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January 08, 2014

Medicare Program; Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs -- Proposes to Ban Doctors and Eliminate Certain Pharmaceuticals from Part D

The Centers for Medicare and Medicaid Services (CMS) pre-released a proposed rule that will require all prescribers of Part D drugs to enroll in Medicare. More significantly, CMS would have the ability revoke Medicare enrollment in cases of "abusive prescribing practices and patterns," which they describe through a list of criteria discussed below. If a prescriber is involved in malpractice suits this may deny them from participating in the Part D program.

The proposed rule also allows CMS to request and collect information directly from pharmacy benefit managers, pharmacies, and other entities that contract with Part D sponsors in order "to better detect fraud," and increases CMS' ability to collect identified Medicare overpayments from Medicare Advantage (MA) plans and Part D sponsors.

The rule no longer requires Part D plans to include substantially all drugs from two drug classes (antidepressant and immunosuppressant) to be on all Part D formularies. They will continue to require all part D plans to cover basically all antineoplastic, anticonvulsant, and antiretroviral drugs and will reevaluate antipsychotics for 2016 and beyond.

As a background, Part D, also known as the Medicare prescription drug benefit, was enacted as part of the Medicare Modernization Act of 2003 and provides extensive drug coverage for seniors and the disabled, allowing them to get prescriptions as quickly as possible. In the time since Part D was enacted, some have argued that Medicare's focus on speedy delivery has its downsides.

ProPublica a special interest investigative journalism shop, has been running articles throughout the last year criticizing CMS for enabling doctors to prescribe large quantities of "inappropriate" medications due to a lack of proper oversight. ProPublica argues that Medicare has wasted billions on "needlessly expensive drugs," and that the Part D program is conducive to fraud. The authors of these reports tend to frame their arguments around a few physicians who prescribe a lot of a single drug, or spot doctors who prescribe in different ways than their peers.

While ProPublica does fall into the trap of oversimplification (the US healthcare system doesn't always fit into neat black and white issues), they make some compelling arguments for Medicare reform, and CMS has taken note. The proposed rule moves away from Medicare's historical deference to physician judgment over whether a drug is medically necessary. The added bureaucracy found in the proposed rule places more emphasis on discovering fraud, but obviously impedes important doctor-patient relationships by chilling lawful, beneficial prescribing practices, often to patients that need medication most.

Enrollment Requirements for Prescribers of Part D Covered Drugs

Under the proposed rules, doctors must formally enroll in Medicare to write prescriptions to Part D enrollees. CMS proposes that to improve their "ability to oversee the Medicare Part D program," physicians must enroll in the Medicare program by January 1, 2015 in order to prescribe covered Part D drugs. CMS requires doctors to verify their credentials and disclose professional discipline and criminal history during the enrollment process. This strategy allows CMS to call on its investigative team to collect information and take action should they suspect abuse.

This deadline would purportedly allow physicians 6 months after the publication of a final rule to initiate and complete the Medicare enrollment process for the purposes of prescribing covered Part D drugs. CMS is soliciting comments regarding the January 1, 2015 effective date.

The proposed rule also contemplates requiring all pharmacies (for example, network, non-preferred, home infusion, non-retail or mail order, and out-of-network) to enroll or maintain enrollment in the Medicare Fee-For-Service program in order to dispense covered Part D drugs. CMS is soliciting comments for this as well.

Improper Prescribing Practices

In the proposed rule, CMS would have the power to revoke a physician or eligible professional's Medicare enrollment if CMS determines that he or she has a pattern or practice of prescribing Part D drugs that is "abusive and represents a threat to the health and safety of Medicare beneficiaries, or fails to meet Medicare requirements."

"We choose not to define 'abusive' and 'threat to the health and safety of Medicare beneficiaries,' CMS states, "because the myriad of questionable situations…requires that CMS have the flexibility to address each case on its own merits." Instead, CMS provides a list of criteria they would use in determining whether a prescriber is "engaging in prescribing practices sufficient to warrant a revocation."

In determining instances of "abusive" prescribing, CMS proposes to consider several factors, including:

  • Whether there are diagnoses to support the indications for which the drugs were prescribed;
  • Whether prescribing a drug would have been impossible (for example, the patient was deceased or out of state at the time of the alleged office visit);
  • Whether the physician or eligible professional has prescribed controlled substances in excessive dosages that are linked to patient overdoses;
  • Disciplinary actions taken against the physician by the licensing body or medical board for the state or states in which he or she practices, and the reason for the action;
  • Whether the physician has any history of "final adverse actions," including:

    (a) a Medicare-imposed revocation of any Medicare billing privileges;

    (b) suspension or revocation of a license to provide health care by any State licensing authority;

    (c) revocation or suspension by an accreditation organization;

    (d) a conviction of a Federal or State felony offense within the last ten years preceding enrollment, revalidation, or re-enrollment; or

    (e) an exclusion or debarment from participation in a Federal or State health care program;

  • Malpractice suits that have been filed against the physician related to prescribing; and
  • Whether any State Medicaid program or any other public or private health insurance program has restricted, suspended, revoked, or terminated the ability to prescribe medications.

In determining whether a physician or eligible professional has a pattern of prescribing that fails to meet Medicare requirements, CMS would consider the following factors, including whether the physician:

  • Has a pattern or practice of prescribing without valid prescribing authority;
  • Has a pattern or practice of prescribing for controlled substances outside the scope of the prescriber's DEA registration; and
  • Has a pattern or practice of prescribing drugs for indications that were not medically accepted—that is, for indications neither approved by the FDA nor medically accepted under 1860D-2(e)(4) of the Act, and whether there is evidence that the physician or eligible professional acted in reckless disregard for the health and safety of the patient.

CMS would also have the authority to deny a physician's Medicare enrollment application if his or her DEA Certificate is currently suspended or revoked. CMS would also have the power to revoke a physician's Medicare enrollment if the DEA Certificate is suspended or revoked, or if the applicable licensing or administrative body for any state in which the physician or eligible professional practices has suspended or revoked the physician's ability to prescribe drugs.

CMS is interested in receiving comments on the following issues:

  • Whether certain proposed criteria should not be used;
  • Whether criteria that they did not propose should be used;
  • Whether certain criteria should be given more or less weight than others; and
  • Whether the proposed additions should be expanded to include pharmacy activities.

Authority to Impose Intermediate Sanctions and Civil Monetary Penalties

The existing regulations designate the Office of Inspector General (OIG) as the sole government agency with the authority to impose penalties for certain Medicare violations. CMS is proposing to revise the language of these provisions to clarify that either CMS or the OIG may impose intermediate sanctions and civil monetary penalties.
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Discussion

There are compelling reasons for Medicare Part D reform. Medicare is overtaxed in all facets, and they have allowed oversight and enforcement to take a backseat to getting prescription drugs quickly in the hands of patients. As evidence of the disorganization, Medicare currently has limited policies in place to discontinue payments even to physicians who are serious criminal offenders.

However, it is easy for the public to paint with a dangerously broad stroke. Articles which focus entirely on prescription number or variance from the general physician population embrace statistics that simply do not work for medicine in all cases. Prescribing is individualized and patient-centric. As stated in the introduction, Medicare's proposed rule moves away from a historical deference to physician judgment over whether a drug is medically necessary.

The added bureaucracy found in the proposed rule places more emphasis on discovering fraud, but obviously impedes important doctor-patient relationships by chilling lawful, beneficial prescribing practices, often to the patients that need medication most. The increased oversight by CMS, and the threat of being kicked out of Medicare enrollment, hopefully will curtail the most egregious practicing habits.

We remain cautiously optimistic that the balance CMS struck in its multi-faceted approach to discovering and enforcing "improper prescription practices" establishes both patient safety and the need for proper medication.

We are however, concerned that the clause on whether there are diagnoses to support the indications for which the drugs were prescribed; could be the beginning of a road that leads health care professionals to avoid writing scripts for new medications that may be critically beneficial to patients out of fear of prosecution or debarment. This form of intimidation and rationing could end up costing years of seniors' lives.

It is also concerning that actions public or private health insurance program to restricted, suspended, revoked, or terminated the ability to prescribe medications is considered a trigger for being barred from the Part D program, as private health insurance companies can restrict access to medications based on their formularies that this will become the norm for the Part D program to restrict access to medications.

Patients on antidepressants, and immunosuppressants may be forced to switch their medications which for antidepressants could take patients months to reestablish a baseline and switching immunosuppresants could cost a patient their lives as there is wide variations of patient reactions in both those drug classes.

Of course ProPublica is not entirely satisfied with the proposal, noting that CMS leaves some aspects of Plan D reform out. The report does not:

  • Detail whether officials now plan to routinely scour their data for providers with suspicious prescribing patterns and, when they find them, what they'll do.
  • Include other suggestions such as requiring diagnosis codes on prescriptions to assess their appropriateness or requiring private insurers in Part D to report suspected fraud, waste and abuse to Medicare's fraud contractor. Such sharing is now voluntary.

Comments

To be assured consideration, CMS recommends that comments be received no later than 5 p.m. on March 7, 2014. You may submit electronic comments on this regulation to http://www.regulations.gov. In commenting, refer to file code CMS-4159-P. Follow the "Submit a comment" instructions.

For the full 678 page document, click here. CMS contends that, if enacted, regulations would strengthen consumer protections, while both cutting costs ($1.3 billion over five years apparently) and improving care for enrollees in the programs.  

Policy and Medicine will post any updates to Part D.

 

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We have been in business since 1938 and we have never had a past due bill. Recently we have seen a decrease in reimbursement from PBM"s on many drugs that were dollars below our net cost. This is creating a cash flow problem for every independent pharmacy I have talked with. Coupled with huge price increases on several drugs has caused this problem. With all this plus the preferred networks , I see an end to independent pharmacy as we know it.I am 73 years old and asking for your help to save thousands of jobs across this country.

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