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What’s the latest on drug shortages?

Nov. 29, 2018

The AADA recently attended an FDA public hearing about the impact of drug shortages on dermatologists and their patients. Speakers at the hearing — including manufacturers, suppliers, and physicians — highlighted the need to address and prevent drug shortages. Additionally, many speakers discussed challenges getting access to sterile injectables — an issue facing many dermatologists particularly with the shortages of lidocaine with and without epinephrine and sodium bicarbonate, as well as bacteriostatic saline.

The FDA has been soliciting information and feedback from physicians, patients, and consumers alike recently about a number of issues related to drug access, including drug shortages. As a result, the AADA is conducting a survey of Academy members about the effects of drug shortages on dermatology patients. The AADA will share the results with the FDA and other policymakers. Take the survey here.

CMS seeks to implement real-time drug pricing widget

Nov. 27, 2018

CMS has issued a proposal that would require Medicare Part D plans to provide a real-time drug price tool by January 2020. This widget would integrate with physicians’ electronic health records or e-prescribing software and would allow physicians to view the real-time price for drugs for specific patients, as well as the price of alternative drugs.

The drug pricing tool was part of a larger proposed rule that would give Medicare Part D and Medicare Advantage plans the option of excluding “protected class” drugs from their formularies when the price of the drug rises more than inflation. For Part D plans, current protected class drugs include antidepressants, antipsychotics, anticonvulsants, immunosuppressants for treatment of transplant rejection, antiretrovirals, and antineoplastics. The proposed rule would also allow more opportunities for health plans to use step-therapy and prior authorization for these protected class drugs.

Although it was not part of the official proposed rule, CMS indicated that it might implement a new policy by 2020 that would require Medicare Part D plans to factor pharmacy price concessions and dispensing fees in patient-cost sharing. This would lower patients’ out-of-pocket costs but is estimated to increase Part D premiums costing the government and taxpayers $13.6 billion to $16.6 billion over 10 years.

Drug shortages affecting your patients? Tell the FDA.

Oct. 24, 2018

The American Academy of Dermatology Association (AADA) is conducting a survey of Academy members about the effects of drug shortages on dermatology patients. The AADA plans to share the results with the FDA and other policymakers on the federal and state legislative levels. Take the survey here.

The AADA has been engaging with stakeholders — including manufacturers, suppliers, the FDA, and Congress — to facilitate access for patient care. Bruce Brod, MD, deputy chair of the Academy’s Council on Government Affairs and Health Policy, recently participated in an FDA listening session with other medical specialties on the clinical and economic impacts of drug shortages. The listening session comes on the heels of the creation of the FDA’s new Drug Shortages Task Force that plans to address the causes of drug shortages and develop long-term solutions.

House and Senate pass legislation prohibiting gag clauses

Oct. 1, 2018

The House and Senate have passed legislation that would prohibit pharmacy benefits managers (PBMs) and private payers from including gag clauses in contracts with pharmacists that forbid them from telling patients a drug may be cheaper out-of-pocket rather than going through their insurance. The Know the Lowest Price Act applies to drug plans under Medicare Part D and Medicare Advantage and the Patient Right to Know Drug Prices Act applies to group health plans and individual market exchange plans. The legislation has been sent to President Trump to be signed into law. The AADA lobbied in support of this legislation.

AADA, coalition urge congressional leaders to ask CMS to reconsider MA step therapy policy

Sept. 14, 2018

The AADA joined more than 240 patient and provider groups in signing on to a letter — organized by the Part B Access for Seniors and Physicians Coalition — that asks House and Senate leadership to call on CMS to reconsider their proposal that would allow Medicare Advantage to implement step therapy to manage Part B drugs. Read more from the coaltion.

AADA supports Ensuring Lasting Smiles Act

Sept. 11, 2018

The AADA, along with several other medical societies, has sent letters to members of the House and Senate in support of bipartisan legislation that would ensure coverage for children born with congenital anomalies or birth defects. HR 6689 and S 3369, the Ensuring Lasting Smiles Act, will address the issue of insurance denials for procedures that functionally repair or restore any body part that is medically necessary to achieve normal body functioning or appearance.

AADA comments on Administration’s plan to lower drug prices

July 12, 2018

The AADA today submitted its comments on the Trump Administration's Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. Patient access to affordable treatments and transparency in drug pricing are top priorities for the Academy.

In its comment letter, the AADA details the increasing complex drug pricing process for both generic and specialty medications. Among its comments, the AADA advocates for transparency in how Pharmacy Benefit Managers (PBMs) operate in setting drug prices and lifting the "gag clause" by health insurance providers and PBMs that restricts pharmacists from informing patients that a certain drug is cheaper if paid out-of-pocket rather than through insurance. The AADA also supports changes to streamline and reduce delays for prior authorizations in Medicare and encourages further action by the Food and Drug Administration to address ongoing drug shortages.

Click here to read AADA comments on the Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs.

Proposed CMS rule overhauls E/M visit codes, reduces modifier 25 payment

June 12, 2018

The Centers for Medicare and Medicaid Services (CMS) today released its proposed 2019 Medicare Physician Fee Schedule rule, which also includes changes to its proposed policies for the 2019 Quality Payment Program (QPP) established under the Medicare Access and CHIP Reauthorization Act (MACRA). In addition to proposing an overhaul of evaluation and management (E/M) visits, the AADA is very concerned that CMS also is proposing a payment reduction for E/M visits billed with a procedure.

AADA staff continues analyzing the proposed rule and plans to submit comments to CMS by Sept. 10, 2018. This Academy webpage includes the AADA's initial topline analysis of the proposed rule, and will be updated with additional details following further review. Information will also be made available in Dermatology World Weekly.

CMS denies Massachussetts' request to limit Medicaid drug coverage

June 27, 2018

The Centers for Medicare and Medicaid Services (CMS) today denied Massachusetts’ request to choose which drugs it would cover in its Medicaid program. Massachusetts would have been the first state with this policy. 

The AADA joined a number of state dermatological societies in opposing this request, arguing that "A formulary that includes only one drug per class is an ineffective, draconian approach to reducing health care costs by creating a one-size-fits-all solution." Members of the Massachusetts delegation in the U.S. House of Representatives also expressed concerns about the request in a letter to the state's governor.

AADA comments on network directory accuracy, rebates, and prior authorization

May 8, 2018

In a statement for the U.S. House Ways and Means Committee's Subcommittee on Health, the AADA expressed concerns regarding network directory accuracy, the rising use of rebates, and significant burdens when meeting Medicare Part C and D plans' prior authorization requirements for medically necessary drugs. The statement was for a hearing entitled the Current Status of and Quality in the Medicare Advantage Program. Read the AADA's statement for the record.

AADA supports prohibiting "gag clauses" keeping pharmacists from revealing lower-cost drug options

April 3, 2018

The AADA has sent letters supporting two bipartisan bills in the Senate aimed at lifting the "gag clause" that restricts pharmacists from informing patients that a drug is cheaper if they purchase it out-of-pocket instead of through their insurance. For example, a recent study published in JAMA identifies prednisone, to treat severe psoriasis, as among the top 20 drugs for which patients paid more going through their insurance than if they were to have paid out-of-pocket. This gag clause is frequently included in contracts between pharmacies, insurers, and pharmacy benefit managers (PBMs).

The Know the Lowest Price Act of 2018 (S. 2553), introduced by Senators Debbie Stabenow (D-MI) and Susan Collins (R-ME), would prohibit gag clause restriction for drugs covered under Medicare Part D and Medicare Advantage plans. The Patient Right to Know Drug Prices Act (S. 2554), introduced by Senators Susan Collins (R-ME) and Sen. Claire McCaskill (D-MO), would prohibit this restriction for drugs covered under the individual market exchanges as well as group plans covered by ERISA. Both bills also prohibit the pharmacy from being penalized for providing this information to the patient.

Read the AADA's letters of support for the Know the Lowest Price Act and the Patient Right to Know Drug Prices Act.

AADA supports bill to streamline prior authorization approval in Medicare

February 27, 2018

The AADA has sent a letter of support for the Standardizing Electronic Prior Authorization for Safe Prescribing Act (HR 4841), legislation intended to streamline and reduce delays for prior authorization approval in Medicare. The legislation would require the Centers for Medicare and Medicaid Services (CMS) to provide for the development of an electronic prior authorization standard for Part D and Medicare Advantage plans. The bill does not mandate that physicians or plans use it, but is intended to be a stepping stone to streamlining the prior authorization process.

Learn more in the AADA's letter of support for the Standardizing Electronic Prior Authorization for Safe Prescribing Act. To access the Academy's prior authorization assistance tools, click here.

AADA, other specialties continue pressing FDA on drug shortages

February 23, 2018

The AADA was joined by other specialties in advocating that the Food and Drug Administration (FDA) build upon working relationships with manufacturers to address drug shortages that continue having adverse impacts on patients. In their letter to FDA Commissioner Scott Gottlieb, MD, the organizations specifically express concern regarding ongoing shortages of lidocaine with epinephrine, lidocaine, and other local anesthetics, and suggest ways the FDA could engage. Read the letter.

Learn more about the AADA’s advocacy on drug shortages.


AADA testified before Congress on compounding issues

January 30, 2017

Bruce A. Brod, MD, FAAD, Chair of the AADA's Congressional Policy Committee, today testified on office-use compounded medications and in-office preparations before the House Energy and Commerce Committee's Subcommittee on Health. Also among those testifying were Scott Gottlieb, MD, who serves as the commissioner of the Food and Drug Administration. Click here for more information on the hearing, to watch the hearing, and to read Dr. Brod's statement for the record.

 Dr. Brod at E&C on compounding issues Photo by the House Energy and Commerce Committee.

AADA congratulates HHS Secretary Azar, encourages reg. relief efforts

January 24, 2018

The AADA congratulated Alex Azar on his appointment as Secretary of Health and Human Services after his nomination was confirmed by the U.S. Senate in a vote of 55-43. In its letter of congratulations, the AADA expressed appreciation for ongoing efforts to advance regulatory relief initiatives that alleviate burdens on physicians. The AADA also encouraged further collaboration in lifting burdensome regulations such as drug prior authorization requirements and requirements threatening access to compounded medications. Click here to read the letter.

AMA announces prior authorization Consensus Statement

January 17, 2018

The American Medical Association (AMA) announced a Consensus Statement along with the American Hospital Association (AHA), America's Health Insurance Plans (AHIP), American Pharmacists Association (APhA), Blue Cross Blue Shield Association (BCBSA) and Medical Group Management Association (MGMA) which outlines a "shared commitment to industry-wide improvements to prior authorization processes and patient-centered care." The Consensus Statement indicates that the organizations will work to reduce the number of health care professionals subject to prior authorization requirements; regularly review the services medications requiring prior authorization, improve channels of communications, protect continuity of care for patients, and accelerate industry adoption of national electronic standards for prior authorization. The AADA has long advocated for efforts to lessen the burden of prior authorization.

 Visit the AMA's website for more information on the Consensus Statement.

AADA, coalition letter on preserving patient access to Part B treatments

December 6, 2017

Several medical societies including the American Academy of Dermatology Association sent a letter to Congressional leaders urging them to preserve patients' access to critical Part B drug treatments by preventing the Centers for Medicare and Medicaid Services (CMS) from applying Merit-based Incentive Payment System (MIPS) score adjustments to Medicare Part B payments. In its 2018 Quality Payment Program (QPP) final rule, CMS announced it will be imposing these payment adjustments to Part B drug payments in addition to physicians' services under the Medicare fee schedule.  The letter requests a technical correction to curtail this policy and preserve patient access to the services and treatments they need.  To read the letter, click here.

AADA sends regulatory relief recs to Medicare Red Tape Relief Project

August 25, 2017 

The American Academy of Dermatology Association (AADA) today sent a letter to the U.S. House Ways and Means Committee offering recommendations for the Committee’s Medicare Red Tape Relief Project ― an initiative that seeks to mitigate burdensome Medicare regulations. Among several recommendations, the AADA suggested the streamlining of drug prior-authorization requirements.

AADA supports bill to ensure access to compounded drugs

June 16, 2017

Congressman Morgan Griffith (R-VA) and Congressman Henry Cuellar (D-TX) have introduced legislation to address the unintended consequences of the Food and Drug Administration's (FDA) interpretation of the Drug Quality and Security Act and facilitate physician access to compounded drugs for administration in a clinical setting. The AADA has sent a letter of support for the legislation, titled the Preserving Patient Access to Compounded Medications Act (H.R. 2871).

AADA sends advocacy positions and priorities to Senate Finance Chairman

May 23, 2017

In response to a request from Senator Orrin Hatch (R-UT), Chair of the Senate Finance Committee, for comments on the American Health Care Act (AHCA) and the Affordable Care Act (ACA), the AADA has sent a letter highlighting the Academy's advocacy positions and priorities.  This letter also includes a copy of the AADA's Health System Reform Principles.  Click here to read the letter.