Thanks to everyone for helping to win this battle- for now.

CMS backed off on the dangerous proposal we all opposed and they agreed to start over in the face of broad, bipartisan opposition inclusive of individual and group opposition.

Here is the original story and the call to action posted in January 2014:

CMS proposal would limit availability of Medicare D antidepressants, immunosuppressants

Please send your comments as soon as possible. They are due by March 7, 2014.

This proposal is open for public comment:

Comments can be easily submitted here online: https://federalregister.gov/a/2013-31497

Option 1:

http://www.regulations.gov. Follow the ”Submit a comment” instructions, using the search term: “CMS-2014-0007-0002″

or here: https://federalregister.gov/a/2013-31497

Submit your comments.

Option 2:

Mail comments to: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-4159-PO Box 8013 Baltimore, MD 21244-8013

More info:

From international law firm Arnold & Porter LLP comes timely views on current regulatory and legislative topics that weigh on the minds of today’s physicians and health care executives.

Physicians may soon face more limited choices of antidepressants and immunosuppressants for their Medicare patients. In a recent proposed rule regarding Medicare Part D and Medicare Advantage programs, CMS proposed eliminating the “protected class” status of these drugs as of 2015.

Part D plans now must include all (or “substantially all”) drugs in six protected classes on their formularies. Essentially all drugs in the six classes have been available on Part D formularies (although protected class drugs can be placed on any tier, so patient cost-sharing can be high). Plans have been unable to impose prior authorization or “fail first” requirements on patients already taking a protected class drug, but can impose these requirements on “new starts.”

If CMS adopts its proposal, antidepressants and immunosuppressants to prevent rejection of transplanted organs would no longer be “protected.” The antineoplastic, anticonvulsant, and antiretroviral classes would retain protected status, as would antipsychotic drugs at least for 2015.

If adopted in CMS’ final rule, these changes would reduce Part D patients’ access to antidepressant and immunosuppressant drugs. Since not all drugs would have to be included on formularies, the range of available treatment options would narrow for patients with depression and for transplant recipients, and bargaining power between plans and manufacturers would shift. Unless brand name drug manufacturers agreed to more favorable rebates, some exclusions and shifts toward generic products would result. CMS’ analysis indicates that formularies could meet other applicable Part D standards with a much smaller presence of branded drugs.

Plans could constrain availability of drugs in classes that lose protected status by excluding specific drugs from formularies; by imposing prior authorization or fail first requirements (as they can already, with “new starts”); or by imposing high cost-sharing (as they can already). Plans would therefore have substantial latitude to limit availability of particular drugs.

CMS proposes to limit protected classes to those satisfying these criteria:

1) “Hospitalization, persistent or significant disability or incapacity, or death likely will result” if a patient does not start therapy within 7 days after the prescription is presented at the pharmacy; and

2) More CMS formulary requirements will not suffice to meet the universe of clinical drug-and-disease-specific applications.”
CMS convened an internal panel (composed of the chief medical officer in CMS’ Center for Medicare, and CMS pharmacists) to determine which drug classes met both of these criteria. Antiretroviral, antineoplastic, and anticonvulsant classes did so. CMS therefore proposes to continue their protected status.

Immunosuppressants met the first test but not the second.

Antidepressants failed both tests. CMS quoted the American Psychiatric Association’s 2010 treatment guideline that “the effectiveness of antidepressant medications is generally comparable between classes and within classes of medications” in explaining why its panel felt that antidepressants failed criterion two.

While antipsychotics also failed the second test, CMS proposed to keep protecting them through at least 2015.

CMS expressed concern that protected class status increases plans’ drug costs (partly by reducing manufacturers’ incentive to offer high rebates) and may lead to overutilization because plans cannot use utilization management tools to the same extent as with other drugs. CMS also alluded to safety concerns (regarding antipsychotics) that could be mitigated by narrowing the protected classes.

For those classes that retain protected status, CMS proposes to add several new exceptions to the general requirement to cover all protected class drugs:

For drugs that are primarily covered by Medicare Parts A or B.
To permit prior authorization to determine whether a drug is being used for a “medically accepted indication” (as defined in the Part D law) or to verify that the drug is not covered under Part A or B as prescribed and dispensed or administered to the patient.
For compounded products and FDA-approved fixed dose combination products containing at least one protected class drug (excepting certain antiretrovirals).

CMS also requests comments on whether to continue a currency exception allowing prior authorization for enrollees who are “new starts” on a protected class drug.

Interested parties can comment to CMS on the proposed rule, which is accessible athttps://federalregister.gov/a/2013-31497. Comments are due March 7.

Here are the highlights:

The Centers for Medicare and Medicaid Services, CMS, recently issued a Proposed Rule that would initiate important changes to prescription drug plans under Medicare Part D and Medicare Advantage. Comments can be submitted through March 7, 2014.
Among the changes CMS proposes are those concerning the criteria for protected drug categories, the costs to Part D enrollees and the government delivered by preferred pharmacy networks, and methods of targeting fraud and abuse by prescribers.
On January 6, 2014, the Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule, “Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs,” (the “Proposed Rule”) with public comments due by March 7, 2014.

The Proposed Rule would bring considerable changes to Medicare Part D and Medicare Advantage prescription drug plans. Most significantly, the Proposed Rule would modify the criteria for protected “drug categories or classes of clinical concern,” require preferred pharmacy networks to deliver lower costs to Part D enrollees and the government, and target fraud and abuse by requiring prescribers to enroll in Medicare in order for their prescriptions to be covered under Part D.

Categories or Classes of Clinical Concern

The Medicare Modernization Act (“MMA”) required Medicare Part D plan formularies to include “all or substantially all” drugs falling within six “protected” classes of drugs — immunosuppressants, anticonvulsants, antineoplastics, antidepressants, antipsychotics and antiretrovirals. The Affordable Care Act (“ACA”) subsequently codified this policy, allowing CMS to specify criteria for identifying protected classes through notice and comment rulemaking.

In the Proposed Rule, CMS indicated that it will continue to require formulary inclusion of all drugs within the antineoplastic, anticonvulsant, and antiretroviral drug classes, but would no longer require all drugs from the antidepressant and immunosuppressant drug classes to be on Part D formularies. Moreover, while CMS also anticipates removing the requirement on antipsychotics, “they will remain protected at least through 2015″ to ensure that CMS has “not overlooked a need for any transitional consideration.”

Preferred Pharmacy Networks

Over the past several years, CMS has expressed concern about preferred pharmacy networks. Specifically, CMS suggested that these networks may not consistently lower costs and noted that, in some cases, costs in preferred networks are higher than non-preferred networks.

The Proposed Rule would allow Part D sponsors to reduce copayments or coinsurance for preferred pharmacies only if they offer consistently lower negotiated prices than are available from other pharmacies in the broader pharmacy network. Further, CMS wants to modify the definition of “negotiated prices” to require all price concessions from pharmacies to be reflected in negotiated prices. Practically speaking, CMS asserts that “this would mean that whatever pricing standard is used to reimburse drugs purchased from network pharmacies in general, a lower pricing standard must be applied to drugs offered at the preferred level of cost sharing.”

Physician Fraud and Abuse

To help control fraud and abuse, CMS proposes to require that all prescribers of Part D-covered drugs be enrolled in Medicare as a condition of coverage for those prescriptions. Moreover, the Proposed Rule suggests that CMS be authorized to revoke a prescriber’s Medicare enrollment if CMS discovers a pattern of prescribing Part D drugs that threatens a beneficiary’s health and safety. Additionally, CMS would be authorized to revoke a prescriber’s Medicare enrollment if the prescriber’s state license or DEA certificate of registration is suspended or revoked.

Additional Proposed Changes

In addition to the above changes, CMS offers the following through the Proposed Rule:

U.S. Citizenship Requirement: The Proposed Rule would require U.S. citizenship and lawful presence as an eligibility requirement for enrollment in Medicare Part D or Medicare Advantage plans.
Enhanced Risk-Adjustment Data Validation (“RADV”) Process: CMS proposes to combine the medical record review-determination and the error rate calculation appeals into a combined process.
Expanded Data Sharing: The Proposed Rule would give “legitimate researchers” (i.e., non-commercial researchers) broader access to healthcare data by expanding access to various identifiers contained in the prescription drug event (“PDE”) data.
Limited Plan Options Per Service Area: CMS proposes to limit prescription drug plans sponsors to offering no more than two Part D plans in the same service area.