definition of �over-ordering� is solely within the discretion of CMS, and will be established retroactively, as long as seven years later. We note that the documentation that supports the orders and referrals must be kept for seven years in order to maintain an active enrollment status. This creates an expensive paperwork burden for professionals, apparently above and beyond the need to keep records needed for patient care, and also sets up a requirement to meet a standard that is unspecified. CMS should be required to state how it determines whether services are being �over-ordered.�

It is noted that you are well aware that Medicare beneficiaries may be patients of physicians or other professionals who do not have appproved enrollment records in PECOS and are receiving services based on the orders or referrals of such providers. You state that you believe that the requirements will address the recommendations offered by the DHHS OIG report titled �Medicare Payments in 2007 for Medical Equipment and Supply Claims with Invalid or Inactive Referring Physician Identifiers, OEI-04-08-00470, February 2009. One of these recommendations was to determine the earliest date to end the provision that allows suppliers to submit claims without referring physician NPIs while maintaining beneficiary access to services. CMS should be required to document how they determined that July 6, 2010, would allow beneficiaries to continue accessing services if the professionals who ordered them are stuck in a process of enrolling in PECOS that at best could take a minimum of 60 days.

On page 24445, the rules refer to the past practice of permitting the provider of services that submits the claim and is thus expecting to be paid for it to use his own NPI in place of the NPI of the ordering or referring physician. Such claims will now fail the claims processing edit. It essentially puts the physicians or facilities that perform services to be deprived of their independent professional status. They cannot perform a service without having a government certified gatekeeper to order it.

We note that the NPI registry enables anyone with a computer with internet access to look up a provider�s NPI by name, and that there are downloadable files. This seems like an open invitation to identify theft. How is CMS able to determine that the NPI that is on a claim was put there by a physician who meant to order the test, or by someone who simply downloaded the NPI from the open file?

Regulations cite Section 6406 of the Affordable Care Act that requires providers to agree to maintain and provide access on request to documentation relating to written orders or requests for payment for durable medical equipment. A physician can be punished by being excluded for a full year simply because he did not have or provide such documentation. This can result from a number of things, including hurricanes and floods. There is also the daunting expense of maintaining these written orders.

On page 24446, Section IV, there is a statement about a waiver of proposed rule making. The extremely short deadline is asserted to be needed because �a delay in implementing these provisions would be contrary to the public interest and to CMS�s efforts to reduce and eliminate fraud and abuse in the Medicare and Medicaid programs. The Secretary does not explain how it could be in the public interest to take the risk of denying access to essential medical tests and supplies because a provider was unable to complete onerous requirements in time, or because the federal agencies were incapable of processing them in a timely fashion.

The rules exempt the agency from the Paperwork Reduction Act because �we believe the associated burden is exempt.� It is ironic that the agency feels itself free to simply disregard a statute that is supposed to protect American citizens against unduly onerous reporting burdens. Simply to assert that �we have determined that this rule will not have a significant economic impact on a substantial number of small entities� and that it �would not have an adverse impact on small entities� is no proof that in fact it will not have very serious adverse impact. The rule also exempts itself from analysis of the financial burden because it does not mandate expenditures by the government or by the private sector. Such expenditures are necessary, however, in order to meet the requirements of the Act! In other words, the rule allegedly does not require the expenditures, yet it can�t be complied with without them!

In summary, we conclude that (1) the agency lacks either the constitutional or the statutory authority to dictate requirements concerning which professionals may order tests or services for any patient; (2) while the agency is exerting authority to dictate these requirements for services to be eligible for Medicare reimbursement, it is significantly restricting the Medicare entitlement. It will significantly decrease senior citizens� access to these life enhancing or life saving procedures. It violates the promises made to Americans when the Medicare law was passed, and represents a major betrayal of their trust. (3) These rules will significantly increase the cost of caring for Medicare beneficiaries, and will thereby further decrease access to care. (4) These rules create significant bureaucratic complexities that will contribute nothing to the agency�s ability to discern the necessity of ordered services.