Congress has provided an exception to this waiting period for SSDI beneficiaries who have amyotrophic lateral sclerosis and has also provided that adults and children with end-stage renal disease are automatically eligible for Medicare whether or not they have qualified for SSDI SSA, b.
In addition, under its compassionate allowances policy, the Social Security Administration has created a mechanism for quickly identifying and processing SSDI applications for individuals with specific conditions that invariably qualify them for benefits.
The initial list of conditions included 25 rare diseases and 25 cancers; nearly all of the 38 conditions added in were rare diseases SSA, a. Although this procedure does not shorten the Medicare waiting time after SSDI qualification, it does reduce the total waiting time.
In , approximately 7. In , Congress also created the federal-state Medicaid program to insure certain categories of low-income individuals primarily low-income mothers and children and low-income aged, blind, or disabled people. The federal government sets many of the basic rules for Medicaid and subsidizes state programs to varying degrees, but states have some leeway in deciding who and what to cover and how much to pay providers.
Following a model that had been established in private health insurance, Congress initially divided Medicare into two parts: hospitalization insurance Part A and supplementary medical insurance for physician and certain other services Part B.
Building on policies initiated in the s, the Medicare Advantage program Part C provides Medicare beneficiaries opportunities to enroll in private health plans. Medicare is managed by the Centers for Medicare and Medicaid Services CMS. For beneficiaries not enrolled in Medicare Advantage plans, how Medicare pays for drugs and what controls it places on payments varies depending on where the drug is administered, for example, hospital, physician office, or home.
Although the committee did not find any systematic analysis, a review of the list of approved orphan drugs suggests that most of them are administered in physician office or outpatient clinic settings or are taken by patients at home. Thus, for most drug companies as well as patients and families, Medicare policies related to Part B and Part D are of greater interest than Part A policies.
As discussed below in the section on coverage of certain costs in clinical trials, Medicare does not cover investigational drugs. CMS and FDA recently signed a memorandum of understanding to share data, including FDA data on drugs and medical devices that have not yet been authorized for marketing 75 Fed.
The agencies are also considering a process of parallel review of products that would reduce the lag between FDA marketing authorization decisions and CMS national coverage determinations 75 Fed. Medicare Part A covers inpatient services provided in hospitals. It also covers certain short stays in skilled nursing facilities, hospice services, and certain home health services.
Payment methods vary for each of these categories. Medicare pays for inpatient hospital care on the basis of prospectively determined rates for specified diagnosis-related, severity-adjusted bundles of services OIG, a.
Oversimplified, each diagnosis-related group DRG payment has a weight assigned to it based on the average amount of resources used in caring for Medicare patients in that group. In addition to diagnosis, assignment to a group takes into account other factors, including procedures, age, and comorbidities or complications.
Resources include facilities and services such as routine nursing care, laboratory tests, imaging services, intensive care, and all medications administered during the hospital stay. Within a payment category, payments generally will not vary based on which drugs are included in a hospital's formulary or other details of how hospitals manage services to beneficiaries.
CMS revises DRGs annually based on analysis of past inpatient claims data. In , Congress provided that CMS could make an additional payment for certain new technologies on an interim basis until claims data were available to guide a normal revision in rates Clyde et al.
In general, Medicare pays half of the incremental cost to the hospital associated with the new technology on a case-by-case basis. To qualify for an add-on payment,. In the first 9 years after the policy was implemented in , CMS rejected more than 20 applications for add-on payments and approved 9 applications, 8 of which were for medical devices Clyde et al.
The one drug for which an add-on payment was approved was not for an orphan drug. Medicare Part B covers physician services, hospital outpatient care, certain home health services, certain clinical laboratory services, some preventive services, durable medical equipment, and certain drugs.
Covered drugs include drugs administered in physician offices that usually are not self-administered, drugs used as part of durable medical equipment e. Under these provisions, Part B covers certain orphan drugs that are administered by infusion or injection in a physician's office or clinic, for example, galsulfase Naglazyme , a treatment for Maroteaux-Lamy syndrome, a rare metabolic disorder.
Likewise, Part B typically covers certain orphan drugs that are administered at home using equipment that is covered by Part B. An example is dornase alfa Pulmozyme , a medication for cystic fibrosis that is inhaled using a neubulizer.
In addition, Part B also covers drugs provided as part of hospital outpatient services. These services are covered by a prospective payment system that includes inexpensive drugs and diagnostic radiopharmaceuticals as part of the packaged payment to an outpatient facility for a service such as a surgical procedure.
More expensive drugs and biologics are reimbursed separately MedPAC, The Medicare Prescription Drug Improvement and Modernization Act of changed the way that Medicare pays physicians for Part B drugs and drug administration services.
Policy makers agreed that the payment rates for Part B drugs were too high, but some providers argued that the high rates for the drugs were needed to offset payment rates for administering the drugs that were lower than the costs of administration.
Since , physicians who provide Part B drugs to their patients are reimbursed for those drugs at percent of the average sales price, which is computed as the average transaction price for all sales in the United States. The law provided that new biologics and single-source drugs brand-name drugs with no generic version would be paid based on an individually determined average sales price so that payment would not be coded or averaged with other products.
At the same time that Congress reduced reimbursement for Part B drugs, it increased the payment to physicians for administering the drugs. A report by the Medicare Payment Advisory Commission MedPAC concluded that the change to the new payment system resulted in lower Part B expenditures for almost all covered drugs, largely due to lower prices MedPAC, For example, from to , the drop in drug expenditures ranged from 1 percent for rheumatology Part B drugs to 52 percent for urology drugs.
Patients pay a general Part B deductible and then 20 percent of the Medicare-approved payment amount. A patient's Part B coinsurance liability for medications is not capped and stays at 20 percent no matter how expensive the drug.
However, as of , just over 90 percent of beneficiaries had some form of public or private supplemental insurance that shielded them from Part B cost sharing requirements MedPAC, b. Some drugs may be covered under Part B or Part D depending on the circumstances. Several of these products were approved as orphan drugs for at least one, generally several, indications.
Medicare Part D adds an outpatient prescription drug benefit to the Medicare program. All Medicare beneficiaries have access to the benefit.
Although they are not required to enroll, beneficiaries who do not enroll during their initial eligibility period and who do not have equivalent alternative coverage will pay more if they enroll later. As of February , more than 26 million beneficiaries were enrolled in a Part D plan KFF, b.
The Part D benefit is administered by private plans approved by CMS. Part D benefits are offered through stand-alone prescription drug plans and through Medicare Advantage plans that cover all Medicare benefits including medications. Congress also specified that drug coverage for all individuals dually eligible for Medicare and Medicaid would shift from the Medicaid program to the Part D benefit.
As a result, all dual eligibles are now enrolled in private Part D plans. com, Beneficiaries with low incomes and modest assets receive substantial financial assistance with Part D premiums and cost sharing.
For example, full-benefit dual eligibles pay no premiums, pay relatively nominal fixed copayments per prescription, and are not subject to the deductible or the coverage gap described below. Plans have the option to deviate from this standard benefit by offering an actuarially equivalent benefit or by offering enhanced benefits.
However, the vast majority of drug plans 80 percent offered no benefits in the coverage gap as of January , and most plans that did offer such benefits covered only generic drugs in the coverage gap KFF, b. Under the Affordable Care Act, beginning January 1, , Part D beneficiaries in the coverage gap will receive a 50 percent discount absorbed by the manufacturer off their plan's negotiated price for brand-name drugs and biologics covered by the plan.
Over the subsequent 10 years, the beneficiary's coinsurance for brand-name drugs in the coverage gap will drop annually or biannually, down to 25 percent by , and the coinsurance for generic drugs will likewise drop to 25 percent.
Within limits specified by the federal government, Part D plans have considerable flexibility in structuring formularies, imposing cost sharing requirements, and establishing procedures for managing drug utilization. For companies making orphan drugs or considering development of an orphan drug, several features of Part D plans could significantly affect beneficiary access and costs.
More details about these features as they affect orphan drugs are included in Appendix C. Most Part D plans use tiered formularies. Generic drugs in tier 1 require the lowest copayment; brand-name drugs preferred by the plan in tier 2 require a somewhat higher copayment; nonpreferred brand-name drugs in tier 3 require a still higher copayment.
Rather than paying a fixed copayment per prescription e. Although the incentives in tiered formularies for beneficiaries to use generic or preferred drugs can provide leverage for plans to negotiate discounts with drug manufacturers, both the lack of competition for many orphan drugs and the small number of users for these drugs, as noted above, weaken the negotiating position of plans.
This assumes that the patient has no other applicable out-of-pocket costs. Depending on how the initiation of treatment matched the start of a coverage year, that period of more generous coverage could last as long as 6 months before the coverage cycle started anew.
A recent GAO b study reported that high-cost drugs i. It also reported that 55 percent of beneficiaries who used at least one specialty-tier drug exceeded the upper threshold of the coverage gap.
In addition, more than 75 percent of prescriptions for specialty tier-eligible drugs were for subsidized beneficiaries such as dual eligibles who qualify for reduced cost sharing for these and other drugs and who are not subject to the coverage gap. In addition to patient cost sharing features, Part D plans also employ a variety of utilization management strategies to control the use of drugs and overall costs as well as to promote medication safety in some instances.
These include prior authorization, step therapy, and quantity limits. Other things being equal, a pharmaceutical company would expect less use of an orphan drug and lower profits if the drug were a target of the most stringent of these utilization controls.
Plans generally require enrollees to obtain prior authorization from the plan to secure coverage for certain medications, particularly higher-cost medications or drugs with particular safety concerns. The committee found no data on the extent to which plans approve or deny requests for prior authorization.
Plans also may employ what are termed step-therapy requirements for certain medications for which alternatives are available. Under step therapy, enrollees are required to try a lower-cost medication and document a poor response to that drug before coverage of a higher-cost medication would be granted.
Quantity limits i. In general, more frequent prescriptions to obtain the same quantity of a drug mean more costs shifted to patients. FDA approval of a drug is for a specific indication or indications based on evidence of safety and effectiveness for each indication.
These indications are described in the FDA-approved labeling for the product. Physicians may legally prescribe drugs for off-label indications. For example, a drug approved for use with a common disease may be used off-label for a rare condition, and physicians likewise may prescribe an orphan drug for either a common indication or a rare indication other than the indication s for which it has been approved.
Some have expressed concern that some companies seeking orphan drug approval and marketing protection are really aiming at off-label use for a common indication and are inappropriately benefiting from the marketing protections attached to orphan drug approval Fugh-Berman and Melnick, ; Wellman-Labadie and Zhou, In addition to cost concerns, off-label use raises concerns about patient exposure to drugs that have not been determined to be safe and effective for uses other than those approved by FDA.
At the same time, such use may provide options for patients for whom FDA-approved products are limited or nonexistent because physicians can try a medically plausible treatment approach to a disease Kocs and Fendrick, ; Gillick, If case reports suggest promise from such an off-label use, then this may prompt companies or others to undertake controlled studies to support approval by FDA of a new indication.
Alternatively, because systematic research could contradict the promising case reports and thereby curtail off-label sales, companies may choose not to pursue further studies.
Studies have indicated that off-label use is common in oncology see, e. Off-label use is likewise common in pediatrics. Indeed, the lack of testing of drugs for use with children prompted legislation to encourage and in some cases require such testing see Chapter 3.
One study of outpatient prescribing patterns reported that of more than medications covered in the study, 21 percent of uses were off-label and most of these off-label uses 73 percent lacked clinical evidence of efficacy Radley et al. Even when off-label uses are backed by research, companies may not wish to incur the costs of pursuing FDA approval unless they expect such approval to encourage further use that will offset those costs.
The initial CMS regulations for the Part D program denied coverage of medications for off-label uses unless the prescribed use was supported by one of three specific medical compendia Le Masurier and Edgar, One concern is that questions have been raised about the independence of compendia compilers, the degree to which they cite current evidence or any evidence , the quality of their methods and their assessments of evidence, and the potential for official acceptance of such compendia to discourage research aimed at FDA approval of off-label uses Tillman and Gardner, ; Abernethy et al.
To inform future off-label coverage determinations, CMS commissioned a technology assessment from the Agency for Healthcare Research and Quality AHRQ to summarize the process by which anticancer drugs are added to various compendia and to identify methods used to collect evidence for listed drugs and biologics and their indicated uses Abernethy et al.
The assessment covered six compendia and a sample of 14 anticancer combinations that were selected to include newer and older agents, common and rare cancers, and biologics and drugs. Among the findings was that there was little agreement in the evidence regarding efficacy cited by the compendia and that the compendia were discordant on whether they discussed adverse effects among patients with specific cancers.
Moreover, when compendia did not include off-label indications, the analysts could not determine whether a particular omission reflected a conscious editorial decision following the evaluation of available evidence or whether the available evidence was not identified and evaluated.
The authors observed that although they could not generalize to other disease areas, the compendia's performance might be expected to be highest in oncology, given their importance for reimbursement. The authors also pointed out the major challenges of managing a near-continuous systematic review of large numbers of drug uses not approved by FDA.
They also noted that FDA itself was not authorized or prepared to undertake such a review. For rare diseases, the volume of drugs and uses is obviously much smaller but so is the research to support evaluations of off-label use.
The growing databases from Part D claims could, when linked to Medicare hospital and physician claims data, be a resource for studying the nature and outcomes of some off-label use of orphan and other drugs for patients with rare conditions.
Congress has not provided CMS itself with the authority to negotiate prices with pharmaceutical manufacturers. For many expensive drugs, including many orphan drugs, insurers may have little leverage in negotiating price discounts. Given the introduction of Part D just 4 years ago, only limited empirical evidence has accumulated on its impact on drug prices.
A recent study by Duggan and Morton found that Part D led to a decrease in the average price for brand-name drugs and an increase in overall utilization of Part D drugs among Medicare recipients Duggan and Morton, They estimate that each percentage point increase in the pre-Part D Medicare market share for a given drug is associated with a 1.
However, Frank and Newhouse found some evidence that the shift from Medicaid to Part D of drug coverage for dual eligibles resulted in higher drug prices for this population. These analyses did not specifically consider orphan or specialty-tier drugs.
An analysis commissioned by MedPAC reported that prices for Part D drugs rose 11 percent between January and December based on national drug codes as the unit of analysis MedPAC, a. However, after taking into account the substitution of generic for brand-name drugs which is encouraged by Part D plans , the analysis found Part D prices declined by 3 percent over the same period.
Appendix C presents the results of a commissioned analysis of Part D plan coverage of orphan drugs as reported in the January CMS Prescription Drug Plan, Pharmacy Network, and Pricing Information Files. For drugs that are not covered by Medicare Part B or, rarely, Part A and that thus are eligible for Part D coverage, the analysis found that the great majority are covered by more than half of Part D plans Table Of the handful of orphan drugs that were not covered by any plan as of January , several of these have now been added to the formularies of at least one plan.
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I could spend hours scrolling the frozen dim sum alone but just about every food category is bursting with options you won't likely find in your local market. Craving a bag of those salty shrimp chips you discovered abroad but can't find here?
When you can't stroll down a busy Tuscan market, Supermarket Italy is the next best thing for scoring Italian goods for your next festa. Supermarket Italy is a trusted importer of Italian and European goods -- both luxury and budget-friendly -- sourcing items from the highest quality vendors in Europe.
Get just about any type of pasta, sauce, cheese, spices and coffee along with cured meats and jars of olives and artichokes for the most decadent antipasti plate outside of Rome.
If it's cans of San Marzano tomatoes and artisan pasta you're after, Ditalia is a good place to find it all.
This importer of specialties has all you'll need for Italian night including pantry staples, premade sauces, salumi, cheese and pasta. Ditalia isn't a budget retailer by any stretch. The online Italian market carries groceries from some high-end producers based in Italy and elsewhere.
With a massive supply of risotto rice, white beans, polenta and penne, it shouldn't be hard to do. There are dozens of excellent options for ordering seafood online. I've tested a whole bunch of them which you can read more about here. For the best selection of high-quality fish, shellfish and other fresh seafood, Fulton Fish Market is my favorite.
Fulton also carries heaps of clams, oysters , caviar and fish roe along with sauces and seasonings to make your fish sing on the grill. I found Fulton's prices to be competitive when compared to other vendors in the category. Most of the fish is flash-frozen at peak freshness and shipped right away.
That means it's probably fresher than what you find at the supermarket since that seafood is often frozen, thawed and then laid out on ice for purchase. This online arm of New York's sprawling seafood market has hundreds of varieties of fish to choose from including filets you most likely won't find in your local shops like fresh barramundi and whole dover sole.
Much like seafood delivery options, there are a host of excellent specialty online butchers. If you're looking for wild boar, venison, duck breast or quail, this online meat shop is your best bet for finding it.
Rastelli's and Porter Road are two of my favorite online butchers, generally, but for specialty meats D'Artagnan has the best selection of unique cuts, wild game and charcuterie.
D'Artagnan has staples in spades -- chicken , ground beef , pork chops and bacon -- but the online butcher also carries a range of rare cuts, charcuterie and pantry goods to fancy up your next barbecue.
iGourmet sports a dizzying display of cheese. The online market stocks favorites including aged cheddars and creamy bries but also less common creations such as Baldauf Chilikase and French raclette. iGourmet has just about any type of cheese you can dream up and the site makes it easy to find them, too.
You can search by country, region, cheese type or producer. The cheese is mostly all cut and packaged directly by iGourmet it'll let you know when it's not which means prices are as fair as any I've seen from a high-end online cheesemonger. If you seek spice in your life, Spicewalla has a staggering supply of individual spices and spice mixes to stock your rack.
From pink peppercorns to barbecue rubs and regional spice mixes, there's not much you won't find in this online spice shop. All of Spicewalla's spices, herbs and spice mixes are sourced directly from quality suppliers in small quantities to make sure they're as fresh as possible when they get to you.
You won't get that same guarantee when you buy those standard spices at the supermarket. Grab some warming garam masala for your next curry or a honey and herb mix for your next grill affair.
While the website interface may be a little clunky, the inventory of Mexican and Latin American foods at MexGrocer. com is truly astounding. You'll find every Mexican sauce, spice and staple you can think of neatly organized into dozens of categories. MexGrocer has fresh foods including queso fresco and cotija cheese along with frozen foods, snacks and chips, beverages and tortillas, which you can peruse both by brand or food type.
The sprawling site even provides over traditional Mexican recipes to get the creative juices flowing. If Spicewalla doesn't have the spice you're looking for, The Spice House likely will. This online spice market also has a vast stock of spices and spice mixes from just about every culinary hotspot on the globe.
You can shop by spice family, region or even plunk in the food you're cooking -- beef, poultry, veggies -- and the site will throw you a few popular suggestions. While Fulton might have the best overall seafood selection, Riviera has the best fish if you're looking for sushi-grade filets. The California-based online fish market has tuna belly, king salmon belly, hamachi and other sushi favorites.
Fish from RSC is flash-frozen and sent to you within two business days. If you need a gift in a hurry and have to send it from afar, wine is a very safe bet. com has an enormous selection of wines from every region and will ship them anywhere that it's legal to do so.
You'll find everything from big, bold cabs from California to rare and hard-to-fdin bubbles from France. Everything you need to stock that wine rack for winter. Be sure to check the local alcohol shipping laws in thestate your sending to before you spend too much time looking. Read more : Best Wine Club for If you're trying to earn some mixology merit badges, you need the right ingredients and Bottles and Bitters has them.
This online specialty store has shrubs, syrups, bitters and garnishes to make your next home happy hour a little happier. A quality bottle of gingerbread or Japanese shiso bitters is just about the easiest way to impress guests or yourself.
If one of the specialty stores above doesn't have what you're looking for, it's always worth checking Amazon's massive online inventory. Speciailty stores are more likely to have a super rare spice, sauce or other ingredient, but Amazon has so much that their may be a suitable substitute to get you through that fancy recipe.
Best Places to Buy Specialty Ingredients and Gourmet Foods Online These are the best places to find rare spices, unusual pantry items and specialty cuts of meat and fish to ace that next recipe. Written by David Watsky. Our expert, award-winning staff selects the products we cover and rigorously researches and tests our top picks.
If you buy through our links, we may get a commission. Reviews ethics statement. David lives in Brooklyn where he's spent more than a decade covering all things edible, including meal kit services, food subscriptions, kitchen tools and cooking tips.
Since earning a BA in English from Northeastern in Boston, he's toiled in nearly every aspect of the food business, including as a line cook in Rhode Island where he once made a steak sandwich for Lamar Odom.
Right now, he's likely somewhere stress-testing a blender or researching the best way to make bacon. Anything with sesame is his all-time favorite food this week. Expertise Kitchen tools, appliances, food science, subscriptions and meal kits.
See full bio. Why You Can Trust CNET. See at iGourmet. Best overall specialty food market. See at Weee! Best for East Asian foods.
See at Supermarket Italy.
More The Adventure of the Rarre Square. However, Frank and Newhouse found some speccialties that the shift from Medicaid to Specialtiee D Low-cost pantry deals drug Low-cost baking essentials for Low-cost baking essentials eligibles resulted in higher drug prices for this Affordable food supplies. Successful Launches Seamless Transitions Service Catalogue. Times Favorite Bookseller" In addition to market size and costs for research and development, an important consideration is the insurance status of target patients—not only whether they are covered at all but also the scope of coverage and the limits placed on it. More Thuvia, Maid of Mars. The law also prohibits plans from canceling coverage because an individual develops health problems.
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